Publications by authors named "Tomohiko Aihara"

27 Publications

  • Page 1 of 1

Prospective cohort study of febrile neutropenia in breast cancer patients administered with neoadjuvant and adjuvant chemotherapies: CSPOR-BC FN study.

Breast 2021 Apr 16;56:70-77. Epub 2021 Feb 16.

Division of Oncology/Hematology, National Cancer Center Hospital East, Chiba, Japan.

Background: As Asians are more vulnerable to febrile neutropenia (FN) than Caucasians, evaluations of FN incidence and risk factors in Asians are important for the appropriate use of primary pegfilgrastim (PEG-G).

Patients And Methods: Japanese breast cancer patients receiving standard adjuvant chemotherapies were prospectively enrolled in multicenter institutions from August 2015 to July 2017. FN was evaluated from 2 treatment policies: true FN (T-FN): ≥37.5 °C, grade 4 neutropenia, mandatory hospital visit (visiting); surrogate FN (S-FN): ≥37.5 °C, oral antibiotic, no mandatory visit (non-visiting). PEG-G was used at the physicians' discretion. The primary endpoint was FN incidence during all cycles. Multivariate logistic regression analysis was performed to identify T-FN risk factors.

Results: Of 1005 enrolled patients, 980 women treated with FEC, E(A)C, and TC were analyzed. The FN incidence proportions in all patients were 22.5%, 27.5%, and 33.9% for FEC, E(A)C, and TC, respectively. Those of T-FN were 27.7%, 22.4%, and 36.6%; those of S-FN were 17.3%, 32.4%, and 31.5% with more frequent primary PEG-G usage. The relative dose intensity (RDI) of the 3 regimens was ≥0.85 in both groups. In the analysis of risk factors, TC (odds ratio = 2.67), age ≥ 65 years (2.24), and pretreatment absolute neutrophil count (ANC)/1000 μl (0.8) remained significant.

Conclusions: FN incidences were above 20% in the 3 regimens, with TC showing the highest. RDI was maintained at a high level in both visiting and non-visiting groups. Patient-related risk factors were age and pretreatment ANC.
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http://dx.doi.org/10.1016/j.breast.2021.01.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907535PMC
April 2021

Randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer.

Breast 2021 Feb 9;55:63-68. Epub 2020 Dec 9.

National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

Background: Chemotherapy-induced peripheral neuropathy is commonly observed in patients treated with nanoparticle albumin-bound paclitaxel (nab-PTX). We conducted a multicenter randomized controlled study to evaluate the optimal dose of nab-PTX.

Methods: We compared three different doses of q3w nab-PTX (Standard: 260 mg/m [SD260] vs Medium: 220 mg/m [MD220] vs Low: 180 mg/m [LD180]) in patients with HER2-negative metastatic breast cancer (MBC). Primary endpoint was progression-free survival (PFS). Grade 3/4 neuropathy rates in the three doses were estimated using the logistic regression model. The optimal dose was selected in two steps. Initially, if the hazard ratio (HR) for PFS was <0.75 or >1.33, the inferior dose was excluded, and we proceeded with the non-inferior dose. Then, if the estimated incidence rate of grade 3/4 neurotoxicity exceeded 10%, that dose was also excluded.

Results: One hundred forty-one patients were randomly assigned to SD260 (n = 47), MD220 (n = 46), and LD180 (n = 48) groups, and their median PFS was 6.66, 7.34, and 6.82 months, respectively. The HRs were 0.73 (95% confidence interval [CI]: 0.42-1.28) in MD220 vs SD260, 0.77 (95% CI 0.47-1.28) in LD180 vs SD260, and 0.96 (95% CI 0.56-1.66) in LD180 vs MD220. SD260 was inferior to MD220 and was excluded. The estimated incidence rate of grade 3/4 neurotoxicity was 29.5% in SD260, 14.0% in MD220, and 5.9% in LD180. The final selected dose was LD180.

Conclusions: Intravenous administration of low-dose nab-PTX at 180 mg/m q3w may be the optimal therapy with meaningful efficacy and favorable toxicity in patients with MBC.
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http://dx.doi.org/10.1016/j.breast.2020.12.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753189PMC
February 2021

The efficacy of sequential second-line endocrine therapies (ETs) in postmenopausal estrogen receptor-positive and HER2-negative metastatic breast cancer patients with lower sensitivity to initial ETs.

Breast Cancer 2020 Sep 11;27(5):973-981. Epub 2020 May 11.

Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.

Purpose: Second-line endocrine therapy (ET) for estrogen receptor (ER)-positive and human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (MBC) is offered based on the response to first-line ET. However, no clinical trials have evaluated the efficacy and safety of secondary ETs in patients with poor responses to initial ET. This study evaluated the efficacy of second-line ET in ER-positive and HER2-negative postmenopausal MBC patients with low or very low sensitivity to initial ET.

