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

Surgical site infections (SSIs) after thyroid surgery are rare complications, with incidence rates of 0.3%-1.6%. Using a Japanese database, we conducted exploratory analyses on the incidence of SSIs, investigated the incidence of SSIs by the National Nosocomial Infections Surveillance risk index, and identified the causative bacteria of SSIs. SSIs occurred in 50 (0.7%) of 7388 thyroid surgery cases. Risk index-0 patients had the lowest incidence rate of SSIs (0.41%). The incidence of SSIs in risk index-1 patients was 3.05 times the incidence of SSIs in risk index-0 patients. The rate of SSI occurrence for risk index-2 patients was 4.22 times the rate of SSI occurrence for risk index-0 patients. Thirty-one bacterial species were identified as the cause of SSIs in thyroid surgery cases, of which 12 (38.7%) SSIs were caused by Staphylococcus aureus and Staphylococcus epidermidis. Of the nine SSIs caused by Staphylococcus aureus, 55.6% (five cases) were attributed to methicillin-resistant Staphylococcus aureus. Therefore, routine prophylactic antibiotic administration should be avoided, while the target for administration should be narrowed, according to the SSI risk. Administration of prophylactic antibiotics, such as 2 g piperacillin or 1 g cefazolin, is considered appropriate.

DOI： 10.1111/iwj.14046

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DOI： 10.1007/s12282-023-01479-w

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BACKGROUND: Cancer patients experience various forms of psychological distress. Their distress, mainly in the form of depression and anxiety, leads to poor quality of life, increased medical spending due to frequent visits, and decrease in treatment adherence. It is estimated that 30-50% among them would require support from mental health professionals: in reality, much less actually receive such support partly due to a shortage of qualified professionals and also due to psychological barriers in seeking such help. The purpose of the present study is to develop the easily accessible and the most efficient and effective smartphone psychotherapy package to alleviate depression and anxiety in cancer patients. METHODS: Based on the multiphase optimization strategy (MOST) framework, the SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience project (SMILE-AGAIN project) is a parallel-group, multicenter, open, stratified block randomized, fully factorial trial with four experimental components: psychosocial education (PE), behavioral activation (BA), assertion training (AT), and problem-solving therapy (PS). The allocation sequences are maintained centrally. All participants receive PE and then are randomized to the presence/absence of the remaining three components. The primary outcome of this study is the Patient Health Questionnaire-9 (PHQ-9) total score, which will be administered as an electronic patient-reported outcome on the patients' smartphones after 8 weeks. The protocol was approved by the Institutional Review Board of Nagoya City University on July 15, 2020 (ID: 46-20-0005). The randomized trial, which commenced in March 2021, is currently enrolling participants. The estimated end date for this study is March 2023. DISCUSSION: The highly efficient experimental design will allow for the identification of the most effective components and the most efficient combinations among the four components of the smartphone psychotherapy package for cancer patients. Given that many cancer patients face significant psychological hurdles in seeing mental health professionals, easily accessible therapeutic interventions without hospital visits may offer benefits. If an effective combination of psychotherapy is determined in this study, it can be provided using smartphones to patients who cannot easily access hospitals or clinics. TRIAL REGISTRATION: UMIN000041536, CTR. Registered on 1 November 2020  https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301 .

DOI： 10.1186/s13063-023-07307-y

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Authorship：Last author   Publisher：Japanese Society of Clinical Pharmacology and Therapeutics  

DOI： 10.3999/jscpt.54.2_63

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Assessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials. The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials. The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.

DOI： 10.1093/jjco/hyad007

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BACKGROUND/AIM: Currently, several ongoing prospective studies are investigating the safety of breast surgery omission in patients with breast cancer who are exceptional responders to neoadjuvant chemotherapy. However, there is little information about the preferences of these patients regarding omission of breast surgery. PATIENTS AND METHODS: We conducted a questionnaire survey to assess preferences regarding omission of breast surgery among patients with breast cancer who had human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors and good clinical response after neoadjuvant chemotherapy. Patients' estimation of the risk of ipsilateral breast tumor recurrence (IBTR) after definitive surgery or breast surgery omission was also assessed. RESULTS: Of 93 patients, only 22 (23.7%) said they would omit breast surgery. Under the scenario of omitting breast surgery, the 5-year IBTR rate estimated by patients who said they would omit breast surgery was significantly lower (median, 10%) than the rate estimated by patients who preferred undergoing definitive surgery (median, 30%) (p=0.017). CONCLUSION: The proportion of our surveyed patients who were willing to omit breast surgery was low. Patients who said they preferred to omit breast surgery overestimated the 5-year IBTR risk.

