Faculty Profiles - NAGAO Shoji

Papers - NAGAO Shoji

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プラチナ抵抗性再発卵巣癌に対してプラチナ製剤を再投与し奏功した2症例

小川麻理子, 依田尚之, 入江恭平, 岡本和浩, 松岡敬典, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 324 2022.2

再発卵巣癌に対するPARP阻害剤維持療法の施行状況と安全性の検討

松岡敬典, 中村圭一郎, 入江恭平, 岡本和浩, 依田尚之, 小川千加子, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 496 2022.2

プラチナ抵抗性再発卵巣癌に対して非プラチナ製剤を投与した後,プラチナ製剤を再投与した症例の検討

依田尚之, 入江恭平, 岡本和浩, 松岡敬典, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 503 2022.2

MRI検査・FDG-PET検査で悪性を疑う所見を認め,術前に悪性外陰腫瘍と考えた結節性筋膜炎の一例

西田康平, 岡本和浩, 入江恭平, 松岡敬典, 依田尚之, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 343 2022.2

MRI検査・FDG-PET検査で悪性を疑う所見を認め,術前に悪性外陰腫瘍と考えた結節性筋膜炎の一例

西田康平, 岡本和浩, 入江恭平, 松岡敬典, 依田尚之, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 343 2022.2

プラチナ抵抗性再発卵巣癌に対してプラチナ製剤を再投与し奏功した2症例

小川麻理子, 依田尚之, 入江恭平, 岡本和浩, 松岡敬典, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 324 2022.2

再発卵巣癌に対するPARP阻害剤維持療法の施行状況と安全性の検討

松岡敬典, 中村圭一郎, 入江恭平, 岡本和浩, 依田尚之, 小川千加子, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 496 2022.2

プラチナ抵抗性再発卵巣癌に対して非プラチナ製剤を投与した後,プラチナ製剤を再投与した症例の検討

依田尚之, 入江恭平, 岡本和浩, 松岡敬典, 小川千加子, 中村圭一郎, 長尾昌二, 増山寿

日本産科婦人科学会雑誌 74 ( 臨増 ) S - 503 2022.2

Clinical practice guideline for the treatment of malignant ascites: section summary in Clinical Practice Guideline for peritoneal dissemination (2021). Reviewed

Keisuke Matsusaki, Kuniaki Aridome, Shigenobu Emoto, Hiroaki Kajiyama, Nobumasa Takagaki, Takao Takahashi, Hiroshi Tsubamoto, Shoji Nagao, Akihiro Watanabe, Hideaki Shimada, Joji Kitayama

International journal of clinical oncology 27 ( 1 ) 1 - 6 2022.1

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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進行上皮性卵巣癌における主治療前化学療法および腫瘍減量手術の適用(GOTIC019試験)

長尾昌二, 田村惇, 澁谷剛志, 三輪真唯子, 加藤友康, 佐藤豊実, 竹井裕二, 紙谷菜津子, 井上直樹, 中村和人, 井上彩, 藤原恵一, 鈴木光明

日本癌治療学会学術集会抄録集 59回 O8 - 1 2021.10

Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. Reviewed International journal

Keiichi Fujiwara, Hiroyuki Fujiwara, Hiroyuki Yoshida, Toyomi Satoh, Kan Yonemori, Shoji Nagao, Takashi Matsumoto, Hiroaki Kobayashi, Hughes Bourgeois, Philipp Harter, Anna Maria Mosconi, Isabel Palacio Vazquez, Alexander Reinthaller, Tomoko Fujita, Philip Rowe, Eric Pujade-Lauraine, Isabelle Ray-Coquard

Journal of gynecologic oncology 32 ( 5 ) e82 2021.9

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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Survival impact of adjuvant concurrent chemoradiotherapy after radical hysterectomy in FIGO stage IIIC1 cervical adenocarcinoma. Reviewed

Kazuhiro Suzuki, Shoji Nagao, Moyu Narita, Hiroshi Nakazawa, Takashi Shibutani, Kasumi Yamamoto, Tomoatsu Jimi, Hiroko Yano, Miho Kitai, Takaya Shiozaki, Kazuko Matsuoka, Satoshi Yamaguchi