Methods: This multicenter prospective observational cohort study evaluated the response of 49 patients to second-line ETs in postmenopausal MBC patients with low or very low sensitivity to initial ET. The primary endpoint was the clinical benefit rate (CBR) for 24 weeks.

Results: Of the 49 patients assessed, 40 (82%) received fulvestrant in the second line, 5 (10%) received selective estrogen receptor modulators, 3 (6%) received aromatase inhibitors (AIs) alone, and 1 received everolimus with a steroidal AI. The overall CBR was 44.9% [90% confidence interval (CI): 34.6-57.6, p = 0.009]; CBR demonstrated similar significance across the progesterone receptor-positive (n = 39, 51.3%, 90% CI: 39.6-65.2, p = 0.002), very low sensitivity (n = 17, 58.8%, 90% CI: 42.0-78.8, p = 0.003), and non-visceral metastases (n = 25, 48.0%, 90% CI: 34.1-65.9, p = 0.018) groups. The median progression-free survival was 7.1 months (95% CI: 5.6-10.6).

Conclusion: Second-line ET might be a viable treatment option for postmenopausal patients with MBC with low and very low sensitivity to initial ET. Future studies based on larger and independent cohorts are needed to validate these findings.
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http://dx.doi.org/10.1007/s12282-020-01095-yDOI Listing
September 2020

Hormonal Therapy Resistant Estrogen-receptor Positive Metastatic Breast Cancer Cohort (HORSE-BC) Study : Current Status of Treatment Selection in Japan.

Acta Med Okayama 2018 Aug;72(4):369-374

Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama 700-8558,

The Hormonal therapy resistant estrogen-receptor positive metastatic breast cancer cohort (HORSE-BC) study is a multicenter observational study evaluating the efficacy and safety of secondary endocrine therapy (ET) for postmenopausal cases of metastatic breast cancer (MBC) with poor response to primary ET. In this initial report we analyze the HORSE-BC baseline data to clarify the current status of treatment selection for MBC in Japan. Baseline data for the 50 patients enrolled in HORSE-BC were analyzed, including patient characteristics, types of secondary ET, and reasons for selecting secondary ET. Postoperative recurrence was detected in 84% of patients (42/50) and de novo stage IV breast cancer in 16% (8/50). Forty-one patients (41/50; 82%) received fulvestrant, 5 patients (10%) received selective estrogen receptor modulators (SERMs), 3 patients (6%) received ET plus a mammalian target of rapamycin (mTOR) inhibitor, and 1 patient received an aromatase inhibitor (AI) as the secondary ET. Forty-five patients selected their secondary ET based on its therapeutic effect, while 14 patients selected it based on side effects. Most patients with progression after primary ET selected fulvestrant as the secondary ET based on its therapeutic and side effects. We await the final results from the HORSE-BC study.
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http://dx.doi.org/10.18926/AMO/56172DOI Listing
August 2018

[Is the LHRH Agonist Recommended for Fertility Preservation ?].

Gan To Kagaku Ryoho 2015 Aug;42(8):1019-21

Dept. of Breast Surgery, Osaka Medical College Hospital.

The POEMS reportedan effect of goserelin for fertility preservation. The Clinical Practice Guideline for Breast Cancer by The Japanese Breast Cancer Society indicates that the use of the LHRH agonist (LHRHa) for preventing chemotherapy-induced early menopause is a grade C-1 recommendation, and its use for fertility preservation is a grade C-2 recommendation. Results from previous studies on the effects of LHRHa for fertility preservation have varied owing to differences in chemotherapy regimens, definitions of ovarian failure, and dosages of tamoxifen. In the POEMS, the primary endpoint of ovarian failure at 2 years was significantly lower, and the secondary endpoint of pregnancy outcomes was better in the combination group; however, precise interpretation is difficult because many cases were excluded. Currently, it is not necessary to revise The Clinical Practice Guideline; however, desirable results from future studies may allow the recommendation of a specific dosage of LHRHa for fertility preservation.
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August 2015

Anastrozole versus tamoxifen as adjuvant therapy for Japanese postmenopausal patients with hormone-responsive breast cancer: efficacy results of long-term follow-up data from the N-SAS BC 03 trial.

Breast Cancer Res Treat 2014 Nov 16;148(2):337-43. Epub 2014 Oct 16.

