Okayama University Medical School Acta Medica Okayama 0386-300X 70 5 2016 A Phase I Trial of 100mg/m2 Docetaxel in Patients with Advanced or Recurrent Breast Cancer 425 427 EN Tomoki Tamura Department of Allergy and Respiratory Medicine, Okayama University Hospital Taizo Hirata Department of Medical Oncology, National Hospital Organization Kure Medical Center Masahiro Tabata Department of Allergy and Respiratory Medicine, Okayama University Hospital Shiro Hinotsu Center for Innovative Clinical Medicine, Okayama University Hospital Akinobu Hamada Division of Clinical Pharmacology & Translational Research, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center Takayuki Motoki Department of Breast and Endocrinological Surgery, Okayama University Hospital Takayuki Iwamoto Department of Breast and Endocrinological Surgery, Okayama University Hospital Taeko Mizoo Department of Breast and Endocrinological Surgery, Okayama University Hospital Tomohiro Nogami Department of Breast and Endocrinological Surgery, Okayama University Hospital Tadahiko Shien Department of Breast and Endocrinological Surgery, Okayama University Hospital Naruto Taira Department of Breast and Endocrinological Surgery, Okayama University Hospital Junji Matsuoka Department of Breast and Endocrinological Surgery, Okayama University Hospital Hiroyoshi Doihara Department of Breast and Endocrinological Surgery, Okayama University Hospital Clinical Study Protocols 10.18926/AMO/54607 Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2. However, the approved dose in Japan is up to 75 mg/m2. We have launched a phase I trial evaluating 100 mg/m2 docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age ≥20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m2 docetaxel. This study will clarify whether 100mg/m2 docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer. No potential conflict of interest relevant to this article was reported.

BioMed Central Ltd. Acta Medica Okayama 1471-2407 13 2013 Effects of lifestyle and single nucleotide polymorphisms on breast cancer risk: a case-control study in Japanese women EN Taeko Mizoo Naruto Taira Keiko Nishiyama Tomohiro Nogami Takayuki Iwamoto Takayuki Motoki Tadahiko Shien Junji Matsuoka Hiroyoshi Doihara Setsuko Ishihara Hiroshi Kawai Kensuke Kawasaki Youichi Ishibe Yutaka Ogasawara Yoshifumi Komoike Shinichiro Miyoshi Background: Lifestyle factors, including food and nutrition, physical activity, body composition and reproductive factors, and single nucleotide polymorphisms (SNPs) are associated with breast cancer risk, but few studies of these factors have been performed in the Japanese population. Thus, the goals of this study were to validate the association between reported SNPs and breast cancer risk in the Japanese population and to evaluate the effects of SNP genotypes and lifestyle factors on breast cancer risk. Methods: A case-control study in 472 patients and 464 controls was conducted from December 2010 to November 2011. Lifestyle was examined using a self-administered questionnaire. We analyzed 16 breast cancer-associated SNPs based on previous GWAS or candidate-gene association studies. Age or multivariate-adjusted odds ratios (OR) and 95% confidence intervals (95% CI) were estimated from logistic regression analyses. Results: High BMI and current or former smoking were significantly associated with an increased breast cancer risk, while intake of meat, mushrooms, yellow and green vegetables, coffee, and green tea, current leisure-time exercise, and education were significantly associated with a decreased risk. Three SNPs were significantly associated with a breast cancer risk in multivariate analysis: rs2046210 (per allele OR = 1.37 [95% CI: 1.11-1.70]), rs3757318 (OR = 1.33[1.05-1.69]), and rs3803662 (OR = 1.28 [1.07-1.55]). In 2046210 risk allele carriers, leisure-time exercise was associated with a significantly decreased risk for breast cancer, whereas current smoking and high BMI were associated with a significantly decreased risk in non-risk allele carriers. Conclusion: In Japanese women, rs2046210 and 3757318 located near the ESR1 gene are associated with a risk of breast cancer, as in other Asian women. However, our findings suggest that exercise can decrease this risk in allele carriers. No potential conflict of interest relevant to this article was reported.