恩度联合FOLFOX4方案应用于Ⅱ和Ⅲ期结直肠癌辅助化疗的临床随机对照研究  

Randomised clinical trial on rh-Endo combined with FOLFOX4 regimen as an adjuvant therapy for stage Ⅱ and Ⅱ colorectal cancer patients

作　　者：谢智华[1] 戴德坚[1] 钟林[2] 易宜[1] 傅骏[1] 张治进[1] 张玉浩[1] 

机构地区：[1]江苏大学附属上海市第八人民医院结直肠外科,200235 [2]上海交通大学附属第一人民医院普外科

出　　处：《中华普通外科杂志》2013年第10期758-762,共5页Chinese Journal of General Surgery

摘　　要：目的 本研究目的是评估恩度（重组人血管内皮抑制素,recombinant human endostatin,rh-Endo）联合FOLFOX4方案在Ⅱ和Ⅲ期结直肠癌患者辅助化疗中的长期有效性.方法 所有符合入组标准患者被随机分配到FOLFOX4组（对照组）和FOLFOX4联合恩度组（试验组）.rh-Endo 7.5 mg/m2静滴第1～7天,每2周重复1次,总共12个周期.结果 本试验共入组197例受试者,其中对照组105例,试验组92例.两组间基线资料分布基本平衡,中位随访时间为42个月.Rh-Endo 联合FOLFOX4较FOLFOX4方案能使Ⅲ期结肠癌患者3年无病生存率显著提高34％,同时使转移复发风险显著降低81％,差异有统计学意义（HR =0.19,95％ CI0.05 ～0.75,P=0.0124）；Rh-Endo联合FOLFOX4较FOLFOX4方案能使Ⅲ期直肠癌患者3年无病生存率提高17％,虽然整体上差异无统计学意义（HR =0.75,95％CI0.31 ～ 1.83,P=0.5589）.两种化疗方案在Ⅱ期结肠癌和直肠癌中的3年无病生存率相比差异均无统计学意义. 结论 Ⅲ期结直肠癌患者应用rh-Endo联合FOLFOX4方案可显著提高3年无病生存率.Objective To evaluate the long-term efficacy of recombinant human endostatin （rh-Endo） combined with FOLFOX4 as an adjuvant treatment for patients of stage Ⅱ and Ⅲ colorectal cancer.Methods Eligible patients were randomly assigned to receive FOLFOX4 or FOLFOX4 plus rh-Endo regimen in which patients receiving 7.5 mg/m2 Ⅳ on day 1-7,repeated every 2 weeks,to a total of 12 cycles in 6 months.Results A total of 197 eligible patients were accrued in this research with 105 patients in the control group and 92 patients in the experimental arm.Median follow-up period was 42 months.The baseline characteristics distributed were balanced by treatment.Rh-Endo combined with FOLFOX4 regimen resulted in significant improvement on DFS compared to FOLFOX4 regimen for patients with stage Ⅲ colon cancer （HR =0.19,95% CI0.05-0.75,P =0.0124）,and with a 34% improvement on 3-year DFS and 81% reduced recurrence.Although rh-Endo combined with FOLFOX4 regimen failed to make significant difference on DFS in the whole （HR =0.75,95% CI 0.31-1.83,P =0.5589）,it was also observed a 17% improveiment on 3-year DFS.No statistical significant difference on DFS was observed in patients with stage Ⅱ disease.Conclusions Rh-Endo combined with FOLFOX4 regimen significantly improved the disease-free survival for patients with stage Ⅲ colorectal cancer,indicating that patients with stage Ⅲ disease,but not stage Ⅱ disease,can benefit from FOLFOX4 plus rh-Endo regimen in adjuvant treatment.

关 键 词：结直肠肿瘤 抗肿瘤联合化疗方案 无病生存 恩度 

分 类 号：R735.3[医药卫生—肿瘤]