Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Background: The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. Methods: In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin area under the curve of 5, paclitaxel 175 mg/m2, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing. Findings: Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3–16·6) with atezolizumab and 10·4 months (9·7–11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49–0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3–36·8) versus 22·8 months (20·3–28·0), respectively (HR 0·68 [95% CI 0·52–0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patients in the experimental group and in 75% of patients in the standard group. Grade 1–2 diarrhoea, arthralgia, pyrexia, and rash were increased with atezolizumab. Interpretation: Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic, persistent, or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option. Funding: F Hoffmann-La Roche.

DOI： 10.1016/S0140-6736(23)02405-4

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Publishing type：Research paper (scientific journal)  

DOI： 10.3802/jgo.2024.35.e115

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Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: Gynecologic cancers are one of the most common types of malignancies in working-age women. We aimed to determine the factors that impede women from returning to the same workplace after treatment for such cancers. METHODS: A questionnaire-based survey was conducted on 194 women who underwent treatment for gynecologic cancer at the Okayama University (≥1 year after cancer treatment and <65 years of age). We performed a logistic regression analysis to determine the relationship between returning to the same workplace and not taking sick leave. RESULTS: The median age at diagnosis was 49.0 years, and the median time from cancer treatment to questionnaire completion was 3.8 years. Not returning to the same workplace was positively associated with not being regularly employed (P = 0.018), short work time per day (P = 0.023), low personal income (P = 0.004), not taking sick leave (P < 0.001), advanced cancer stage (P = 0.018) and long treatment time (P = 0.032). Interestingly, not taking sick leave was strongly associated with not returning to the same workplace in the multivariable analysis (P < 0.001). CONCLUSIONS: Not taking sick leave likely was negatively associated with returning to the same workplace after the treatment for gynecologic cancer. Therefore, we suggest that steps be taken to formally introduce a sick leave system over and above the paid leave system in Japan.

DOI： 10.1093/jjco/hyad159

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Language：Japanese   Publisher：金原出版(株)  

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Language：Japanese   Publisher：中国四国産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：English  

The abscopal effect is a rare phenomenon, in which tumor shrinkage in the nonirradiated metastatic region is observed after radiotherapy. Certainly, this response is sometimes reported with the combined use of immune-checkpoint inhibitors, but a pure abscopal effect is extremely rare, especially in endometrial cancer. We present the case of a 79-year-old woman with an advanced endometrial carcinosarcoma. She was treated with surgical reduction of the primary lesion, followed by radiotherapy of the metastatic regional lymph nodes. Distant metastases were detected in radiological imaging test 2 months after the completion of radiotherapy, and we carefully followed up without any treatment considering the patient's tolerability for further procedures. Six months after recurrence, she experienced cytoreduction in the metastatic lesions confirmed through imaging findings, which was believed to be an abscopal effect, and maintained this shrinking state for 15 months. Herein, we describe this pure abscopal effect from the perspective of imaging, pathological and molecular findings, and therapeutic strategies.

DOI： 10.1016/j.radcr.2023.04.031

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：中国四国産科婦人科学会  

今回,我々は卵巣癌治療中に急激な筋力低下,嚥下障害を伴った皮膚筋炎を経験した。全身状態不良の中で積極的な卵巣癌治療を優先的に行うことで皮膚筋炎の改善を認めたため報告する。【症例】68歳,女性。1ヵ月前に当院にて審査腹腔鏡手術を行い卵巣癌IIIC期(FIGO2014,pT3cN0M0)高異型度漿液性癌と診断した。MyChoice診断システムを提出した上で,結果開示までの間,術前化学療法としてddTC(Dose dense PTX+CBDCA)療法を開始した。1サイクル施行後,急激な筋力低下,嚥下障害が出現し,皮膚筋炎が疑われ当科入院となった。Gottron丘疹や著明な筋原性酵素の上昇を認め,抗TIF1γ抗体陽性であり,卵巣癌を契機に発症した皮膚筋炎と診断した。皮膚筋炎に対しステロイド投与を開始した。肝酵素の上昇を伴っていたが,筋原性酵素の低下に伴い改善したことから筋肉の崩壊に伴う肝酵素の上昇と診断し,第8病日に化学療法2サイクル目を施行した。卵巣癌の病状制御は良好であったが,皮膚筋炎に対する治療反応が乏しく免疫グロブリン療法も併用した。ステロイド投与と抗癌剤治療による低免疫状態のため全身管理に苦慮し,リハビリテーションも遅々としたものであった。化学療法5サイクル終了後,残存病変の完全切除による皮膚筋炎の改善を期待し,単純子宮全摘出術,両側附属器摘出術,大網切除術を施行し,肉眼的残存腫瘍なしとできた。その後も化学療法とリハビリテーションを継続し,術前に比して著明に四肢の筋力や嚥下機能の向上を認めた。【結語】皮膚筋炎と卵巣癌の治療を併用することは長期的で繊細な全身管理を要するが,化学療法だけでなく手術療法を伴った卵巣癌の標準治療を適切に敢行することが皮膚筋炎の改善に繋がった。(著者抄録)

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Authorship：Lead author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

INTRODUCTION: Three randomized controlled trials have resulted in extremely extensive application of the strategy of using neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) for patients with advanced epithelial ovarian cancer in Japan. This study aimed to evaluate the status and effectiveness of treatment strategies using NAC followed by IDS in Japanese clinical practice. PATIENTS AND METHODS: We conducted a multi-institutional observational study of 940 women with Federation of Gynecology and Obstetrics (FIGO) stages III-IV epithelial ovarian cancer treated at one of nine centers between 2010 and 2015. Progression-free survival (PFS) and overall survival (OS) were compared between 486 propensity-score matched participants who underwent NAC followed by IDS and primary debulking surgery (PDS) followed by adjuvant chemotherapy. RESULTS: Patients with FIGO stage IIIC receiving NAC had a shorter OS (median OS: 48.1 vs. 68.2 months, hazard ratio [HR]: 1.34; 95% confidence interval [CI] 0.99-1.82, p = 0.06) but not PFS (median PFS: 19.7 vs. 19.4 months, HR: 1.02; 95% CI: 0.80-1.31, p = 0.88). However, patients with FIGO stage IV receiving NAC and PDS had comparable PFS (median PFS: 16.6 vs. 14.7 months, HR: 1.07 95% CI: 0.74-1.53, p = 0.73) and OS (median PFS: 45.2 vs. 35.7 months, HR: 0.98; 95% CI: 0.65-1.47, p = 0.93). CONCLUSIONS: NAC followed by IDS did not improve survival. In patients with FIGO stage IIIC, NAC may be associated with a shorter OS.

DOI： 10.1007/s10147-023-02329-7

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Authorship：Lead author   Publishing type：Research paper (scientific journal)   Publisher：Massachusetts Medical Society  

DOI： 10.1056/evidoa2200225

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: The phase 3 VELIA trial evaluated veliparib with carboplatin/paclitaxel and as maintenance in patients with high-grade serous ovarian carcinoma. METHODS: Patients with previously untreated stage III-IV high-grade serous ovarian carcinoma were randomized 1:1:1 to control (placebo with carboplatin/paclitaxel and placebo maintenance), veliparib-combination-only (veliparib with carboplatin/paclitaxel and placebo maintenance), or veliparib-throughout (veliparib with carboplatin/paclitaxel and veliparib maintenance). Randomization stratification factors included geographic region (Japan versus North America or rest of the world). Primary end point was investigator-assessed median progression-free survival. Efficacy, safety, and pharmacokinetics were evaluated in a subgroup of Japanese patients. RESULTS: Seventy-eight Japanese patients were randomized to control (n = 23), veliparib-combination-only (n = 30), and veliparib-throughout (n = 25) arms. In the Japanese subgroup, median progression-free survival for veliparib-throughout versus control was 27.4 and 19.1 months (hazard ratio, 0.46; 95% confidence interval, 0.18-1.16; p = 0.1 [not significant]). In the veliparib-throughout arm, grade 3/4 leukopenia, neutropenia, and thrombocytopenia rates were higher for Japanese (32%/88%/32%) versus non-Japanese (17%/56%/28%) patients. Grade 3/4 anemia rates were higher in non-Japanese (65%) versus Japanese (48%) patients. Early introduction of olanzapine during veliparib monotherapy maintenance phase may help prevent premature discontinuation of veliparib, via its potent antiemetic efficacy. CONCLUSIONS: Median progression-free survival was numerically longer in Japanese patients in the veliparib-throughout versus control arm, consistent with results in the overall study population. Pharmacokinetics were comparable between Japanese and non-Japanese patients. Data for the subgroup of Japanese patients were not powered to show statistical significance but to guide further investigation.

DOI： 10.1007/s10147-022-02258-x

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Language：Japanese   Publisher：中国四国産科婦人科学会  

子宮頸部に胃型粘液を産生する多嚢胞性病変を認めた場合に分葉状頸管腺過形成(Lobular endocervical glandular hyperplasia:LEGH)と最小偏倚腺癌(minimal deviation adenocarcinoma:MDA)を含む胃型粘液性癌(mucinous carcinoma,gastric type:GAS)とを鑑別することは非常に困難である。LEGHと診断し,腹腔鏡下子宮全摘出術を行い子宮頸部上皮内胃型腺癌と診断した1例を経験したので報告する。症例は56歳女性,4妊2産。前医の子宮頸管細胞診にてatypical glandular cells(AGC)を認めた。その後の子宮頸管細胞診の再検や頸管内掻爬組織診では異常所見を認めないが,子宮頸部多発嚢胞がありLEGH疑いにて精査加療目的に当科紹介となった。頸管内掻爬組織診の再検にて,子宮頸管線上皮はMUC5AC陽性,MUC6陽性,HIK1083一部陽性を示し,Endocervical epithelium with gastric type mucinであり,LEGHと診断した。画像所見や子宮頸管細胞診・組織診から悪性を強く疑わず,経過観察又は,子宮摘出を提示したところ,患者は子宮摘出を希望した。腹腔鏡下子宮全摘出術,両側付属器摘出術を施行し,術後病理学的診断はAdenocarcinoma in situ(gastric type)associated with LEGHであった。その後,外来にて定期検診を施行しているが明らかな再発を認めない。MRI所見,子宮頸管細胞診異常,gastric type mucinから術前診断し,LEGHの治療戦略を立てるべきだが,腹腔鏡下子宮摘出術を選択する場合には,AISやMDAの合併している可能性に留意した術式を工夫すべきかもしれない。(著者抄録)

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Other Link： https://search.jamas.or.jp/default/link?pub_year=2022&ichushi_jid=J05038&link_issn=&doc_id=20221221480017&doc_link_id=%2Fcv0mtrob%2F2022%2F007101%2F017%2F0099-0103%26dl%3D0&url=https%3A%2F%2Fwww.medicalonline.jp%2Fjamas.php%3FGoodsID%3D%2Fcv0mtrob%2F2022%2F007101%2F017%2F0099-0103%26dl%3D0&type=MedicalOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00004_2.gif

Language：Japanese   Publisher：中国四国産科婦人科学会  

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Language：English   Publishing type：Research paper (scientific journal)  

We analyzed the local control (LC) of cervical squamous cell carcinoma treated by computed tomography (CT)-based image-guided brachytherapy (IGBT) using central shielding (CS). We also examined the value of tumor diameter before brachytherapy (BT) as a factor of LC. In total, 97 patients were analyzed between April 2016 and March 2020. Whole-pelvic (WP) radiotherapy (RT) with CS was performed, and the total pelvic sidewall dose was 50 or 50.4 Gy; IGBT was delivered in 3-4 fractions. The total dose was calculated as the biologically equivalent dose in 2 Gy fractions, and distribution was modified manually by graphical optimization. The median follow-up period was 31.8 months (6.3-63.2 months). The 1- and 2-year LC rates were 89% and 87%, respectively. The hazard ratio was 10.11 (95% confidence interval: 1.48-68.99) for local recurrence in those with a horizontal tumor diameter ≥ 4 cm compared to those with < 4 cm before BT. In CT-based IGBT for squamous cell carcinoma, favorable LC can be obtained in patients with a tumor diameter < 4 cm before BT. However, if the tumor diameter is ≥ 4 cm, different treatment strategies such as employing interstitial-BT for dose escalation may be necessary.

DOI： 10.1093/jrr/rrac040

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

AIM: Several years have passed since olaparib maintenance therapy was approved in patients with platinum sensitive recurrent ovarian cancer (PSROC). We speculated that the response to platinum-based chemotherapy (PBC) would be impaired at the time of recurrence after olaparib maintenance therapy. We conducted a noninterventional retrospective study to clarify this clinical question in a single institution. METHODS: We included all patients with PSROC who received olaparib after second or later line of PBC between April 18, 2018, and August 31, 2021. We evaluated the effect of olaparib maintenance therapy on PBC after progression. RESULTS: We identified 42 patients who received olaparib maintenance therapy after second or later line of PBC. Twenty-four patients relapsed after olaparib maintenance therapy, and 17 patients received PBC again. Four of 17 patients (complete response 2, partial response 2) responded to the PBC. The median progression-free survival was longer in patients with platinum-free interval ≥12 months than platinum-free interval of 6-12 months (9.7 vs 2.6 months, hazard ratio, 0.20: 95% confidence interval, 0.04-0.90; p = 0.04). CONCLUSIONS: In the patients with PSROC who experienced disease progression after olaparib maintenance therapy, especially in those with platinum-free interval of 6-12 months, the response to subsequent PBC was extremely poor. The efficiency of re-administration of PBC for PSROC patients with a short-term recurrence after olaparib treatment may need to be reconsidered.

DOI： 10.1111/jog.15184

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：English   Publishing type：Research paper (scientific journal)  

Patients with peritoneal dissemination (PD) caused by abdominal malignancies are often associated with massive ascites, which shows extremely dismal prognosis because of the discontinuation of systemic chemotherapy mostly due to poor performance status. Many treatment methods, such as simple drainage, peritoneovenous shunting (PVS) and cell-free and concentrated reinfusion therapy (CART), have been used for symptom relief. However, the clinical efficacies of these methods have not been fully investigated yet. Recently, we developed the Clinical Practice Guideline for PD caused by various malignancies according to "Minds Clinical Practice Guideline Development Guide 2017". In this guideline, we systematically reviewed information on clinical diagnosis and treatments for PD using PubMed databases (2000 - 2020), and clarified the degree of recommendation for clinical questions (CQ). The evidence level was divided into groups by study design and quality. The literature level and a body of evidence were evaluated in reference to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Based on the results of systematic review, the strength of the recommendations was evaluated at a consensus meeting of the Guideline Committee. This is the English synopsis of the part of treatment of malignant ascites in Clinical Practice Guideline for PD, 2021 in Japanese. The guidelines summarize the general aspect of the treatment of malignant ascites and statements with recommendation strengths, evidence levels, agreement rates and future perspective for four raised clinical questions.