Breast Center, Aihara Hospital, 3-4-30, Makiochi, Minoh, Osaka, 562-0004, Japan,

Aromatase inhibitors are superior to tamoxifen as adjuvant therapy in postmenopausal patients with hormone-responsive breast cancer. We report the follow-up efficacy results from the N-SAS BC 03 trial (UMIN CTRID: C000000056) where anastrozole was compared with tamoxifen as adjuvant therapy in postmenopausal Japanese patients with hormone-responsive early breast cancer. The full analysis set contained 696 patients (anastrozole arm, n = 345; tamoxifen arm, n = 351). The log-rank test was used to compare the two groups in terms of disease-free survival (DFS) and relapse-free survival (RFS); Kaplan-Meier estimates were calculated. The treatment effects were estimated by Cox's proportional hazards model. To examine time-varying effect of hazard ratios, we estimated time-varying hazard ratios at time t [HR(t)] using data from time t up to 12 months. After a median follow-up of 98.5 months, hazard ratios (95% CIs) were 0.90 (0.65-1.24; log-rank p = 0.526) for DFS and 0.83 (0.56-1.23; log-rank p = 0.344) for RFS. Hazard ratios (95% CIs) for DFS and RFS up to 36 months were 0.69 (0.40-1.17) and 0.54 (0.27-1.06) and those after 36 months were 1.06 (0.70-1.59) and 1.05 (0.64-1.73), respectively. Time-varying hazard ratios for both DFS and RFS showed that hazard ratios were initially in favor of anastrozole and approached 1.0 at around 36 months. Superior efficacy of anastrozole to tamoxifen suggested by the initial analysis was not confirmed in the present analysis after a long-term follow-up period. Advantage of anastrozole was the greatest immediately after switching from tamoxifen and then decreased thereafter.
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http://dx.doi.org/10.1007/s10549-014-3155-8DOI Listing
November 2014

The Japanese Breast Cancer Society Clinical Practice Guideline for systemic treatment of breast cancer.

Breast Cancer 2015 Jan 9;22(1):5-15. Epub 2014 Sep 9.

Division of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan,

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http://dx.doi.org/10.1007/s12282-014-0563-xDOI Listing
January 2015

[Diagnosis of metachronous bilateral breast cancer].

Nihon Rinsho 2012 Sep;70 Suppl 7:284-7

Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine.

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September 2012

Incidence of contralateral breast cancer in Japanese patients with unilateral minimum-risk primary breast cancer, and the benefits of endocrine therapy and radiotherapy.

Breast Cancer 2014 May 4;21(3):284-91. Epub 2012 Oct 4.

Breast Center, Aihara Hospital, 3-4-30 Makiochi, Minoh, Osaka, 562-0004, Japan,

Background: Tamoxifen is recommended as adjuvant endocrine therapy for patients with minimum-risk breast cancer. It is primarily effective at prevention of contralateral and ipsilateral breast cancer recurrence after breast-conserving surgery. The incidence of contralateral breast cancer and the absolute benefit of endocrine therapy among patients with unilateral minimum-risk breast cancer in Japan, where the incidence of breast cancer is low, are unknown.

Patients And Methods: We retrospectively studied the incidence of contralateral breast cancer, and the efficacy of endocrine therapy, in a cohort of 2074 Japanese women with unilateral breast cancer whose primary tumor was pTis (n = 1905) or pT1mic (n = 169) (unknown for endocrine therapy, n = 4; unknown for radiotherapy, n = 2). We also assessed the efficacy of endocrine therapy and radiotherapy for prevention of ipsilateral and contralateral breast cancer recurrence in 1205 patients who underwent breast-conserving surgery (unknown for endocrine therapy, n = 2; unknown for radiotherapy, n = 2).

Results: The incidence of contralateral breast cancer per 1000 person-years was 5.1 (95 % confidence interval (CI), 3.7-7.1) among patients without endocrine therapy (n = 1364) and 3.6 (95 % CI 2.1-6.1) among those with endocrine therapy (n = 706). The incidence of ipsilateral breast cancer recurrence after breast-conserving surgery per 1000 person-years was 9.2 (95 % CI 6.5-13) among patients without endocrine therapy (n = 753) and 4.2 (95 % CI 2.2-8.1) among those with endocrine therapy (n = 450). The incidence of ipsilateral breast cancer recurrence after breast-conserving surgery per 1000 person-years was 9.9 (95 % CI 6.3-15.6) among patients without radiotherapy (n = 380) and 5.9 (95 % CI 3.9-9.0) among those with radiotherapy (n = 823).

Conclusion: The incidence of contralateral breast cancer among minimum-risk breast cancer patients in Japan, where the incidence of breast cancer is low, was similar to that in Western countries. Endocrine therapy is indicated for this population.
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http://dx.doi.org/10.1007/s12282-012-0396-4DOI Listing
May 2014

The current status and future perspectives of CSPOR-BC.

Breast Cancer 2013 Oct 28;20(4):287-90. Epub 2012 Jun 28.

