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S-1联合伊立替康(CPT-11)治疗晚期结直肠癌的II期研究。

Phase II study of S-1 combined with irinotecan (CPT-11) in patients with advanced colorectal cancer.

作者信息

Tsunoda A, Yasuda N, Nakao K, Narita K, Watanabe M, Matsui N, Kusano M

机构信息

Department of Gastroenterological and General Surgery, Showa University School of Medicine, Tokyo, Japan.

出版信息

Oncology. 2009;77(3-4):192-6. doi: 10.1159/000236017. Epub 2009 Sep 3.

DOI:10.1159/000236017
PMID:19729976
Abstract

OBJECTIVE

To determine the efficacy and tolerability of oral fluoropyrimidine S-1 plus irinotecan in patients with previously untreated advanced colorectal cancer.

METHODS

S-1 was administered orally at 80 mg/m(2)/day for 21 consecutive days followed by a 2-week rest. CPT-11 was given intravenously on days 1 and 15 of each course, at a dose of 80 mg/m(2)/day. Courses were repeated every 5 weeks, unless disease progression or severe toxicities were observed.

RESULTS

A total of 282 courses of treatment were administered to 40 patients, achieving complete response in 1 and partial responses in 24 with an overall response rate of 62.5% (95% CI: 47.5-77.5%). Median progression-free survival was 7.8 months (95% CI: 6.7-9.6 months). The rates of grade 3 or 4 toxicities were as follows: neutropenia 12.5%, anorexia 12.5%, fatigue 10%, and diarrhea 7.5%.

CONCLUSION

Combined treatment with S-1 and irinotecan is an effective, well-tolerated and convenient regimen in patients with advanced colorectal cancer which is easily maintained.

摘要

目的

确定口服氟尿嘧啶S-1联合伊立替康治疗既往未治疗的晚期结直肠癌患者的疗效和耐受性。

方法

S-1按80mg/m²/天口服,连续21天,随后休息2周。CPT-11在每个疗程的第1天和第15天静脉给药,剂量为80mg/m²/天。除非观察到疾病进展或严重毒性,否则每5周重复一个疗程。

结果

共对40例患者进行了282个疗程的治疗,1例完全缓解,24例部分缓解,总缓解率为62.5%(95%CI:47.5-77.5%)。无进展生存期的中位数为7.8个月(95%CI:6.7-9.6个月)。3级或4级毒性发生率如下:中性粒细胞减少12.5%,厌食12.5%,疲劳10%,腹泻7.5%。

结论

S-1和伊立替康联合治疗对晚期结直肠癌患者是一种有效、耐受性良好且方便维持的治疗方案。

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