DOI： 10.1007/s10147-021-02077-6

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Language：English   Publisher：(一社)日本癌治療学会  

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Asian Society of Gynecologic Oncology$\mathsemicolon$ Korean Society of Gynecologic Oncology and Colposcopy  

OBJECTIVE: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. METHODS: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). RESULTS: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11-1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16-2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. CONCLUSION: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02477644.

DOI： 10.3802/jgo.2021.32.e82

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media {LLC}  

BACKGROUND: We evaluated the survival effect of adjuvant concurrent chemoradiotherapy after radical hysterectomy in patients with clinical pelvic node-positive cervical adenocarcinoma. METHODS: Patients with pelvic node-positive cervical adenocarcinoma diagnosed between 2000 and 2016 at our institution were identified. Survival was compared between patients who underwent radical hysterectomy alone and those who received concurrent chemoradiotherapy as an adjuvant treatment. Survival analysis using log-rank test and Cox proportional hazards model was performed. RESULTS: We identified 80 patients who underwent radical hysterectomy for clinical pelvic node-positive cervical adenocarcinoma; of these, four with pathological pelvic node-negative adenocarcinoma were excluded. Of the 76 patients, 27 underwent radical hysterectomy alone and 49 received radical hysterectomy followed by concurrent chemoradiotherapy. With a median follow-up of 53 months, the 5-year overall survival rate was 51.0% in patients who underwent radical hysterectomy alone versus 53.0% in patients who received additional concurrent chemoradiotherapy (log-rank p = 0.455). CONCLUSION: The addition of concurrent chemoradiotherapy after radical hysterectomy did not significantly improve survival among patients with pelvic node-positive cervical adenocarcinoma. More appropriate treatment strategies are needed to improve the survival outcomes of these patients.

DOI： 10.1007/s10147-021-01904-0

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Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: Tissue factor pathway inhibitor 2 (TFPI2) is a novel serum biomarker that discriminates ovarian clear cell carcinoma (CCC) from borderline ovarian tumors (BOTs) and non-clear cell epithelial ovarian cancers (EOCs). Here, we examined the performance of TFPI2 for preoperative diagnosis of CCC. METHODS: Serum samples were obtained preoperatively from patients with ovarian masses, who needed surgical treatment at five hospitals in Japan. The diagnostic powers of TFPI2 and cancer antigen 125 (CA125) serum levels to discriminate CCC from BOTs, other EOCs, and benign lesions were compared. RESULTS: A total of 351 patients including 69 CCCs were analyzed. Serum TFPI2 levels were significantly higher in CCC patients (mean ± SD, 508.2 ± 812.0 pg/mL) than in patients with benign lesions (154.7 ± 46.5), BOTs (181 ± 95.5) and other EOCs (265.4 ± 289.1). TFPI2 had a high diagnostic specificity for CCC (79.5%). In patients with benign ovarian endometriosis, no patient was positive for TFPI2, but 71.4% (15/21) were CA125 positive. TFPI2 showed good performance in discriminating stage II-IV CCC from BOTs and other EOCs (AUC 0.815 for TFPI2 versus 0.505 for CA125) or endometriosis (AUC 0.957 for TFPI2 versus 0.748 for CA125). The diagnostic sensitivity of TFPI2 to discriminate CCC from BOTs and other EOCs was improved from 43.5 to 71.0% when combined with CA125. CONCLUSIONS: High specificity of TFPI2 for preoperative detection of CCC was verified with the defined cutoff level of TFPI2 in clinical practice. TFPI2 and CA125 may contribute substantially to precise prediction of intractable CCC.

DOI： 10.1007/s10147-021-01914-y

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Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: This phase II study evaluated the efficacy and safety of docetaxel/carboplatin chemotherapy for treating patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix. METHODS: A total of 50 patients with International Federation of Gynecology and Obstetrics stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix were enrolled and administered docetaxel at a dose of 60 mg/m2, followed by carboplatin at a dose based on the area under the receiver operating characteristic curve of 6. The treatments were repeated every 21 days until disease progression or unacceptable adverse events. Except for two patients, 48 were eligible for evaluation. Another patient withdrew consent before treatment; adverse events were evaluated in 47. RESULTS: The response rate was 47.9% with 5 patients achieving complete response, 18 partial response, 14 stable disease, and 6 progressive disease. The disease control rate was 77.1%. With a median follow-up duration of 368 days, the median progression-free survival and overall survival were 6.1 months (95% CI 5.5-8.6) and 15.8 months (95% CI 18.2-28.3), respectively. The most frequent grade 3 and grade 4 hematological toxicity was neutropenia, with 38 patients (81%) having grade 4 and 4 (9%) having grade 3 neutropenia. The non-hematological toxicities were mainly grade 1 or 2 in severity. CONCLUSION: Docetaxel/carboplatin chemotherapy was effective, with a higher disease control rate and well-tolerated chemotherapeutic regimen for patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix.

DOI： 10.1007/s10147-021-01903-1

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

AIM: To determine the optimal treatment for locally advanced squamous cell cervical cancer with clinical positive pelvic lymph nodes metastasis (cN1). METHODS: We enrolled patients with squamous cell cervical cancer with 2008 FIGO stages IB, IIA, or IIB diagnosed with cN1, who were treated at Hyogo Cancer Center between April 2010 and December 2016. Patients with para-aortic lymph nodes metastasis were excluded. RESULTS: Of the 69 eligible patients, 24 underwent concurrent chemoradiotherapy (CCRT), 11 underwent radical hysterectomy with pelvic lymphadenectomy (RH) with or without adjuvant RT, and 34 underwent neoadjuvant chemotherapy (NAC) followed by RH as initial treatment. The regimens of NAC included dose-dense TC (paclitaxel 80 mg/m2 , days 1, 8, 15; and carboplatin at an area under the curve = 6 on day 1, every 3 weeks) and dose-dense TP (paclitaxel 80 mg/m2 on days 1, 8, 15; and cisplatin 75 mg/m2 on day 1, every 3 weeks). The median observation period was 57 (12-107) months. The 5-year disease-free survival rates of the CCRT, RH, and NAC groups were 78.7%, 63.6%, and 88.2%, respectively (p = 0.14). The 5-year overall survival rates of the CCRT, RH, and NAC groups were 78.6%, 70.1%, and 94.1%, respectively (p = 0.11). CONCLUSIONS: We recommend avoiding RH as primary treatment for cN1 with locally advanced squamous cell cervical cancer. Although CCRT should be considered for cN1, further studies are required to determine if NAC followed by RH will serve as an effective option.

DOI： 10.1111/jog.14816

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer  

Purpose: Advanced cervical cancer with distant metastases is often difficult to treat and has an extremely poor prognosis. In this study, we aimed to examine treatment modalities that may contribute to prolonging overall survival. Methods: Under institutional review board approval, we conducted a retrospective study of 91 patients with advanced cervical cancer with distant metastasis who were treated at our hospital from 2000 to 2018. Overall survival was analyzed for each of the following prognostic factors: age, local stage, histological type, metastatic morphology (hematogenous metastasis or lymphadenopathy), presence or absence of local treatment with surgery or radiotherapy, and use of bevacizumab. Results: The median age was 58 years, and the median duration of observation was 34.5 months. The most common histological type was squamous cell carcinoma (64.8%). Eighty percent of patients opted for platinum-based chemotherapy as their first treatment. Univariate analysis detected histological type, metastatic morphology, presence or absence of local treatment with surgery or radiotherapy, and use of bevacizumab as significant prognostic factors, whereas multivariate analysis detected metastatic morphology, presence or absence of local treatment with surgery or radiotherapy, and use of bevacizumab as significant prognostic factors. Conclusion: In advanced cervical cancer, distant metastases can be controlled with chemotherapy, and the prognosis is relatively good when combined with local treatment. The results suggest that combined treatment strategies may contribute to prolonged survival and that bevacizumab use may extend survival.

DOI： 10.1007/s40944-021-00509-9

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Wolters Kluwer Medknow Publications  

We present a patient diagnosed with high-grade cervical intraepithelial neoplasia (CIN) combined with macroscopic lesions of the vaginal epithelium. There was no lesion in pelvic magnetic resonance imaging examination, and histopathological examination revealed CIN3 and vaginal intraepithelial neoplasia (VAIN) 3 without invasion. We chose minimally invasive surgery for her and total laparoscopic hysterectomy with partial resection of the vagina was carried out. To determine appropriate surgical margins, vaginal colpotomy was performed. No recurrence of VAIN has been observed to date that passed for 9 months either.

DOI： 10.4103/GMIT.GMIT_119_19

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Wiley  

AIM: Cell-free and concentrated ascites reinfusion therapy (CART) is applied to relieve symptoms in patients with malignant ascites. We performed a prospective cohort study to evaluate the efficacy and safety of CART performed on patients with advanced ovarian and peritoneal cancers with massive ascites during the initial treatment. METHODS: From April 2018 to July 2020, CART was performed during the initial treatment of 31 patients with advanced ovarian and peritoneal cancers with cancerous ascites. Patient characteristics and clinical information before and after CART were collected. We performed quality of life assessment using the Japanese version of the M.D. Anderson Symptom Inventory (MDASI-J) 24 h before and after CART. RESULTS: CART was performed 38 times in 24 patients before or during neoadjuvant chemotherapy and 11 times in 11 patients prior to surgery. Four patients underwent CART before primary surgery and before and/or during chemotherapy. Grade 1-2 fever was observed in 18 of 31 cases (58%), and all were controllable by nonsteroidal anti-inflammatory drugs. CART did not adversely affect the main treatment, chemotherapy, or surgery. CART significantly improved the MDASI-J symptom and interference scores within 24 h after the procedure. The symptom and interference scores decreased from 2.4 to 1.8 and from 4.8 to 3.0, respectively. CONCLUSIONS: CART can be safely performed and is useful for symptom relief and improvement of general condition prior to initial surgery and during initial chemotherapy in ovarian and peritoneal cancers. Performing CART at the time of initial treatment may facilitate initiation of the main treatment.

DOI： 10.1111/jog.14670

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Asian Society of Gynecologic Oncology$\mathsemicolon$ Korean Society of Gynecologic Oncology and Colposcopy  

OBJECTIVE: The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. METHODS: Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens. The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs). RESULTS: Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8-79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration. Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease). CONCLUSION: The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759587.

DOI： 10.3802/jgo.2021.32.e21

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Authorship：Lead author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media {LLC}  

BACKGROUND: We proposed a novel treatment strategy, consisting of triweekly cisplatin plus dose-dense weekly paclitaxel before and after radical hysterectomy without adjuvant radiation therapy to treat locally advanced cervical cancer. However, cisplatin-related severe non-hematologic toxicities were frequent during this strategy. This study aimed to assess the applicability of replacing cisplatin with carboplatin in our proposed strategy. METHODS: Women with International Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB2, IIA2, or IIB cervical cancer received three cycles of carboplatin (based on an area under the curve of six), each 21 days apart, starting on day 1, and 80 mg/m2 of paclitaxel on days 1, 8, and 15 of each 21-day cycle before undergoing radical hysterectomy. Patients with one or more high-risk factors, including lymph vascular invasion, parametrial invasion, lymph-node metastasis, or positive margins, received three additional cycles of chemotherapy after hysterectomy. Concurrent chemoradiation therapy was only applied to those patients who failed to respond to neoadjuvant chemotherapy. RESULTS: Between September 2014 and July 2016, 50 women (13 women with FIGO stage IB2, 5 with stage IIA2, and 32 with stage IIB) were enrolled in this study. The overall response rate to chemotherapy was 92%, including 22% with pathological complete response. Forty-nine women (98%) completed the planned radical hysterectomy, and 11 (22%) women with one or more high-risk factors received three additional cycles of chemotherapy. Only four women (8%) received concurrent chemoradiation therapy after surgery. The 2- and 3-year progression-free survival rates were 88.0% and 83.8%, respectively, and the 2- and 3-year overall survival rates were 98.0% and 95.4%, respectively. Only two patients reported grade 3 or higher non-hematologic toxicities including grade 3 nausea in one patient and grade 3 liver dysfunction in one patient. CONCLUSIONS: Replacement the platinum agent resulted in equivalent efficacy, with reduced toxicity, in women with locally advanced cervical cancer. This strategy could considerably diminish the application of radiation therapy without reduced survival. A study to identify those patients who will benefit from this new multidisciplinary strategy is warranted.

DOI： 10.1007/s10147-020-01787-7

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BACKGROUND: The aim of the current study was to evaluate oncologic outcomes of patients who were treated with salvage hysterectomy (HT), compared to systemic chemotherapy (CT) for persistent cervical cancer after definitive radiotherapy (RT)/ concurrent chemoradiotherapy (CCRT). METHODS: Patients with persistent cervical cancer treated with definitive RT/CCRT at 35 institutions from 2005 to 2014 were reviewed retrospectively (n = 317). Those who underwent a HT for persistent cervical cancer after definitive RT/CCRT were matched with propensity scores for patients who underwent systemic CT. Oncologic outcomes between the two groups using a propensity score matched-cohort analysis were compared. RESULTS: A total of 142 patients with persistent cervical cancer after definitive RT/CCRT were included after matching (HT: 71, systemic CT: 71). All background factors between HT and CT groups were well balanced. Median overall survival was 3.8 and 1.5 years in the HT and CT groups, respectively (p = 0.00193, hazards ratio [HR] 0.41, 95% confidence interval [CI] 0.23-0.73), Increasing residual tumor size was significantly associated with a high incomplete resection rate (p = 0.016, Odds Ratio 1.11, 95%CI 1.02-1.22). Severe late adverse events occurred in 7 patients (9.9%) in the HT cohort. CONCLUSION: The current study demonstrated that, when compared to systemic CT, the adoption of salvage HT for patients with persistent cervical cancer after definitive RT/CCRT reduced mortality rate by about 60%. This indicates that salvage HT could be curative treatment for those patients. Further prospective clinical trials with regard to salvage HT after RT/CCRT are warranted.

