Background and objective: Icotinib hydrochloride is the third single target EGFR-TKI used in clinical treatment of advanced non-small cell lung cancer (NSCLC). Clinical research reports on its efficacy and survival in patients with Recurrent Advanced NSCLC are still little.The aim of this study is to evaluate the efficacy and survival of Icotinib hydrochloride for patients with advanced non-small cell lung cancer who failed to previous chemotherapy and explore the association of clinical features with the efficacy and survival.
Methods: The clinical data of 60 NSCLC patients referred to the Beijing Chest Hospital, Capital Medical University from March 2009 to July 2012 were retrospectively analyzed.
Results: The overall response rate (ORR) was 45.0% and the disease control rate (DCR) was 80.0%. The median progression-free survival (PFS) time was 6.7 months. RR and PFS in female were superior to male (P=0.014, 0.013, respectively). RR, DCR in 2nd-line subgroup were superior to ≥3rd-line subgroup (P=0.020, 0.024, respectively). RR, DCR and PFS in EGFR mutation carriers were significantly superior to wild-type patients (P=0.006, <0.001, 0.002, respectively). There was no statistical difference in RR and PFS between those age<65 and ≥65 or PS<2 and PS≥2. There was no statistical difference in RR and DCR between exon 19 deletion and exon 21 mutations, while the former had much longer PFS (P=0.020). EGFR mutation and exon 19 deletion are the independent prognostic factors to significantly improve the PFS (P=0.009, 0.012, respectively). The side effects were generally mild and consisted of rash and diarrhea.
Conclusions: Icotinib hydrochloride is effective especially in EGFR mutation carriers and well tolerated in patients with recurrent advanced non-small-cell lung cancer.
背景与目的 盐酸埃克替尼是第三个在临床上应用于晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）治疗的单靶点表皮生长因子受体酪氨酸激酶抑制剂（epidermal growth factor receptor tyrosine kinase inhibitor, EGFR-TKI），关于其在复发肺癌患者中的疗效及生存的临床研究报道仍甚少。本研究回顾性分析盐酸埃克替尼在晚期复发NSCLC中的疗效及安全性，并探讨影响因素。 方法 对2009年3月-2012年7月北京胸科医院收治的60例接受盐酸埃克替尼治疗的晚期复发NSCLC患者的临床资料进行回顾性分析。结果 60例均可评价疗效，总有效率45%，疾病控制率80%，中位无进展生存期（progression free survival, PFS）6.7个月。女性患者的有效率、PFS优于男性（P值分别为0.014、0.013）；二线治疗组的有效率和疾病控制率优于三线及以上组（P值分别为0.020、0.024）；年龄≥65岁与<65岁，PS评分<2分与≥2分，埃克替尼二线治疗与三线以上治疗组患者的疗效及PFS无明显差别。EGFR敏感突变患者的有效率、疾病控制率及无进展生存均明显优于EGFR野生型患者（P值分别为0.006、<0.001、0.002）；外显子19缺失突变组与外显子21 L858R突变组近期疗效无明显差别，而前者PFS明显更长（P=0.020）。EGFR敏感突变、外显子19缺失突变是具明显生存优势的独立因子（P值分别为0.009、0.012）。毒副反应主要为轻度皮疹及腹泻。结论 盐酸埃克替尼是治疗晚期复治NSCLC的有效药物，安全性好，尤其在携带敏感突变的患者中疗效更佳。