Breast Center, Aihara Hospital, 3-4-30, Makiochi, Minoh, Osaka, 562-0004, Japan,

The Comprehensive Support Project for Oncology Research in Breast Cancer (CSPOR-BC) was initiated in 2000 as part of the investigation project of the Stress Science Research Institute, which was founded by the Public Health Research Foundation. The main objective of CSPOR-BC is to comprehensively support investigator-initiated clinical trials, research related to health-related quality of life (HR-QOL), and epidemiological research for breast cancer. After its initiation, 6 randomized controlled trials (RCTs) on adjuvant therapy for breast cancer and 2 RCTs on metastatic breast cancer have been conducted. To date, patient recruitment has been completed in 3 trials on adjuvant therapy and 1 trial on metastatic breast cancer. In addition to the assessment of efficacy and quality of life, treatment-related side effects have been evaluated. Large cohort studies have been accompanied by some RCTs to evaluate the effect of lifestyle, use of complementary and alternative medicine, sociopsychological factors, and supportive therapies on prognoses of patients with primary breast cancer. These subanalyses are unique to clinical trials conducted by CSPOR-BC. In this report, the current status and future perspectives of CSPOR-BC are described.
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http://dx.doi.org/10.1007/s12282-012-0386-6DOI Listing
October 2013

The effects of natural S-equol supplementation on skin aging in postmenopausal women: a pilot randomized placebo-controlled trial.

Menopause 2012 Feb;19(2):202-10

Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd, Saga, Japan.

Objective: The aim of this study was to investigate the effects of the natural S-equol supplement on skin aging in equol-nonproducing Japanese postmenopausal women.

Methods: A randomized, double-blind, placebo-controlled trial examined the use of the natural S-equol supplement for 12 weeks in 101 postmenopausal Japanese women who were equol nonproducers. They were randomly assigned to one of three groups: placebo (n = 34), 10 mg S-equol/day (EQL10; n = 34), or 30 mg S-equol/day (EQL30; n = 33). Skin parameters of crow's-feet wrinkles (area and depth), hydration, transepidermal water loss, and elasticity were measured at baseline and at monthly intervals during treatment. Vaginal cytology, endometrial thickness, and mammography were performed before and after treatment. Serum hormone concentrations were measured at the same time as skin parameters.

Results: The EQL10 and EQL30 groups showed significant reductions in wrinkle area compared with the placebo group (P < 0.05). There was a significant difference in wrinkle depth between the placebo group and the EQL30 group (P < 0.05). Other skin parameters did not show significant differences after the treatment in any group. There were no abnormal results in hormone status or gynecological examinations.

Conclusions: Our data suggest that natural S-equol supplementation (EQL10 and EQL30) may have a beneficial effect on crow's-feet wrinkles in postmenopausal women without serious adverse events.
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http://dx.doi.org/10.1097/gme.0b013e318227427bDOI Listing
February 2012

Health-related quality of life and psychological distress of breast cancer patients after surgery during a phase III randomized trial comparing continuation of tamoxifen with switching to anastrozole after adjuvant tamoxifen for 1-4 years: N-SAS BC 03.

Breast Cancer Res Treat 2011 May 24;127(1):143-52. Epub 2011 Feb 24.

Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minami-umemoto-machi, Matsuyama, Ehime 791-0280, Japan.

To investigate whether the health-related quality of life (HRQOL) of patients switching from tamoxifen to anastrozole in a randomized trial is identical to that of those who continued tamoxifen after 1-4 years of adjuvant tamoxifen in Japanese postmenopausal breast cancer patients. Eligible patients for the randomized trial, the National Surgical Adjuvant Study of Breast Cancer 03, were recurrence-free postmenopausal women who had received definitive surgery for primary breast cancer with positive hormone receptor(s), and had been taking tamoxifen for 1-4 years postoperatively. They were randomly assigned to continue tamoxifen or to switch to anastrozole for a total duration of five years. Subjects were asked to reply to a self-administered QOL questionnaire survey to assess HRQOL (FACT-B [breast cancer scale], FACT-ES [endocrine symptom scale]) and psychological distress (CES-D: Center for Epidemiologic Studies Depression scale) at randomization (baseline), 3 months, 1, and 2 years after randomization, respectively. At baseline 694 patients (346 in the tamoxifen group and 348 in the anastrozole group) responded to the survey. The total scores of FACT-G, FACT-ES, and those of the FACT-G physical well-being subscale were statistically significantly better in the tamoxifen group than in the anastrozole group (P = 0.042, 0.038, and 0.005, respectively). However, there was no statistically significant difference between the treatment groups in the CES-D scores. Continuation of tamoxifen treatment after adjuvant tamoxifen for 1-4 years may provide Japanese breast cancer patients with better HRQOL than by switching to anastrozole.
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http://dx.doi.org/10.1007/s10549-011-1400-yDOI Listing
May 2011

Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in Japanese postmenopausal women with hormone-responsive breast cancer: N-SAS BC03 study.

Breast Cancer Res Treat 2010 Jun;121(2):379-87

Breast Center, Aihara Hospital, 3-4-30 Makiochi, Osaka, Minoh 562-0004, Japan.

