• Koichi Goto, Makoto Nishio, Noboru Yamamoto, Kenichi Chikamori, Toyoaki Hida, Makoto Maemondo, Nobuyuki Katakami, Toshiyuki Kozuki, Hiroshige Yoshioka, Takashi Seto, Tamaki Fukuyama, and Tomohide Tamura.
• Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: kgoto@east.ncc.go.jp.
• Lung Cancer. 2013 Oct 1; 82 (1): 109-14.

IntroductionThe 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.MethodsEligible patients received erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival (PFS) and safety.ResultsA 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).ConclusionErlotinib should be considered for first-line treatment in this subset of Japanese patients, with close monitoring for ILD-like events.Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

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