阿法替尼治疗晚期非小细胞肺癌的疗效和安全性观察

目的：观察第二代表皮生长因子受体酪氨酸激酶抑制剂（EGFR －TKIs）阿法替尼治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。方法纳入37例经病理学或细胞学确诊的Ⅳ期非小细胞肺癌（NSCLC）患者。一线表皮生长因子受体（EGFR）突变患者10例，给予阿法替尼每日40 mg 口服；二线及以上患者27例，其中2例二线鳞癌患者给予阿法替尼每日40 mg 口服，其余二线以上患者给予每日50 mg 口服，直至疾病进展，观察近期疗效、无进展生存期（PFS）及不良反应。结果全组37例患者，完全缓解（CR）0例，部分缓解（PR）14例（37．8％），疾病稳定（SD）19例（51．4％），疾病进展（PD）4例（10．8％），客观有效率（ORR）37．8％，疾病控制率（DCR）89．2％，PFS 为6．9个月（95％CI 3．8～10．0）。亚组分析显示，一线 EGFR 突变患者ORR 100％，PFS 12．1个月，二线及以上 EGFR 突变未知患者 ORR 14．8％，PFS 5．3个月，两组间差异有显著性意义（P ＜0．01）。最常见的不良反应为腹泻（100．0％），皮疹（83．8％）。结论阿法替尼用于一线治疗具有 EGFR 基因突变的晚期NSCLC 患者疗效确切，患者耐受性较好。

Efficacy and safety of Afatinib in patients with advanced non-small cell lung cancer

Objective To observe the clinical efficacy and safety of afatinib,a second generation epidermal growth factor receptor tyro-sine kinase inhibitor (EGFR-TKIs),in the treatment of patients with advanced non-small cell lung cancer (NSCLC).Methods A to-tal of 37 patients with advanced NSCLC diagnosed pathologically were enrolled into the study.Ten patients with EGFR mutations were first-line treated with oral afatinib 40 mg·d -1 until disease progression.Two squamous carcinoma patients were second-line treated with 40 mg·d -1 of afatinib,and others with 50 mg·d -1 for second-line and beyond treatment.The short-term efficacy,progression free sur-vival (PFS)and adverse events were observed.Results Among the 37 patients,there was no case with complete response;14 cases (37.8%)had partial response,19 cases (51.4%)had stable disease and 4 case (10.8%)had progressive disease;the objective re-sponse rate (ORR)was 37.8% and the disease control rate (DCR)was 89.2%;the median progression free survival (PFS)was 6.9 months (95%CI 3.8 ~10.0).Further sub group analysis showed that the first-line treated subjects with EGFR mutations (ORR 100%,PFS 12.1 months)were more effective than that second-line and beyond treatment with unknown EGFR mutations (ORR 14.8%,PFS 5.3 months)with statistically significant difference (P ﹤ 0.01 ).The most common adverse events were diarrhea (100.0%)and rash (83.8%).Conclusions Afatinib is effective and safe as fist-line treatment for patients with EGFR mutations advanced NSCLC.