Hamamatsu, Japan
Hamamatsu, Japan

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Sato K.,Kyoto University | Watanabe T.,Hamamatsu Oncology Center | Katsumata N.,Nippon Medical School | Sato T.,Kyoto University | Ohashi Y.,University of Tokyo
Clinical Trials | Year: 2014

Background Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. Purposes To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Methods Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Results Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Limitations Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Conclusion Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences. © 2013 The Author(s).


Oral fluoropyrimidine anticancer agents (oral 5-fluorouracil [5-FU]) able to be used as chemotherapy for breast cancer include tegafur-uracil (UFT), tegafur- gimeracil-oteracil potassium (S-1), doxifluridine, and capecitabine. Since the 1980s, UFT has been most widely used for postoperative chemotherapy in breast cancer. UFT is an oral preparation that was designed to achieve and maintain high concentrations of 5-FU in plasma by combining tegafur, a prodrug of 5-FU, with uracil. UFT is characterized by mild adverse events, allowing long-term treatment. The prolonged maintenance of high plasma 5-FU concentrations has been suggested to inhibit micrometastases after surgery. Recently, large clinical trials conducted in Japan have shown that UFT-based postoperative chemotherapy is therapeutically useful in patients with nodenegative (n0), high-risk breast cancer. We review the results of clinical trials of postoperative chemotherapy with UFT in Japan and discuss its roles and future prospects. © The Author(s) 2013.


Shimozuma K.,Ritsumeikan University | Ohashi Y.,University of Tokyo | Takeuchi A.,University of Tokyo | Aranishi T.,University of Tokyo | And 9 more authors.
Supportive Care in Cancer | Year: 2012

Purpose To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node- positive breast cancer patients treated with taxane-containing regimens. Methods We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline-cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX. Results PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P=.003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P=.669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments. Conclusions Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable. © Springer-Verlag 2012.


Inoue K.,Saitama Cancer Center | Nakagami K.,Shizuoka General Hospital | Mizutani M.,Mikawa Breast Cancer Clinic | Hozumi Y.,Jichi Medical University | And 13 more authors.
Breast Cancer Research and Treatment | Year: 2010

We evaluated the efficacy and safety of sequential therapy with trastuzumab monotherapy (H-mono) followed by H plus docetaxel (D) after disease progression (H → H + D) versus combination therapy with H + D as first-line therapy. Patients with human epidermal growth factor receptor type 2 (HER2)-positive metastatic breast cancer (MBC) and left ventricular ejection fraction >50% were randomly assigned to either (a) H → H + D [H, once weekly 2 mg/kg (loading dose, 4 mg/kg); D, once every 3 weeks 60 mg/m2] or (b) H + D. Primary endpoints were progression-free survival (PFS) for the H-mono stage of the H → H + D group and H + D group and overall survival (OS) for both groups. Secondary endpoints were overall response rate, time to treatment failure, second PFS and safety. The planned number of patients was 160 patients in total. Of 112 patients enrolled, 107 were eligible. After 112 patients were enrolled, the Independent Data Monitoring Committee recommended stopping enrollment because PFS and OS were greater in the H + D group than the H → H + D group. Median PFS was 445 days in the H + D group versus 114 days for H-mono in the H → H + D group [hazard ratio (HR), 4.24; P < 0.01]. OS was significantly longer in the H + D group (HR, 2.72; P = 0.04). H + D therapy is significantly superior to H → H + D therapy as first-line therapy in patients with HER2-positive MBC, especially in terms of OS. © 2009 Springer Science+Business Media, LLC.


Ohsumi S.,Shikoku Cancer Center | Shimozuma K.,Ritsumeikan University | Ohashi Y.,University of Tokyo | Takeuchi A.,University of Tokyo | And 4 more authors.
Oncology | Year: 2012

Objective: To elucidate the time course of taxane-induced edema which may affect the patients' quality of life (QOL). Patients and Methods: Our study included the first 300 Japanese patients assigned to 1 of 4 regimens using docetaxel (DTX) or paclitaxel (PTX) by 1:1:1:1 in a randomized controlled trial to evaluate the efficacy of adjuvant therapies for node-positive breast cancer. Patients' QOL was prospectively assessed by the Functional Assessment of Cancer Therapy (FACT)-breast and-taxane (FACT-T) subscale. The scores of FACT items regarding edema and body weight were used as indicators of edema. Results: The scores for 'anasarca', 'edema of the hands' and 'edema of the legs and feet' of the FACT-T subscale worsened up to 1-2 months after chemotherapy, and body weights increased remarkably until cycle 8 in patients treated with DTX alone (75 mg/m 2, 8 cycles, every 3 weeks). Edema-related symptoms and body weight were relatively stable in the other treatment groups. There were statistically significant differences in the scores of those items and in the changes of body weight both between the DTX-alone group and the other three groups combined, and between the groups using DTX and those using PTX. Conclusion: Many patients receiving DTX for >4 cycles suffered significantly from edema. Copyright © 2012 S. Karger AG, Basel.


