Randomised clinical trial on rh-Endo combined with FOLFOX4 regimen as an adjuvant therapy for stage Ⅱ and Ⅱ colorectal cancer patients / 中华普通外科杂志
Chinese Journal of General Surgery
;
(12): 758-762, 2013.
Artigo
em Chinês
| WPRIM
| ID: wpr-442141
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.
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DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio Clínico Controlado
Idioma:
Chinês
Revista:
Chinese Journal of General Surgery
Ano de publicação:
2013
Tipo de documento:
Artigo
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