DOI： 10.1186/s12885-020-07672-w

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media {LLC}  

BACKGROUND: Occurrence of hypersensitivity reaction (HSR) in patients having received multiple doses of carboplatin has been reported. Several studies demonstrated reduction of carboplatin-associated HSR with in combination with pegylated liposomal doxorubicin (PLD). The objective of this study was to determine the suppressive effect on carboplatin-induced HSR via combined treatment with PLD within clinical practice. METHODS: We reviewed the medical records of women with primary or recurrent ovarian, fallopian tube, or peritoneal cancer treated with carboplatin containing regimen at our hospital between January 2009 and March 2019. We compared the incidence of carboplatin-induced HSR among patients who received more than one cycle of PLD plus carboplatin (PLD-C) therapy (i.e., PLD-C group) versus patients who never received PLD-C therapy (non-PLD-C group). RESULTS: A total of 414 women were included in this study (48: PLD-C group, 366: non-PLD-C group). Carboplatin-induced HSR occurred in 34 total patients (8.2%) [1/48 (2.1%) in the PLD-C group and 33/366 (9.0%) in the non-PLD-C group], with a median cycle number of carboplatin administration at onset of HSR being 9. Incidences of carboplatin-induced HSR within the PLD-C versus non-PLD-C group at the 8th, 12th, and 16th cycles of carboplatin administration were 2.2% vs 11.2%, 2.2% vs 28.6%, and 2.2% vs 39.1%, respectively [hazard ratio: 19.2 (95% confidence interval: 9.82-39.4), p < 0.0001]. CONCLUSION: Based on the data analyzed here, a suppressive effect on carboplatin-induced HSR via combination therapy with PLD was confirmed within clinical practice.

DOI： 10.1007/s10147-020-01706-w

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media {LLC}  

BACKGROUND: The purpose of this study was to determine the optimal regimen of neoadjuvant chemotherapy (NAC) for advanced epithelial ovarian, fallopian tube, and peritoneal cancers. METHODS: A clinical information survey involving 171 patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer was conducted. These patients underwent NAC followed by interval debulking surgery at the Hyogo Cancer Center (Hyogo, Japan) between January 2006 and December 2015. RESULTS: The median observation period was 41 (range 4-138) months. Dose-dense paclitaxel and carboplatin (TC) was administered in 101 patients (59%); tri-weekly TC was administered 70 patients (41%). Median progression-free survival was 21 [95% confidence interval (CI) 18-23] months and 15 (95% CI 13-17) months in the dose-dense TC and conventional-TC group [hazard ratio (HR) = 0.69, 95% CI 0.46-0.96; p = 0.02], respectively. The median overall survival was 59 (95% CI 46-72) and 40 (95% CI 32-57) months in the dose-dense TC group and conventional-TC group (HR = 0.72, 95% CI 0.48-1.06; p = 0.09). Multivariate analysis for progression-free survival demonstrated that dose-dense TC represented an independent prognostic factor (HR = 0.70, 95% CI 0.50-0.99; p = 0.04). CONCLUSIONS: Dose-dense TC is a promising regimen of NAC for advanced epithelial ovarian cancer.

DOI： 10.1007/s10147-019-01567-y

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Authorship：Lead author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media {LLC}  

INTRODUCTION: Bevacizumab and gemcitabine are key drugs for treating recurrent epithelial ovarian cancer. However, information about the combination of bevacizumab and gemcitabine is insufficient. We conducted a phase II study to assess the feasibility, clinical activity, and toxicity of this combination chemotherapy. METHODS: This study included women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer who received one to three regimens of platinum-based chemotherapy between April 1, 2015 and December 31, 2018. The patients received bevacizumab 15 mg/kg intravenously on day 1 and gemcitabine 1000 mg/m2 intravenously on days 1 and 8 every 21 days until disease progression or unacceptable toxicity. The primary endpoint was the completion rate of three cycles of chemotherapy. This study was registered in the University Medical Information Network (UMIN) Clinical Trials Registry (UMIN000016619). RESULTS: Among the 19 patients, 18 (95%) received ≥3 and 9 (47%) received ≥6 cycles of the study therapy. The objective response rate was 42% (complete response of 16% and partial response of 26%), and the clinical control rate was 84%. Hematological toxicity included neutropenia grade 3/4 in 9 patients (47%), anemia grade 3/4 in 2 (11%), and thrombocytopenia grade 3/4 in 1 (5%). One patient (5%) had grade 3 hypertension, and 1 (5%) had grade 3 protein urea. Possibly related grade 3 pulmonary toxicity was observed in 1 patient. Three patients needed dose reduction of gemcitabine to 800 mg/m2 due to treatment delay by 15 to 21 days on day1. There was no treatment delay more than 14 days on day 8. The median progression-free survival duration was 5.1 months and median overall survival duration was 21.3 months. CONCLUSION: The combination chemotherapy with gemcitabine and bevacizumab was feasible, effective and safe. This combination chemotherapy may be explored in a further randomized trial.

DOI： 10.1186/s13048-020-0617-y

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: Most cases of leptomeningeal metastasis (LM) arise from solid tumors, such as breast cancer, lung cancer, or malignant melanoma. LM arising from gynecological cancers are extremely rare. Longer survival owing to recent advances in chemotherapy and other treatments has contributed to the increased frequency of gynecological cancers metastasizing to the central nervous system (CNS). Detailed information regarding LM is scarce; therefore, we conducted a study concerning LM arising from primary gynecological cancers. METHODS: Among 24 patients with CNS metastases from gynecological cancer treated at our hospital between January 2011 and August 2018, those who were eventually diagnosed with LM were included in this retrospective study. RESULTS: Among 24 patients with CNS metastases, five patients (20.8%) were diagnosed with LM. The primary cancer was endometrial in two, cervical in one, and peritoneal in two patients. Of these five patients, three developed LM as a complication 1-11 months after the treatment of brain metastases; one patient had multiple brain metastases diagnosed at the same time as LM, and one had LM alone, without accompanying brain metastases. The median survival after the diagnosis of LM was 23 (12-69) days, while the median survival of 24 patients after the initial diagnosis of CNS metastases was 106 (13-959) days. CONCLUSION: Although LM arising from gynecological cancers is considered rare, identification of LM may be important to predict prognosis and develop new therapeutic strategies.

DOI： 10.1007/s10147-019-01556-1

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Language：Japanese   Publishing type：Research paper (scientific journal)  

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BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. CONCLUSIONS: In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation. (Funded by ARCAGY Research and others; PAOLA-1 ClinicalTrials.gov number, NCT02477644.).

DOI： 10.1056/NEJMoa1911361

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Language：English   Publishing type：Research paper (scientific journal)  

According to the statement from the 5th Ovarian Cancer Consensus Conference in 2015, the primary systemic chemotherapy for advanced ovarian cancer is a combination of paclitaxel plus carboplatin administered every 3 weeks (PCq3w). Optional alternatives include weekly dose-dense paclitaxel, in combination and maintenance therapy with bevacizumab, and intraperitoneal chemotherapy. Since then, in addition to the PCq3w strategy, there has been emerging new evidence, especially for poly(adenosine diphosphate-ribose) polymerase inhibitors. Moreover, there are multiple randomized, phase 3 trials testing the addition of antiangiogenic and/or immune checkpoint inhibitors in this patient population. In this article, current and future perspectives of systemic chemotherapy for advanced ovarian cancer are discussed.

DOI： 10.1002/cncr.32475

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OBJECTIVE: To examine the association between ovarian conservation and oncologic outcome in surgically-treated young women with early-stage, low-grade endometrial cancer. METHODS: This multicenter retrospective study examined women aged <50 with stage I grade 1-2 endometrioid endometrial cancer who underwent primary surgery with hysterectomy from 2000 to 2014 (US cohort n = 1196, and Japan cohort n = 495). Recurrence patterns, survival, and the presence of a metachronous secondary malignancy were assessed based on ovarian conservation versus oophorectomy. RESULTS: During the study period, the ovarian conservation rate significantly increased in the US cohort from 5.4% to 16.4% (P = 0.020) whereas the rate was unchanged in the Japan cohort (6.3-8.7%, P = 0.787). In the US cohort, ovarian conservation was not associated with disease-free survival (hazard ratio [HR] 0.829, 95% confidence interval [CI] 0.188-3.663, P = 0.805), overall survival (HR not estimated, P = 0.981), or metachronous secondary malignancy (HR 1.787, 95% CI 0.603-5.295, P = 0.295). In the Japan cohort, ovarian conservation was associated with decreased disease-free survival (HR 5.214, 95% CI 1.557-17.464, P = 0.007) and an increased risk of a metachronous secondary malignancy, particularly ovarian cancer (HR 7.119, 95% CI 1.349-37.554, P = 0.021), but was not associated with overall survival (HR not estimated, P = 0.987). Ovarian recurrence or metachronous secondary ovarian cancer occurred after a median time of 5.9 years, and all cases were salvaged. CONCLUSION: Our study suggests that adoption of ovarian conservation in young women with early-stage low-grade endometrial cancer varies by population. Ovarian conservation for young women with early-stage, low-grade endometrial cancer may be potentially associated with increased risks of ovarian recurrence or metachronous secondary ovarian cancer in certain populations; nevertheless, ovarian conservation did not negatively impact overall survival.

DOI： 10.1016/j.ygyno.2019.08.007

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PURPOSE: To compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer. METHODS: Ovarian cancer patients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m2 plus carboplatin area under the curve (AUC) 5 mg/mL/min on day 1] every 4 weeks or GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin AUC 4 mg/mL/min on day 1) every 3 weeks for at least 6 cycles. The primary endpoint was progression-free survival, and overall response rate, overall survival, toxicity, and dose administration were secondary endpoints. RESULTS: One-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2-15.0) for PLDC and 9.8 months (8.9-12.3) for GC [HR 0.69 (0.455-1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0-72.3) for PLDC and 56.4% (39.6-72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001). CONCLUSIONS: PLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancer patients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk-benefit profile than that of GC for patients.

DOI： 10.1007/s10147-019-01471-5

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Language：English   Publisher：(一社)日本癌治療学会  

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVE: We evaluated the efficacy and safety of the combination of paclitaxel, carboplatin, and bevacizumab in patients with advanced or recurrent cervical cancer. METHODS: Subjects included patients with advanced or recurrent cervical cancer not amenable to curative treatment with surgery or radiation therapy. Treatment consisted of paclitaxel 175 mg/m2, carboplatin area under the curve 6 mg/mL/min, and bevacizumab 15 mg/kg every 21 days until disease progression, complete remission, or limiting toxicity. The primary endpoint was the objective response. RESULTS: In total, 34 patients received a median of 6 treatment cycles (range 2-25). The median follow-up period was 18.5 months (range 2-29). The objective response was 88% (95% confidence interval: 72.5%-96.7%). Seventeen patients (50%) experienced complete response, whereas 13 patients experienced (38%) partial response with a median duration of 6 months. Grades 3 and 4 hematologic toxicities manifested as neutropenia in 14 (41.2%), leukopenia in 14 (41.2%), anemia in 11 (32.4%), and thrombocytopenia in 9 (26.5%) patients. One patient who underwent prior pelvic irradiation developed grade 2 rectovaginal fistula. CONCLUSION: The combination of paclitaxel, carboplatin, and bevacizumab is effective and safe in patients with advanced or recurrent cervical cancer.

DOI： 10.1016/j.ygyno.2019.05.018

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•We present a case of endometrial carcinoma (EC) in a 14-year-old girl with no risk factors for EC.•The patient received MPA therapy and endometrial curettage.•At 47 weeks after her last MPA treatment, she has had no recurrence.•EC should be considered in diagnosing juveniles with sustained abnormal uterine bleeding, even those without risk factors.

DOI： 10.1016/j.gore.2019.05.006

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Language：Japanese   Publisher：(一社)日本産科婦人科内視鏡学会  

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Language：Japanese   Publisher：(一社)日本産科婦人科内視鏡学会  

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Language：Japanese   Publisher：(一社)日本産科婦人科内視鏡学会  

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OBJECTIVE: We conducted a retrospective study to evaluate the correlation between pre-operative and post-operative histological diagnoses on endometrial cancer, and to describe the treatments and outcomes when post-operative diagnoses are downgraded from pre-operative histology. METHODS: Patients who underwent surgery for endometrial cancer in our facility between 2010 and 2013 were enrolled in the study. The definition of downgrade discordance is in accordance with the following criteria: 1) the pre-operative and post-operative histological diagnoses were both endometrioid and the final pathology was a lower grade than the pre-operative pathology and 2) the pre-operative diagnosis was not endometrioid, whereas the post-operative diagnosis was endometrioid grade 2 or less. RESULTS: A total of 250 patients were enrolled, and the concordance rates were 56% for endometrioid adenocarcinoma grade 1 (EMG1), 67% for EMG2, 67% for EMG3, 82% for carcinosarcoma, 71% for serous carcinoma, and 67% for clear cell carcinoma. Eighteen cases (6.6%) were identified as downgrade discordancy. Of the 18 patients, the triage for adjuvant therapy remained the same for 15 cases (83%), all of whom had no evidence of disease at their last visit. Three cases had discordances with respect to triage for adjuvant therapy; the therapies were triaged based on post-operative diagnosis. Of these patients one had a recurrence. CONCLUSIONS: Good correlation was observed between pre-operative and final histological diagnoses of endometrioid carcinoma (56%-67%) and type 2 carcinoma (67%-82%). Approximately 7% (18/250) of patients had downgrade discordancy; however, triage for adjuvant therapy did not change for approximately 80% (15/18) of the patients with downgrade discordancy. Further studies are needed to evaluate the effectiveness of triages that are based on post-operative diagnoses.

DOI： 10.1136/ijgc-2018-000041

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Authorship：Lead author   Language：Japanese   Publishing type：Research paper (scientific journal)  

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Cancer immunotherapy has now been established as a leading standard therapeutic option in a subset of patients with cancer. In this study, we conducted a phase I dose-escalation trial using a mixture of 5 peptides to vaccinate cervical cancer patients with HLA-A*2402. The primary endpoints were safety and determination of a recommended vaccine dose, and the secondary endpoints were evaluations of immunologic responses and clinical efficacy. All patients had recurrent or persistent disease and had failed to respond to or were intolerant to prior standard chemotherapy. Peptides derived from forkhead box protein M1 (FOXM1), maternal embryonic leucine zipper kinase (MELK), Holliday junction-recognition protein, and vascular endothelial growth factor receptors 1 and 2 were administered to 9 patients in a 3 patient-cohort design, with doses of 0.5, 1, or 2 mg of each of the individual peptides in a mixture with incomplete Freund's adjuvant. The major adverse events were anemia and injection site reactions, which were seen in 77.8% (7/9) and 66.7% (6/9) of patients, respectively. Grade 3 anemia was observed in 1 patient. No dose-limiting toxicity of the vaccine was observed. Seven (78%) patients achieved stable disease, and the median progression-free survival was 3.3 months (102 d). Interferon-γ enzyme-linked immunospot assays for each of the 5 antigens showed that 8 (89%) and 7 (78%) patients had high T-cell responses to FOXM1 and MELK, respectively. In conclusion, we demonstrated that this 5-peptide vaccine was tolerable, and that FOXM1 and MELK could be promising targets for immunotherapy in patients with cervical cancer.