Ohashi Y.,University of Tokyo | Watanabe T.,Hamamatsu Oncology Center | Sano M.,Niigata Cancer Center Hospital | Koyama H.,Japan National Cardiovascular Center Research Institute | And 2 more authors.
Breast Cancer Research and Treatment | Year: 2010

Two randomized clinical studies comparing the efficacy of oral UFT (2 years) with that of classical cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) (six courses) have been conducted in patients with resected early breast cancer. We have performed a pooled analysis of these two randomized studies. A pooled analysis was performed using individual patient data from the two trials. Hazard ratios (HRs) were determined with a Cox model stratified by study and adjusted for clinical characteristics. We preplanned to verify the following two hypotheses: UFT is non-inferior to CMF in all patients (hypothesis 1) or in ER-positive patients (hypothesis 2) with respect to relapse-free survival (RFS). Non-inferiority of UFT versus CMF was established if the upper limit of the two-sided confidence interval (CI) of the HR for RFS did not exceed 1.30. Hochberg multiplicity adjustment for the significance level was performed. A total of 1,057 patients were analyzed (CMF, n = 528; UFT, n = 529). Median follow-up time was 5.6 years. The HR for RFS was 1.04 (95% CI, 0.78-1.40) in all patients and 0.79 (97.5% CI, 0.49-1.27) in ER-positive patients. UFT was shown to be non-inferior to CMF in ER-positive patients. An exploratory subgroup analysis showed that RFS was better with UFT than with CMF in ER-positive patients who were 50 years or older (HR, 0.58; 95% CI, 0.34-1.01). UFT is non-inferior to CMF in terms of inhibiting recurrence of ER-positive, early breast cancer. © 2009 Springer Science+Business Media, LLC.


Mukai H.,National Cancer Center Hospital East | Katsumata N.,National Cancer Center Hospital | Ando M.,National Cancer Center Hospital | Watanabe T.,Hamamatsu Oncology Center
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2010

Objectives: Evaluation of the safety and efficacy of docetaxel and cisplatin in the treatment of unknown primary cancer. Patients and Methods: Inclusion criteria included histologic evidence of carcinoma originating in an unknown primary organ, no prior chemotherapy, age range 20 to 75 years, WHO PS ≤3, measurable or evaluable lesions, and adequate organ function. Docetaxel (60 mg/m2) followed by cisplatin (80 mg/m2) was administered intravenously every 3 weeks. Patients were assessed for tumor response after 2 cycles of chemotherapy, and 4 additional cycles were administered unless disease progression was demonstrated. Results: Between September 1997 and September 2002, 45 patients were enrolled. The median age was 56.5 years (28-73 years), and their performance status (PS) were 0 (11 patients), 1 (26 patients), and 2 (6 patients), respectively, (2 patients were removed from the trial after initial enrolment). A total of 26 patients (60%) presented with lymphadenopathy, 14 patients (33%) with visceral disease, and 3 (7%) with bone and soft-tissue metastases. The overall response rate was 65.1% (4 complete response, 24 partial response, 8 NC, 7 progressive diseases: 95% confidence interval, 48.0-78.4). The median time to progression was 5.0 months. The median survival time was 11.8 months. No treatment-related deaths were observed. Commonly observed side effects included neutropenia (grade 3-4, 16 patients), nausea (grade 3, 13 patients), and nephrotoxicity (grade 2, 5 patients). Conclusions: These results indicate that the combination of docetaxel and cisplatin is a safe and effective regimen for patients with unknown primary cancer. © 2010 by Lippincott Williams & Wilkins.


Coates A.S.,University of Sydney | Winer E.P.,Dana-Farber Cancer Institute | Goldhirsch A.,Italian National Cancer Institute | Gelber R.D.,Dana-Farber Cancer Institute | And 46 more authors.
Annals of Oncology | Year: 2015

