CAJ | 학술논문

阿法替尼是一种口服给药的酪氨酸激酶ErbB家族不可逆抑制药。两项随机、开放标签、多中心Ⅲ期临床试验结果表明，与培美曲塞+顺铂(LUX-Lung 3)或吉西他滨+顺铂(LUX-Lung 6)化疗相比，阿法替尼可显著延长EGFR突变的晚期非小细胞肺癌患者的无进展生存期，患者报告的咳嗽和呼吸困难症状以及健康相关生活质量也优于化疗组。阿法替尼于2013年7月获得美国FDA批准上市，一线治疗伴EGFR外显子19缺失或外显子21替代突变的晚期非小细胞肺癌。本文对阿法替尼的作用机制、药动学特性、临床研究进展以及安全性等作一综述。
아법체니시일충구복급약적락안산격매ErbB가족불가역억제약。량항수궤、개방표첨、다중심Ⅲ기림상시험결과표명，여배미곡새+순박(LUX-Lung 3)혹길서타빈+순박(LUX-Lung 6)화료상비，아법체니가현저연장EGFR돌변적만기비소세포폐암환자적무진전생존기，환자보고적해수화호흡곤난증상이급건강상관생활질량야우우화료조。아법체니우2013년7월획득미국FDA비준상시，일선치료반EGFR외현자19결실혹외현자21체대돌변적만기비소세포폐암。본문대아법체니적작용궤제、약동학특성、림상연구진전이급안전성등작일종술。
Afatinib is an irreversible inhibitor for the ErbB family of tyrosine kinases with oral administration. In two randomized, open-label and multinational phase III trials, the progression-free survival was significantly prolonged by afatinib compared with peme-trexed plus cisplatin (LUX-Lung 3) or gemcitabine plus cisplatin (LUX-Lung 6) in the treatment-naive patients with advanced non-small cell lung cancer ( NSCLC) with activating EGFR mutations. The patient-reported symptoms such as cough and dyspnoea, and certain health-related quality of life after the treatment by afatinib were also better than those treated by control dugs. Afatinib was ap-proved by FDA in July 2013 as the first-line treatment drug for the patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. The action mechanisms, pharmacokinetics, clinical trials and adverse events were reviewed in this paper.