摘要
目的 比较奥沙利铂联合多西他赛（TOMOX）与奥沙利铂联合5-氟尿嘧啶和亚叶酸（FOLFOX4）两种方案作为原发性肝癌一线化疗药物的疗效。方法 采用奇偶数随机分组方法,将183例患者随机分为FOLFOX4组91例,TOMOX组92例。FOLFOX4组在治疗的第1~2天用亚叶酸200 mg/m^2、5-FU片剂400 mg/m^2联合静脉持续注射600 mg/m^25-FU,以后每天85 mg/m^2奥沙利铂,每2周为一个疗程。TOMOX组每天注射3 mg/m^2多西他赛15 min,45 min后注射130 mg/m^2奥沙利铂,3周为一个疗程。本研究治疗终止时间为出现进展性疾病（PD）,患者死亡或不可耐受的毒性。主要观察指标为肿瘤反应率（ORR）、完全缓解（CR）、部分缓解（PR）、稳定（SD）和进展（PD）。次要目标有生存期（OS）、无时进展生存期（PFS）和药物毒性反应等。结果 FOLFOX4组的ORR为36.3%,TOMOX组为45.6%,两组比较差异有统计学意义（χ2=3.046,P=0.032）。药物毒性发生率方面,FOLFOX4组发生白细胞减少和中性粒细胞减少的比例明显高于TOMOX组,差异均有统计学意义（χ2=6.397,P=0.028;χ2=8.906,P=0.032）。结论 TOMOX疗法具有安全稳定等特点,可以作为氟尿嘧啶一种很好的替代方案。
Objective To compare the clinical efficacy of docetaxel combined with oxaliplatin（TOMOX）,docetaxel combined with 5-fluorouracil and folinic acid（FOLFOX4） as first-line chemotherapy drugs for primary liver cancer. Methods Based on odd/even randomized method, 183 patients were divided into FOLFOX4 group of 91 cases and TOMOX group of 92 cases. FOLFOX4 group was treated with 200 mg/m^2 folinic acid, 400 mg/m^25-FU tablets combined with continuous intravenous injection of 600 mg/m^25-FU on day 1-2, followed by 85 mg/m^2 oxaliplatin every day, with 2 weeks as a course of treatment. TOMOX group applied daily injections of 3 mg/m^2 docetaxel for15 min, followed by injection of 130 mg/m^2 oxaliplatin 45 min later, with 3 weeks as a course of treatment. Time for termination was progressive disease（PD）, death or intolerable toxicity. Main indicators observed were tumor response rate（ORR）, complete remission（CR）, partial remission（PR）, stable disease（SD） and progressive disease（PD）. The secondary indicators include overall survival（OS）, progression free survival（PFS） and drug toxicity reactions. Results ORR was36.3% in FOLFOX4 group and 45.6% TOMOX group, with statistically significant difference between the two groups（χ^2=3.046, P=0.032）. For drug toxicity reactions, the incidence of leukopenia and neutropenia in the FOLFOX4 group were significantly higher than TOMOX group（χ^2=6.397, P=0.028; χ^2=8.906, P=0.032）. Conclusion TOMOX therapy has good security and stability, which can be used as an alternative to fluorouracil.
出处
《海南医学》
CAS
2015年第3期329-332,共4页
Hainan Medical Journal
基金
广东省2012年科技计划项目(编号:2012B031800181)
关键词
原发性肝癌
奥沙利铂
多西他赛
5-氟尿嘧啶
亚叶酸
Primary hepatic carcinoma
Oxaliplatin
Docetaxel（TOMOX）
5-Fluorouracil
Folinic acid（FOLFOX4）