DOI： 10.1097/CJI.0000000000000214

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Language：Japanese   Publishing type：Research paper (scientific journal)  

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OBJECTIVE: Gastric-type mucinous carcinoma (GAS) is a novel variant of mucinous carcinoma of the uterine cervix, characterized by aggressive clinical behavior and absence of high-risk human papillomavirus. We conducted this study to evaluate the chemosensitivity of GAS compared with that of usual-type endocervical adenocarcinoma (UEA) in patients who had been enrolled in our previous study. METHODS: Of 52 patients from our previous phase 2 study (SGSG005) of neoadjuvant chemotherapy with docetaxel and carboplatin for stage IB2 to IIB nonsquamous cervical cancer, 47 (stage IB2, 12; stage IIA2, 7; stage IIB, 28) were enrolled in this study with written informed consent. The biopsy specimens before neoadjuvant chemotherapy and surgical specimens after chemotherapy were centrally reviewed based on the updated World Health Organization classification (2014). RESULTS: Of 47 patients with nonsquamous cell carcinoma, 20 (42.6%) were diagnosed with UEA, 13 (27.7%) with GAS, 12 (25.5%) with adenosquamous carcinoma, and 1 patient each (2%) with small cell carcinoma and serous carcinoma. Consequently, 33 patients, consisting of 20 patients with UEA and 13 patients with GAS, were eligible for the current study. The response rate of GAS was significantly lower than that of UEA (46.2% vs 85.0%, P = 0.048). Of 16 cases of stage II UEA, 11 (68.8%) were downstaged on microscopic examination of postsurgical specimens, but none of the 8 patients with stage II GAS showed any response (P < 0.01). Two inoperative tumors were GAS. With a median follow-up duration of 56 months, the 5-year progression-free and overall survival rates of GAS were significantly worse than those of UEA (38.5% vs 75.0% [P = 0.011] and 36.9% vs 90.0% [P < 0.001], respectively). CONCLUSIONS: These findings suggest that GAS should be distinguished from UEA by its chemoresistance, necessitating an alternative treatment strategy established for this distinct subtype of endocervical adenocarcinoma.

DOI： 10.1097/IGC.0000000000001145

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVES: This study clarified the incidence of and identified the risk factors for post-radiation pelvic insufficiency fractures (PIFs) in women who received postoperative definitive or adjuvant radiotherapy (RT) for cervical cancer. PATIENTS AND METHODS: The medical records and data of imaging studies, including computed tomography scan and magnetic resonance imaging, of women with cervical cancer who received external-beam RT for the entire pelvic area between January 2003 and December 2012 at our institution were reviewed. RESULTS: A total of 533 patients with histologically diagnosed cervical cancer who received RT (298: definitive RT, 235: adjuvant RT) were included in this study. Eighty-four patients (15.8%) developed PIF in the irradiated field. Median age at onset of PIF was 72.5years (range: 54-95years), and 82 of them (98%) were postmenopausal women. Sixty-nine patients (80%) developed PIF within 3years from the completion of RT. The median time for the development of PIF was 14months (range: 1-81months). The most commonly involved fracture site was the sacral bone. Postmenopausal state, coexistence of rheumatoid arthritis, and high-dose-rate intracavitary brachytherapy (HDR-ICBT) use were significant predisposing factors for the development of PIF, according to multivariate analysis. CONCLUSIONS: The incidence rate of PIF among patients who received RT for locally advanced cervical cancer was 15.8%. The principal predisposing factors for post-radiation PIF were postmenopausal state, rheumatoid arthritis, and HDR-ICBT use. Active interventions, including bone density screening followed by medication, should be considered during the early stage of RT for women with high-risk factors of PIF.

DOI： 10.1016/j.ygyno.2017.09.035

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The aim of this study is to evaluate the outcome and safety of the multidisciplinary strategy using cisplatin plus dose-dense paclitaxel (dose-dense TP) before and after radical hysterectomy (RH) for stage IB2, IIA2, or IIB patients with cervical cancer. In the dose-finding phase, 12 patients received 3 cycles of cisplatin (75 mg/m2, day 1) with paclitaxel (70 or 80 mg/m2, days 1, 8, and 15) every 21 days as neoadjuvant chemotherapy (NAC). In the phase II study, 51 patients received 3 cycles of dose-dense TP at the recommended dose as NAC, and another 2 cycles of the same regimen after RH. The primary endpoint was 2-year progression-free survival (PFS). The secondary endpoints were 2-year overall survival (OS), adverse events (AEs), response rate (RR), and pathological complete response (pCR) rates. The recommended dose of paclitaxel at dose-finding phase was 80 mg/m2. In the phase II study, 34 patients (66.7%) had FIGO stage IIB disease. The RR and pCR rates were 94 and 28%. With a median follow-up duration of 58 months, each of the 2- and 5-year PFS rates was 88.2%, the 2- and 5-year OS rates were 94.1 and 88.2%, respectively. The incidence of grade 3/4 AEs was neutropenia (34%), nausea (12%), appetite loss (10%), fatigue (6%), and anemia (6%). Febrile neutropenia was uncommon (2%). Dose-dense TP before and after RH achieved a good long-term survival and was feasible for patients with locally advanced cervical cancer.

DOI： 10.1007/s12032-017-0992-4

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：「産婦人科の進歩」編集室  

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BACKGROUND: The cell surface glycoprotein mesothelin is highly expressed in several malignant diseases. Normal mesothelin expression is limited to mesothelial cells lining the pleura, peritoneum, and pericardium, making it a biomarker and an attractive target for cancer therapy. METHODS: We investigated tumor mesothelin expression and serum mesothelin levels in patients with epithelial ovarian cancer or borderline tumors. In total, 161 patients selected from a previous prospective study were analyzed for tumor mesothelin expression using immunohistochemistry and serum mesothelin expression using enzyme-linked immunosorbent assay. RESULTS: Eighty-eight (68.8%) epithelial ovarian cancers and eight (24.2%) borderline tumors showed high mesothelin expression, which was associated with shorter progression-free and overall survival. The tumor mesothelin expression status was moderately correlated with serum mesothelin levels in epithelial ovarian cancer patients. Based on receiver operating characteristic analysis, a serum mesothelin level above 2.20 nM predicted high tumor mesothelin expression in epithelial ovarian cancer patients (area under the curve = 0.81). In 45 patients with recurrent epithelial ovarian cancer, we observed relatively lower levels of serum mesothelin, compared to the level at the primary diagnosis. We also tracked the change in the serum mesothelin level during the course of second-line chemotherapy and found a discrepancy between the clinical response and the serum mesothelin change in some patients, which suggested tumor heterogeneity among the tumor cells with or without mesothelin expression. CONCLUSION: Serum mesothelin may be a useful noninvasive biomarker surrogate for tumor mesothelin expression in future clinical trials for mesothelin-targeted therapy.

DOI： 10.1007/s40291-017-0255-2

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BACKGROUND: We conducted a phase II study to evaluate the efficacy of neoadjuvant chemotherapy with docetaxel and carboplatin followed by radical hysterectomy for patients with non-squamous cell carcinoma of the uterine cervix. METHODS: Sixty-one patients with International Federation of Gynecology and Obstetrics stage IB2, IIA2, or IIB non-squamous cell carcinoma of the uterine cervix were enrolled. The patients were administered docetaxel at a dose of 60 mg/m2, followed by carboplatin at a dose based on an area under the curve of 6. The treatments were repeated every 21 days for one to three cycles. Fifty-two patients were eligible to evaluate the efficacy of neoadjuvant chemotherapy followed by radical hysterectomy. Adverse events were evaluated in 59 patients. RESULTS: The response rate was 69 % (95 % CI, 57-82 %), with 5 patients achieving complete response, 31 partial response, 15 stable disease, and 1 progressive disease. Median follow-up duration was 1913 days with a range of 145-2632 days. Of 52 patients, 50 underwent radical hysterectomy after neoadjuvant chemotherapy. The 2-year overall survival rate was 81.8 % for stage IB2, 85.7 % for stage IIA2, and 92.6 % for stage IIB. The most frequent grade 3 and 4 hematological toxicity was neutropenia, with 43 patients experiencing grade 4 and 11 with grade 3. The nonhematological toxicities were mainly grade 1 or 2 in severity. CONCLUSION: Neoadjuvant chemotherapy with docetaxel and carboplatin followed by radical hysterectomy may be a useful strategy for patients with non-squamous cell carcinoma of uterine cervix.

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Language：Japanese   Publisher：「産婦人科の進歩」編集室  

症例は39歳(1経妊0経産)で、近医で不妊治療中に子宮内膜細胞異常を指摘され紹介受診した。子宮内膜掻爬で類内膜腺癌G1と診断され、妊孕性温存希望のため高用量プロゲスチン(MPA)療法を開始した。6ヵ月後の内膜組織診で効果ありと判断し、2ヵ月間の追加治療後に経過観察としたが、初回治療終了6ヵ月後に類内膜腺癌G1の再発を認め、2回目のMPA療法を行った。8ヵ月後に腺癌は消失し、MPA療法を2ヵ月間追加して経過観察とした。2回目終了8ヵ月後に複雑型子宮内膜異型増殖症を認め、治療抵抗性の判断で子宮全摘術を勧めたが、妊孕性温存希望で3回目MPA療法となったが、4ヵ月後に増殖症の遺残を認め、患者・家族の了解のもと腹腔鏡下子宮全摘術、両側卵管切除術を行った。病理診断は複雑型子宮内膜異型増殖症を背景とした類内膜腺癌G1であった。術後1年経過で再発は認めていない。全経過を通じプロゲステロン受容体は陰性、エストロゲン受容体は陽性であった。

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Other Link： https://search.jamas.or.jp/default/link?pub_year=2016&ichushi_jid=J00536&link_issn=&doc_id=20160815080004&doc_link_id=%2Fch5aioag%2F2016%2F006803%2F004%2F0237-0242%26dl%3D0&url=https%3A%2F%2Fwww.medicalonline.jp%2Fjamas.php%3FGoodsID%3D%2Fch5aioag%2F2016%2F006803%2F004%2F0237-0242%26dl%3D0&type=MedicalOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00004_2.gif

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BACKGROUND: There are no definitive criteria for identifying which patients with The International Federation of Gynecology and Obstetrics (FIGO) stage IB cervical cancer will benefit from adjuvant therapy after radical hysterectomy. The aims of this study were to clarify the efficacy of adjuvant therapy and assess complications after radical hysterectomy in patients with FIGO stage IB1 cervical cancer with intermediate risk factors. METHODS: Between January 2005 and December 2009, the medical records of 75 stage IB1 patients' intermediate risk factors (i.e., tumor size 2-4 cm, lymphovascular involvement, and/or deep stromal invasion >1/2) who underwent radical hysterectomy at six institutions were collected, and these patients were enrolled in this nonrandomized retrospective study. We simplified the criteria of intermediate risk factors as much as possible, as the criteria adopted in some clinical studies are complicated in practice. RESULTS: The patients were grouped according to the receipt of adjuvant therapy as follows: 46 patients, no further treatment; 19 patients, external beam radiation treatment, including 9 patients who received brachytherapy; 5 patients, concurrent chemoradiotherapy (CCRT); and 5 patients, chemotherapy (CT). The clinical outcomes and complications in each group were analyzed. After an average follow-up of 82.6 months (range, 24-135 months), only one patient with all three risk factors who received radiotherapy (RT) experienced recurrence. Excluding this patient, the remaining patients who received RT, CCRT, or CT had two or three risk factors. Lymphedema was significantly more common among patients who received RT or CCRT, whereas the incidence of ileus and ureteral obstruction was not different among the treatment groups. However, an unsutured peritoneum increased the risk of ileus. CONCLUSIONS: The findings of this study suggest that RT and CCRT after radical hysterectomy are not beneficial in patients with intermediate risk factors. In particular, RT and CCRT appeared to increase the incidence of lymphedema. A prospective randomized study is needed to verify the findings of this study.

DOI： 10.1186/s12957-016-0931-4

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Authorship：Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVE: The purpose of this study is to investigate the clinical characteristics to determine the optimal timing of interval debulking surgery following neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer. METHODS: We reviewed the charts of women with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent interval debulking surgery following neoadjuvant chemotherapy at our cancer center from April 2006 to April 2014. RESULTS: There were 139 patients, including 91 with ovarian cancer [International Federation of Gynecology and Obstetrics (FIGO) Stage IIIc in 56 and IV in 35], two with fallopian tube cancers (FIGO Stage IV, both) and 46 with primary peritoneal cancer (FIGO Stage IIIc in 27 and IV in 19). After 3-6 cycles (median, 4 cycles) of platinum-based chemotherapy, interval debulking surgery was performed. Sixty-seven patients (48.2%) achieved complete resection of all macroscopic disease, while 72 did not. More patients with cancer antigen 125 levels ≤25.8 mg/dl at pre-interval debulking surgery achieved complete resection than those with higher cancer antigen 125 levels (84.7 vs. 21.3%; P< 0.0001). Patients with no ascites at pre-interval debulking surgery also achieved a higher complete resection rate (63.5 vs. 34.1%; P< 0.0001). Moreover, most patients (86.7%) with cancer antigen 125 levels ≤25.8 mg/dl and no ascites at pre-interval debulking surgery achieved complete resection. CONCLUSIONS: A low cancer antigen 125 level of ≤25.8 mg/dl and the absence of ascites at pre-interval debulking surgery are major predictive factors for complete resection during interval debulking surgery and present useful criteria to determine the optimal timing of interval debulking surgery.

DOI： 10.1093/jjco/hyw029

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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We herein present atypical histologic and immunohistochemical features of DSRCT. The various differential diagnoses of DSRCT may occasionally generate confusion. Cytogenetic analysis may solve diagnostic dilemmas such as that in our case. Further studies are required to establish a standard treatment for DSRCT.

