一项关于替吉奥（TS-1）与顺铂周疗用于晚期胃癌患者的Ⅰ期研究

[A phase I study of TS-1 and weekly cisplatin in patients with advanced gastric cancer].

作者信息

Kondo Ken, Kinoshita Mizunobu, Kataoka Masato, Shimoyama Satofumi, Yamamura Kazuo, Ohshima Yukiko, Furuta Kei, Chin Kakusyo, Hatsuno Takeshi, Kajikawa Masaki, Miura Keita, Horisawa Masumasa

机构信息

Dept. of Surgery, Nagoya National Hospital.

出版信息

Gan To Kagaku Ryoho. 2005 May;32(5):637-9.

PMID:15918563

Abstract

This is a phase I study to determine the maximum tolerated dose (MTD) and toxicity of a combination of TS-1 and weekly cisplatin (CDDP) in advanced gastric cancer patients. TS-1 was administered orally twice daily after meals, at a standard dose of 80 mg/m2. One course consisted of 21 days' consecutive administration followed by 14 days' rest. Cisplatin (CDDP) was injected intravenously on days 8, 15 and 22 using the following dose levels: dose level 1 20 mg/m2, dose level 2 25 mg/m2, and dose level 3 30 mg/m2. Twelve patients were entered in this trial. One of the 6 patients at dose level 3 had neutropenia NCI-CTC grade 3, while another patient at dose level 3 suffered from DLT (liver function grade 3. The maximal tolerable dose (MTD) was not reached using dose level 3. Partial responses were seen in 5 (62.5%) of 8 patients with evaluable lesions. At level 2 (25 mg/m2), the response rate was 100%. We recommended dose level 2 for phase II trials from the standpoint of toxicity and response rate.

摘要

这是一项I期研究，旨在确定替吉奥（TS-1）与顺铂（CDDP）每周给药方案联合应用于晚期胃癌患者的最大耐受剂量（MTD）及毒性。TS-1餐后口服，每日2次，标准剂量为80mg/m²。一个疗程为连续给药21天，随后休息14天。顺铂（CDDP）于第8、15和22天静脉注射，采用以下剂量水平：剂量水平1为20mg/m²，剂量水平2为25mg/m²，剂量水平3为30mg/m²。12例患者进入该试验。剂量水平3组的6例患者中有1例出现3级中性粒细胞减少（美国国立癌症研究所通用毒性标准[NCI-CTC]），另1例剂量水平3组患者出现剂量限制性毒性（肝功能3级）。剂量水平3未达到最大耐受剂量（MTD）。8例具有可评估病灶的患者中有5例（62.5%）出现部分缓解。在剂量水平2（25mg/m²）时，缓解率为100%。从毒性和缓解率角度考虑，我们推荐在II期试验中采用剂量水平2。