A prospective, phase II, open-label study (JO22903) of first-line erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC)
A prospective, phase II, open-label study (JO22903) of first-line erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC)
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DOI：
10.1016/j.lungcan.2013.07.003
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发表时间：
2013-10-01
期刊：
影响因子：
5.3
通讯作者：
Tamura, Tomohide
中科院分区：
文献类型：
--
作者：
Goto, Koichi;Nishio, Makoto;Tamura, Tomohide
简介：表皮生长因子受体（EGFR）酪氨酸激酶抑制剂厄洛替尼与EGFR突变阳性非小细胞肺癌（NSCLC）患者的生存获益相关。这项II期、单组研究检查了一线厄洛替尼在日本EGFR突变阳性非小细胞肺癌患者中的疗效和安全性。方法：符合条件的患者接受厄洛替尼150 mg/天治疗，直至疾病进展或出现不可接受的毒性。主要终点是无进展生存期（PFS）和safety.Results：高度的一致性，观察不同的突变检测方法之间，这表明早期，快速检测EGFR突变的可行性。在数据截止日期（2012年6月1日），中位PFS为11.8个月（95%置信区间[CI]：9.7-15.3）（n=102）。与L 858 R突变相比，外显子19缺失似乎与较长的PFS相关; T790 M突变与较短的PFS暂时相关。安全性特征与预期一致：皮疹（任何级别; 83%）和腹泻（任何级别; 81%）最常见。报告了6例间质性肺病（ILD）样病例，其中5例被院外委员会确认为ILD样事件。2例患者死于治疗相关性肺炎（JAPIC临床试验信息编号：Japic CTI-101085）。结论：应考虑将厄洛替尼作为该亚组日本患者的一线治疗，并密切监测ILD样事件。(C)2013作者由Elsevier爱尔兰有限公司出版。保留所有权利。
Introduction: The epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib is associated with survival benefits in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC). This phase II, single-arm study examined the efficacy and safety of first-line erlotinib in Japanese patients with EGFR mutation-positive NSCLC.Methods: Eligible patients received erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival (PFS) and safety.Results: A high degree of concordance was observed between different mutation testing methodologies, suggesting feasibility of early, rapid detection of EGFR mutations. Median PFS was 11.8 months (95% confidence interval [CI]: 9.7-15.3) at data cut-off (1 June 2012) (n=102). Exon 19 deletions seemed to be associated with longer PFS compared with L858R mutations; T790M mutations were tentatively linked with shorter PFS. The safety profile was as expected: rash (any grade; 83%) and diarrhea (any grade; 81%) were most common. Six interstitial lung disease (ILD)-like cases were reported, and 5 were confirmed as ILD-like events by the extramural committee. Two patients died of treatment-related pneumonitis (JAPIC Clinical Trials Information number: Japic CTI-101085).Conclusion: Erlotinib should be considered for first-line treatment in this subset of Japanese patients, with close monitoring for ILD-like events. (C) 2013 The Authors. Published by Elsevier Ireland Ltd. All rights reserved.