mFOLFOX6方案用于进展期胃癌术后辅助化疗的临床研究

Clinical Observation of Oxaliplatin,Fluorouracil and Folinic Acid in Locally Advanced Gastric Cancer

目的观察mFOLFOX6方案用于进展期胃癌术后辅助化疗的临床疗效及不良反应。方法进展期胃癌术后患者29例入mFOLFOX6组,用奥沙利铂85mg/m2,静脉滴注(>2h),第1天;四氢叶酸钙400mg/m2,静脉滴注(2h),第1天;氟尿嘧啶0.4g/m2,静脉推注(四氢叶酸钙之后用);氟尿嘧啶2.4g/m2,持续静脉灌注(经化疗泵灌注)46小时。每2周重复1次,2次为1个疗程。同期进展期胃癌术后患者26例入PF组,用顺铂20mg/m2,静脉滴注,第1～5天;四氢叶酸钙300mg/m2,静脉滴注(2h),第1～5天;氟尿嘧啶500mg/m2,静脉滴注(四氢叶酸钙之后用),第1～5天;每3周重复1次,为1个疗程。结果mFOLFOX6组和PF组的中位疾病无进展时间分别为8.5个月和6.3个月,有显著性差异,P<0.05。1年总生存率分别为71%和67%,无显著性差异,P>0.05,3年总生存率分别为32%和29%,无显著性差异,P>0.05。mFOLFOX6组恶心呕吐发生率明显低于PF组,P<0.05。mFOLFOX6组外周神经毒性发生率高于PF组,P<0.05,但多数为Ⅰ～Ⅱ度。结论mFOLFOX6用于进展期胃癌术后辅助化疗,疾病无进展时间优于旧方案,毒性反应轻,胃癌术后患者容易接受。

Objective To evaluate the efficacy and safety of mFOLFOX6 regimen for patients with locally advanced gastric cancer after surgery. Methods Twenty-nine patients with locally advanced gastric cancer after surgery were treated by Oxaliplatin 85mg/m^2 and folinic acid （FA） 400 mg/m^2 （2-hour intravenous infusion） followed by fluorouracil （5-FU） 400 mg/m^2 bolus and then 5-FU 2 400 mg/m^2 （46-hour continuous infusion） every 14 days（ mFOLFOX6 group）. Twenty-six patients were treated by cisplatin 20 mg/m^2 and FA 300mg/m^2 followed by 5-FU 500mg/m^2 dl - d5 intravenous infusion every 21 days （ PF group）. Results Time to progression in mFOLFOX6 group and PF group was 8.5 months and 6.3 months respectively （ P 〈0.05 ）. One year overall survival rates in the two groups were 71% and 67% respectively （ P〉0.05 ）. Three years overall survivals in the two groups were 32% and 29% respectively （ P 〉0.05 ）. Nausea/vomiting in mFOLFOX6 group were milder than that in PF group （P 〈0.05）. Peripheral neuropathy toxicity occurred in mFOLFOX6 group more than in PF group （P 〈0.05）. Most common toxicities in mFOLFOX6 group were grade I and II peripheral neuropathy. Conclusion mFOLFOX6 regimen shows good efficacy acceptable toxicities in locally advanced gastric cancer after surgery.