国产伊立替康加5-氟尿嘧啶加亚叶酸钙联合沙利度胺治疗晚期大肠癌的随机对照研究

A randomized trial of irinotecan plus fuorouracil and leucovorin with thalidomide versus without thalidomide in the treatment for advanced colorectal cancer

目的 评价国产伊立替康（CPT-11）＋5．氟尿嘧啶（5-Fu）＋亚叶酸钙（LV）联合沙利度胺治疗晚期大肠癌的疗效。方法 65例符合入组条件的晚期大肠癌患者随机分为治疗组和对照组，治疗组采用国产CPT-11＋5-Fu＋LV方案联合沙利度胺化疗，对照组采用国产CPT-11＋5．Fu＋LV方案化疗。结果 治疗组和对照组的有效率分别为28．1％和15．2％，临床获益率分别为53．1％和48．5％，两组差异均无统计学意义（P值分别为0．2034和0．7083）；中位疾病进展时间（’IⅥ’）分别为3．8和2．5个月，差异无统计学意义（P=0．1312）；在恶心呕吐、黏膜炎、腹痛、腹泻、胆碱能综合征、血液学毒性方面的发生率，差异均无统计学意义；治疗前后东部肿瘤协作组（ECOG）PS评分，差异亦无统计学意义。结论 国产CPT-11＋5-Fu＋LV治疗晚期大肠癌疗效确切，患者耐受性好，联合沙利度胺能否提高疗效、降低毒性尚需进一步临床试验评价。

Objective To evaluate the efficacy, side-effects and quality of life in the advanced colorectal cancer patients treated by irinotecan plus fuorouracil and leucovorin with thalidomide or without thalidomide. Methods Eligible patients were randomly assigned to the treatment group and control group in a 1：1 ratio. In the treatment group, 32 evaluable patients were treated with irinotecan 180 mg/m^2 i.v. on day 2, fuorouracil 400 mg/m^2 bolus on day 1, 2 at a dose of 1200 mg/m^2 civ. for43 hours; leucovorin 200 mg/m^2 i.v. on day 1, 2 ; thalidomide 300 mg, orally on day 1 - 14, two weeks as a cycle. In the control group, the regimen was the same as in the treatment group except oral intake of thalidomide. Results The response rate was 28. 1% in the treatment group vs. 15.2% in the control group （P = 0. 2034） with a median TIP of 3.8 months vs. 2.5 months （P =0. 1312）. Furthermore, there was no statistically difference either between two groups regarding to adverse effects. Conclusion Irinotecan plus fuorouracil and leucovorin without oral intake of thalidomide is as effective and tolerable as irinotecan plus fuorouracil and leucovorin combined with oral thalidomide for advanced colorectal cancer.