羟基喜树碱联合用药治疗进展期结直肠癌的临床研究

目的：比较羟基喜树碱联合草酸铂（OH方案）和羟基喜树碱联合亚叶酸钙、氟尿嘧啶（HLF方案）治疗进展期结直肠癌的临床疗效和安全性。方法：经病理证实的进展期结直肠癌病例59例,37例采用OH方案化疗,22例采用HLF方案化疗,观察化疗毒副反应,2周期后评价疗效,随访观察无疾病进展生存期、总生存期,统计1年生存率。结果：OH和HLF方案化疗完全缓解率均为0,部分缓解率分别为32.4%（12/37）和22.7%（5/22）,两组差异无统计学意义（P〉0.05）;中位无进展生存期（mPFS）分别为5.7个月和7.3个月,两组差异无统计学意义（P〉0.05）;中位总生存期（mOS）分别为11.1个月和10.1个月,两组差异无统计学意义（P〉0.05）;1年生存率分别为30.98%和15.02%,两组差异无统计学意义（P〉0.05）。两组Ⅲ、Ⅳ度毒副反应均以骨髓抑制和消化道反应为主,其中粒细胞减少、恶心和呕吐、腹泻、外周神经毒性的发生率方面,OH组均高于HLF组（P〈0.05）。结论：OH和HLF方案治疗进展期结直肠癌疗效相似,前者粒细胞减少、胃肠道反应和外周神经毒性较常见,而贫血和血小板减少两者相似。

Clinical study of combined chemotherapy of oxaliplatin or 5-fluorouracil/leucovorin plus hydroxycamptothecine for advanced colorectal cancer

Objective：To estimate the efficacy and safety of combined chemotherapy of oxaliplatin or 5-fluorouracil/leucovorin plus hydroxycamptothecine for advanced colorectal cancer.Methods：Fifty-nine patients with advanced colorectal cancer confirmed by pathology were enrolled into this study.The OH group with 37 patients received oxaliplatin（130mg/m^2d1） plus hydroxycamptothecine（6mg/m^2d1-d4）,and the HLF group with 22 patients received hydroxycamptothecine（6mg/m^2d1-d4） plus 5-fluorouracil（0.375g/m^2d1-d5） and leucovorin（300mg d1-d5）.Chemotherapy was repeated every three weeks and the side effects were evaluated after two cycles of treatment.The efficacy was investigated after two cycles of chemotherapy.Results：The efficacy could be investigated in 37 and 22 patients respectively,and the overall response rate（CR＋PR） was 32.4% in the OH group and 22.7% in the HLF group.There were no complete responses（CR） and there was no significant statistical difference（χ2=0.876,P=0.704） in two groups.The 1-year survival rate was 30.98% in the OH group and 15.02% in the HLF group,and no significant difference was found between two groups.The mPFS and mOS was 5.7 and 11.1 months for OH group versus 7.3 and 10.1 months for HLF group,respectively.There were no significant differences between two groups（P〉0.05）.The major grade Ⅲ and Ⅳ side effects of two groups were myelosuppression and gastrointestinal reactions and significant statistical difference appeared in leukopenia,nausea/vomiting,diarrhea,and peripheral neuropathy（P〈0.05）.Conclusion：The efficacy is almost equal between OH and HLF group.The two regimens can be chosen after the first-line treatments for colorectal cancer.Leucopenia,nausea,diarrhea and peripheral neuropathy appeared frequently in OH group,anemia and thrombocytopenia are almost equal between OH and HLF group.