Tsutsumi Soichi, Yamaguchi Satoru, Ide Munenori, Tsuboi Kaori, Fukasawa Takaharu, Yamaki Sayaka, Asao Takayuki, Kuwano Hiroyuki
Department of General Surgical Science (Surgery I), Gunma University Graduate School of Medicine Gunma, Japan.
Hepatogastroenterology. 2006 Mar-Apr;53(68):196-200.
BACKGROUND/AIMS: A phase I clinical trial has been planned to determine the recommended dose and to assess the safety and efficacy of combination chemotherapy of S-1 with cisplatin and irinotecan (SCI regimen) as a second-line treatment in 5-fluorouracil (5-FU) resistant colorectal cancer (CRC).
Patients with unresectable recurrent or metastatic CRC were enrolled in this study for second-line treatment. On an outpatient basis, the patients received a treatment SCI regimen comprising S-1 oral administration for 28 days followed by withdrawal for 2 weeks, plus cisplatin and irinotecan were administered on days 1, 8, 15 and 22 by intravenous injection. These courses were repeated every 6 weeks. Starting doses were 70 mg/m2 S-1, 6 mg/m2 Cisplatin, and 60 mg/m2 Irinotecan.
A total of 29 patients was enrolled. Dose-limiting toxicities were fatigue, nausea, and leucopenia. Twenty-three patients at recommended dose were evaluable for treatment response. The response rate was 21.7% (5 partial responses, 13 stable diseases, and 5 progressive diseases). The median progression-free survival rate was 4.3 months; the median survival time was 9.6 months.
The SCI regimen is feasible in an outpatient setting and should be considered as second-line chemotherapy for patients with 5-FU resistant CRC.
背景/目的：已计划开展一项I期临床试验，以确定推荐剂量，并评估S-1联合顺铂和伊立替康（SCI方案）作为二线治疗方案用于5-氟尿嘧啶（5-FU）耐药的结直肠癌（CRC）患者的安全性和疗效。
将不可切除的复发性或转移性CRC患者纳入本研究进行二线治疗。在门诊环境中，患者接受SCI治疗方案，包括口服S-1 28天，随后停药2周，加上在第1、8、15和22天通过静脉注射给予顺铂和伊立替康。这些疗程每6周重复一次。起始剂量为S-1 70mg/m²、顺铂6mg/m²和伊立替康60mg/m²。
共纳入29例患者。剂量限制性毒性为疲劳、恶心和白细胞减少。23例接受推荐剂量治疗的患者可评估治疗反应。缓解率为21.7%（5例部分缓解，13例病情稳定，5例病情进展）。无进展生存期的中位数为4.3个月；总生存时间的中位数为9.6个月。
SCI方案在门诊环境中是可行的，应被视为5-FU耐药CRC患者的二线化疗方案。
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