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Hamamatsu, Japan

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). Source

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. Source

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. Source

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. Source

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. Source

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