中国临床药理学与治疗学2017，Vol.22Issue(6)：674-679,6.
持续泵注恩度联合化疗新辅助治疗局部晚期直肠癌的对比研究
Comparison study of modified FOLFOX6 combined with durative transfusion of endostatin as neoadjuvant treatment vs. treatment without endostatin for locally advanced rectal cancer
摘要
Abstract
AIM:To investigate the clinical efficacy,pathological remission rate and safety of mFOLOFX6 regimen combined with durative transfusion recombinant human endostatin as neoadjuvant treatment for locally advanced rectal cancer.METHODS:62 patients who met the inclusion criteria were randomly assigned to mFOLFOX6 group (control group) and mFOLFOX6 combined with endostatin group (experiment group).The control group received oxaliplatin 85 mg/m2 and leucovorin 200 mg/m2(i.v.drip) for 2 h on day 1,5-fluorouracil 400 mg/m2 (i.v.push),5-fluorouracil 2.6 g/m2 (continuous i.v.pump) right after leucovorin for 46 h every two weeks.The experiment group received daily endostatin 7.5 mg · m-2 · d-1 (continuous i.v.pump) for 7 d,repeatedly every two weeks on the basis of mFOLFOX6.All patients received 4 to 6 cycles of treatment before surgery.RESULTS:62 patients received a total of 310 cycles of treatment with ratable clinical efficacy.The total response rate of experimental group was 62.5％,which was significant higher than 36.6％ of the control group (P ＜ 0.05).The pathological complete remission rate of experimental group was 28.1％,which was significant higher than 6.7％ of the control group (P ＜ 0.05).The anus preservation rate of experimental group was 81.3％,which was significant higher than 56.7％ of the control group (P ＜ 0.05).Two groups presented with minor toxic reactions (major grade Ⅰ and Ⅱ) and low-rate complications,no significant difference perceived (P ＞ 0.05).CONCLUSION:Endostatin combined with mFOLOFX6 regimen as neoadjuvant treatment for locally advanced rectal cancer can improve the response rate,pathologic complete response rate and anal preservation rate while maintain minor adverse reactions and complications,which is referential for clinical application.关键词
恩度/直肠癌/新辅助治疗/病理缓解率/疗效/毒性反应Key words
endostatin/rectal cancer/neoadjuvant therapy/pathologic complete response rate/efficacy/toxicity分类
医药卫生引用本文复制引用
蒋三亚,单亚兵,陈文斌..持续泵注恩度联合化疗新辅助治疗局部晚期直肠癌的对比研究[J].中国临床药理学与治疗学,2017,22(6):674-679,6.基金项目
浙江省医药卫生项目(2012KYB028) （2012KYB028）
