FOLFOX6方案与改良EOF方案治疗晚期胃癌Ⅱ期临床随机对照研究

A phase II randomized controlled study on treatment outcome for advanced gastric carcinoma comparing modified EOF regimen with FOLFOX6 regimen

目的 分析改良EOF与FOLFOX6方案的前瞻性随机对照临床研究,以期比较两者疗效与毒性差异,确定两方案在晚期胃癌治疗中的地位.方法 初治胃癌104例,随机分为改良EOF组48例,FOLFOX6组56例,分组均衡有可比性.改良EOF组:EPI 50 mg/m2, 第1天(d1), 静脉注射; L-OHP 130 mg/m2, d1,静脉滴注,2 h;5-Fu 3.0 g/m2鞘内注射,120 h; 21 d为1个周期.FOLFOX6组:L-OHP 100 mg/m2,静脉滴注,d1; CF 400 mg/m2,静脉滴注,2 h,d1; 5-Fu 400 mg/m2,bolus,d1; 5-Fu 2.4～3.0 mg/m2, 鞘内注射,46 h;每14天为1个周期,治疗至少2个周期以上,按WHO标准评价疗效,不良反应及KPS评分变化.结果 改良EOF组缓解率54.1%;FOLFOX6组缓解率46.4%,两组差异无统计学意义(P>0.05).KPS评分改善率改良EOF组为45.8%,FOLFOX6组为75.0%,二者比较差异有统计学意义(P<0.05).mTTP(中位无进展生存)两组比较改良EOF组较高(8.1个月VS 6.5个月),差异有统计学意义(P<0.05).不良反应改良EOF组较高,以恶心呕吐、骨髓抑制、脱发、静脉炎常见,FOLFOX6组不良反应较轻(P<0.05).结论 改良EOF方案与FOLFOX6方案治疗晚期胃癌近期疗效均好,尤以前者有效率略高;两组不良反应均可耐受,FOLFOX6方案毒性低,KPS评分改善较好,可依患者不同情况选择方案,值得继续组织大样本多中心临床研究.

Objective A stage II randomized controlled study for advanced gastric carcinoma were designed in order to compare the efficacy and toxity of modified EOF regimen with FOLFOX6 regimen and determine the role of these two regimens on treatment for gastric carcinoma. Methods One hundred and four untreated patients were randomized into the modified EOF group (48 cases) and FOLFOX6 group (56 cases).The distribution between the two groups was balanced. Modified EOF regimen:EPI 50 mg/m2 , d1 , iv ; L-OHP 130 mg/m2 , d1, ivgtt , 2 h; 5-Fu 3.0 g/m2 civ , 120 h; every three weeks for one cycle.FOLFOX6 regimen:L-OHP 100 mg/m2 ,ivgtt d1; CF 400 mg/m2,ivgtt 2 h,d1; 5-Fu 400 mg/m2,bolus,d1; 5-Fu 2.4-3.0 mg/m2, civ 46 h; every two weeks for one cycle. Every patients must perform at least two cycles. The efficacy, toxity and KPS scores were evaluated with WHO standard. Results The total response rates (RR) in the modified EOF group and FOLFOX6 group were 54.1% and 46.4%respectively. No significant difference was found(P>0.05). However improvement of KPS scores were 45.8% vs 75.0% (P<0.05). Media TTP was 8.1 months vs 6.5 months(P<0.05).Toxity in modified EOF group was a little higher than in the FOLFOX6 group(P<0.05). The common toxity included nausea, vomiting, bone marrow suppression, alopecia and phlebitis. Conclusions The reponse rates of modified EOF regimen and FOLFOX6 regimen were high for advanced gastric carcinoma. The RR of the regimen of modified EOF were a litter higher than FOLFOX6. The toxity of two groups can be tolerated. The toxity of the FOLFOX6 regimen was low with improvement of KPS score. Regimens can be seclected according to difference of patients and the trail was worth to investigate in large multi-center clinical study.