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)

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, Akihito Kubo
Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2014 June 20, 32 (18): 1902-8

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.

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