Randomised clinical trial on rh-Endo combined with FOLFOX4 regimen as an adjuvant therapy for stage Ⅱ and Ⅱ colorectal cancer patients
10.3760/cma.j.issn.1007-631X.2013.10.011
- VernacularTitle: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
- Author:
Zhihua XIE
;
Dejian DAI
;
Lin ZHONG
;
Yi YI
;
Jun FU
;
Zhijin ZHANG
;
Yuhao ZHANG
- Publication Type:Journal Article
- Keywords:
Colorectal neoplasms;
Antineoplastic combined chemotherapy protocols;
Disease-free survival;
Recombinant human endostatin
- From:
Chinese Journal of General Surgery
2013;28(10):758-762
- CountryChina
- Language:Chinese
-
Abstract:
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.