DOI： 10.21873/invivo.13143

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

DOI： 10.1177/01410768221095240

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

The area of residual tumor (ART) is a prognostic factor in patients treated with neoadjuvant chemotherapy (NAC) for lung, pancreatic, and rectal cancers. This study aimed to evaluate the usefulness of ART as a method for predicting the prognosis of triple-negative breast cancer (TNBC) patients after neoadjuvant chemotherapy. We included 143 patients with TNBC treated with NAC. The ART at the maximum cut surface of the residual tumor was measured. We divided the patients into three groups: ART-0 (ART=0 mm2 ), ART-low (0 mm2 < ART ≤ 136mm2 ), and ART-high (ART > 136 mm2 ), and compared their clinicopathological factors and prognosis. There were no significant differences in both recurrence-free survival (RFS) and overall survival (OS) between ART-0 and ART-low; however, the ART-high group had significantly shorter RFS and OS than the ART-0 and ART-low groups. Multivariate analysis showed that ART-0, and -low and ypN (-) were independent favorable prognostic factors for RFS. Groups with both ART-low and ypN(-) as well as those with ART-0 and ypN(-) showed significantly longer OS and RFS than the other groups (p<0.05). Moreover, there was no significant difference in the RFS and OS between the ART-0 and ypN(-) groups and the ART-low and ypN(-) groups (p=0.249 and p=0.554, respectively). We concluded that ART is a candidate histopathological evaluation method for predicting the prognosis of TNBC patients treated with NAC. Furthermore, postoperative chemotherapy could be omitted in patients with ART-0 and ypN(-) (pathological complete response) and those with ART-low and ypN(-).

DOI： 10.1111/cas.15273

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We present a case of two recurrences in the brachial lymph nodes after initial resection, which was performed for radical cure. A 66-year-old woman was diagnosed with left breast cancer T4bN3cM0 Stage IIIC and an immunohistochemistry assay showed estrogen receptor (ER) positivity (5%), progesterone-receptor (PgR) positivity (1%), human epidermal growth factor receptor-2 (HER2) positivity (3+), and low Ki-67 (15%). After four courses of adriamycin and cyclophosphamide, followed by four courses of trastuzumab plus docetaxel, the patient underwent left mastectomy and axillary dissection. Postoperatively, she was diagnosed with breast cancer ypT1cN0M0, and trastuzumab and anastrozole were started. Postoperative irradiation was performed. Three years and 5 months after the initial breast cancer surgery, she had left brachial lymph node recurrence. It was resected, and tamoxifen was administered postoperatively. One year and 9 months after, she had another left brachial lymph node recurrence, and it was resected. She received radiation therapy to her upper limb and started taking exemestane. After 1 year and 3 months since the second recurrence surgery, there has been no recurrence. Our case suggests that the replacement of regional lymph nodes with tumor cells may result in the reconstruction of lymph flow to the upper arm and the development of brachial lymph node metastasis. There are no reports of resection of the recurrent tumor in the brachial lymph node for curative treatment. Therefore, careful follow-up is important in the future.

DOI： 10.1159/000525295

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

INTRODUCTION: Although there is a lack of data on health-state utility values (HSUVs) for calculating quality-adjusted life-years in Japan, cost-utility analysis has been introduced by the Japanese government to inform decision making in the medical field since 2016. OBJECTIVES: This study aimed to determine whether the Lloyd model which was a predictive model of HSUVs for metastatic breast cancer (MBC) patients in the UK can accurately predict actual HSUVs for Japanese patients with MBC. DESIGN: The prospective observational study followed by the validation study of the clinical predictive model. SETTING AND PARTICIPANTS: Forty-four Japanese patients with MBC were studied at 336 survey points. METHODS: This study consisted of two phases. In the first phase, we constructed a database of clinical data prospectively and HSUVs for Japanese patients with MBC to evaluate the predictive accuracy of HSUVs calculated using the Lloyd model. In the second phase, Bland-Altman analysis was used to determine how accurately predicted HSUVs (based on the Lloyd model) correlated with actual HSUVs obtained using the EuroQol 5-Dimension 5-Level questionnaire, a preference-based measure of HSUVs in patients with MBC. RESULTS: In the Bland-Altman analysis, the mean difference between HSUVs estimated by the Lloyd model and actual HSUVs, or systematic error, was -0.106. The precision was 0.165. The 95% limits of agreement ranged from -0.436 to 0.225. The t value was 4.6972, which was greater than the t value with 2 degrees of freedom at the 5% significance level (p=0.425). CONCLUSIONS: There were acceptable degrees of fixed and proportional errors associated with the prediction of HSUVs based on the Lloyd model for Japanese patients with MBC. We recommend that sensitivity analysis be performed when conducting cost-effectiveness analyses with HSUVs calculated using the Lloyd model.

DOI： 10.1136/bmjopen-2020-046273

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

We aimed to determine the dynamic trends in health state utility values (HSUVs) in patients with end-stage breast cancer. We selected 181 patients comprising 137 with primary breast cancer (PBC) and 44 with metastatic breast cancer (MBC) (28 survivors and 16 patients with MBC death). HSUVs were 0.90 and 0.89 in patients with PBC and 0.83 and 0.80 in those with MBC (survivors) at 6 and 3 months, respectively, before the end of the observation period; these values were 0.73 and 0.66, respectively, in those with MBC (deceased) during the aforementioned period. The root-mean-squared error (RMSE) for the decrease in HSUVs over 3 months was 0.10, 0.096, and 0.175 for patients with PBC, MBC (survivors), and MBC (deceased), respectively. One-way analysis of variance for differences in absolute error among the groups was significant (p = 0.0102). Multiple comparisons indicated a difference of 0.068 in absolute error between patients with PBC and those with MBC (deceased) (p = 0.0082). Patients with end-stage breast cancer had well-controlled HSUVs 3 months before death, with a sharp decline in HSUVs in the 3 months leading up to death.

