吉西他滨同药维持化疗治疗晚期肺鳞癌的临床研究

Maintenance chemotherapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer

目的评价顺铂联合吉西他滨诱导化疗后吉西他滨同药维持化疗治疗肺鳞癌的临床疗效。方法 45例顺铂联合吉西他滨化疗后病情无进展的晚期肺鳞癌(IV期)患者随机均分为吉西他滨维持化疗组(n=22例)和最佳支持治疗组(n=23),吉西他滨维持化疗组患者静脉注射吉西他滨(1 000 mg/m^2,第1、8天),每21 d为一周期,病情进展或出现不能耐受的不良反应后停用;最佳支持治疗组停化疗药观察,两组均给予最佳支持治疗。主要临床终点为无进展生存期(PFS),次要临床终点为总生存期(OS)。结果吉西他滨维持化疗组患者PFS较最佳支持治疗组明显延长(中位PFS 3.8个月vs. 2.6个月,HR:0.518;95%CI:0.281～0.955 log-rank P <0.05)。两种治疗方案总生存期(OS)差异无统计学意义(P>0.05)。结论吉西他滨维持化疗能明显延长肺鳞癌患者的无进展生存期。

【Objective】To investigate the efficacy of continuation maintenance chemotherapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung carcinoma.【Methods】Forty-five patients with stage IV squamous cell lung carcinoma without progression disease after four cycles of cisplatine-gemcitabine chemotherapy were randomly divided into two groups: maintenance chemotherapy with gemcitabine(n =22) and best supportive care(n =23). Patients in maintenance chemotherapy group were treated with gemcitabine 1000 mg/m^2, days 1 and 8 of a 3-week cycle. Patients in control group were treated with watch-and-wait strategy. Both groups were treated with best supportive care. The primary endpoint was progression-free survival(PFS), and secondary endpoint was overall survival(OS).【Results】The progression free survival were prolonged by gemcitabine [median PFS 3.8 vs. 2.6 month, hazard ratio(HR) 0.518;95%CI 0.281~0.955 log-rank P <0.05]. There were no significant differences in overall survival between two groups.【Conclusion】Continuation maintenance chemotherapy with gemcitabine prolongs progression free survival of advanced squamous cell lung cancer.