多西他赛培美曲塞和表皮生长因子受体酪氨酸激酶抑制剂二线治疗晚期非小细胞肺癌的近期疗效与安全性

Efficacy and safety of docetaxol, pemetrexed and EGFR-TKIs as second-line treatment for patientswith advanced non-small-cell lung cancer

目的比较多西他赛、培美曲塞和表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）二线治疗晚期非小细胞肺癌（NSCLC）的近期疗效及安全性。方法标准一线治疗失败的170例晚期肺癌患者分为A组、B组和C组，A组60例，接受多西他赛二线治疗；B组49例，患者接受培美曲塞治疗；C组61例，接受EGFR-TKIs治疗。采用Kaplan-Meier方法、Logrank检验和Cox回归分析3组患者二线治疗后的无进展生存时间（PFS）和中位生存时间（MST）。结果A组、B组和C组患者的有效率分别为15．0％（9／60）、24．5％（12／49）和36．1％（22／61）。A组、B组和C组患者二线治疗后的PFS分别为（5．49±0．75）个月（95％CI为4．03-6．95个月）、（5．45±0．60）个月（95％CI为4．23-6．60个月）和（9．31±1．24）个月（95％CI为6．88-11．73个月），差异有统计学意义（P=0．045）。A组、B组和C组患者的MST分别为（14．89±1．87）个月（95％CI为11．23-18．55个月）、（15．81±I．89）个月（95％口为12．11-19．52个月）、（17．47±2．09）个月（95％CI为13．38-21．56个月），差异无统计学意义（P=0．574）。多因素回归分析显示，二线治疗时功能状态评分（PS）和二线治疗后反应为各亚组独立预后因素，且病理类型也为C组独立预后因素（P=0．003）。结论一线治疗失败的晚期NSCLC患者选择多西他赛、培美曲塞和EGFR-TKIs作为二线治疗，安全性相当，但以EGFR-TKIs治疗的有效率最高，且PFS较多西他赛、培美曲塞差异显著。

Objective To compare the efficacy and safety of docetaxol, pemetrexed and EGFR- TKIs in the second-line treatment for patients with advanced non-small cell lung cancer. Methods The clinical data of 170 patients with advanced non-small cell lung cancer who failed standard first-line chemotherapy were reviewed. Those who received doeetaxol as second-line therapy were designated as group A （n = 60）, those who received pemetrexed as second-line therapy were designated as group B （n = 49 ）, and those who received EGFR-TKIs as second-line therapy were designated as group C （ n = 61 ）. PFS and MST were estimated by Kaplan-Meier method and the differences between groups were compared by log-rank test. Results The response rate in the groups A, B and C group was 15.0% （9/60）, 24.5% （12/49） and 36.1% （22/61） , respectively. The PFS after second-line therapy in the groups A, B and C was 5.49 months （95%CI： 4.03-6.95 months）, 5.42 months （95% CI： 4.23-6.60 months） and 9.31 months （95%CI： 6.88-11.73 months）, respectively （P =0. 045）. The MST after second-line therapy in the groups A, B and C was 14.89 months （95% CI： 11.23-18.55 months） , 15.81 months（95% CI： 12.11- 19.52 months） and 17.47 months（95% CI： 13.38-21.56 months）, respectively （P =0. 574）. Regression analysis showed that the performance status score （PS） and response for second-line treatment are independent prognostic factors in each sub-group, and pathological type is an independent prognostic factorin the group C （ P = O. 003）. Conclusions The safety of the three drugs used as second-line treatment for patients with advanced non-small-cell lung cancer, who failed standard first-line chemotherapy, is comparable, but the EGFR-TKIs group has the highest response rate, and the EGFR-TKIs group has the longest PFS with a statistically significant difference, while there is no significant difference in MST among the three groups. When patients receive second-line treatment, the performance status 〈 2 and the response rate for second-line treatment are independent prognostic factors. Furthermore, pathological type ） is also an independent prognostic factor for EGFR-TKIs as second-line treatment.