DOI： 10.3390/curroncol28050356

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In a substantial number of patients, ductal carcinoma in situ (DCIS) of the breast will never progress to invasive ductal carcinoma, and these patients are often overtreated under the current clinical criteria. Although various candidate markers are available, relevant markers for delineating risk categories have not yet been established. In this study, we analyzed the clinical characteristics of 431 patients with DCIS and performed whole-exome sequencing analysis in a 21-patient discovery cohort and targeted deep sequencing analysis in a 72-patient validation cohort. We determined that age <45 years, HER2 amplification, and GATA3 mutation are possible indicators of relapse. PIK3CA mutation negativity and PgR negativity were also suggested to be risk factors. Spatial transcriptome analysis further revealed that GATA3 dysfunction upregulates epithelial-to-mesenchymal transition and angiogenesis, followed by PgR downregulation. These results reveal the existence of heterogeneous cell populations in DCIS and provide predictive markers for classifying DCIS and optimizing treatment.

DOI： 10.1038/s42003-021-01959-9

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Authorship：Lead author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：Oxford University Press (OUP)  

<title>Abstract</title>
In April 2016, the Japanese government introduced health technology assessment as a response to rising medical expenses due to ‘medical innovation’. This study investigates how Japanese breast cancer patients who received treatment in Japan consider the financial value (willingness-to-pay; WTP) for their life and health by using the contingent valuation method (CVM) prospectively. First, 168 patients (84 primary breast cancer patients and 84 metastatic breast cancer patients) were pre-examined their WTP with dichotomous-choice method survey form. Next, 1,596 patients (798 primary breast cancer patients and 798 metastatic breast cancer patients) will be surveyed to their WTP for hypothetical scenarios in CVM. Based on our results, we will construct an evaluation axis from the patients’ viewpoint for the cost-effectiveness of clinical trials to establish standard treatments for breast cancer. We believe this research can contribute to create a meaningful healthcare system for patients, clinicians, industries, and healthcare policymakers.

DOI： 10.1093/jjco/hyaa241

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

BACKGROUND: Advance care planning (ACP) is a process that supports adults in understanding and sharing their personal values, life goals, and preferences regarding future medical care. We examined the current status of ACP and end-of-life (EOL) communication between oncologists and patients with metastatic breast cancer. MATERIALS AND METHODS: We conducted a survey among 41 institutions that specialize in oncology by using an online tool in October 2019. Participants (118 physicians) from 38 institutions completed a 39-item questionnaire that measured facility type and function; physicians' background and clinical approach, education about EOL communication, and understanding about ACP; and the current situation of ACP and EOL discussions. RESULTS: Ninety-eight responses concerning physicians' engagement in ACP with patients were obtained. Seventy-one (72%) answered that they had engaged in ACP. Among these, 23 (33%) physicians used a structured format to facilitate the conversation in their institutions, and only 6 (8%) settled triggers or sentinel events for the initiation of ACP. In the multivariable analysis, only the opportunity to learn communication skills was associated with physicians' engagement with ACP (odds ratio: 2.8, 95% confidence interval: 1.1-7.0). The frequency and timing of communication about ACP and EOL care with patients substantially varied among the oncologists. Communication about patients' life expectancy was less frequent compared with other topics. CONCLUSION: The opportunity to improve EOL communication skills promoted physicians' engagement with ACP among patients with metastatic/advanced breast cancer. However, there were still substantial variabilities in the method, frequency, and timing of ACP and EOL communication among the oncologists. IMPLICATIONS FOR PRACTICE: This study found that the opportunity to improve end-of-life (EOL) communication skills promoted physicians' engagement in advance care planning (ACP) among patients with metastatic/advanced breast cancer. All oncologists who treat said patients are encouraged to participate in effective education programs concerning EOL communication skills. In clinical practice, there are substantial variabilities in the method, frequency, and timing of ACP and EOL communication among oncologists. As recommended in several clinical guidelines, the authors suggest a system that identifies patients who require conversations about their care goals, a structured format to facilitate the conversations, and continuous measurement for improving EOL care and treatment.

DOI： 10.1002/onco.13640

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Other Link： https://onlinelibrary.wiley.com/doi/full-xml/10.1002/onco.13640

Publishing type：Research paper (scientific journal)   Publisher：Scientific Research Publishing, Inc.  

DOI： 10.4236/jct.2021.1210047

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An amendment to this paper has been published and can be accessed via the original article.

