国产奥沙利铂联合亚叶酸钙和氟尿嘧啶治疗晚期胃癌的临床研究

Clinical Study on Patients with Advanced Gastric Cancer Treated with FOLFOX Regimen

目的:评价奥沙利铂(OXA)联合亚叶酸钙(LV)和氟尿嘧啶(5-Fu)方案治疗国人晚期胃癌的近期疗效和毒性反应。方法: 28例晚期胃癌,给予FOLFOX改良方案,即OXA120mg/m、静脉滴注4小时,LV200mg、静脉滴注2小时, 5-Fu500mg于LV滴完后静脉推注, 5-Fu3.0g持续静脉滴注46小时,每3周重复。按WHO标准评价近期疗效和毒性反应;同时观察TTP和MST。结果:可评价疗效者26例,获得PR11例(42.31% ),SD11例(42.31% ),PD4例(15.38% ),总有效率(CR+PR)为42.31%。中位TTP5 6个月,MST9个月。主要毒性反应为恶心、呕吐、骨髓抑制及一过性感觉异常,全组无治疗相关性死亡。结论:OXA联合LV/5-Fu组成的FOLFOX改良方案治疗晚期胃癌患者有效,临床缓解率较高,不良反应轻,可以耐受。

Objective：To evaluate the efficacy and toxicity of oxaliplatin（OXA） in combination with leucovorin （LV） and 5- fluorouracil（5-Fu） in the treatment of advanced gastric cancer. Methods：28 patients with advanced gastric cancer enrolled. All patients received modified FOLFOX regimen, namely OXA 120mg/m^2 iv 4h, LV 200rag iv 2h followed by 5-Fu 500rag（bolus） and 5-Fu 3.0g（46h-continuous infusion）, repeated every 3 weeks. The efficacy and toxicity were evaluated according to WHO standard. Resuits：26 patients might be evaluated for clinical response. PR was observed in 11 patients（42. 31% ） and SD in 11 （42. 31% ）. The rest 4 patients（ 15.38% ） got PD. The total response rate（ CR ＋ PR） was 42. 31%. Median time to progression（mTFP） was 5.6 months, and median overall survival time（MST） was 9 months. The most common toxicities were nausea, vomiting, suppression of marrow and mild neuro-sensory abnormity. There was no treatment related death. Conclusion： OXA in combination with LV and 5-Fu is an effective and well tolerated regimen in the treatment of advanced gastric cancer with mild toxicity.