Clinical trials conducted in Western countries have shown that aromatase inhibitors are associated with better disease-free survival (DFS) than tamoxifen in postmenopausal early breast cancer. Because pharmacogenetic differences in drug-metabolizing genes may cause ethnic differences, assessment of the efficacy and tolerability of aromatase inhibitors in non-white women is warranted. This open-label, randomized clinical trial included 706 postmenopausal Japanese women with hormone-receptor-positive breast cancer, who had received tamoxifen for 1 to 4 years as adjuvant therapy. This study was closed early after entry of approximately 28% of the initially planned patients. They were randomly assigned to either switch to anastrozole or to continue tamoxifen for total treatment duration of 5 years. Primary endpoints were DFS and adverse events. At a median follow-up of 42 months, the unadjusted hazard ratio was 0.69 (95% confidence interval, 0.42-1.14; P = 0.14) for DFS and 0.54 (95% CI, 0.29-1.02; P = 0.06) for relapse-free survival (RFS), both in favor of anastrozole. The incidence of thromboembolic events in the tamoxifen group and bone fractures in the anastrozole group was not excessively high. Switching from tamoxifen to anastrozole was likely to decrease disease recurrence in postmenopausal Japanese breast cancer patients. Ethnic differences in major adverse events may be attributable to a low baseline risk of these events in Japanese.
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http://dx.doi.org/10.1007/s10549-010-0888-xDOI Listing
June 2010

[The marriage, pregnancy, childbirth on the breast cancer--psychologic care].

Nihon Rinsho 2006 Mar;64(3):575-80

Kansai Rousai Hospital.

It tends to crisis situation that age of the women in whom marriage, pregnancy and childbirth are possible receives the treatment of a breast cancer also developmental task. We understand patient psychology from viewpoints, such as a developmental task and moratorium, and support for decision-making, which considered a patient's mental suffers is desired.
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March 2006

[A case of recurrent gastric cancer with peritoneal dissemination successfully treated over 1 year 8 months with combined chemotherapy of paclitaxel and TS-1].

Gan To Kagaku Ryoho 2006 Feb;33(2):255-7

Dept. of Surgery, Kansai Rousai Hospital.

We report a case of gastric cancer with peritoneal recurrence that responded to chemotherapy with paclitaxel and TS-1. A 62-year-old woman, who underwent total gastrectomy for advanced gastric cancer 2 years and 6 months ago, was admitted to our hospital with a chief complaint of abdominal distention and intestinal obstruction due to a large amount of ascites. Cytology of ascites revealed peritoneal dissemination, and chemotherapy with bi-weekly paclitaxel (90 mg/body) was begun. Clinical symptoms, including ascites and intestinal obstruction, were improved only after the second administration of paclitaxel. As she was able to take food orally, she was placed on combined chemotherapy consisting of tri-weekly paclitaxel (9 0 mg/body-120 mg/body: day 1) and TS-1 (80 mg/day: day 1-14) and 1 or 2 weeks rest. The patient had no signs or symptoms of peritoneal metastasis or toxicity except for general fatigue and watery eyes 1 year and 8 months after the diagnosis of peritoneal metastasis. Paclitaxel and TS-1 therapy was thought to be an effective chemotherapy against recurrent gastric cancer with peritoneal dissemination.
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http://dx.doi.org/10.2217/14750708.3.2.255DOI Listing
February 2006

[Two cases of gastric cancer with peritoneal dissemination that responded to TS-1 without progression or recurrence for over 3 years].

Gan To Kagaku Ryoho 2006 Feb;33(2):243-6

Dept. of Surgery, Kansai Rousai Hospital.

for over 3 years. A 67-year-old woman underwent distal gastrectomy for advanced gastric cancer. Histological examination of several nodules in the posterior gastric wall led to suspicion of peritoneal dissemination. Low-dose FP treatment was performed for only 5 days after surgery. Peritoneal dissemination was diagnosed at the time of surgery for postoperative abdominal hernia 20 months after the gastrectomy. TS-1 was administered postoperatively, and recurrence or progression has not been detected for 3 years 4 months. Another patient, a 68-year-old woman,underwent distal gastrectomy for advanced gastric cancer with multiple lymph node metastasis and peritoneal dissemination. TS-1 was administered after surgery, and no recurrence or progression has been detected for 3 years and 7 months. These cases suggest that TS-1 is a promising treatment for gastric cancer with peritoneal dissemination.
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February 2006

[Two cases of successful local control with intermittent hepatic arterial infusion therapy using 5-FU and external radiation therapy for unresectable advanced gall bladder cancer].

Gan To Kagaku Ryoho 2005 Oct;32(11):1855-8

Dept. of Surgery, Kansai Rosai Hospital.