DOI： 10.1186/s13063-020-04408-w

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© 2020 The Author(s). Background: Trastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast cancer (HER2+ mBC) but has some safety issues due to taxane-induced toxicities. This has led to ongoing efforts to seek less toxic alternatives to taxanes that are equally effective when used in combination with Tmab plus Pmab. This study aims to show the non-inferiority of eribulin, a non-taxane microtubule inhibitor, against taxane, as a partner for dual HER2 blockade. Methods/design: This multicenter, randomized, open-label, parallel-group, phase III study will involve a total of 480 Japanese women with HER2+ mBC who meet the following requirements: (1) age 20-70 years; (2) no prior cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥ 6 months after prior neoadjuvant or adjuvant cytotoxic chemotherapy; (4) presence of any radiologically evaluable lesion; (5) left ventricular ejection fraction ≥ 50%; (6) Eastern Cooperative Oncology Group performance status score of 0 or 1; (7) adequate organ function; and (8) life expectancy of at least 6 months. They will be randomized 1:1 to receive eribulin (1.4 mg/m2 on days 1 and 8) or taxane (docetaxel 75 mg/m2 on day 1 or paclitaxel 80 mg/m2 on days 1, 8, and 15) in combination with Tmab (8 mg/kg then 6 mg/kg) plus Pmab (840 mg then 420 mg) on day 1 of each 21-day cycle. The treatment will be continued until disease progression or unmanageable toxicity. The primary endpoint is progression-free survival as per investigator according to RECIST v1.1 criteria. Key secondary endpoints include objective response rate, overall survival, quality of life and safety. Non-inferiority will be tested with two margins of 1.33 and 1.25 in a stepwise manner. If non-inferiority is shown with a margin of 1.25, superiority will then be tested. Discussion: If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first-or second-line treatment option for HER2+ mBC in Japan. Trial registration: ClinicalTrials.gov, ID: NCT03264547. Registered on 28 June 2017.

DOI： 10.1186/s13063-020-04341-y

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：(有)科学評論社  

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BACKGROUND: In treating human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, the efficacy of capecitabine combined with HER2-directed agents such as trastuzumab and lapatinib is supported by some evidence. The combination of T-DM1 and S-1, another oral 5-FU, may be a safe alternative treatment for metastatic breast cancer. OBJECTIVES: The optimal dose of S-1 was evaluated in combination with T-DM1 for patients with HER2-positive advanced or metastatic breast cancer. The safety and clinical response of this combination treatment were also assessed. METHODS: This 3 + 3 dose-escalation study of S-1 given for the first 2 of 3 weeks, in combination with T-DM1 (3.6 mg/kg given every 3 weeks) to patients with trastuzumab-pretreated HER2-positive advanced or metastatic breast cancer was designed to evaluate the dose-limiting toxicity (DLT) occurrence in the first cycle. We also evaluated the safety and clinical activity of this combination treatment in multiple cycles. Two different dose levels of S-1 (65 and 80 mg/m2/day) were planned, although the capecitabine arm was abandoned because of slow recruitment. RESULTS: Twelve out of the 13 patients enrolled were evaluable for DLT. One DLT (grade ≥3 non-hematological adverse events) occurred at dose level 0, leading to the expansion of this cohort to 6 patients, with an additional DLT (≥7 days discontinuation of medication), while no DLT occurred at dose level 1. As a result, the maximum tolerable dose of S-1 was determined to be 80 mg/m2/day for 14 days with T-DM1 3.6 mg/kg, repeated every 3 weeks. Two patients had grade 3 thrombocytopenia at dose level 0, and 1 patient at dose level 1. CONCLUSIONS: S-1 can be safely combined with the clinically relevant dose of T-DM1 in patients with HER2-positive advanced or metastatic breast cancer. Further evaluation with a larger sample size is required for efficacy assessment.

DOI： 10.1159/000497276

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：(有)科学評論社  

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Authorship：Lead author,　Corresponding author  

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Libertas Academica Ltd.  

The double-stranded RNA-binding protein TARBP2 has been suggested to act as an upstream regulator of breast cancer metastasis by destabilizing transcripts of the possible metastasis suppressors amyloid precursor protein (APP) and ZNF395. We examined this hypothesis by immunostaining of TARBP2, APP, and ZNF395 in 200 breast cancer specimens using tissue microarrays and analyzed the relationships between expression levels and clinicopathological parameters and prognosis. Increased TARBP2 overexpression was associated with shorter overall survival and diseasefree survival, and increased but not reduced APP expression correlated with lower overall survival and disease-free survival. ZNF395 expression levels had no prognostic value, but reduced expression correlated with reduced lymph node metastasis. There was no significant relationship between TARBP2 overexpression and reduced APP and/or ZNF395 expression. Patients with tumors with higher TARBP2 or APP expression had unfavorable prognoses. Although reduced ZNF395 expression was significantly related to reduced lymph node metastasis, further studies are needed to clarify the role of TARBP2/ APP/ZNF395 in breast cancer.

