Tomoya Kawaguchi1, Masahiko Ando2, Kazuhiro Asami2, Yoshio Okano2, Masaaki Fukuda2, Hideyuki Nakagawa2, Hidenori Ibata2, Toshiyuki Kozuki2, Takeo Endo2, Atsuhisa Tamura2, Mitsuhiro Kamimura2, Kazuhiro Sakamoto2, Michihiro Yoshimi2, Yoshifumi Soejima2, Yoshio Tomizawa2, Shun-ichi Isa2, Minoru Takada2, Hideo Saka2, Akihito Kubo2. 1. 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. 2. 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.
Abstract
PURPOSE: To 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 METHODS: The 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. RESULTS:From 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. CONCLUSION:Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population.
RCT Entities:
PURPOSE: To 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 METHODS: The 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. RESULTS: From 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. CONCLUSION:Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population.
Authors: Cathy J Bradley; K Robin Yabroff; Angela B Mariotto; Christopher Zeruto; Quyen Tran; Joan L Warren Journal: J Clin Oncol Date: 2017-01-03 Impact factor: 44.544
Authors: Sung Yong Lee; Eun Joo Kang; Suk Young Lee; Hong Jun Kim; Kyung Hoon Min; Gyu Young Hur; Jae Jeong Shim; Kyung Ho Kang; Sang Cheul Oh; Jae Hong Seo; Jun Suk Kim Journal: Oncol Lett Date: 2017-11-03 Impact factor: 2.967