DOI： 10.1002/ccr3.558

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Authorship：Lead author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVE: Paclitaxel is known to produce the "platelet-sparing effect" that prevents the carboplatin-induced decrease in platelet count. We conducted a pilot study to assess whether the addition of low-dose paclitaxel to carboplatin-based combination chemotherapy prevents thrombocytopenia. METHODS: Patients with platinum-sensitive recurrent ovarian cancer received intravenous (IV) paclitaxel at 60 mg/m(2) followed by IV carboplatin at an area under the curve of 6 and IV pegylated liposomal doxorubicin at 30 mg/m(2) on day 1 in a 28-day cycle (DC-LOP) or IV gemcitabine at 1000 mg/m(2) on days 1 and 8 in a 21-day cycle (GC-LOP). RESULTS: During May 2011 to December 2011, 7 patients received 29 cycles of DC-LOP; during January 2012 to May 2013, 15 patients received 88 cycles of GC-LOP. Grade 3/4 thrombocytopenia occurred in 2 (33%) of 6 and 9 (56%) of 16 patients in the DC-LOP and GC-LOP groups, respectively. No grade 3/4 nonhematological toxicity was observed. Only one patient who received GC-LOP had grade 2 sensory and motor peripheral neuropathy. Paclitaxel-related toxicities, including muscle pain, arthralgia, and peripheral neuropathy, were consistently rare and mild. The response rates of DC-LOP and GC-LOP were 33% (0, complete response; 2, partial response; 3, stable disease; 1, progression disease) and 50% (2, complete response; 6, partial response; 7, stable disease; 1, progression disease), respectively. CONCLUSIONS: Although low-dose paclitaxel addition did not alleviate thrombocytopenia in the setting of this pilot study, the results do not deny the existence of the "platelet-sparing effect" by low-dose paclitaxel. Further investigation of the carboplatin-based combination chemotherapy including a drug with mild hematological toxicity is warranted.

DOI： 10.1097/IGC.0000000000000630

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Language：Japanese   Publishing type：Research paper (scientific journal)  

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Language：Japanese   Publisher：(一社)日本産科婦人科内視鏡学会  

症例は45歳(3経妊3経産)で、過多月経と腹部腫瘍が指摘され、近医にて過多月経と貧血に対し子宮内膜全面掻爬とGnRHa投与が行われ、約半年後に不正性器出血を認め、内膜細胞診class IIIで紹介受診した。エコーで後壁が有意に肥厚した境界明瞭で内部不均一な腫瘤を認め、MRIで子宮体部後壁に35mmのT2で低信号を呈し、内部に点状の高信号を認め、子宮腺筋症を疑い腹腔鏡下子宮全摘出術を行った。摘出子宮を経腟的に回収し、腟断端を吸収糸で連続縫合し閉鎖した。病理所見では、子宮腺筋症は子宮筋層に限局し、子宮底層に淡赤色のごく一部で内膜側に連続する類内膜腺癌の病変を認め、類内膜腺癌G2と診断した。切除断端は陰性、左右付属器に浸潤・転移は認めなかったが、CT・PET-CTによる全身検索で傍大動脈リンパ節に腫大を認め、子宮体癌IIIC2期の診断で開腹による傍大動脈リンパ節、骨盤リンパ節郭清術を追加した。術後化学療法を行い、1年経過で再発は認めていない。

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Other Link： https://search.jamas.or.jp/default/link?pub_year=2015&ichushi_jid=J02563&link_issn=&doc_id=20151228470027&doc_link_id=%2Fcj7sanai%2F2015%2F003101%2F027%2F0244-0248%26dl%3D0&url=https%3A%2F%2Fwww.medicalonline.jp%2Fjamas.php%3FGoodsID%3D%2Fcj7sanai%2F2015%2F003101%2F027%2F0244-0248%26dl%3D0&type=MedicalOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00004_2.gif

Authorship：Lead author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVE: Neuroendocrine carcinoma of the cervix is a rare and aggressive subtype of cervical cancer and includes small cell neuroendocrine carcinoma (SCNEC) and large cell neuroendocrine carcinoma (LCNEC). We conducted a single-institution retrospective review to explore the pattern of treatments and outcomes with the aim of defining an optimum treatment strategy for these carcinomas. METHODS: Twenty-three consecutive patients with SCNEC or LCNEC of the cervix diagnosed at the Hyogo Cancer Center between 1996 and 2013 were included in this study. Pertinent information, including clinical and pathological characteristics, and survival data were collected from clinical records and/or telephone surveys. The pathological review was conducted by a pathologist specializing in gynecologic cancer. RESULTS: Eleven patients had SCNEC and 12 had LCNEC. Eighteen patients with International Federation of Gynecology and Obstetrics (FIGO) stage I/II underwent type III radical hysterectomy with pelvic lymphadenectomy. After surgery, 9 received adjuvant chemotherapy (8, irinotecan plus cisplatin; 1, paclitaxel plus carboplatin), 7 received concurrent chemoradiation therapy (CCRT; 6, nedaplatin; 1, cisplatin), and 2 received radiation therapy (RT). Patients who received adjuvant chemotherapy had a better overall survival than did patients who received CCRT or RT (hazard ratio, 0.21; 95% confidence interval, 0.030-1.51; P = 0.12). Although the overall survival rates are not statistically significant, the 9 patients who underwent radical hysterectomy followed by adjuvant chemotherapy are all alive. Among the remaining 5 patients who did not undergo radical hysterectomy, 2 with FIGO stage III and 1 with stage IVa received CCRT, and 2 with stage IVb received palliative RT or chemotherapy. These 5 patients with FIGO stage III/IV died of disease within 36 months. CONCLUSIONS: Radical hysterectomy followed by platinum-based chemotherapy, especially the irinotecan plus cisplatin combination, is beneficial for long-term survival in patients with early-stage neuroendocrine carcinoma of the cervix.

DOI： 10.1097/IGC.0000000000000495

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Language：Japanese   Publisher：(一社)日本癌治療学会  

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Language：Japanese   Publisher：(一社)日本癌治療学会  

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Authorship：Lead author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

PURPOSE: We previously reported that the concept of "platinum sensitivity" could be applied to recurrent endometrial cancer. We conducted an ancillary analysis to determine an appropriate second-line regimen for patients who received a platinum agent as first-line chemotherapy. METHODS: We extracted and reanalyzed data of patients treated with doxorubicin and cisplatin (AP), paclitaxel and carboplatin (TC), or docetaxel and carboplatin (DC) as first- and second-line chemotherapies from the SGSG012/GOTIC004/Intergroup study. RESULTS: We identified 216 patients: 38 received AP as first-line chemotherapy, of which 36 received TC or DC (Tax-C) as second-line chemotherapy; and 178 received Tax-C as first-line chemotherapy, of which 51 received AP and 127 received Tax-C as second-line chemotherapy. Median progression-free survival (PFS) and overall survival (OS) after second-line chemotherapy decreased in the order of Tax-C followed by Tax-C (10 and 48 months, respectively), AP followed by Tax-C (9 and 23 months, respectively), and Tax-C followed by AP (3 and 12 months, respectively). Median PFS and OS after second-line chemotherapy for platinum-resistant patients receiving Tax-C as first-line chemotherapy were longer in Tax-C than in AP (7 and 23 vs. 3 and 10 months, respectively) as second-line chemotherapy [hazard ratio (HR) 3.255, 95 % confidence interval (CI) 1.908-5.555, p < 0.0001; HR 3.179, 95 % CI 1.835-5.507, p < 0.0001, respectively]. Median PFS and OS after second-line chemotherapy for platinum-sensitive patients receiving Tax-C as first-line chemotherapy were almost equivalent to those receiving Tax-C or AP as second-line chemotherapy. CONCLUSIONS: For platinum-resistant recurrent endometrial cancer patients, Tax-C may be preferred over AP as second-line chemotherapy.

DOI： 10.1007/s00280-015-2793-9

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Language：Japanese   Publisher：(一社)日本産科婦人科内視鏡学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publisher：「産婦人科の進歩」編集室  

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Language：Japanese   Publisher：「産婦人科の進歩」編集室  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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OBJECTIVE: We evaluated the feasibility of combination chemotherapy with paclitaxel, doxorubicin and cisplatin without prophylactic granulocyte colony-stimulating factor injection for intermediate-to-high-risk or recurrent endometrial cancer. METHODS: Women with histologically confirmed FIGO Stages I-II with >1/2 myometrial invasion, Stage III/IV or recurrent endometrial cancer were enrolled. Patients received intravenous doxorubicin (45 mg/m(2)), followed by cisplatin (50 mg/m(2)) on Day 1 and intravenous paclitaxel (160 mg/m(2)) on Day 2. Granisetron (75 µg) was administered depending on neutrophil counts on Days 3 and 8. Treatment was repeated every 21 days for six cycles or until disease progression or unacceptable toxicity. The primary endpoint was the completion rate of the scheduled chemotherapy; secondary endpoints were Grade 3/4 toxicity and response rate in patients with measurable lesions. RESULTS: From September 2010 to December 2012, 35 women, including 7 with FIGO Stage I, 4 with Stage II, 13 with Stage III, 10 with Stage IV and 1 with recurrent endometrial cancer, were enrolled. There were 26 endometrial carcinomas (Grade 1, 16; Grade 2, 6; Grade 3, 4), 4 carcinosarcomas, 2 serous adenocarcinomas, 1 neuroendocrine carcinoma, 1 poorly differentiated carcinoma and 1 mixed carcinoma. Twenty-five patients (71%) completed six chemotherapy cycles. Grade 3/4 hematological toxicities included neutrocytopenia (97%), thrombocytopenia (6%) and anemia (34%). Three patients (9%) experienced neutropenic fever. Grade 3/4 non-hematological toxicities were observed in 13 patients. In 15 patients with evaluable lesions, the response rate was 80%. CONCLUSIONS: Combination chemotherapy with paclitaxel, doxorubicin and cisplatin without prophylactic granulocyte colony-stimulating factor injection is feasible.

DOI： 10.1093/jjco/hyu124

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Clear cell carcinomas of the uterine corpus and cervix are rare gynecological cancers with limited information regarding the pathogenesis and biology. At present, the approach to management is the same as for patients with the more common histological subtypes of endometrioid endometrial cancer and adenocarcinoma of the cervix. Surgical resection is the standard treatment for patients with early-stage disease, but there is no evidence-based approach to direct the management of patients with more advanced-stage disease at presentation or with recurrent disease. We review the epidemiology, pathology, and what is known about both uterine corpus and cervical clear cell cancers and make management recommendations.

DOI： 10.1097/IGC.0000000000000297

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Language：Japanese   Publisher：(公社)日本婦人科腫瘍学会  

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Language：Japanese   Publishing type：Research paper (scientific journal)  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Authorship：Lead author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVE: The concept of "platinum sensitivity" has been widely applied in the management of recurrent ovarian cancer. This study aimed to evaluate the applicability of this concept to recurrent endometrial cancer. PATIENTS AND METHODS: In this multicenter retrospective cohort study, the clinical data of patients with recurrent endometrial cancer, who had a history of receiving first-line platinum-based chemotherapy and who received second-line platinum-based chemotherapy at the time of recurrence between January 2005 and December 2009 were reviewed. RESULTS: A total of 262 patients from 30 centers with initial FIGO stage classifications of I (29), II (23), III (122), and IV (88) were enrolled. In total, 153 endometrioid adenocarcinomas, 34 serous adenocarcinomas, 17 clear cell adenocarcinomas, 36 carcinosarcomas, and 22 "other" tumors were documented. The response rates for patients with platinum-free intervals of <6 months, 6-11 months, 12-23 months, and ≥24 months were 25%, 38%, 61%, and 65%, respectively. The median progression-free survival after second-line platinum-based chemotherapy for patients with platinum-free intervals of <12 months and ≥12 months was 4.4 (95% confidence interval (CI)=3.7-5.8) months and 10.3 (95% CI=8.2-12.6) months, respectively (log-rank P<0.0001), and the median overall survival was 13.8 (95% CI=10.6-18.1) months and 40.9 (95% CI=25.3-54.2) months, respectively (log-rank P<0.0001). CONCLUSION: Platinum-free interval is a predictor of response and survival after second-line platinum-based chemotherapy in patients with recurrent endometrial cancer. The concept of "platinum sensitivity" could be applicable to recurrent endometrial cancer.

DOI： 10.1016/j.ygyno.2013.09.021

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Language：Japanese   Publisher：(一社)日本癌治療学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Background: This is the first attempt to conduct a large-scale phaseIII oncology trial using the Evaluation System of Investigational Medical Care (ESIMeC). Methods: The study design is a randomized phase II / III trial comparing administration routes of carboplatin either intravenously (IV) or intraperitoneally (IP) in combination with weekly administration of paclitaxel for ovarian cancer patients. Target accrual is 746. Both IP carboplatin and weekly paclitaxel have not been approved for national insurance coverage in Japan. Results: Because of the expensive drug cost, it was first assumed impossible to conduct the trial if the study chair is responsible for purchasing the investigational drugs from the limited research grant or the patients have to pay for the investigational drugs without insurance coverage. Therefore, we negotiated with the pharmaceutical companies including generic makers to supply the investigational drugs with free of charge. The duration from initial consultation to the Ministry of Health, Labor, and Welfare to the finial approval to conduct the trial using ESIMeC was 8 months. Conclusion: The ESIMeC appears to be an efficient system as the official evaluation process of investigator-initiated, non-indication directed clinical trials, which manifestly require quality control of the trials. However, cost coverage for the investigational medicine or technique remains as an important issue to be resolved in the future, especially in large phase III oncology trials.

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Clinical practice guidelines for gynecologic cancers have been published by the National Comprehensive Cancer Network and the National Cancer Institute. Whereas these guidelines form the basis for the standard of care for gynecologic malignancies in the United States, it has proven difficult to institute them in Japan due to differences in patient characteristics, health-care delivery systems, and insurance programs. Therefore, evidence-based guidelines for treating cervical cancer specifically in Japan have been under development. The Guidelines Formulation Committee and Evaluation Committee were independently established within the Committee for Treatment Guidelines for Cervical Cancer. Opinions from within and outside the Japan Society of Gynecologic Oncology (JSGO) were incorporated into the final draft, and the guidelines were published after approval by the JSGO. These guidelines are composed of ten chapters and comprise three algorithms. Each chapter consists of a clinical question, recommendations, background, objectives, explanations, and references. The objective of these guidelines is to clearly delineate the standard of care for cervical cancer treatment in Japan in order to ensure equitable care for all Japanese women diagnosed with cervical cancer.

DOI： 10.1007/s10147-010-0061-x

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：ASIAN PACIFIC ORGANIZATION CANCER PREVENTION  

Splenic metastasis from ovarian cancer is unusual. Most splenic metastases are encountered in the setting of widespread visceral metastases. We present 6 cases of splenic metastasis of epithelial ovarian cancer. Three cases underwent a splenectomy as a part of interval debulking surgery, and the rest received a splenectomy as a surgery for recurrent disease. The splenectomies were well-tolerated in all patients and no serious morbidity or mortality resulted. Only one patient experienced a transient elevation in platelet count.