DOI： 10.4137/BCBCR.S40820

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：(株)篠原出版新社  

患者は59歳、女性。2010年右乳癌(cT1N0M0)の診断で右乳房温存手術を実施し、術後放射線治療およびホルモン療法を行った。2014年多発肝転移の診断で化学療法を開始した。一時的に効果は認められたが、徐々に病勢は進行していき、2015年排尿困難を主訴に受診、精査の結果乳癌の尿道転移の診断に至った。放射線治療を行ったところ尿道腫瘍は画像上消失し、自尿での排尿を認め、膀胱ろうの増設や尿道カテーテルの留置を要さずに自宅退院が可能となった。約1ヵ月後肝転移の増悪により患者は死亡したが、その間Activities of Daily Living(ADL)が高い状態で療養することができた。乳癌患者で排尿困難が現れた際には泌尿器系の転移検索も考慮すべきであり、また今回の症例では放射線治療が非常に効果的であった。(著者抄録)

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：日本内分泌外科学会・日本甲状腺外科学会  

症例は64歳の男性。2011年春より腹痛、食欲不振、体重減少を認めていた。2012年2月にアルコール性慢性膵炎急性増悪および十二指腸潰瘍と診断された。また血液検査でCa 12.2mg/dl、iPTH 396pg/dlと異常高値を指摘され原発性副甲状腺機能亢進症と診断された。身体所見では右前頸部の鎖骨背面に硬い腫瘤の一部を触知した。頸部超音波およびMRIでも同部位に一致して24mmの一部境界不明瞭な不整形腫瘤を認めた。99mTc-MIBIシンチグラフィでも甲状腺右葉下極尾側に早期像・後期像ともに異常集積を認めた。以上より臨床的に副甲状腺癌を疑い甲状腺右葉および右下副甲状腺腫瘍切除+胸腺舌部を含めた気管周囲リンパ節郭清術(II、右III、IV番)を施行した。術後の病理組織診断では副甲状腺異型腺腫と診断された。副甲状腺癌と副甲状腺異型腺腫を術前に診断することは困難とされ、本症例でも診断および治療法の決定に難渋した。稀な副甲状腺異型腺腫の診断と治療について文献的考察を含めて報告する。(著者抄録)

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Other Link： https://search.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2015&ichushi_jid=J06244&link_issn=&doc_id=20151229380015&doc_link_id=10.11226%2Fjaesjsts.32.4_290&url=https%3A%2F%2Fdoi.org%2F10.11226%2Fjaesjsts.32.4_290&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_3.gif

Language：English   Publishing type：Thesis (other)  

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：WILEY-BLACKWELL  

Objective: The aims of the present study were as follows: (i) to clarify the proportion of women who experience psychological distress during breast cancer diagnosis and (ii) to identify the predictors of psychological distress related to the diagnostic process.
Methods: This was a longitudinal prospective study of women who required further breast examination. Questionnaires were administered at pre-medical consultations (Time 1), after describing radiological examination (Time 2), and after explaining pathological findings (Time 3). All participants completed Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Cancer Therapy-Breast, and Functional Assessment of Chronic Illness Therapy-Spiritual subscale at Time 1 to identify predictors. Participants also completed HADS at Times 2 and 3 to identify the presence or absence of psychological distress.
Results: Of the 222 eligible patients, at Time 2, 31 (22.6%) participants with no clinical abnormalities and 39 (45.9%) participants with abnormal findings had HADS scores of &gt;= 11 points (chi(2) test, 13.14; p &lt; 0.001). At Time 3, 14 (28.0%) participants with benign breast changes and 24 (68.6%) participants with breast cancer had scores of &gt;= 11 (chi(2) test, 13.71; p &lt; 0.001). Higher HADS scores at Time 1 were associated with the presence of psychological distress at all stages of breast cancer diagnosis. Advanced tumor stage was a predictor of psychological distress for participants with breast cancer (odds ratios = 3.314, 95% confidence interval = 1.033-9.509; p = 0.044).
Conclusion: These results suggest that intensive psychological intervention is necessary for breast cancer patients with large tumors, as well as for women with suspected breast cancer with high HADS scores at pre-consultation. Copyright (C) 2012 John Wiley & Sons, Ltd.

DOI： 10.1002/pon.3023

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

Background: This retrospective study aimed to determine whether adverse events are more common in docetaxel followed by cyclophosphamide (TC) as compared to the reverse infusion order (rTC). Methods: A retrospective analysis was undertaken at a single institution for 92 consecutive cases treated with TC or rTC for stage I-III breast cancer in a neoadjuvant/adjuvant setting between December 2006 and June 2011. TC was administered during the first 2.5 years and rTC in the latter 2 years. Results: Among the 92 cases, 50 were in the TC arm and 42 in the rTC arm. Fatigue (72.0 vs. 23.8%), edema (48.0 vs. 16.7%), peripheral neuropathy (66.0 vs. 14.3%), myalgia (48.0 vs. 9.5%) and stomatitis (48.0 vs. 16.7%) occurred significantly more often in cases receiving TC compared to rTC, respectively. Conclusion: Nonhematological toxicities are less common in cases receiving rTC in comparison to those receiving TC. Copyright (C) 2013 S. Karger AG, Basel

