• Tomoya Kawaguchi, Masahiko Ando, Kazuhiro Asami, Yoshio Okano, Masaaki Fukuda, Hideyuki Nakagawa, Hidenori Ibata, Toshiyuki Kozuki, Takeo Endo, Atsuhisa Tamura, Mitsuhiro Kamimura, Kazuhiro Sakamoto, Michihiro Yoshimi, Yoshifumi Soejima, Yoshio Tomizawa, Shun-ichi Isa, Minoru Takada, Hideo Saka, and Akihito Kubo.
• Tomoya Kawaguchi, Kazuhiro Asami, and Shun-ichi Isa, National Hospital Organization Kinki-Chuo Chest Medical Center; Minoru Takada, Koyo Hospital, Osaka; Masahiko Ando, Center for Advanced Medicine and Clinical Research, Nagoya University Hospital; Akihito Kubo, Aichi Medical University School of Medicine, Aichi; Yoshio Okano, National Hospital Organization Kochi Hospital, Kochi; Masaaki Fukuda, National Hospital Organization Nagasaki Medical Center, Nagasaki; Hideyuki Nakagawa, National Hospital Organization Hirosaki Hospital, Hirosaki; Hidenori Ibata, National Hospital Organization Mie Chuo Medical Center, Tsu; Toshiyuki Kozuki, National Hospital Organization Shikoku Cancer Center, Matsuyama; Takeo Endo, National Hospital Organization Mito Medical Center, Mito; Atsuhisa Tamura, National Hospital Organization Tokyo Hospital; Mitsuhiro Kamimura, National Hospital Organization Disaster Medical Center, Tokyo; Kazuhiro Sakamoto, National Hospital Organization Yokohama Medical Center, Yokohama; Michihiro Yoshimi, National Hospital Organization Fukuoka East Medical Center, Fukuoka; Yoshifumi Soejima, National Hospital Organization Ureshino Medical Center, Ureshino; Yoshio Tomizawa, National Hospital Organization Nishigunma Hospital, Gunma; and Hideo Saka, National Hospital Organization Nagoya Medical Center, Nagoya, Japan. t-kawaguchi@kch.hosp.go.jp.
• J. Clin. Oncol. 2014 Jun 20;32(18):1902-8.

PurposeTo investigate the efficacy of erlotinib versus docetaxel in previously treated patients with advanced non-small-cell lung cancer (NSCLC) in an epidermal growth factor receptor (EGFR) -unselected patient population.Patients And MethodsThe primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate, safety, and analyses on EGFR wild-type tumors. Patients with stage IIIB or IV NSCLC, previous treatment with one or two chemotherapy regimens, evaluable or measurable disease, and performance status of 0 to 2 were eligible.ResultsFrom August 2009 to July 2012, 150 and 151 patients were randomly assigned to erlotinib (150 mg daily) and docetaxel (60 mg/m(2) every 3 weeks), respectively. EGFR wild-type NSCLC was present in 109 and 90 patients in the erlotinib and docetaxel groups, respectively. Median PFS for erlotinib versus docetaxel was 2.0 v 3.2 months (hazard ratio [HR], 1.22; 95% CI, 0.97 to 1.55; P = .09), and median OS was 14.8 v 12.2 months (HR, 0.91; 95% CI, 0.68 to 1.22; P = .53), respectively. In a subset analysis of EGFR wild-type tumors, PFS for erlotinib versus docetaxel was 1.3 v 2.9 months (HR, 1.45; 95% CI, 1.09 to 1.94; P = .01), and OS was 9.0 v 10.1 months (HR, 0.98; 95% CI, 0.69 to 1.39; P = .91), respectively.ConclusionErlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population.© 2014 by American Society of Clinical Oncology.

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