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：LIPPINCOTT WILLIAMS & WILKINS  

Nagao S, Fujiwara K, Ohishi R, Nakanishi Y, Iwasa N, Shimizu M, Goto T, Shimoya K. Combination chemotherapy of intraperitoneal carboplatin and intravenous paclitaxel in suboptimally debulked epithelial ovarian cancer. Int J Gynecol Cancer 2008;18:1210-1214.
The objective of this study was to retrospectively assess the efficacy and safety of combination chemotherapy of intraperitoneal (IP) carboplatin and intravenous (IV) paclitaxel in suboptimally debulked ovarian cancer. Between March 1998 and March 2006, 44 patients with histologically confirmed epithelial ovarian carcinoma or peritoneal carcinoma with a residual mass greater than 1 cm received combination chemotherapy of IV paclitaxel and IP carboplatin. Administration of IV paclitaxel at 175 mg/m(2) immediately followed by IP carboplatin at an area under the curve of 6 was scheduled every 3 weeks for at least six cycles. The diagnosis and stage were ovarian carcinoma stage II in 8, III in 25, and IV in 6 cases, and peritoneal carcinoma stage III in 5 cases. Eighty-three percent of patients completed more than six cycles of chemotherapy. The incidences of grade 3/4 hematologic toxicities were 41 (93%) for neutrocytopenia, 10 (41%) for thrombocytopenia, and 18 (23%) for anemia. Observed grade 3/4 nonhematologic toxicities were 1 (2%) for allergy, 1 (2%) for fatigue, 1 (2%) for vomiting, 1 (2%) for liver dysfunction, and 4 (9%) for peripheral neuropathy. Two patients (5%) encountered catheter problems (one obstruction and one infection). Overall response rate was 80% (16 complete response, 19 partial response, 3 stable disease, and 6 progressive disease). Median progression-free survival and overall survival were 24 and 31 months, respectively. Combination chemotherapy of IP carboplatin and IV paclitaxel is effective and safe in suboptimally debulked ovarian cancer, and further evaluation is warranted.

DOI： 10.1111/j.1525-1438.2008.01192.x

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Language：Japanese   Publishing type：Research paper (scientific journal)  

To evaluate the validity of administration of paclitaxel and carboplatin with or without pirarubicin (THP-ADR) as first line chemotherapy in elderly patients with gynecologic cancer, we explored the efficacy and safety of these regimens. From October 1, 1998 to September 30, 2001, we administered paclitaxel and carboplatin with or without THP-ADR pursuant to the chart we prepared originally as first line chemotherapy in patients with gynecologic cancer. Eleven elderly patients (age > 70 years) and 62 younger patients (age < 70 years) were entered into the present study. Paclitaxel was administered as a 3-hour intravenous (i.v.) infusion at dosages of 135 to 180 mg/m2 immediately followed by carboplatin over 60 minutes at dosages of area under the curve (AUC) 3 to 5, administered intravenously or intraperitoneally. We observed grade 3/4 anemia more frequently in elderly patients receiving the regimen including paclitaxel and carboplatin without THP-ADR (9% v.s. 47%, p < 0.0001). Grade 3/4 anemia (10% v.s. 22%, p = 0.02) and grade 3/4 thrombocytopenia (7% v.s. 22%, p = 0.007), febrile neutropenia (14% v.s. 44%, p = 0.02) also occurred more frequently in elderly patients receiving the regimen including paclitaxel and carboplatin with THP-ADR. The overall response rates were equivalent among elderly and younger patients (69% and 78%), respectively. The regimen consisting of paclitaxel and carboplatin without THP-ADR was applied safely to elderly patients.

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Myalgia/arthralgia is a crucial side effect of paclitaxel, and may become the major dose-limiting side effect. However, this is a situation where there is little effective preventive treatment. L-Glutamine was reported as a neuroprotective agent for vincristine-induced neurotoxicity. In Japan, there have been reports on steroid and Shakuyaku-Kanzou-to (a herbal medicine) for paclitaxel-induced myalgia/arthralgia. This study aimed to compare the effect of L-Glutamine and Shakuyaku-Kanzou-to, and to discuss the validity of these agents for the paclitaxel-induced myalgia/arthralgia. Our results suggested that Shakuyaku-Kanzou-to showed no remarkable effects against paclitaxel-induced myalgia/arthralgia as had been reported before; however, both L-Glutamine and Shakuyaku-Kanzou-to decreased the duration of grade 2 toxicity (CALGB Expanded Common Toxicity Criteria) in comparison with those who were not treated. L-Glutamine and Shakuyaku-Kanzou-to might therefore a preventive effect against moderate or severer myalgia/arthralgia during paclitaxel-treated chemotherapy. Further trials are needed to confirm the value of these drugs.

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A rapid quantitative real-time PCR method was employed to quantify the copy number of E2 and E6 genes for analysis of the physical status of human papillomavirus type 16 (HPV-16) DNA. Significant differences with respect to both copy numbers were found when more than 40% of HPV-16 DNA was integrated with disruption of the E2 gene in an experimental model. The physical status of HPV-16 DNA in 50 clinical samples was exclusively episomal in 21 cases (42%), concomitant in 14 cases (28%), and integrated in 15 cases (30%). The prevalence of integrated and/or concomitant forms of HPV-16 DNA increased with progression of cervical disease. Four of 11 cervical intraepithelial neoplasia involved integrated forms of HPV-16 DNA partially or exclusively. This rapid, sensitive technique is useful in the analysis of the physical status of HPV DNA.

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Language：Japanese   Publisher：JAPAN SOCIETY OF GYNECOLOGIC AND OBSTETRIC ENDOSCOPY AND MINIMALLY INVASIVE THERAPY  

DOI： 10.5180/jsgoe.14.121

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Language：Japanese   Publisher：JAPAN SOCIETY OF GYNECOLOGIC AND OBSTETRIC ENDOSCOPY AND MINIMALLY INVASIVE THERAPY  

DOI： 10.5180/jsgoe.12.83

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Other Link： http://search.jamas.or.jp/link/ui/1997132586

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＜文献概要＞目的:進行卵巣癌に対するレジメン選択は,ベバシズマブ(BEV)の使用を含め施設間で異なっている可能性がある。われわれはわが国におけるレジメン選択の現状を把握することを目的とし,三海婦人科癌スタディグループ(SGSG)参加施設へアンケート調査を実施した。方法:2019年9月にSGSG参加施設35施設に対して,初回術後治療,術前化学療法(NAC),インターバル腫瘍減量手術(IDS)後,プラチナ感受性再発,のそれぞれのタイミングで第一選択として使用するレジメンをアンケート形式で調査した。成績:全35施設中20施設から回答があった。初回術後治療としてTC+BEV療法を第一選択としている施設は15施設(75%)であった。プラチナ感受性再発に対してBEV併用レジメンを第一選択としている施設は17施設(85%)であった。NACにおける第一選択のレジメンはTC療法が8施設(40%),dose-dense TC療法が6施設(30%),TC+BEV療法が6施設(30%)であった。IDS後にレジメンを変更している施設が8施設(40%)あった。結論:初回治療とプラチナ感受性再発に対してBEV併用レジメンを使用している施設が多く,NACの治療方針は多様であった。

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Language：Japanese   Publisher：(一社)日本女性医学学会  

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Language：Japanese   Publisher：金原出版(株)  

＜文献概要＞当院で子宮頸癌に対する広汎子宮全摘術後に補助放射線治療を行った81例において,放射線治療が要因と思われる水腎症を8例(約10%)に認めた。半数は一過性の水腎症で自然軽快したものの,残りの半数は進行性持続性となっている。広汎子宮全摘術後早期に水腎症を認めなくてもその後の放射線治療により水腎症を発症し,腎機能を保持するために侵襲的な処置を要する場合があり,放射線治療中や治療後の注意深い腎臓評価が必要である。

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＜文献概要＞症例は53歳,主訴は不正性器出血。子宮内膜組織診は類内膜腺癌Grade 2,骨盤部MRIでは子宮体部に結節状腫瘤を認めた。子宮体癌IA期の術前診断で腹腔鏡下単純子宮全摘,両側付属器切除術を実施。術後の病理組織診断はpT1a,脱分化癌,高度のリンパ管侵襲を認めた。術後補助化学療法はTC療法を実施したが,8ヵ月後肺門部リンパ節,肺転移をきたした。TC療法を再開したが効果なく,MSI-Highを確認しペムブロリズマブを開始。2サイクル後軽度増悪傾向を示したが4サイクル後に縮小に転じ,以後奏効を維持している。

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Language：Japanese   Publisher：(一社)日本女性医学学会  

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：OXFORD UNIV PRESS  

DOI： 10.1093/annonc/mdz339.028

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：AMER SOC CLINICAL ONCOLOGY  

DOI： 10.1200/JCO.2018.36.15_suppl.5527

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：AMER SOC CLINICAL ONCOLOGY  

DOI： 10.1200/JCO.2017.35.15_suppl.e17022

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Language：Japanese   Publisher：診断と治療社  

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Other Link： http://search.jamas.or.jp/link/ui/2016409736

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Other Link： http://search.jamas.or.jp/link/ui/2017033871

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Other Link： https://projects.repo.nii.ac.jp/?action=repository_uri&item_id=456527

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Introduction: Intraperitoneal (i.p.) chemotherapy has been extensively studied in the ovarian cancer field. Despite the fact that three large randomized trials that were conducted in the United States showed survival benefit, meta-analysis also showed survival benefit and the National Cancer Institute (NCI) released a clinical announcement recommending i.p. chemotherapy for optimally debulked advanced stage ovarian cancer in 2006, i.p. chemotherapy has not been widely accepted by the gynecologic oncology community, mainly because of its toxicities. Areas covered: In this review, previously available evidence, new evidence published since the NCI clinical announcement and ongoing clinical trials will be discussed. Expert opinion: Three currently ongoing randomized Phase III trials will provide extremely important information about whether a less toxic i.p. regimen using carboplatin will be beneficial for patients with advanced ovarian cancer. They are important because it may be possible to solve many of the questions or unmet needs in i.p. chemotherapy by combining these three trials. © 2013 Informa UK, Ltd.

DOI： 10.1517/14656566.2013.820705

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Other Link： http://search.jamas.or.jp/link/ui/2013306024

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：AMER SOC CLINICAL ONCOLOGY  

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DOI： 10.1158/1538-7445.AM2012-1883

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Objective: This study aimed to evaluate intravenous (IV)/intraperitoneal (IP) paclitaxel and IP carboplatin (TCipTip therapy) feasibility in epithelial ovarian (EOC), fallopian tube (FTC), or peritoneal carcinoma (PC) patients.
Methods: From December 2007 to August 2010, 20 women with histologically confirmed stage IC to IV EOC, FTC, or PC received 6 TCipTip cycles after the primary cytoreductive surgery. Intravenous paclitaxel was administered at 135 mg/m(2) followed by IP carboplatin based on the area under the curve = 6 on day 1; IP paclitaxel at 60 mg/m2 was administered on day 8. The toxicity grade was determined by CTCAE version 3.0. The institutional review board requested we reduce the IP paclitaxel dose in the first cycle to ensure safety.
Results: Twenty women, including 18 with EOC, 1 with stage IIC FTC, and 1 with stage IV primary PC, received TCipTip therapy. There were 12 serous, 5 endometrioid, 1 mucinous, 1 clear cell adenocarcinoma, and 1 mixed carcinoma (clear cell and endometrioid) cases. Eleven women achieved optimal status at primary surgery. Grade 3/4 hematologic toxicity incidence was 73% (neutrocytopenia), 9% (thrombocytopenia), and 24% (anemia). Grade 3/4 nonhematologic toxicities were observed in 5 patients (4 with grade 3 allergy and 1 with grade 3 ileus). Twelve patients (60%) completed more than 6 chemotherapy cycles. Reasons for interruption included paclitaxel allergy, grade 2 abdominal pain, carboplatin allergy during the seventh cycle, disease progression, pleural embolism, ileus, and address change.
Conclusions: Toxicities for TCipTip therapy were acceptable; this therapy is feasible for EOC, FTC, or PC patients. Further TCipTip therapy evaluation is warranted.

DOI： 10.1097/IGC.0b013e318234f927

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The efficacy and toxicity of combination chemotherapy with docetaxel + carboplatin were evaluated in patients with locally advanced or recurrent cervical cancer. A total of 71 patients with cervical cancer were enrolled into this trial, and 66 patients were considered eligible. The patients were administered docetaxel at 60 mg/m2 followed by carboplatin based on area under the curve of 6, both by intravenous infusion, every 3 weeks, with the treatment repeated for 1 to 6 cycles depending on the goal of the therapy. The response was evaluated based on the Response Evaluation Criteria in Solid Tumors criteria. Toxicity to chemotherapy was evaluated according to the National Cancer Institute Common Toxicity Criteria. Of the 66 eligible patients, 62 had locally advanced cervical cancer with no history of previous treatment, whereas 4 patients had recurrent cervical cancer. A total 149 cycles of chemotherapy were administered, with a median of 2.3 cycles (range, 1-6) per patient. The overall clinical response rate was 63.7% (44/66, 95% confidence interval, 52.1-75.3). In the neoadjuvant chemotherapy setting, the overall clinical response rate was 69.3% (43/62; 43/62, 95% confidence interval, 57.8-80.8), and the response rates in patients with squamous cell carcinoma and nonsquamous cell carcinoma were 69.7% (23/33, 95% confidence interval, 54.0-85.4) and 68.9% (20/29, 95% confidence interval, 52.1-85.7), respectively. On the other hand, in patients with recurrent cervical cancer, the overall response rate was 25.0% (1/4, 95% confidence interval, -17.4 to 67.4). Nonhematological toxicities were mainly grade 1 or 2. Hematological toxicity was encountered mostly in the form of neutropenia and thrombocytopenia. Combination chemotherapy with docetaxel + carboplatin is a safe and well-tolerated treatment for patients with advanced cervical cancer and is effective against not only squamous cell carcinoma, but also adenocarcinoma.

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Language：Japanese   Publisher：医学書院  

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Other Link： http://search.jamas.or.jp/link/ui/2011254522

Language：English   Publishing type：Research paper, summary (international conference)   Publisher：AMER SOC CLINICAL ONCOLOGY  

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Language：English   Publisher：OXFORD UNIV PRESS  

Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperitoneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-free survival and secondary endpoints include overall survival, quality of life assessment and cost-benefit. The first 120 patients will be evaluated for the feasibility of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.