DOI： 10.1159/000351112

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：IVYSPRING INT PUBL  

Background: Hepatitis C virus (HCV) infection is one of the major causes of chronic liver disease, and more than 880,000 people are estimated to be infected with HCV in Japan. Little information is available on the outcomes of HCV during chemotherapy for solid tumors, and the impact of HCV infection on toxicity of chemotherapy is unknown.
Materials and methods: We performed a retrospective survey of 1,110 patients diagnosed with breast cancer between January 2006 and March 2011 at our institution. All patients had been screened for hepatitis C serology at diagnosis of breast cancer. We retrospectively investigated the change in HCV load and the toxicities of chemotherapy, based on review of their medical records.
Results: 23 patients were identified as having a positive test for anti-HCV antibodies. Ten of these patients received chemotherapy. Their median age was 66 years. No patient had decompensated liver disease at baseline. Eight patients received cytotoxic agents with or without trastuzumab, and two patients received trastuzumab alone. Four of eight patients who received cytotoxic chemotherapy developed febrile neutropenia and one developed transaminases elevation. Serum HCV-ribonucleic acid (RNA) level before and after chemotherapy was evaluated in six patients. Median serum HCV-RNA level at baseline and after chemotherapy was 6.5 and 6.7 logIU/ml, respectively.
Conclusion: Chemotherapy for breast cancer patients with HCV infection is feasible, and viral load doesn't change during the chemotherapy.

DOI： 10.7150/jca.6231

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More than 50% of patients with multiple endocrine neoplasia type 1 (MEND develop gastroenteropancreatic neuroendocrine tumors (GEPNETs), and insulinoma is the second most common functioning GEPNET. Compared to other functioning and nonfunctioning GEPNETs in MEN1, insulinoma is considered to develop at a younger age. To clarify the clinical features of insulinoma developed in Japanese patients with MEN I, a recently constructed database of Japanese MEN I patients was analyzed. Among 560 registered cases, insulinoma was seen in 69 patients and information on age at diagnosis was available for 54 patients. Tumors predominantly occurred in the body and tail of the pancreas. The mean age at diagnosis of insulinoma (34.8 +/- 16.7 yrs) was significantly younger than that of gastrinoma (50.6 +/- 14.3 yrs) and nonfunctioning tumor (44.7 +/- 13.3 yrs) in patients with MEN I. Patients diagnosed as having insulinoma during middle-age (30 - 49 yrs) tended to have a long period from appearance of hypoglycemic symptoms to diagnosis of the tumor. Of note, 13 patients (24%) were diagnosed as having insulinoma before 20 yrs of age. Such young onset was not seen in other GEPNETs. Since the development of GEPNETs during adolescence is quite rare, insulinoma diagnosed before 20 yrs strongly suggests the presence of MEN1 and warrants further investigation, including MEN1 genetic testing. Also, clinicians should be aware that insulinoma can often be missed in middle-aged patients.

DOI： 10.1507/endocrj.EJ12-0173

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：JAPAN ENDOCRINE SOC  

The morbidity and mortality of individuals with multiple endocrine neoplasia type 1 (MEN I) can be reduced by early diagnosis of MENI and related endocrine tumors. To find factors contributing to early diagnosis, we collected clinical information on MENI patients through a MEN study group, "MEN Consortium of Japan" and analyzed the time of initial symptom-dependent detection of parathyroid tumors, gastro-entero-pancreatic neuroendocrine tumors (GEPNETs) and pituitary tumors, and that of tumor detection-dependent MENI diagnosis in 560 patients. Main tumors were identified up to 7.0 years after symptoms appeared and there was no difference in age at the diagnosis of GEPNETs alone between probands and family members. In patients with typical symptoms (peptic ulcers, urolithiasis, fasting hypoglycemia, bone fracture/loss and amenorrhea), the mean interval between symptom manifestation and tumor detection was extended up to 9.6 years. In particular, 21.7% (5/23) of patients with amenorrhea were diagnosed with pituitary tumors in under one year. In patients with peptic ulcers (from parathyroid tumors or GEPNETs) and urolithiasis (from parathyroid tumors), the interval was positively correlated with age at tumor detection. The interval between tumor detection and MENI diagnosis was also prolonged to approximately four years in patients with fasting hypoglycemia (from GEPNETs) and amenorrhea. A substantial delay in the diagnosis of symptom-related tumors and subsequent MENI and inadequate screening of GEPNETs in family members were indicated. A greater understanding of MEN! may assist medical practitioners to make earlier diagnoses, to share patients' medical information and to give family members sufficient disease information.

DOI： 10.1507/endocrj.EJ12-0071

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

Nodular fasciitis of the breast is a rare, benign, soft-tissue tumor that can clinically and radiologically mimic invasive ductal carcinoma. A 25-year-old woman presented with a palpable lesion in the lower inner aspect of the left breast. Radiologically, breast carcinoma could not be excluded. On examination of the core needle biopsy, the tumor was characterized histologically as a spindle cell tumor. Excisional biopsy was performed. The tumor was diagnosed as nodular fasciitis of the breast. The imaging and histological findings of this case are presented.

