全球阿法替尼指定患者使用项目，适用于先前治疗后进展的晚期非小细胞肺癌患者。
Global named patient use program of afatinib in advanced non-small-cell lung carcinoma patients who progressed following prior therapies.
机构信息
AUSL della Romagna, Ospedale Santa Maria delle Croci, viale Randi 5, 48100 Ravenna, Italy.
National University Health System & Cancer Science Institute of Singapore, Levels 8-10 NUH Medical Centre (NUHMC), 1 Kent Ridge Road, Singapore.
出版信息
Future Oncol. 2018 Jun;14(15):1477-1486. doi: 10.2217/fon-2017-0666. Epub 2018 Jan 29.
AIM
A global afatinib named patient use program in non-small-cell lung carcinoma (NSCLC) commenced in 2010.
MATERIALS & METHODS: Eligible NSCLC patients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had activating EGFR/HER2 mutations, exhausted all other treatments, and were ineligible for afatinib trials.
RESULTS
Data, as of January 2016, were reported on 3966 heavily pretreated NSCLC patients (41 countries; six continents). Among 2595/3966 (65.4%) patients with tumor EGFR status, 2407 (92.8%) were EGFR mutation positive. Median time to treatment failure (2862/3966 [72.2%] patients with available data) was 4.4 months. Among 1141/2862 (39.9%) patients with response reported, objective response rate was 23.4% (267/1141). Safety findings were as expected.
CONCLUSION
Time to treatment failure durations and objective response rates were encouraging.
目的
一项针对非小细胞肺癌（NSCLC）的阿法替尼全球患者使用计划于 2010 年启动。
材料与方法
符合条件的 NSCLC 患者在先前接受厄洛替尼/吉非替尼有临床获益后进展，且具有激活的 EGFR/HER2 突变，已用尽所有其他治疗方法，且不符合阿法替尼试验条件。
结果
截至 2016 年 1 月的数据报告了 3966 例接受过大量预处理的 NSCLC 患者（41 个国家；六大洲）。在 2595/3966（65.4%）例有肿瘤 EGFR 状态的患者中，2407（92.8%）例为 EGFR 突变阳性。中位治疗失败时间（2862/3966[72.2%]例有可用数据的患者）为 4.4 个月。在 1141/2862（39.9%）例报告有反应的患者中，客观缓解率为 23.4%（267/1141）。安全性发现与预期一致。
结论
治疗失败时间和客观缓解率令人鼓舞。
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