CAJ | 학술논문

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.
목적 본연구목적시평고은도(중조인혈관내피억제소,recombinant human endostatin,rh-Endo)연합FOLFOX4방안재Ⅱ화Ⅲ기결직장암환자보조화료중적장기유효성.방법 소유부합입조표준환자피수궤분배도FOLFOX4조(대조조)화FOLFOX4연합은도조(시험조).rh-Endo 7.5 mg/m2정적제1～7천,매2주중복1차,총공12개주기.결과 본시험공입조197례수시자,기중대조조105례,시험조92례.량조간기선자료분포기본평형,중위수방시간위42개월.Rh-Endo 연합FOLFOX4교FOLFOX4방안능사Ⅲ기결장암환자3년무병생존솔현저제고34％,동시사전이복발풍험현저강저81％,차이유통계학의의(HR =0.19,95％ CI0.05 ～0.75,P=0.0124)；Rh-Endo연합FOLFOX4교FOLFOX4방안능사Ⅲ기직장암환자3년무병생존솔제고17％,수연정체상차이무통계학의의(HR =0.75,95％CI0.31 ～ 1.83,P=0.5589).량충화료방안재Ⅱ기결장암화직장암중적3년무병생존솔상비차이균무통계학의의. 결론 Ⅲ기결직장암환자응용rh-Endo연합FOLFOX4방안가현저제고3년무병생존솔.
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.