DOI： 10.1007/s12282-009-0149-1

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

Objective Multiple endocrine neoplasia type 1 (MEN1) is less well recognized in Asian countries, including Japan, than in the West. The clinical features and optimal management of MEN1 have yet to be clarified in Japan. The aim of this study was to clarify the clinical features of Japanese patients with MEN1. Design/Patients We established a MEN study group designated the ` MEN Consortium of Japan' in 2008, and asked physicians and surgeons to provide clinical and genetic information on patients they had treated. Of 680 registered patients, 560 were analysed. Measurements Clinical and genetic features of Japanese patients with MEN1 were examined. Results Primary hyperparathyroidism, gastroenteropancreatic neuroendocrine tumours (GEPNET), and pituitary tumours were seen in 94 4%, 58 6% and 49 6% of patients, respectively. The prevalence of insulinoma was higher in the Japanese than in the West (22% vs 10%). In addition, 37% of patients with thymic carcinoids were women, while most were men in western countries. The MEN1 mutation positive rate was 91 7% in familial cases and only 49 3% in sporadic cases. Eight novel mutations were identified. Despite the availability of genetic testing for MEN1, the application of genetic testing, especially presymptomatic diagnosis for at-risk family members appeared to be insufficient. Conclusions We established the first extensive database for Asian patients with MEN1. Although the clinical features of Japanese patients were similar to those in western countries, there were several characteristic differences between them.

DOI： 10.1111/j.1365-2265.2011.04227.x

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Language：Japanese   Publisher：国家公務員共済組合連合会  

近年、乳癌の増加に伴い乳房再建を希望する患者も増加している。乳房の再建には乳癌手術時より再建を行う一次再建と、乳癌手術後にある期間をおいてから再建を開始する二次再建がある。当院では希望する患者に対し乳腺・内分泌外科、形成外科連携のもと積極的に一次再建を行っているので、その概要を報告する。乳房再建には自家組織(皮弁形成術など)を用いるものと、人工物(インプラント)を用いる方法とがある。当院ではインプラントによる再建を希望する患者が多い。本方法は、乳癌手術時に大胸筋下にティッシュ・エキスパンダーを留置し、術後2週より拡張を開始し、拡張後にエキスパンダーをインプラントに置き替えるものである。また乳頭再建は局所皮弁による方法を中心に行い、乳輪の再建は色素注入(Tattoo法)により行っている。インプラントに関連した早期の合併症は少なく、整容的にも満足な結果が得られている。(著者抄録)

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52歳男性。患者は食道癌および中咽頭癌に対する内視鏡治療の目的で、はじめ消化器内科へ受診となった。術前精査の頸部エコーでは右外側区域にリンパ節と考えられる15mm大の腫瘤が認められ、また甲状腺右葉には5mm大の腫瘤が確認された。そこで、食道癌および中咽頭癌に対し内視鏡下粘膜下層剥離術を行ったところ、病理組織学的に頸部食道扁平上皮癌、中咽頭扁平上皮癌と診断された。以後、右頸部腫瘤の精査目的で耳鼻咽喉科へ紹介となり、原発不明癌の頸部リンパ節転移の疑いで右頸部外側区域リンパ節郭清術が施行され、腫瘤が右内頸静脈へ浸潤していることから合併切除された。その結果、、病理組織学的に甲状腺乳頭癌のリンパ節転移で、術後は内分泌外科にて甲状腺全摘および中央区域リンパ節郭清が行われた。だが、Stage IVAの甲状腺乳頭癌であったため、あわせて131I内照射治療も施行された。

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DOI： 10.1200/JCO.2010.31.2801

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52歳女。患者は左乳房腫瘤を主訴とした。マンモグラフィで左MLO viewのL領域、左CC viewのS領域に局所性非対称陰影が認められ、カテゴリー3であった。また、超音波(US)ならびに造影MRIでは境界不明瞭で内部が不均一な腫瘤影がみられた。乳癌を疑い、針生検を施行したところ、病理組織像では小葉周囲を中心にリンパ球浸潤が認められ、更にリンパ球、形質細胞とともに多核巨細胞が確認された。一方、多核巨細胞を伴う類上皮細胞性肉芽腫の小葉中心性分布も認められ、以上より、本症例は肉芽腫性乳腺炎と診断された。治療としてプレドニゾロン20mgの内服治療を行なった結果、7週間でUS上にて腫瘤が不明瞭となり、ブレドニゾロンの減量を開始、13週間で腫瘤影はほぼ消失した。尚、ステロイドによる副作用は認められず、MRIでも腫瘤影消失がみられ、臨床的に完治したと判断された。目下、6ヵ月ごとの触診、USでの経過観察しているが、再発は認められていない。

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：Japanese Journal of Cancer and Chemotherapy Publishers Inc.  

