目的：评价替吉奥（S-1）联合伊立替康（CPT-11）治疗FOLFOX耐药的晚期结直肠癌患者的临床疗效和不良反应。方法选择对FOLFOX方案耐药的有可评价病灶的晚期结直肠癌患者144例，将其随机分为实验组（72例）和对照组（72例）。实验组给予替吉奥联合伊立替康（IRIS）方案，对照组给予伊立替康联合亚叶酸钙、5-氟尿嘧啶（FOLFIRI）方案。每2个周期评价疗效及不良反应发生情况。结果144例患者均可评价疗效，实验组和对照组的CBR分别为54.17％和50.00％，RR分别为19.4％和12.86％，PFS分别为6.8和5.1个月。两组间PFS的差异有统计学意义（P<0.05）。两组患者主要Ⅲ/Ⅳ度不良反应（血液学毒性、腹泻、手足综合症）的发生率比较，差异均无统计学意义（P>0.05）。结论替吉奥联合伊立替康治疗FOLFOX耐药的晚期结直肠癌患者，其中位无进展期高于FOLFIRI方案，而毒副反应严重程度无显著差异，可作为转移性结直肠癌晚期二线化疗的一种新的选择。%Objective To evaluate the clinical efficacy and adverse reactions of Tizio (S-1) combined with irinotecan (CPT-11) in the treatment of FOLFOX (5-FU+oxaliplatin+sub Ye Suangai)-resistant advanced colorectal cancer. Methods 144 patients with advanced colorectal cancer who were resistant to FOLFOX programme and could be evaluated were randomly divided into the experimental group (72 cases) and control group (72 cases). The experimental group was treated with S-1 plus irinotecan (IRIS) scheme. The control group was treated with irinotecan combined with leucovorin and fluorouracil (FOLFIRI) scheme. The curative effect, including progression free survival (PFS), clinical benefit rate (CBR), total efficiency (RR) and incidence of adverse reac-tions were evaluated every two cycles. Results All the 144 patients were evaluated. The CBR of experimental group and control group were respectively 54.17%and 50.00%;RR were respectively 19.4%and 12.86%;PFS were respectively 6.8 months and 5.1 months. The PFS of experimental group was significantly longer than that of the control group (P<0.05). No obvious differences were found in the incidence rates of mainⅢ/Ⅳdegree adverse reactions between the two groups (P>0.05). Conclusion S-1 plus irinotecan was not inferior to FOLFIRI regimen in the treatment of FOLFOX-resistant advanced colorectal cancer. It had longer medium progression free survival than but caused equal toxicity to FOLFIRI regimen. Thus, it could be used as a new option for the second-line chemotherapy for metastatic advanced colorectal cancer.
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