• Frances A Shepherd, Rodrigues PereiraJoséJ, Tudor Ciuleanu, Eng Huat Tan, Vera Hirsh, Sumitra Thongprasert, Daniel Campos, Savitree Maoleekoonpiroj, Michael Smylie, Renato Martins, Maximiliano van Kooten, Mircea Dediu, Brian Findlay, Dongsheng Tu, Dianne Johnston, Andrea Bezjak, Gary Clark, Pedro Santabárbara, Lesley Seymour, and National Cancer Institute of Canada Clinical Trials Group.
• Department of Medical Oncology, University Health Network, Princess Margaret Hospital Site, University of Toronto, Canada.
• N. Engl. J. Med. 2005 Jul 14; 353 (2): 123132123-32.

BackgroundWe conducted a randomized, placebo-controlled, double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy.MethodsPatients with stage IIIB or IV non-small-cell lung cancer, with performance status from 0 to 3, were eligible if they had received one or two prior chemotherapy regimens. The patients were stratified according to center, performance status, response to prior chemotherapy, number of prior regimens, and prior platinum-based therapy and were randomly assigned in a 2:1 ratio to receive oral erlotinib, at a dose of 150 mg daily, or placebo.ResultsThe median age of the 731 patients who underwent randomization was 61.4 years; 49 percent had received two prior chemotherapy regimens, and 93 percent had received platinum-based chemotherapy. The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group (P<0.001); the median duration of the response was 7.9 months and 3.7 months, respectively. Progression-free survival was 2.2 months and 1.8 months, respectively (hazard ratio, 0.61, adjusted for stratification categories; P<0.001). Overall survival was 6.7 months and 4.7 months, respectively (hazard ratio, 0.70; P<0.001), in favor of erlotinib. Five percent of patients discontinued erlotinib because of toxic effects.ConclusionsErlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy.Copyright 2005 Massachusetts Medical Society.

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