The US oncology 9735 study showed the superior result of TC (docetaxel/cyclophosphamide) over AC (doxorubicin/ cyclophosphamide), and now TC has been widely adopted for the treatment of early breast cancer. But in Japan there are few data on the safety and tolerability of this regimen. From January 2007 to April 2009, we treated 51 early breast cancer patients with TC in our hospital, and we summarized safety and tolerability profile, including hematologic toxicity and nonhematologic toxicity. Our patients experienced more febrile neutropenia (25.5%) compared with the original USO 9735 result (5%). This might be because we did not use prophylactic oral antibiotics. Skin toxicity was sometimes troublesome, including 3 cases (5.9%) of grade 3 skin rash. Toxicity assessment showed more asthenia, edema, neuropathy and myalgia, as is well known. Finally, we recommend prophylactic oral antibiotics, steroid premedication from the day before treatment and skin moisture, which may minimize the toxicity.

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：(NPO)日本乳癌検診学会  

2005年1月〜2007年10月の間に当院でMMGとUSを施行され、手術検体で非浸潤性乳管癌(DCIS)と診断された53症例を対象とし、各々カテゴリー3以上を正診として仮想検診感度を求め、両者の比較を行った。仮想検診感度は、MMGで71.7%(38/53)、USで81.1%(43/53)と有意差は認めなかった。年齢別に解析した結果では、49歳以下でMMG75.0%(21/28)、US82.1%(23/28)、50歳以上ではMMG68.0%(17/25)、US80.0%(20/25)であったが、有意差は認められなかった。USは、DCISの検出においてMMGに劣らなかった。また、53症例中、MMG・US何れの検査でも検出できたものは54.7%(29/53)、MMGのみで検出できたものは17.0%(9/53)、USのみで検出できたものは26.4%(14/53)であり、うち5例に点状高エコーを認めた。石灰化検出におけるUSの意義も検討すべき結果となった。また、何れかの検査で検出できた症例は98%(52/53)に達し、DCISの検出においても、MMGとUSは相補的な役割を果たすと考えられた。(著者抄録)

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Language：Japanese   Publishing type：Research paper (scientific journal)   Publisher：金原出版(株)  

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

Adenomatous polyposis coli (APC), whose mutation causes colorectal cancers, is a key player in the Wnt signaling pathway. While the role of APC in inhibition of beta-catenin/LEF1-dependent activation of transformation-inducing genes has been intensively studied and well established, regulation of APC expression at the protein level is only partially understood. Here we report that APC is up-regulated by EDD, the mammalian orthologue of Drosophila melanogaster "hyperplastic discs" gene (hyd) that is considered to be a putative tumor suppressor. Screening of APC immunocomplexes by mass spectrometry identified EDD as a putative APC-interacting protein. Exogenously expressed and endogenous APC interacted with EDD in vivo. Indirect immunofluorescent analyses demonstrated that APC and EDD co-localized in the cytoplasm of the cell. Over-expression of EDD enhanced the protein expression level of APC and its binding partner Axin, resulting in inhibition of Wnt signaling downstream of beta-catenin. Conversely, siRNA knock-down of EDD down-regulated APC at the protein level without altering its mRNA level, causing enhanced protein expression of beta-catenin. Thus, through protein-protein interaction, EDD stabilizes APC and up-regulates APC's function to inhibit beta-catenin, suggesting that EDD could act as a colorectal tumor suppressor.

DOI： 10.1111/j.1365-2443.2007.01138.x

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DOI： 10.1158/1538-7445.SABCS19-OT3-13-01

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Language：English   Publishing type：Research paper, summary (international conference)   Publisher：CHURCHILL LIVINGSTONE  

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Language：Japanese   Publisher：(株)癌と化学療法社  

US oncology 9735 studyによってTC療法(docetaxel/cyclophosphamide)がAC療法(doxorubicin/cyclophosphamide)を上回ることが示されて以降、TC療法は早期乳癌補助療法に幅広く用いられている。しかしながら本邦にはこのレジメンの安全性、認容性に関するデータはこれまで乏しかった。2007年1月〜2009年4月までにわれわれは51例の早期乳癌患者のTC療法を当院で行い、その安全性、認容性に関するプロフィールを得たのでこれを今回まとめた。われわれのデータでは25.5%の発熱性好中球減少を認め、これはUS oncology 9735 studyに示されている5%を上回っていた。この理由として、われわれが抗生物質の予防投与を行っていなかったことが考えられた。また、しばしば難渋する皮膚毒性を認め、grade 3のskin rashが3例含まれていた。その他の毒性としては全身倦怠感、浮腫、筋肉痛が目立っていたが、これらはある程度予想された結果であった。最後に、われわれはこうした毒性を軽減するであろう抗生物質の予防投与、治療前日からのステロイドの予防投与、そして保湿剤の投与を推奨する。(著者抄録)

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Language：Japanese  

J-GLOBAL

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Language：Japanese  

J-GLOBAL

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Language：Japanese   Publisher：(NPO)日本乳癌検診学会  

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