Unresectable advanced gall bladder cancer has a very poor prognosis. No good chemotherapeutic regimen is available. We report two cases of unresectable advanced gall bladder cancer patients who received the combination of intermittent hepatic arterial infusion chemotherapy and external radiation therapy. A 45-year-old male was alive for 576 days, and a 69-year-old male was alive for 246 days after the first diagnosis. They have been able to maintain a good quality of life without any severe adverse effects.
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October 2005

Phase II study of weekly paclitaxel for docetaxel-resistant metastatic breast cancer in Japan.

Breast J 2004 Nov-Dec;10(6):509-13

Department of Surgical Oncology, Osaka University Graduate School of Medicine, 2-2 E10 Yamadaoka, Suita, Osaka, 565-0871, Japan.

The purpose of the study was to evaluate the efficacy of weekly paclitaxel (PTX) against metastatic breast cancer (MBC) that was resistant to docetaxel (DTX) given every 3 weeks. A multicenter phase II study was performed. Women with MBC resistant to DTX were eligible for enrollment. DTX resistance was defined as no tumor response to DTX and stable disease, partial response, or complete response to DTX preceding disease progression. PTX 80 mg/m(2) was administered over 1 hour once a week for 3 weeks per 4-week cycle. Among 47 enrolled patients, 46 patients were assessable for response and toxicity. The overall objective response rate (complete responses [CRs] and partial responses [PRs]) was 17.4% and overall clinical benefit rate (CRs, PRs, and stable disease >or=24 weeks) was 26.1%. The median time to progression was 11 weeks. There were a few severe hematologic toxicities related to the therapy, with grade 4 neutropenia (4.3%) and thrombocytopenia (2.2%). Grade 3 anaphylaxis and grade 3 neuropathy were observed in one patient (2.2%) each. The median delivered dose intensity was 77.6 mg/m(2)/week, 97.1% of the planned dose intensity. Weekly PTX has activity in patients with MBC resistant to DTX every 3 weeks.
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http://dx.doi.org/10.1111/j.1075-122X.2004.21555.xDOI Listing
February 2005

The novel germline mutation of the hMLH1 gene in a case of suspected hereditary non-polyposis colorectal cancer (HNPCC) in a patient with no family history of cancer.

Jpn J Clin Oncol 2004 Sep;34(9):556-60

Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo 660-8511, Japan.

Hereditary non-polyposis colorectal cancer (HNPCC) is a very important clinical entity in oncology. In order to identify HNPCC, the international diagnostic criteria, named 'Amsterdam criteria', has been used. In this report, we present a patient with HNPCC who completely lacks a family history of cancer, thus does not meet the revised Amsterdam criteria and was finally confirmed as HNPCC by genetic testing which revealed a novel germline mutation of the hMLH1 gene. The proband was a 52-year-old Japanese female with a diagnosis of advanced ascending colon cancer. She had a past history of Miles' operation for rectal cancer at the age of 40. A subtotal colectomy was performed and the subsequent microsatellite instability (MSI) analysis revealed high MSI in the resected tumor tissue. PCR/direct sequencing analysis of the genomic DNA revealed the base deletion 2006delAAAAG at codon 669 in exon 18 of the hMLH1 gene, which was considered to be a pathogenic mutation. According to the Human Mutation Database and International Collaborative Group on HNPCC (ICG-HNPCC) Database, this is the first report of this type of deletion mutation in the hMLH1 gene.
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http://dx.doi.org/10.1093/jjco/hyh092DOI Listing
September 2004

Comparison of frozen section and touch imprint cytology for evaluation of sentinel lymph node metastasis in breast cancer.

Ann Surg Oncol 2004 Aug 12;11(8):747-50. Epub 2004 Jul 12.

Department of Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan.

Background: Sentinel lymph node metastasis of breast cancer is evaluated by frozen section (FS) or touch imprint cytology (TIC). However, which of the two methods is superior remains controversial. Here we directly compared the sensitivity of these methods prospectively.

Methods: The study included 208 SNs harvested from 107 consecutive patients with breast cancer who underwent sentinel lymph node biopsy. SNs were serially sectioned at 2-mm intervals, and two sections were subjected to intraoperative evaluation of FS with hematoxylin and eosin staining. TIC specimens were prepared from all cut surfaces and analyzed by Papanicolaou (TIC) and cytokeratin (TIC with immunohistochemistry; TIHC) immunohistochemistry.

Results: Thirty-five SNs from 27 patients were positive by final histopathology. The sensitivity per sentinel lymph node of FS was 89%; it was 86% for TIC and 89% for TIHC. Among 173 negative SNs, the results of FS were concordant with final histopathology, but TIC and TIHC were positive in 1 and 5 histopathology-negative SNs, respectively. The sensitivity per patient of FS was 85%; it was 85% for TIC and 89% for TIHC. Among 80 patients with node-negative disease, the results of FS and TIC were concordant with final histopathology, whereas TIHC was positive in 3 patients (3.8% were upstaged). A slight improvement of sensitivity per patient was achieved by the combination of FS and TIC (to 89%) or FS and TIHC (to 93%).

