一项针对晚期结直肠癌患者的S-1与伊立替康（CPT-11）联合治疗的I期研究。
A phase I study of combination therapy with S-1 and irinotecan (CPT-11) in patients with advanced colorectal cancer.
作者信息
Shiozawa Manabu, Sugano Nobuhiro, Tsuchida Kazuhito, Morinaga Soichiro, Akaike Makoto, Sugimasa Yukio
机构信息
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi-ku, Yokohama, 241-0815, Japan.
出版信息
J Cancer Res Clin Oncol. 2009 Mar;135(3):365-70. doi: 10.1007/s00432-008-0480-5. Epub 2008 Oct 31.
PURPOSE
The aim of this study was to determine the maximum tolerated dose, recommended dose and dose-limiting toxicities of irinotecan (CPT-11) plus S-1 in advanced colorectal cancer.
METHODS
S-1 was administered orally at 80 mg/m(2) per day for 14 consecutive days followed by a 2-week rest. CPT-11 was given intravenously on days 1 and 15 of each course, at an initial dose of 80 mg/m(2) per day, stepping up to 100, 120 or 150 mg/m(2) per day. Courses were repeated every 4 weeks, unless disease progression or severe toxicities were observed.
RESULTS
A total of 21 patients were entered in this study. The maximum tolerated dose of CPT-11 was considered to be 150 mg/m(2), because 2 of 3 patients developed dose-limiting toxicities such as leukopenia, neutropenia, diarrhea and anorexia. The recommend dose of CPT-11 was set at 120 mg/m(2). Tumor response rate was 42.8% and median progression-free survival time was 10 months (95% confidential interval, 6.0-14.0 months).
CONCLUSION
A combination of S-1 and CPT-11 showed a good safety profile and can be recommended for further phase II studies in patients with colorectal cancer.
目的
本研究旨在确定伊立替康（CPT-11）联合S-1用于晚期结直肠癌的最大耐受剂量、推荐剂量及剂量限制性毒性。
方法
S-1口服给药，剂量为80mg/m²，每日1次，连续服用14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，初始剂量为80mg/m²，每日递增至100、120或150mg/m²。每4周重复1个疗程，除非观察到疾病进展或严重毒性。
结果
本研究共纳入21例患者。CPT-11的最大耐受剂量为150mg/m²，因为3例患者中有2例出现了白细胞减少、中性粒细胞减少、腹泻和厌食等剂量限制性毒性。CPT-11的推荐剂量设定为120mg/m²。肿瘤缓解率为42.8%，无进展生存期的中位数为10个月（95%置信区间，6.0-14.0个月）。
结论
S-1与CPT-11联合应用显示出良好的安全性，可推荐用于结直肠癌患者的进一步II期研究。
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