Taguchi T, Morimoto K, Horikoshi N, Takashima S, Toge T, Kimura M, Sano M, Aoyama H, Ota J, Noguchi S
Second Dept. of Surgery, Osaka City University Medical school.
Gan To Kagaku Ryoho. 1998 Jun;25(7):1035-43.
An early phase II clinical study of S-1 in patients with advanced or recurrent breast cancer was undertaken by a cooperative study group (Breast Cancer Working Group) of 14 institutes in Japan. S-1 was administered twice daily at 75 or 50 mg (dose FT)/body for 28 consecutive days with 14 days rest (one course). Twenty-eight patients were enrolled, 27 were eligible for the study, and 25 were evaluable for efficacy. Four complete responses and seven partial responses were obtained, and the response rate was 40.7% (11/27) [ninety percent confidence interval for this response was 26.7-56.4%]. The major adverse reactions observed were myelosuppression represented by leukopenia 44.4% (12/27), neutropenia 40.7% (11/27), RBC decreased 37.0% (10/27), hemoglobin decreased 29.6% (8/27), anorexia 55.6% (15/27), nausea/vomiting 48.1% (13/27), and fatigue 33.3% (13/27). The results suggested that the efficacy and safety of S-1 were effective against advanced or recurrent breast cancer. The objective of study judged should be investigated in a late phase II clinical study.
日本14家机构组成的合作研究组（乳腺癌工作组）开展了一项关于S-1治疗晚期或复发性乳腺癌患者的II期早期临床研究。S-1以75或50mg（剂量FT）/体，每日两次连续给药28天，休息14天（一个疗程）。共入组28例患者，27例符合研究条件，25例可进行疗效评估。获得4例完全缓解和7例部分缓解，缓解率为40.7%（11/27）[该缓解率的90%置信区间为26.7 - 56.4%]。观察到的主要不良反应为骨髓抑制，表现为白细胞减少44.4%（12/27）、中性粒细胞减少40.7%（11/27）、红细胞减少37.0%（10/27）、血红蛋白降低29.6%（8/27）以及厌食55.6%（15/27）、恶心/呕吐48.1%（13/27）、疲劳33.3%（13/27）。结果表明S-1对晚期或复发性乳腺癌的疗效和安全性良好。研究判定的目标应在II期晚期临床研究中进行调查。