Conclusions: The sensitivity of FS was almost equivalent to that of TIC. TIHC had a better sensitivity than FS and TIC, but it upstaged a few node-negative patients.
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http://dx.doi.org/10.1245/ASO.2004.01.014DOI Listing
August 2004

Feasibility of sentinel node biopsy for breast cancer after neoadjuvant endocrine therapy: a pilot study.

J Surg Oncol 2004 Feb;85(2):77-81

Department of Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan.

Background And Objectives: Sentinel node biopsy (SNB) is used for evaluation of axillary lymph node status of patients with breast cancer. The usefulness of SNB after neoadjuvant chemotherapy is not established. In addition, SNB after endocrine therapy has rarely been evaluated. We assessed the feasibility of dye guided SNB after neoadjuvant endocrine therapy in comparison with those of SNB after chemotherapy.

Methods: A total of 36 patients subjected to SNB after endocrine therapy alone (n = 16) (tamoxifen, anastrozole or combination of goserelin and tamoxifen) or after chemotherapy (n = 20) (anthracycline and/or taxane) were included. SNB was performed with indigocarmine dye prior to the wide resection of the tumor or mastectomy.

Results: Sentinel nodes were successfully identified in 100% (16/16) of patients after endocrine therapy and in 85% (17/20) of patients after chemotherapy. The mean number of harvested sentinel nodes was 2.2 after endocrine therapy and 1.8 after chemotherapy. There was no false negative case after endocrine therapy and there was one false negative case after chemotherapy (8% of overall false negative rate).

Conclusions: SNB seemed feasible and accurate after neoadjuvant endocrine therapy in patients with breast cancer.
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http://dx.doi.org/10.1002/jso.20010DOI Listing
February 2004

[A case of gastric cancer with peritoneal dissemination which showed the intraperitoneal CR by administrating TS-1 orally and paclitaxel intraperitoneally].

Gan To Kagaku Ryoho 2003 Oct;30(11):1661-4

Dept. of Surgery, Kansai Rosai Hospital.

A 66-year-old male was diagnosed with advanced gastric cancer with pylorus stenosis, and the first abdominal computed tomography (CT) revealed a large amount of ascites. A staging laparoscopy revealed peritoneal dissemination and positive cytology for numerous amounts of ascites (s-T3(SE), N0, M0, p(+), cy(+), H0, s-Stage IV). The patient received TS-1 orally and paclitaxel administered to the peritoneal cavity. After finishing the second course of the combined chemotherapy, second-look staging laparoscopy was performed, which showed the disappearance of peritoneal dissemination and negative cytology. Chemotherapy combined with oral TS-1 and paclitaxel administered to the peritoneal cavity might be an effective strategy against advanced gastric cancer with peritoneal dissemination.
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October 2003

The novel germline mutation of hMSH2 gene in a case of a hereditary non-polyposis colorectal cancer (HNPCC) patient who meets the revised Amsterdam criteria.

Jpn J Clin Oncol 2003 Sep;33(9):486-9

Department of Surgery, Kansai Rosai Hospital, 3-1-69 Inaba-so, Amagasaki, Hyogo 660-8511, Japan.

Hereditary non-polyposis colorectal cancer (HNPCC) is a very important clinical entity in oncology. In order to identify HNPCC, the international diagnostic criteria named "Amsterdam criteria" have been used. In this report, we present a case of an HNPCC patient who met the revised Amsterdam criteria after the sequential history taking in which a novel germline mutation of hMSH2 gene was detected by genetic testing. The proband was a 69-year-old Japanese female who was admitted to our hospital with a diagnosis of advanced ascending colon cancer. Microsatellite instability (MSI) analysis revealed high MSI in the resected tumor tissue. PCR/direct sequencing analysis of the genomic DNA revealed the TTG(Leu) to TAG(Stop) nonsense mutation at codon 302 in exon 5 of the hMSH2 gene, which was considered to be a pathogenic mutation. According to the Human Mutation Database and International Collaborative Group on HNPCC (ICG-HNPCC) Database, this type of nonsense mutation is the first report in the hMSH2 gene.
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http://dx.doi.org/10.1093/jjco/hyg082DOI Listing
September 2003

Application of immunofluorescence for intraoperative evaluation of sentinel lymph nodes in patients with breast carcinoma.

Cancer 2003 Oct;98(8):1562-8

Department of Pathology, Kansai Rosai Hospital, Osaka, Japan.

Background: Sentinel lymph node (SLN) sampling is used to predict axillary lymph node (AxLN) metastasis in patients with breast carcinoma; AxLN sampling can be avoided in SLN-negative patients. Multistep sectioning and immunohistochemistry are reported to increase the sensitivity of micrometastasis detection. The authors used immunofluorescence (IF) staining with cytokeratin (CK) antibodies for intraoperative evaluation of touch imprints from multistep sections of SLNs.