The 14th St Gallen International Breast Cancer Conference (2015) reviewed substantial new evidence on locoregional and systemic therapies for early breast cancer. Further experience has supported the adequacy of tumor margins defined as 'no ink on invasive tumor or DCIS' and the safety of omitting axillary dissection in specific cohorts. Radiotherapy trials support irradiation of regional nodes in node-positive disease. Considering subdivisions within luminal disease, the Panel was more concerned with indications for the use of specific therapies, rather than surrogate identification of intrinsic subtypes as measured by multiparameter molecular tests. For the treatment of HER2-positive disease in patients with node-negative cancers up to 1 cm, the Panel endorsed a simplified regimen comprising paclitaxel and trastuzumab without anthracycline as adjuvant therapy. For premenopausal patients with endocrine responsive disease, the Panel endorsed the role of ovarian function suppression with either tamoxifen or exemestane for patients at higher risk. The Panel noted the value of an LHRH agonist given during chemotherapy for premenopausal women with ER-negative disease in protecting against premature ovarian failure and preserving fertility. The Panel noted increasing evidence for the prognostic value of commonly used multiparameter molecular markers, some of which also carried prognostic information for late relapse. The Panel noted that the results of such tests, where available, were frequently used to assist decisions about the inclusion of cytotoxic chemotherapy in the treatment of patients with luminal disease, but noted that threshold values had not been established for this purpose for any of these tests. Multiparameter molecular assays are expensive and therefore unavailable in much of the world. The majority of new breast cancer cases and breast cancer deaths now occur in less developed regions of the world. In these areas, less expensive pathology tests may provide valuable information. The Panel recommendations on treatment are not intended to apply to all patients, but rather to establish norms appropriate for the majority. Again, economic considerations may require that less expensive and only marginally less effective therapies may be necessary in less resourced areas. Panel recommendations do not imply unanimous agreement among Panel members. Indeed, very few of the 200 questions received 100% agreement from the Panel. In the text below, wording is intended to convey the strength of Panel support for each recommendation, while details of Panel voting on each question are available in supplementary Appendix S2, available at Annals of Oncology online. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Shiroiwa T.,Ritsumeikan University | Fukuda T.,University of Tokyo | Shimozuma K.,Ritsumeikan University | Kuranami M.,Kitasato University | And 3 more authors.
Value in Health | Year: 2011

Objective: To examine health-related quality of life, we investigated the effect of adjuvant chemotherapy regimens on utility scores assessed by the EuroQoL-5D (EQ-5D) instrument in a randomized, controlled trial for breast cancer patients after surgery. We also investigated the relationship between Functional Assessment of Cancer Therapy (FACT) scale scores and EQ-5D utilities. Methods: Patients were randomly assigned to the following four chemotherapy regimens: four cycles of anthracycline followed by paclitaxel (ACP), four cycles of anthracycline-containing regimens followed by docetaxel (ACD), eight cycles of paclitaxel (PTX), and eight cycles of docetaxel (DTX). Of 1060 registered, the first 300 consecutive patients were included in the current utility study. Utility scores were assessed using the EQ-5D instrument at baseline; cycles 3, 5, and 7; 7 months; and 1 year. We also evaluated the correlation between these scores and FACT-G, -B, and -Taxane scores at each time point. Results: Utility scores were significantly lower in the DTX group than in the ACP and ACD groups. Mean utility scores in the DTX group were lowest at 7 months and tended to remain low for a long time. The combined anthracycline followed by taxane group had significantly higher utility scores that the taxane-alone group, with no significant difference depending on the type of taxane. Only the FACT-G social/family well-being subscale had no relationship with EQ-5D responses and utility scores. Conclusions: Although the regimens in this study were similar in that they included taxane, the mean utility scores and longitudinal patterns of utility scores were different among regimens. © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Sawaki M.,Nagoya University | Mukai H.,National Cancer Center Hospital East | Tokudome N.,Cancer Institute Hospital | Nakayama T.,Osaka University | And 7 more authors.
Breast Cancer | Year: 2012

Background For targeting anti-HER-2, trastuzumabincorporated chemotherapy is the standard for HER-2-overexpressing breast cancer in adjuvant settings. But there are few data on trastuzumab in elderly patients. We evaluated the incidence of adverse events among an elderly population of trastuzumab-treated HER-2-positive breast cancer patients in adjuvant settings. Methods Data on 39 elderly HER-2 overexpressing breast cancer patients treated with both curative surgery and adjuvant trastuzumab were retrospectively collected from a Japanese multicenter study. The loading dose was 8 mg/kg body weight, and the maintenance dose was 6 mg/kg every 3 weeks; or the loading dose was 4 mg/kg followed by 2 mg/kg weekly as maintenance. Results After a median follow-up of 20.0 (2.4- 53.9) months, a total of 32 patients (82.1%) completed 1-year trastuzumab treatment. The median treatment duration was 12.0 months (range 2-12; mean 10.5). Adverse events occurred in 11 patients (28.2%). Four (10.2%) discontinued or interrupted treatment after experiencing toxicity. One patient died because of interstitial pneumonia. Three patients (7.7%) had congestive heart failure (CHF), one of whom had a history of angina. Three patients (7.7%) had a lower left ventricular ejection fraction (LVEF), and brain natriuretic peptide elevation was totally observed in three patients (7.7%). Three patients with lower LVEF had received chemotherapy containing doxorubicin before trastuzumab. Of the three patients, two discontinued therapy because of CHF, but all recovered with proper medication containing a diuretic agent. Conclusions Elderly patients tolerated trastuzumab well, although careful management is needed. © 2011 The Japanese Breast Cancer Society.

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