摘要
目的比较晚期非小细胞肺癌行4周期一线含铂方案联合化疗后,单药吉西他滨维持治疗与最佳支持治疗两组之间无进展生存期(PFS)和总生存(OS)之间的差别。方法选择经过一线化疗后获得疾病控制的Ⅲb期或Ⅳ期非小细胞肺癌(NSCLC)患者62例,随机分为维持治疗组和对照观察组,维持治疗组给予吉西他滨按1g·m-2d1、d8维持化疗,三周重复一次,直至疾病进展;对照观察组只给予最佳支持治疗,观察两组患者的PFS和OS的差别。结果维持治疗组的中位PFS为4.2月,明显优于对照观察组的2.9月,两组比较差异有显著性意义(P<0.05);维持治疗组和对照观察组的中位OS分别为13.7个月和11.4个月,两组比较差异无显著性意义(P>0.05)。结论非小细胞肺癌4周期一线含铂方案联合化疗后采用单药吉西他滨维持治疗能改善PFS,副作用轻微,耐受性好。
Objective The primary objective of this study was to show difference in progression-free survival （PFS） and overall survival （OS） in patients with advanced non-small cell lung caner （NSCLC） treated with single-agent gemcitabine maintenance therapy versus best supportive care following platinum-based combination regimens as firstline treatment. Method 62 patients with stage IIIB/IV NSCLC achieving ob- jective response or disease stabilization were randomly divided into maintenance therapy group （n=30） and control group （n=32）. Patients in the maintenance therapy group received maintenance gemcitabine （lg.m^-2 on days 1 and 8 every 21 days） until disease progression, patients in control group were given the best sup- portive care. PFS and OS of the two groups were evaluated. Results Median PFS throughout the mainte- nance period was 4.30 and 2.50 months for maintenance therapy group and control group respectively, PFS was significantly higher in treatment group （P〈0.05）. Median OS throughout the maintenance period was 13.7 and 11.4 months for maintenance therapy group and control group respectively, no statistically difference was shown between two groups （P〉0.05）. Conclusion Gemcitabline maintenance therapy prolonged the median time to progression in patients with advanced non-small cell lung cancer who responded to platinum- based combination regimens as firsthne treatment, less toxicity, and good tolerance.
出处
《肿瘤药学》
CAS
2011年第3期209-211,共3页
Anti-Tumor Pharmacy
关键词
非小细胞肺癌
维持治疗
吉西他滨
Non-small Cell Lung Cancer, Maintenance
Gemcitabine
