SOX方案与改良mFOLFOX6方案治疗弥散型进展期胃癌的疗效和安全性比较

Comparison of Efficacy and Safety of Gio Combined with Oxaliplatin versus Fluorouracil Combined with Calcium Folinate and Oxaliplatin in the Treatment of Diffuse Advanced Gastric Cancer

目的:比较替吉奥联合奥沙利铂(SOX方案)与5-氟尿嘧啶(5-FU)、左亚叶酸钙联合奥沙利铂(改良m FOLFOX6方案)治疗弥散型进展期胃癌的疗效和安全性。方法:回顾性收集128例弥散型进展期胃癌患者资料,按用药方案不同将所有患者分为SOX组(66例)和m FOLFOX6组(62例)。SOX组患者给予替吉奥胶囊,体表面积<1.25 m2为40 mg,1.25~1.5 m2为50 mg,>1.5m2为60 mg,早晚餐后口服,d_(1-14)+注射用奥沙利铂130 mg/m^2,静脉滴注,d1;3周为1个周期,每2个周期评价疗效,最多治疗8个周期,至少治疗2个周期。m FOLFOX6组患者给予注射用奥沙利铂85 mg/m^2,静脉滴注,d1+注射用左亚叶酸钙200 mg/m^2,静脉滴注,d1+注射用5-FU 400 mg/m^2,快速静推,d1,后给予5-FU 2 400 mg/m^2,持续泵入维持46 h;2周为1个周期,每3个周期评价疗效,最多治疗12个周期,至少治疗3个周期。观察两组患者的临床疗效,疾病进展时间、生存时间及毒副反应发生情况。结果:SOX组患者客观有效率、中位疾病进展时间、中位生存时间均显著优于m FOLFOX6组,差异均有统计学意义(P<0.05或P<0.01)。两组患者疾病控制率、毒副反应发生率比较,差异均无统计学意义(P>0.05)。结论:SOX方案治疗弥散型进展期胃癌的疗效优于改良m FOLFOX6方案,可延长患者生存时间,且安全性相似。

OBJECTIVE：To compare the efficacy and safety of gio combined with oxaliplatin（SOX） versus 5-fluorouracil（5-FU）combined with calcium folinate and oxaliplatin（m FOLFOX6）in the treatment of diffuse advanced gastric cancer. METHODS：The data of 128 patients with diffuse advanced gastric cancer was retrospectively analyzed and patients were divided into SOX group（66 cases）and m FOLFOX6 group（62 cases）by different medication. SOX group received Gio capsule after breakfast and dinner,which was 1.25 m2,40 mg,〈1.25-1.5 m^2,50 mg,〉1.5 m2,60 mg,d1-14＋130 mg/m^2 Oxaliplatin for injection,intravenously,d1;3-week was regarded as a treatment course,the efficacy was evaluated every 2 courses,and it lasted a maximum of 8courses but a minimum of 2 courses. m FOLFOX6 group received 85 mg/m2 Oxaliplatin for injection,intravenously,d1＋200 mg/m^2 calcium folinate,intravenously,d1＋400 mg/m25-FU for injection by rapid intravenous injection,d1,then 2 400 mg/m25-FU,maintaining 46 h by continuous infusion. 2-week was regarded as a treatment course,the efficacy was evaluated every 3 courses,and chemotherapy was conducted in a maximum of 12 courses but a minimum of 3 courses. Clinical efficacy,time to progression,survival time and incidence of toxicities in 2 groups were observed. RESULTS：The objective response rate,time to progression and median survival time in SOX group was significantly higher than m FOLFOX6 group,the difference was statistically significant（P〈0.05 or P〈0.01）. There was no significant difference in the disease control rate and incidence of toxicities in 2 groups（P〉0.05）. CONCLUSIONS：The efficacy of SOX is superior to m FOLFOX6 in the treatment of diffuse advanced gastric cancer,it can prolong the survival time,with similar safety.