Arai Kuniyoshi, Iwasaki Yoshiaki, Kimura Yutaka, Takahashi Keiichi, Yamaguchi Tatsuro, Honma Shigenori, Takahashi Toshio
Dept. of Surgery, Tokyo Metropolitan Komagome Hospital.
Gan To Kagaku Ryoho. 2003 Sep;30(9):1297-301.
The efficacy and safety of the oral fluoropyrimidine TS-1, which contains a dihydropyrimidine dehydrogenase (DPD) inhibitor, were examined in fifty-five patients with gastric cancer. The patients were divided into 28 with measurable cancer lesions (TUM group) and 27 without them (ADJ group). The total number of courses was 164 (mean: 5.9 courses) in the TUM group and 146 (mean; 5.4 courses) in the ADJ group. The response rate in the TUM group, excluding three patients who could not be evaluated because of incomplete administration, was 40% (CR: 4, PR: 6, NC: 6, PD: 9). Among responders, the mean number of courses to response was 2.2 and the median survival time (MST) was 21.7 months. In terms of safety, adverse reactions appeared in forty-five patients (82%) and the incidence was higher in the ADJ group. Major toxicities were leukopenia (38%), anorexia (27%), increased total bilirubin concentration (25%) and diarrhea (24%). Adverse reaction of grade 3 was found in only three patients (5.5%) and there were no drug-related deaths. In conclusion, TS-1 is safe and effective if attention is given to biweekly examinations for the development of adverse reactions.
对含有二氢嘧啶脱氢酶（DPD）抑制剂的口服氟嘧啶替吉奥胶囊（TS-1）在55例胃癌患者中的疗效和安全性进行了研究。患者被分为有可测量癌灶的28例（TUM组）和无可测量癌灶的27例（ADJ组）。TUM组的疗程总数为164个（平均：5.9个疗程），ADJ组为146个（平均：5.4个疗程）。TUM组中，排除3例因给药不完整而无法评估的患者后，缓解率为40%（完全缓解：4例，部分缓解：6例，疾病稳定：6例，疾病进展：9例）。在缓解者中，达到缓解的平均疗程数为2.2个，中位生存时间（MST）为21.7个月。在安全性方面，45例患者（82%）出现了不良反应，ADJ组的发生率更高。主要毒性反应为白细胞减少（38%）、厌食（27%）、总胆红素浓度升高（25%）和腹泻（24%）。仅3例患者（5.5%）出现3级不良反应，且无药物相关死亡病例。总之，如果每两周检查一次以监测不良反应的发生，替吉奥胶囊是安全有效的。