DOI： 10.1093/jjco/hyq182

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Language：Japanese   Publisher：(公社)日本産科婦人科学会  

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Other Link： https://projects.repo.nii.ac.jp/?action=repository_uri&item_id=447131

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Other Link： http://search.jamas.or.jp/link/ui/2011116406

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Other Link： http://search.jamas.or.jp/link/ui/2011018117

Language：English   Publisher：WILEY-BLACKWELL PUBLISHING, INC  

Aim:
To evaluate toxicity, response and progression-free survival of single nedaplatin chemotherapy in women with platinum/taxane-resistant/refractory epithelial ovarian, tubal and peritoneal cancer.
Methods:
Seventeen patients with platinum/taxane-resistant/refractory epithelial ovarian, fallopian tube or primary peritoneal cancer who were treated with a single nedaplatin regimen at 90 mg/m2 administration on day 1 of a 28-day cycle in our institution between 2005 and 2007 were retrospectively investigated.
Results:
Ten of 17 patients (59%) had measurable disease. Seven patients were evaluated according to cancer antigen (CA) 125 levels. The overall response was 24% (complete response, 2 patients; partial response, 2 patients). Two of these 4 patients had measurable disease. Stable disease and progressive disease was noted in 6 (35%) and 7 (41%) patients. Median progression-free survival was 8 months (range 3-11) in patients who responded to therapy and 4 months (range 2-6) in patients with stable disease. Mean platinum-free interval due to treatment without using platinum analogues after developing platinum-resistant/refractory disease was 11 months (range 8-12) in patients who responded to nedaplatin regimen and 3 months (range 1-11) in patients who did not (P &lt; 0.01), whereas mean treatment-free interval was 3 months (range 1-5) in responders and 1 month (range 1-3) in non-responders, which did not show a significant difference. Grade 4 hematological toxicity was observed in 2 of 17 patients (12%). No grade 3 or 4 non-hematological toxicity occurred. All toxicities were managed on an outpatient basis.
Conclusions:
Single nedaplatin treatment for platinum/taxane-resistant/refractory ovarian, tubal and peritoneal cancer patients is the candidate of salvage chemotherapy with comparable effectiveness and less toxicity to other approved regimens.

DOI： 10.1111/j.1447-0756.2010.01217.x

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Language：English   Publisher：WILEY-BLACKWELL PUBLISHING, INC  

Aim:
To evaluate toxicity, response and progression-free survival of single nedaplatin chemotherapy in women with platinum/taxane-resistant/refractory epithelial ovarian, tubal and peritoneal cancer.
Methods:
Seventeen patients with platinum/taxane-resistant/refractory epithelial ovarian, fallopian tube or primary peritoneal cancer who were treated with a single nedaplatin regimen at 90 mg/m2 administration on day 1 of a 28-day cycle in our institution between 2005 and 2007 were retrospectively investigated.
Results:
Ten of 17 patients (59%) had measurable disease. Seven patients were evaluated according to cancer antigen (CA) 125 levels. The overall response was 24% (complete response, 2 patients; partial response, 2 patients). Two of these 4 patients had measurable disease. Stable disease and progressive disease was noted in 6 (35%) and 7 (41%) patients. Median progression-free survival was 8 months (range 3-11) in patients who responded to therapy and 4 months (range 2-6) in patients with stable disease. Mean platinum-free interval due to treatment without using platinum analogues after developing platinum-resistant/refractory disease was 11 months (range 8-12) in patients who responded to nedaplatin regimen and 3 months (range 1-11) in patients who did not (P &lt; 0.01), whereas mean treatment-free interval was 3 months (range 1-5) in responders and 1 month (range 1-3) in non-responders, which did not show a significant difference. Grade 4 hematological toxicity was observed in 2 of 17 patients (12%). No grade 3 or 4 non-hematological toxicity occurred. All toxicities were managed on an outpatient basis.
Conclusions:
Single nedaplatin treatment for platinum/taxane-resistant/refractory ovarian, tubal and peritoneal cancer patients is the candidate of salvage chemotherapy with comparable effectiveness and less toxicity to other approved regimens.

DOI： 10.1111/j.1447-0756.2010.01217.x

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Language：English   Publisher：LIPPINCOTT WILLIAMS & WILKINS  

Purpose: To assess the antitumor efficacy and safety of 2 treatment modalities: intraperitoneal carboplatin combined with intravenous (IV) paclitaxel.
Patients and Methods: Eligible patients were those with epithelial ovarian carcinoma or primary peritoneal carcinoma stages 11 to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m(2) followed by intraperitoneal carboplatin AUC6. The primary end point was a response. Secondary end points were toxicity, progression-free survival, and overall survival.
Results: Twenty-six patients were enrolled, and 24 patients were eligible for assessment. The response rate was 83.3% (95% CI, 62.6%-95.3%; Table 4). The median progression-free survival was 25 months. The median overall survival had not been reached. Incidences of grade (G) 3/4 hematological toxicities were absolute neutrophil count, 96%; hemoglobin, 29%; and thrombocytopenia, 16%. Nonhematological toxicities included G2 liver function, 4%; G3 sensory neuropathy, 8%; and G3 myalgia and arthralgia, 4%.
Conclusions: Intraperitoneal administration of carboplatin combined with IV paclitaxel was well tolerated and showed satisfactory response in the patients with bulky residual tumor. Large-scale phase III trial comparing with IV carboplatin is warranted in this patient population.

DOI： 10.1111/IGC.0b013e3181a29dfe

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Language：English   Publisher：LIPPINCOTT WILLIAMS & WILKINS  

Purpose: To assess the antitumor efficacy and safety of 2 treatment modalities: intraperitoneal carboplatin combined with intravenous (IV) paclitaxel.
Patients and Methods: Eligible patients were those with epithelial ovarian carcinoma or primary peritoneal carcinoma stages 11 to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m(2) followed by intraperitoneal carboplatin AUC6. The primary end point was a response. Secondary end points were toxicity, progression-free survival, and overall survival.
Results: Twenty-six patients were enrolled, and 24 patients were eligible for assessment. The response rate was 83.3% (95% CI, 62.6%-95.3%; Table 4). The median progression-free survival was 25 months. The median overall survival had not been reached. Incidences of grade (G) 3/4 hematological toxicities were absolute neutrophil count, 96%; hemoglobin, 29%; and thrombocytopenia, 16%. Nonhematological toxicities included G2 liver function, 4%; G3 sensory neuropathy, 8%; and G3 myalgia and arthralgia, 4%.
Conclusions: Intraperitoneal administration of carboplatin combined with IV paclitaxel was well tolerated and showed satisfactory response in the patients with bulky residual tumor. Large-scale phase III trial comparing with IV carboplatin is warranted in this patient population.

DOI： 10.1111/IGC.0b013e3181a29dfe

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Other Link： http://search.jamas.or.jp/link/ui/2009177979

Language：English   Publishing type：Research paper, summary (international conference)   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

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Language：English   Publisher：Cancer Information Group, LP  

In current Gynecologic Oncology Group studies, serum creatinine level is adjusted to 0.6 mg/dL in patients with levels &lt
0.6 mg/dL (Adjusted-Jelliffe formula). The purpose of this study is to evaluate whether this adjustment is suitable. Patients and Methods: Carboplatin clearance was estimated in 115 patients with serum creatinine &lt
0.6 mg/dL who received carboplatin-based chemotherapy for gynecologic malignancies between January 1996 and August 2004. The clearance was estimated using the Cockroft-Gault, Jelliffe, and Adjusted-Jelliffe formulae. The 3 estimations were then compared with each other using the post hoc Wilcoxon signed rank test. Bias was assessed by mean percentage error (MPE), and precision was assessed by mean absolute percentage error (MAPE). The relationships between body surface area (BSA) and ratios of estimated carboplatin clearance (Jelliffe formula/Cockroft-Gault formula and Adjusted-Jelliffe formula/Cockroft-Gault formula) were evaluated by simple regression analysis. Results: The carboplatin clearance calculated by the Jelliffe formula was significantly larger than the other 2 formulae (P &lt
.0001). Although MPE was reduced from +20 to +6 by adjustment of serum creatinine, MAPE was barely reduced from 21 to 14. The simple regression line represents correlation between BSA and ratios of estimated carboplatin clearance was merely translated to below by adjusting the serum creatinine level, and the bias by BSA was not corrected. Conclusion: Despite adjusting the serum creatinine level, the Adjusted-Jelliffe formula overestimates the creatinine clearance when compared with the Cockcroft-Gault formula.

DOI： 10.3816/COC.2009.n.007

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The objective of this study was to retrospectively assess the efficacy and safety of combination chemotherapy of intraperitoneal (IP) carboplatin and intravenous (IV) paclitaxel in suboptimally debulked ovarian cancer. Between March 1998 and March 2006, 44 patients with histologically confirmed epithelial ovarian carcinoma or peritoneal carcinoma with a residual mass greater than 1 cm received combination chemotherapy of IV paclitaxel and IP carboplatin. Administration of IV paclitaxel at 175 mg/m2 immediately followed by IP carboplatin at an area under the curve of 6 was scheduled every 3 weeks for at least six cycles. The diagnosis and stage were ovarian carcinoma stage II in 8, III in 25, and IV in 6 cases, and peritoneal carcinoma stage III in 5 cases. Eighty-three percent of patients completed more than six cycles of chemotherapy. The incidences of grade 3/4 hematologic toxicities were 41 (93%) for neutrocytopenia, 10 (41%) for thrombocytopenia, and 18 (23%) for anemia. Observed grade 3/4 nonhematologic toxicities were 1 (2%) for allergy, 1 (2%) for fatigue, 1 (2%) for vomiting, 1 (2%) for liver dysfunction, and 4 (9%) for peripheral neuropathy. Two patients (5%) encountered catheter problems (one obstruction and one infection). Overall response rate was 80% (16 complete response, 19 partial response, 3 stable disease, and 6 progressive disease). Median progression-free survival and overall survival were 24 and 31 months, respectively. Combination chemotherapy of IP carboplatin and IV paclitaxel is effective and safe in suboptimally debulked ovarian cancer, and further evaluation is warranted. © 2008, Copyright the Authors.

DOI： 10.1111/j.1525-1438.2008.01192.x

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Background. Carboplatin dosing for gynecologic malignancies is traditionally based on the Jelliffe formula that lacks dose adjustment for weight. Obese women may therefore receive a sub-therapeutic carboplatin dose. This study assessed the association between BM I and outcome for ovarian cancer patients treated with carboplatin-based chemotherapy.
Methods. An analysis of patients treated with carboplatin and paclitaxel on Gynecologic Oncology Group (GOG) protocol 158 was perfonned. The dose of carboplatin for each patient was based on an area under the curve of 7.5 and a glomerular filtration rate (GFR) derived from the Jelliffe formula which is derived from age and serum creatinine. Patients were stratified based on body mass index (BMI).
Results. A total of 387 patients were included in the analysis. The patients were stratified into three groups: normal weight (BMI &lt; 25.0, 50%), overweight (BMI 25-29.9, 32%) and obese (BMI &gt;= 30.0, 18%). Compared to pretreatment values, the obese patients had a lower relative decrease in their platelet counts (- 25% for BMI &gt;= 30 vs. - 6 1% for BMI &lt; 25) (p = 0.01). Similar trends were noted for relative changes in hemoglobin (p = 0.006) and hematocrit (p = 0.002). Dose reductions were required in 34% of normal weight compared to 2 1% of the obese women (p = 0.004). There was a trend toward increased risk for disease progression in women with a BMI &gt;= 30 (RR: 1.25, 95% CI: 0.93-1.69, p = 0. 14).
Conclusion. Obese ovarian cancer patients treated with carboplatin experience substantially less toxicity than normal weight women. The lower toxicity suggests that obese patients may be receiving a substandard drug dose. (c) 2008 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2008.02.023

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：AMER SOC CLINICAL ONCOLOGY  

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Language：English   Publishing type：Rapid communication, short report, research note, etc. (scientific journal)   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

DOI： 10.1016/j.ygyno.2007.04.014

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：TAYLOR & FRANCIS INC  

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Other Link： https://projects.repo.nii.ac.jp/?action=repository_uri&item_id=439647

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Objective. The aim of this study is to evaluate the feasibility of extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy for cervical and endometrial carcinoma.
Methods. Seventy-six patients underwent extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy between February 1999 and September 2005. The lymph nodes dissected with the laparoscopic procedure included the inframesenteric para-aortic lymph nodes, the sacral lymph nodes, and the bilateral common iliac lymph nodes. The extraperitoneal laparoscopic operation was performed with pelvic open surgery using Lap Disc to ensure the safety of patients.
Results. The number of patients with cervical and endometrial carcinoma was 36 and 40, respectively. The median age of patients was 51 years (range 24-75 years). Conversion to open surgery was necessary in 8 patients. These include 3 patients who encountered blood loss of 400, 136 and 128 ml; 2 extremely obese women; and 3 patients who had peritoneal tears causing CO2 gas leakage. Among the remaining 68 patients, the median operating time for extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy was 75 min (range 45-145 min), and the median estimated blood loss was 5 ml (range 5-138 ml). The median total number of resected nodes was 14 (range 2-31), and 4 patients had lymph node metastasis. No patient encountered postoperative complications attributable to extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy.
Conclusions. Extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy with pelvic open surgery using Lap Disc is a feasible procedure, particularly in the surgeons learning phase. (c) 2006 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2006.04.026

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Objective. The aim of this study is to evaluate the feasibility of extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy for cervical and endometrial carcinoma.
Methods. Seventy-six patients underwent extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy between February 1999 and September 2005. The lymph nodes dissected with the laparoscopic procedure included the inframesenteric para-aortic lymph nodes, the sacral lymph nodes, and the bilateral common iliac lymph nodes. The extraperitoneal laparoscopic operation was performed with pelvic open surgery using Lap Disc to ensure the safety of patients.
Results. The number of patients with cervical and endometrial carcinoma was 36 and 40, respectively. The median age of patients was 51 years (range 24-75 years). Conversion to open surgery was necessary in 8 patients. These include 3 patients who encountered blood loss of 400, 136 and 128 ml; 2 extremely obese women; and 3 patients who had peritoneal tears causing CO2 gas leakage. Among the remaining 68 patients, the median operating time for extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy was 75 min (range 45-145 min), and the median estimated blood loss was 5 ml (range 5-138 ml). The median total number of resected nodes was 14 (range 2-31), and 4 patients had lymph node metastasis. No patient encountered postoperative complications attributable to extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy.
Conclusions. Extraperitoneal laparoscopic para-aortic and common iliac lymphadenectomy with pelvic open surgery using Lap Disc is a feasible procedure, particularly in the surgeons learning phase. (c) 2006 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2006.04.026

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We previously reported a new technique for ovarian transposition to the abdominal subcutaneous fat tissue (OTAFT) following hysterectomy. The purpose of this study is to assess the hormonal function after OTAFT. From 1993 to 2000, OTAFT was performed in 27 patients (group A). Forty-two women underwent hysterectomy and retained ovaries without transposition (group B). In 19 cases, bilateral oophorectomy with hysterectomy was performed, and they received a hormone replacement therapy (HRT) (group C). Serum follicle-stimulating hormone (FSH) level of patients was monitored every 2-12 months, and the time of menopause (defined as FSH &gt
40 mIU/mL two times consecutively) was determined in groups A and B. After a median follow-up of 65 months, cumulative ovarian survival did not show significant difference between group A and group B (HR = 0.52, 95% CI = 0.17-1.16
P= 0.10). In patients who were 40 years old or younger, ovarian function declined significantly in group A compared to group B (HR = 0.29, 95% CI = 0.02-0.91
P= 0.04). However, FSH level of postmenopausal patients in group A was not different from FSH level of patients in group C, but FSH level of postmenopausal patients in group B was significantly higher than FSH level of patients in group C (P= 0.002). Although the procedure of OTAFT may somewhat affect the ovarian function, the transposed ovary in postmenopausal women presumably still secrete a small amount of estrogen which is equivalent to an estrogen level by HRT. © 2006, IGCS.

