S-1与每周一次紫杉醇联合治疗晚期或复发性胃癌的I/II期研究

Phase I/II study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer.

作者信息

Kawabata Ryohei, Fujiwara Yoshiyuki, Doki Yuichiro, Fujita Junya, Tsukahara Yasuo, Yamasaki Makoto, Miyata Hiroshi, Takiguchi Shuji, Monden Morito

机构信息

Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.

出版信息

Oncology. 2007;72(3-4):219-25. doi: 10.1159/000112945. Epub 2008 Jan 7.

DOI:10.1159/000112945

PMID:18176087

Abstract

OBJECTIVE

A phase I/II study of a combination of S-1 and weekly paclitaxel was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) and objective response rate (RR) in patients with advanced or recurrent gastric cancer.

METHODS

S-1 was administered orally at a fixed dose of 80 mg/m(2) per day on days 1-14. Paclitaxel was injected intravenously on days 1, 8, and 15, starting with a dose of 50 mg/m(2). The dose was increased in a stepwise manner.

RESULTS

In phase I, level 2 (60 mg/m(2)) was considered the MTD, because 2 of 3 patients in level 2 developed DLTs (grade 3 neutropenia and anemia, and grade 4 diarrhea and stomatitis). Therefore, the RD was determined to be level 1 (50 mg/m(2)). In phase II, efficacy and safety were assessed in 18 patients treated with the RD. The RR was 64.7% and the median survival time was 13.5 months. The most severe toxicities were grade 3 leukopenia (5.5%) and grade 3 neutropenia (5.5%).

CONCLUSION

Our study showed that S-1 combined with 50 mg/m(2) paclitaxel is effective and safe in patients with advanced or recurrent gastric cancer.

摘要

目的

开展一项S-1与每周一次紫杉醇联合用药的I/II期研究，以确定晚期或复发性胃癌患者的最大耐受剂量（MTD）、推荐剂量（RD）、剂量限制性毒性（DLT）和客观缓解率（RR）。

方法

S-1按固定剂量80mg/m²口服，第1 - 14天给药。紫杉醇于第1、8和15天静脉注射，起始剂量为50mg/m²，剂量逐步增加。

结果

在I期，2级（60mg/m²）被认为是MTD，因为2级的3例患者中有2例出现了DLT（3级中性粒细胞减少和贫血，4级腹泻和口腔炎）。因此，RD确定为1级（50mg/m²）。在II期，对18例接受RD治疗的患者进行了疗效和安全性评估。RR为64.7%，中位生存时间为13.5个月。最严重的毒性反应为3级白细胞减少（5.5%）和3级中性粒细胞减少（5.5%）。