FOLFOX4与FLP方案用于食管胃结合部癌和远端胃癌辅助化疗的比较

Comparison of FOLFOX 4 regimen and FLP regimen as adjuvant chemotherapy for esophagogastric junction carcinoma and distal gastric carcinoma

目的回顾分析FOLFOX 4方案与FLP方案在食管胃结合部癌和远端胃癌根治术后辅助化疗中的疗效和不良反应。方法 2007年3月至2009年10月,我科收治食管胃结合部癌及远端胃癌根治术后应用FOLFOX 4方案及FLP方案治疗的患者267例,其中食管胃结合部癌123例,远端胃癌144例,均经病理诊断证实。FOLFOX 4方案：奥沙利铂85mg/m2静滴,d1;氟尿嘧啶400mg/m2静推,600mg/m2持续静滴22h,d1、d2;亚叶酸钙200mg静滴,d1、d2;2周为1周期。FLP方案：顺铂30mg/m2静滴,d1~d3;氟尿嘧啶500mg/m2静滴4h,d1~d5;亚叶酸钙200mg静滴,d1~d5;3周为1周期。主要观察指标为无病生存期（DFS）、总生存期（OS）及不良反应,并对两组疗效和不良反应进行比较。结果食管胃结合部癌中,FOLFOX 4方案组及FLP方案组的中位DFS分别为35.9个月和16.8个月（P=0.008）,中位OS分别为41.3个月和25.6个月（P=0.013）。远端胃癌中,FOLFOX 4方案组及FLP方案组的中位DFS分别为35.8个月和31.8个月（P=0.925）,中位OS分别为46.6个月和43.5个月（P=0.720）。FOLFOX 4及FLP方案耐受性均良好,血液学不良反应无显著性差异,FOLFOX 4方案非血液学不良反应主要表现为外周神经毒性,FLP方案为消化道反应。结论在食管胃结合部癌辅助化疗中,与FLP方案比较,FOLFOX 4方案可延长患者的DFS和OS,且不良反应能够耐受,可开展进一步前瞻性研究;在远端胃癌辅助化疗中,未发现上述两方案的DFS或OS差异,不良反应能够耐受,均可作为根治术后辅助化疗方案。

Objective To retrospectively compare the efficacy and toxicity of 5-fluorouraciL/leucovorin （5-FU/LV） plus ox- aliplatin regimen （ FOLFOX 4 ） regimen versus 5-fluorouraciL/leucovorin （5-FU/LV） plus cisplatin （FLP） regimen as adjuvant chemo-therapy for esophagogastrie junction （EGJ）carcinoma and distal gastric carcinoma. Methods Two hundred sixty-seven patients with EGJ carcinoma and distal gastric carcinoma who accepted radical operation were collected from March 2007 to October 2009 in our department, with EGJ carcinoma 123 cases and distal gastric carcinoma 144 cases. The patients received either FOLFOX 4 regimen （ox- aliplatin 85mg/m2 infusion, d1;fluorouraeil 400mg/m^2 intravenous push, 600mg/m2 22-hour infusion, d1 ,d2 ; leueovorin 200rag infusion, d1, d2 ;2 weeks as a cycle）and FLP regimen（ eisplatin 30mg/m^2 infusion d1-d3 ;fluorouracil 500mg/m^2, 4-hour infusion d1 -d5; leueovorin 200mg,infusion d1-d5 ;3 weeks as a cycle）. Disease-free survival （DFS） and overall survival （OS） and toxicity as end points were compared between the two groups. Results In EGJ carcinoma, the median DFS of FOLFOX 4 and FLP regimen were 35.9 months and 16. 8 months respectively （ P = 0. 008 ） , and the median OS of FOLFOX 4 regimen and FLP regimen were 41.3 months and 25. 6 months respectively（ P = 0. 013 ）. In distal gastric carcinoma, the median DFS of FOLFOX 4 regimen and FLP regi- men were 35.8 months and 31.8 months, respectively（P =0. 925） , and the median OS of FOLFOX 4 regimen and FLP regimen were 46. 6 months and 43.5 months respectively （ P = 0. 720）. Two regimens were both tolerable, and hematology toxicities did not show significant difference. FOLFOX 4 regimen＇s non-hematology toxicities mainly showed peripheral neurotoxicity, and FLP regimen was gastrointestinal reaction. Conclusion As an adjuvant chemotherapy of EGJ carcinoma, FOLFOX 4 regimen extends the patients＇ DFS and OS comparing with FLP regimen, and toxicities are tolerable. Therefore,we can develop further prospective study. For the adjuvant chemotherapy of distal gastric carcinoma,between FOLFOX 4 regimen and FLP regimen,there are no statistically significant differences in DFS, OS and survival rate,and FOLFOX 4 regimen is as effective as FLP regimen.