DOI： 10.1111/j.1525-1438.2006.00280.x

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Language：Japanese   Publisher：日本産科婦人科学会  

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Other Link： https://projects.repo.nii.ac.jp/?action=repository_uri&item_id=437884

Language：English   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

Objective. To clarify the pharmacological advantage of carboplatin-based intraperitoneal chemotherapy using the three-compartment mathematical model. Methods. Eleven consecutive patients in one institution underwent intraperitoneal administration of carboplatin, and 11 consecutive patients in another institution received intravenous administration. Carboplatin (AUC = 6 mg x min/ml) was diluted in 500 ml 5% glucose and administered either as an intraperitoneal bolus infusion or intravenous drip infusion during I h. Patients undergoing intravenous injection also received an infusion of 500 ml 5% glucose to obtain intraperitoneal samples. Intraperitoneal fluid and blood samples were obtained, immediately and 1, 2, 4, 8 12, and 24 h after administration. The mathematical model consisting of a three-compartment model was applied to analyze the pharmacokinetics. The model was created with simultaneous differential equations and was solved by the Runge-Kutta method. Results. The rate constants of platinum diffusion from the peritoneal cavity to serum, serum to peritoneal cavity, serum to peripheral space, peripheral space to serum, and elimination were 0.94 +/- 0.79 (mean +/- SD), 1.28 +/- 2.50, 16.50 +/- 9.26, 0.99 +/- 0.62, and 4.14 +/- 1.45 (h(-1)), respectively. When the theoretical pharmacological concentration of platinum was calculated using this mathematical model, 24-h platinum AUC in the serum was exactly the same regardless of intraperitoneal or intravenous administration of carboplatin. However, the 24-h platinum AUC in the peritoneal cavity was approximately 17 times higher when carboplatin was administered by the intraperitoneal route. Conclusion. The present pharmacological analysis suggests that intraperitoneal infusion of carboplatin is feasible not only as an intraperitoneal regional therapy but also as a more reasonable route for systemic chemotherapy. (c) 2005 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2005.06.055

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Language：English   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

Objective. To clarify the pharmacological advantage of carboplatin-based intraperitoneal chemotherapy using the three-compartment mathematical model. Methods. Eleven consecutive patients in one institution underwent intraperitoneal administration of carboplatin, and 11 consecutive patients in another institution received intravenous administration. Carboplatin (AUC = 6 mg x min/ml) was diluted in 500 ml 5% glucose and administered either as an intraperitoneal bolus infusion or intravenous drip infusion during I h. Patients undergoing intravenous injection also received an infusion of 500 ml 5% glucose to obtain intraperitoneal samples. Intraperitoneal fluid and blood samples were obtained, immediately and 1, 2, 4, 8 12, and 24 h after administration. The mathematical model consisting of a three-compartment model was applied to analyze the pharmacokinetics. The model was created with simultaneous differential equations and was solved by the Runge-Kutta method. Results. The rate constants of platinum diffusion from the peritoneal cavity to serum, serum to peritoneal cavity, serum to peripheral space, peripheral space to serum, and elimination were 0.94 +/- 0.79 (mean +/- SD), 1.28 +/- 2.50, 16.50 +/- 9.26, 0.99 +/- 0.62, and 4.14 +/- 1.45 (h(-1)), respectively. When the theoretical pharmacological concentration of platinum was calculated using this mathematical model, 24-h platinum AUC in the serum was exactly the same regardless of intraperitoneal or intravenous administration of carboplatin. However, the 24-h platinum AUC in the peritoneal cavity was approximately 17 times higher when carboplatin was administered by the intraperitoneal route. Conclusion. The present pharmacological analysis suggests that intraperitoneal infusion of carboplatin is feasible not only as an intraperitoneal regional therapy but also as a more reasonable route for systemic chemotherapy. (c) 2005 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2005.06.055

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Language：English   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

Objective. Although the Calvert Formula is the standard method to calculate the dose of carboplatin, there is no consensus how to determine the glomerular filtration rate (GFR) without Using [Cr-51]-ethylenediamine tetraacetic acid (Cr-51-EDTA). Creatinine clearance (Ccr), calculated using the Cockroft-Gault, Jelliffe, Modified-Jelliffe or Wright formulae, has been used as a substitute for the GFR. In addition to these four formulae, the Chatelut formula has been proposed as a way to calculate carboplatin clearance. Among these formulae, Jelliffe formula does not include body surface area (BSA) or body weight, it to adjust the body size and thus may have greater bias than the other four formulae ill estimating carboplatin clearance. The Purpose of this Study is to evaluate if these five formulae could equally estimate the carboplatin clearance.
Methods. Carboplatin clearance was estimated in 253 patients with gynecologic cancer who received carboplatin-based chemotherapy between January 1996 and August 2004. Ccr was estimated using the Cockroft-Gault, Jelliffe, Modified-Jelliffie or Wright formulae. Carboplatin clearance was also calculated directly by using the Chatelut formula. The five estimations of carboplatin clearance were compared with each other using the post-hoc Wilcoxon signed rank test. The median percent en-or (MPE) and the median absolute percent error (MAPE) were evaluated by comparing carboplatin clearance. The relationships between BSA and ratios of estimated carboplatin clearance (Jelliffe/Cockroft-Gault, Jelliffe/Modified-Jelliffe, Jelliffe/Wright, Jelliffe/Chatelut) were evaluated by using simple regression.
Results. The estimated carboplatin clearances were: Cockroft-Gault formula, 109.8 +/- 28.4; Jelliffe formula, 128.5 +/- 28.2; Modified-Jelliffe formula, 110.8 +/- 25.7; Wright formula, 112.2 +/- 24.3; Chatelut formula, 114.1 +/- 33.0. A statistically significant difference was observed between carboplatin clearance Calculated using Jelliffe formula and that given by each of the other four formulae. Comparing the results of the Cockroft-Gault formula with the Jellife, Modified-Jelliffe, Wright and Chatelut formulae yielded MPEs of +19%, +2%, +3% and +3% and MAPEs of 27%, 5%, 6% and 6%, respectively. There was a significant correlation between BSA and ratio of estimated carboplatin clearance (Jellife/Cockroft-Gault, Jelliffe/Modified-Jellife, Jelliffe/Wright, Jelliffe/Chatelut), with Pearson correlation coefficients of 0.928, 0.847, 0.965 and 0.839 respectively. As the BSA of patient became smaller, the differences between the carboplatin clearance calculated by the Jelliffe formula from other four formulas became larger.
Conclusions. Estimates of carboplatin clearance calculated by the Jelliffe formula tend to have greater positive bias compared to the other four formulae, particularly when the BSA of the patient is small. Ill order to conduct collaborative international Studies, it may be necessary to standardize the formula used to estimate carboplatin clearance to perforin international collaboration Studies. (c) 2005 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2005.06.003

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Language：English   Publisher：ACADEMIC PRESS INC ELSEVIER SCIENCE  

Objective. Although the Calvert Formula is the standard method to calculate the dose of carboplatin, there is no consensus how to determine the glomerular filtration rate (GFR) without Using [Cr-51]-ethylenediamine tetraacetic acid (Cr-51-EDTA). Creatinine clearance (Ccr), calculated using the Cockroft-Gault, Jelliffe, Modified-Jelliffe or Wright formulae, has been used as a substitute for the GFR. In addition to these four formulae, the Chatelut formula has been proposed as a way to calculate carboplatin clearance. Among these formulae, Jelliffe formula does not include body surface area (BSA) or body weight, it to adjust the body size and thus may have greater bias than the other four formulae ill estimating carboplatin clearance. The Purpose of this Study is to evaluate if these five formulae could equally estimate the carboplatin clearance.
Methods. Carboplatin clearance was estimated in 253 patients with gynecologic cancer who received carboplatin-based chemotherapy between January 1996 and August 2004. Ccr was estimated using the Cockroft-Gault, Jelliffe, Modified-Jelliffie or Wright formulae. Carboplatin clearance was also calculated directly by using the Chatelut formula. The five estimations of carboplatin clearance were compared with each other using the post-hoc Wilcoxon signed rank test. The median percent en-or (MPE) and the median absolute percent error (MAPE) were evaluated by comparing carboplatin clearance. The relationships between BSA and ratios of estimated carboplatin clearance (Jelliffe/Cockroft-Gault, Jelliffe/Modified-Jelliffe, Jelliffe/Wright, Jelliffe/Chatelut) were evaluated by using simple regression.
Results. The estimated carboplatin clearances were: Cockroft-Gault formula, 109.8 +/- 28.4; Jelliffe formula, 128.5 +/- 28.2; Modified-Jelliffe formula, 110.8 +/- 25.7; Wright formula, 112.2 +/- 24.3; Chatelut formula, 114.1 +/- 33.0. A statistically significant difference was observed between carboplatin clearance Calculated using Jelliffe formula and that given by each of the other four formulae. Comparing the results of the Cockroft-Gault formula with the Jellife, Modified-Jelliffe, Wright and Chatelut formulae yielded MPEs of +19%, +2%, +3% and +3% and MAPEs of 27%, 5%, 6% and 6%, respectively. There was a significant correlation between BSA and ratio of estimated carboplatin clearance (Jellife/Cockroft-Gault, Jelliffe/Modified-Jellife, Jelliffe/Wright, Jelliffe/Chatelut), with Pearson correlation coefficients of 0.928, 0.847, 0.965 and 0.839 respectively. As the BSA of patient became smaller, the differences between the carboplatin clearance calculated by the Jelliffe formula from other four formulas became larger.
Conclusions. Estimates of carboplatin clearance calculated by the Jelliffe formula tend to have greater positive bias compared to the other four formulae, particularly when the BSA of the patient is small. Ill order to conduct collaborative international Studies, it may be necessary to standardize the formula used to estimate carboplatin clearance to perforin international collaboration Studies. (c) 2005 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2005.06.003

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Objectives. This is a pilot study for a future trial to assess the efficacy and safety of combination chemotherapy with docetaxel and carboplatin in advanced or recurrent uterine cervix cancer.
Methods. The patients eligible for this study had histologically confirmed, advanced (stage IB2-IV) or recurrent uterine cervix cancer. Eligible patients had measurable lesions and must have sufficient bone marrow, renal, and liver functions. Docetaxel was administered intravenously (IV) at 60 mg/m(2) followed by IV carboplatin administration based on AUC = 6. Chemotherapy was repeated in 1-6 courses depending on the purpose of the therapy. The response was evaluated based on RECIST criteria. The toxicity grade was determined by NCI-CTC version 2.
Results. During January 2001 and April 2004, 17 patients were entered in this study. The distribution of stage was IB2, 3; IIB, 8; IIIB, 3; IVB, 1; recurrent, 2. There were 9 squamous cell carcinomas, 6 adenocarcinomas, 1 adenosquamous cell carcinoma, and 1 small cell carcinoma. The overall response rate was 76% (2 CR, 11 PR, and 4 SD). No progression of disease was observed. All 5 adenocarcinoma patients in the neoadjuvant chemotherapy group responded including 1 pathological CR. The incidences of grade 3/4 toxicities were 76% for neutrocytopenia, 12% for thrombocytopenia, and 6% for anemia. No grade 3/4 neurotoxicity was observed.
Conclusions. The combination of docetaxel and carboplatin is an effective and safe treatment for uterine cervix cancer. Further evaluation particularly targeted on cervical adenocarcinoma is warranted. (c) 2004 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2004.11.044

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Objectives. This is a pilot study for a future trial to assess the efficacy and safety of combination chemotherapy with docetaxel and carboplatin in advanced or recurrent uterine cervix cancer.
Methods. The patients eligible for this study had histologically confirmed, advanced (stage IB2-IV) or recurrent uterine cervix cancer. Eligible patients had measurable lesions and must have sufficient bone marrow, renal, and liver functions. Docetaxel was administered intravenously (IV) at 60 mg/m(2) followed by IV carboplatin administration based on AUC = 6. Chemotherapy was repeated in 1-6 courses depending on the purpose of the therapy. The response was evaluated based on RECIST criteria. The toxicity grade was determined by NCI-CTC version 2.
Results. During January 2001 and April 2004, 17 patients were entered in this study. The distribution of stage was IB2, 3; IIB, 8; IIIB, 3; IVB, 1; recurrent, 2. There were 9 squamous cell carcinomas, 6 adenocarcinomas, 1 adenosquamous cell carcinoma, and 1 small cell carcinoma. The overall response rate was 76% (2 CR, 11 PR, and 4 SD). No progression of disease was observed. All 5 adenocarcinoma patients in the neoadjuvant chemotherapy group responded including 1 pathological CR. The incidences of grade 3/4 toxicities were 76% for neutrocytopenia, 12% for thrombocytopenia, and 6% for anemia. No grade 3/4 neurotoxicity was observed.
Conclusions. The combination of docetaxel and carboplatin is an effective and safe treatment for uterine cervix cancer. Further evaluation particularly targeted on cervical adenocarcinoma is warranted. (c) 2004 Elsevier Inc. All rights reserved.

DOI： 10.1016/j.ygyno.2004.11.044

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