Methods: A combined total of 150 SLNs from 69 patients who had breast carcinoma and underwent surgery were analyzed. SLNs were sectioned at 2 mm intervals, and touch imprints subsequently were prepared. After ethanol fixation, slides were incubated with fluorescein isothiocyanate-conjugated CK and propidium iodide and then subjected to microwave irradiation for 3 minutes. Finally, fluorescence microscopy was used to evaluate slides for the presence or absence of metastatic disease.

Results: Metastatic disease was identified in 36 (24.0%), 26 (17.3%), 32 (21.3%), and 31 (20.7%) of 150 lymph nodes using IF staining, Papanicolaou (Pap) staining, immunocytochemical (ICC) staining, and hematoxylin and eosin (H and E) staining, respectively. The sensitivities of IF, Pap, ICC, and H and E staining were 94.6%, 70.3%, 86.5%, and 83.8%, respectively. Except for IF staining (specificity, 99.1%), each method had a specificity of 100%. The accuracy rates for IF, Pap, ICC, and H and E staining were 98.0%, 92.7%, 96.7%, and 96.0%, respectively.

Conclusions: IF is a rapid, highly sensitive, and highly specific staining technique by which touch imprints can be used to intraoperatively evaluate SLNs in patients with breast carcinoma.
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http://dx.doi.org/10.1002/cncr.11689DOI Listing
October 2003

Dye-guided sentinel node biopsy revisited; validation and observational study from a single institute.

Breast Cancer 2003 ;10(3):254-9

Department of Surgery, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki, Hyogo 660-8511, Japan.

Background: The aims of this study were to evaluate the feasibility and accuracy of indigocarmine dye-guided sentinel node biopsy and to apply this method to avoid further axillary node dissection in sentinel node negative cases.

Methods: Sixty consecutive clinically node-negative breast cancer patients underwent sentinel node biopsy using 0.5% indigocarmine followed by standard axillary node dissection. Sentinel node biopsy was then applied to 42 clinically node-negative patients to avoid axillary node dissection with intraoperative diagnosis made by frozen section.

Results: Validation study: Sentinel nodes were successfully detected in all 60 patients. The mean number of harvested nodes was 1.7 (range 1-3). Sentinel nodes were positive in all 20 axillary node-positive patients, and therefore the false negative rate was 0% (0/20). Only sentinel nodes contained metastases in 55% (11/20) of node positive patients. Observational study: Sentinel nodes were successfully detected in all 42 patients. The mean number of harvested nodes was 1.6 (range 1-3). Sentinel nodes were positive in 12 patients by final histology, and there was one false negative case by frozen section (8%, 1/12). Only sentinel nodes contained metastases in 55% (6/11) of node positive patients. The detection rate, mean number of harvested sentinel nodes and proportion of node positive patients were similar between the validation and observational studies.

Conclusions: Indigocarmine dye-guided sentinel node biopsy was feasible and accurate. This method can be applied to observational studies after successful validation.
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http://dx.doi.org/10.1007/BF02966726DOI Listing
January 2004

Phase II study of concurrent administration of doxorubicin and docetaxel as first-line chemotherapy for metastatic breast cancer.

Oncology 2003 ;64(2):124-30

Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.

Objective: To evaluate the efficacy and toxicity of concurrent administration of doxorubicin and docetaxel, without prophylactic use of granulocyte colony-stimulating factor, as first-line chemotherapy in patients with metastatic breast cancer (MBC).

Methods: This multi-institutional study enrolled 40 women; 37 were assessable for efficacy and all 40 patients were evaluated for toxicity. Treatment consisted of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel on day 1 every 3-4 weeks.

Results: Patients received a total of 251 cycles of chemotherapy (median, 5 cycles; range, 1-13 cycles). Of the 37 patients assessable for efficacy, 2 had a complete response and 24 had partial responses, which accounted for a 70% objective response rate (95% confidence interval, 53-84%). The median time to treatment failure was 30.1 weeks (range, 3.3-80.7 weeks). Grade 4 neutropenia was observed in 88% of patients and was the most frequent haematological toxicity. Febrile neutropenia was seen in 40% of patients, but no severe infections were observed. Non-haematological toxicity was generally tolerable. There were 2 grade 4 adverse events, which included 1 bleeding duodenal ulcer and 1 hypersensitivity reaction, but grade 3 episodes were infrequent. None of the patients developed congestive heart failure or asymptomatic decrease of left ventricular ejection fraction to less than 50%. Fluid retention syndrome
Conclusion: Concurrent administration of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel is active with a manageable toxicity profile as first-line chemotherapy for MBC.
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http://dx.doi.org/10.1159/000067771DOI Listing
March 2003