探索伊立替康联合雷替曲塞方案二线治疗晚期结直肠癌的疗效与安全性。

纳入2013年6月至2016年4月于中国医科大学附属第一医院肿瘤内科晚期二线治疗结直肠癌患者13例，所有患者接受伊立替康联合雷替曲塞方案治疗，具体用药为：伊立替康：180 mg/m² d1，d8静脉滴注；雷替曲塞：3 mg/m² d1静脉滴注（15 min）；每3周。SPSS 21.0进行统计学分析，生存分析采用Kaplan-Meier及Log-rank检验法。

至随访终止时间（2016年12月1日），中位随访时间10.1个月，共11例二线进展，中位疾病进展时间（TTP）为4.0个月；死亡病例共6例；疾病控制率为46.2%（SD 6例；PD 7例）；单因素分析显示：性别、年龄、BMI、原发肿块部位等对化疗疗效均无显著影响；在可评估不良反应中，主要为乏力（90%）、恶心（70%）、腹泻（60%）、肝功能损伤（37.5%）、骨髓抑制（22.2%）等，毒副反应基本可以耐受。

伊立替康联合雷替曲塞方案在晚期结直肠癌的二线治疗中效果肯定，且毒副反应可耐受，有望成为晚期结直肠癌的二线治疗的替代方案。

This study evaluated the efficacy and safety of irinotecan plus raltitrexed as second-line treatment for advanced colorectal cancer patients.

An exploratory study was made among patients with advanced, previously treated colorectal cancer from June 2013 to April 2016 in the First Hospital of China Medical University. A total of 13 patients eligible were enrolled to receive irinotecan at a dose of 180 mg/m² d1, d8 plus raltitrexed at a dose of 3 mg/m² d1, every 3 weeks. All statistical analyses were performed using the SPSS (21.0) software program. Kaplan–Meier analysis and Log-rank test were used for survival analysis. P<0.05 was considered as statistically significant. The primary end point was time to progression (TTP) and objective response rate(ORR), the secondary end point was safety.

The median follow-up time was 10.1 months at data cut-off on Dec1, 2016. Eleven patients were defined progression of disease (PD) based on the criteria of RECIST 1.1, while the median TTP of second-line was 4.0 months and 6 patients died. The rate of disease control rate (DCR) was 46.2% (6 patients stable disease and 6 patients progression of disease). In univariate analysis, sex, age, body mass index (BMI), site of tumor were not associated with efficacy of chemotherapy. The main toxicities were fatigue (90%), nausea (70%), diarrhea (60%), hepatic toxicity(37.5%) and hematologic toxic (22.2%). All the toxic side effects were tolerable.

In advanced colorectal cancer patients, irinotecan plus raltitrexed as second-line treatment showed encouraging clinical activity and a tolerable safety profile. So it is expected to become an alternative chemotherapy regimen as second-line treatment of advanced colorectal cancer.