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J Clin Oncol. 2014 Jun 20;32(18):1902-8. doi: 10.1200/JCO.2013.52.4694. Epub 2014 May 19.

Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA).

Author information

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.

PMID:
24841974
DOI:
10.1200/JCO.2013.52.4694
[Indexed for MEDLINE]

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