Background and objective: This study compared the efficacy and safety of icotinib with standard second-line chemotherapy (single-agent docetaxel or pemetrexed) in previously treated advanced non-small cell lung cancer (NSCLC).
Methods: Thirty-two consecutive patients treated with icotinib and 33 consecutive patients treated with standard second-line chemotherapy in Xuanwu Hospital from January 2012 to July 2013 were enrolled in our retrospective research. The Response Evaluation Criteria in Solid Tumors were used to evaluate the tumor responses, and the progression-free survival (PFS) was evaluated by Kaplan-Meier method.
Results: Icotinib was comparable with standard second-line chemotherapy for advanced NSCLC in terms of overall response rate (ORR) (28.1% vs 18.2%, P=0.341), disease control rate (DFS)(43.8% vs 45.5%, P=0.890), and PFS (4.3 months vs 3.8 months, P=0.506). In the icotinib group, the ORR of epidermal growth factor receptor (EGFR) mutant was significantly higher than that of EGFR unknown or wild type (P=0.017). In multivariate analysis, age, gender, histology, and the optimum first-line treatment response were dependent prognostic factors based on the PFS of the icotinib group. The incidence of adverse events was significantly fewer in the icotinib group than in the chemotherapy group (P=0.001).
Conclusions: Compared with the standard second-line chemotherapy, icotinib is active in the treatment of advanced NSCLC patients, especially with EGFR unknown in the second line, with an acceptable adverse event profile.
背景与目的 比较埃克替尼作为晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）二线治疗药物与化疗的疗效及不良反应。方法 收集2012年1月-2013年7月首都医科大学宣武医院收治的32例接受盐酸埃克替尼作为二线药物以及33例同期接受化疗的晚期NSCLC患者的临床资料并进行回顾性分析。结果 埃克替尼组有效率（overall response rate, ORR）为28.1%，化疗组为18.2%，组间无统计学差异（χ2=0.905, P=0.341）。埃克替尼组疾病控制率为43.8%，化疗组为45.5%，组间无统计学差异（χ2=0.019, P=0.890）。埃克替尼组中，表皮生长因子受体（epidermal growth factor receptor, EGFR）突变者的ORR明显高于EGFR状态不明或阴性者（χ2=8.460, P=0.017）。埃克替尼中位无进展生存时间（progression-free survival, PFS）为4.1个月，化疗组为3.8个月，组间无明显差异（P=0.506）。通过Cox多因素回归分析，埃克替尼组患者的PFS与年龄、性别、病理类型以及一线最佳疗效无关。在不良反应的观察中发现埃克替尼不良反应发生率低于化疗组（P=0.001）。结论 与传统化疗相比，盐酸埃克替尼可作为治疗晚期NSCLC，尤其是EGFR基因状态未明的患者的有效药物，安全性更高，患者的耐受性更好。.