多西他赛联合替吉奥对比多西他赛单药二线冶疗晚期非小细胞肺癌临床观察

目的 探讨多西他赛联合替吉奥对比多西他赛单药二线冶疗晚期非小细胞肺癌的临床疗效.方法 收集经一线治疗后进展的晚期非小细胞肺癌患者100例,参照抽签法将患者随机分为试验组和对照组,每组各50例.试验组患者行多西他赛(60 mg/m2,静滴1 h,第1天)联合替吉奥(40 mg/m2,早晚饭后各服1次,连服14 d,每3周重复)治疗;对照组患者行多西他赛单药治疗(75 mg/m2,静滴1 h,第1天,每3周重复),所有患者随访至疾病进展或死亡.对比两组患者的临床疗效、生存情况及不良反应发生情况.结果 试验组患者的疾病控制率(72.00%)高于对照组患者(56.00%)(P﹤0.05);两组患者的客观缓解率比较,差异无统计学意义(P﹥0.05);试验组患者的中位无进展生存期为4.6个月(95%CI:3.994~5.206)长于对照组患者的3.1个月(95%CI:2.494~3.706)(P﹤0.05);试验组患者的中位生存期为9.2个月(95%CI:8.871~10.529)长于对照组患者的7.9个月(95%CI:5.575~10.225)(P﹤0.05);两组患者各种不良反应发生率及总不良反应发生率比较,差异均无统计学意义(P﹥0.05).结论 多西他赛联合替吉奥二线治疗晚期非小细胞肺癌的临床疗效优于多西他赛单药治疗.

Clinical observation of docetaxel plus S-1 versus docetaxel monotherapy as second-line treatment for patients with advanced non-small cell lung cancer

Objective To evaluate the efficacy and toxicities of docetaxel plus S-1 compared with docetaxel mono-therapy as second-line treatment for advanced non-small cell lung cancer (NSCLC). Method A total of 100 patients with stage Ⅲb or Ⅳ NSCLC who had failed first-line platinum-based therapies were enrolled. All patients were randomized 1:1 as study group or control group. The study group received docetaxel (60 mg/m2, i.v., on d1 of every 21 d) plus oral S-1 (40 mg/m2 on d1-14 of every 21 d);while the control group received docetaxel (75 mg/m2, i.v., on d1 of every 21 d) alone, all patients were followed up until disease progression or death. Result The disease control rate in the study group (72.00%) was significantly higher than that in the control group (56.00%) (P<0.05);But as to the objective response rate in the two groups, there was no statistically significant difference observed (P>0.05);The median progression-free surviv-al time in the study group was 4.6 months (95%CI:3.994-5.206), which was significantly longer than that of the control group at 3.1 months (95% CI: 2.494-3.706) (P<0.05); The median OS was 9.2 months (95% CI: 8.871-10.529) in the study group, longer than that of the control group at 7.9 months (95%CI:5.575-10.225) (P<0.05);Similar incidence of ad-verse reactions and overall adverse reactions were observed in the two groups (P>0.05). Conclusion Docetaxel plus S-1 is superior to docetaxel monotherapy as second-line treatment for advanced non-small cell lung cancer..