International journal of clinical oncology 26 ( 7 ) 1322 - 1329 2021.7

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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Validation of tissue factor pathway inhibitor 2 as a specific biomarker for preoperative prediction of clear cell carcinoma of the ovary. Reviewed

Etsuko Miyagi, Noriaki Arakawa, Kentaro Sakamaki, Naho Ruiz Yokota, Takeharu Yamanaka, Yuki Yamada, Satoshi Yamaguchi, Shoji Nagao, Yasuyuki Hirashima, Yuka Kasamatsu, Hisamori Kato, Tae Mogami, Yohei Miyagi, Hiroshi Kobayashi

International journal of clinical oncology 26 ( 7 ) 1336 - 1344 2021.7

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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Docetaxel and carboplatin chemotherapy for treating patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix: a phase II study. Reviewed

Muneaki Shimada, Shinya Sato, Tadahiro Shoji, Shoji Nagao, Hideki Tokunaga, Kotaro Sueoka, Kazuhiro Takehara, Keiichiro Nakamura, Satoshi Yamaguchi, Junzo Kigawa

International journal of clinical oncology 26 ( 7 ) 1314 - 1321 2021.7

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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Treatment strategy for locally advanced squamous cell cervical cancer with clinically positive pelvic lymph nodes metastasis. Reviewed International journal

Takashi Shibutani, Shoji Nagao, Kazuhiro Suzuki, Kasumi Yamamoto, Tomoatsu Jimi, Hiroko Yano, Miho Kitai, Takaya Shiozaki, Satoshi Yamaguchi

The journal of obstetrics and gynaecology research 47 ( 7 ) 2442 - 2448 2021.7

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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Prognostic Factors of Advanced Cervical Cancer with Distant Metastasis Reviewed

Miho Kitai, Shoji Nagao, Kayoko Tsujino, Satoshi Yamaguchi

Indian Journal of Gynecologic Oncology 19 ( 2 ) 2021.6

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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Successful endoscopic treatment for high-grade cervical intraepithelial neoplasia with gross lesions of the vagina Reviewed

Koyo Yamamoto, Miho Kitai, Kasumi Yamamoto, Toshiko Sakuma, Shoji Nagao, Satoshi Yamaguchi

Gynecology and Minimally Invasive Therapy 10 ( 2 ) 124 - 126 2021.4

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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Quality of life assessment of cell-free and concentrated ascites reinfusion therapy during initial treatment for advanced ovarian cancer: A prospective cohort study. Reviewed International journal

Kasumi Yamamoto, Shoji Nagao, Tomoharu Tsu, Taeko Matsushima, Yoshimi Ishido, Moyu Narita, Kazuhiro Suzuki, Hiroshi Nakazawa, Takashi Shibutani, Tomoatsu Jimi, Hiroko Yano, Miho Kitai, Takaya Shiozaki, Kazuko Matsuoka, Satoshi Yamaguchi

The journal of obstetrics and gynaecology research 47 ( 4 ) 1536 - 1543 2021.4

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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Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer. Reviewed International journal

Kazuhiro Takehara, Takashi Matsumoto, Junzo Hamanishi, Kosei Hasegawa, Motoki Matsuura, Kiyonori Miura, Shoji Nagao, Hidekatsu Nakai, Naotake Tanaka, Hideki Tokunaga, Kimio Ushijima, Hidemichi Watari, Yoshihito Yokoyama, Yoichi Kase, Shuuji Sumino, Ajit Suri, Hiroaki Itamochi, Nobuhiro Takeshima

Journal of gynecologic oncology 32 ( 2 ) e21 2021.3

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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Phase II study of a new multidisciplinary therapy using once every 3 week carboplatin plus dose-dense weekly paclitaxel before and after radical hysterectomy for locally advanced cervical cancer. Reviewed

Shoji Nagao, Kasumi Yamamoto, Tetsuro Oishi, Satoshi Yamaguchi, Kazuhiro Takehara, Muneaki Shimada, Junzo Kigawa

International journal of clinical oncology 26 ( 1 ) 207 - 215 2021.1

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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Papers - NAGAO Shoji