奥沙利铂联合小剂量氟尿嘧啶持续输注治疗晚期结直肠癌的临床研究

目的:评价奥沙利铂(L蛳OHP)联合小剂量氟尿嘧啶(5蛳Fu)持续输注治疗晚期结直肠癌的近期疗效及安全性。方法:126例复治的晚期结直肠癌患者随机分为治疗组(小剂量5蛳Fu持续输注方案)61例、对照组(FOLFOX方案)65例。治疗组:L蛳OHP 100 mg静脉滴注2 h,第1天、第8天、第15天;5蛳Fu 250 mg/m2持续静脉滴注,第1天~第21天,28 d为1周期。对照组:L蛳OHP 130 mg/m2静脉滴注第1天;亚叶酸钙(CF)200 mg/m2静脉滴注2 h,接用5蛳Fu 400 mg/m2静脉推注,继以5蛳Fu 1.6 g/m2持续静脉滴注22 h,第1天、第2天,14 d为1周期。上述方案重复4周期后间隔1个月评定疗效。结果:126例总有效率为43.7 %。治疗组和对照组的有效率分别为42.6 %、44.6 %,组间差异无显著性。全部病例的中位生存期为8个月、缓解者为10个月、治疗无效病例为5个月;获得缓解病例的中位缓解期为6个月。主要毒副反应为消化道毒性、末梢神经炎及骨髓抑制等,多为Ⅰ度~Ⅱ度。结论:L蛳OHP联合小剂量5蛳Fu持续输注方案与FOLFOX方案疗效相当、毒副反应能耐受,均为晚期结直肠癌的有效治疗方案,值得临床推广使用。

Study on Oxaliplatin Combined Low Dose Fluorouracil Continuous Infusion for Advanced Colorectal Cancer

Objective: To evaluate the efficacy and toxicity of Oxaliplatin combined low dose fluorouracil continuous infusion for advanced colorectal cancer. Methods: In a randomized manner, 126 patients with advanced colorectal cancer were divided into treatment group (low dose fluorouracil continuous infusion regimens) and comparison group (FOLFOX). Among these patients, 61 received low dose fluorouracil continuous infusion regimens (L- OHP 100 mg,ivgtt.2 h, day1,8,15; 5- Fu 250 mg continuous infusion, day1~21; every four weeks) and 65 received FOLFOX (L- OHP 130 mg/m2,ivgtt.2 h, day1; CF 200 mg/m2 ivgtt.2 h, day1~2; 5- Fu 400 mg/m2 iv, 5- Fu 1.6 g/m2 continuous infusion, 22 h, day1~2; every two weeks). After four cycles, we evaluated the efficacy and toxicity interval of one month. Results: The overall response rate was 43.7 %(55/126). The response rate of patients in treatment group and comparison group were 42.6 % and 44.6 %. They had no statistic significance (P >0.05). The overall median survival was 8 months. The median survival of responsive patients and nonresponsive patients were 10 months and 5 months. The median duration of responsive patients was 6 months. The primary toxicities were digestive tract toxicity, end- brush neurotoxicity and myelosuppression. More of them were grade I~II. Conclusions: The treatment of Oxaliplatin combined low dose fluorouracil continuous infusion regimens for advanced colorectal cancer had similar efficiency to FOLFOX, and the side effect was endurable. They were all efficacious program for advanced colorectal cancer. It can be used extensively in clinical treatment.