阿法替尼治疗晚期非小细胞肺癌的疗效和安全性观察  

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

作　　者：张丽[1] 汤依群[1] 史美祺[2] 夏国豪[2] 王丽[2] 寇莹莹[2] 马祥垒 

机构地区：[1]中国药科大学临床药学教研室 [2]江苏省肿瘤医院内科,江苏南京210009

出　　处：《安徽医药》2015年第7期1375-1378,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：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。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.

关 键 词：阿法替尼 非小细胞肺癌 疗效 安全性 

分 类 号：R734.2[医药卫生—肿瘤]