Erlotinib in Previously Treated Non–Small-Cell Lung Cancer
Frances A. Shepherd, M.D., José Rodrigues Pereira, M.D., Tudor Ciuleanu, M.D., Eng Huat Tan, M.D., Vera Hirsh, M.D., Sumitra Thongprasert, M.D., Daniel Campos, M.D., Savitree Maoleekoonpiroj, M.D., Michael Smylie, M.B., Ch.B., Renato Martins, M.D., Maximiliano van Kooten, M.D., Mircea Dediu, M.D., Brian Findlay, M.D., Dongsheng Tu, Ph.D., Dianne Johnston, Andrea Bezjak, M.D., Gary Clark, Ph.D., Pedro Santabárbara, M.D., Ph.D., Lesley Seymour, M.D., Ph.D., for the National Cancer Institute of Canada Clinical Trials Group
Background We conducted a randomized, placebo-controlled, double-blindtrial to determine whether the epidermal growth factor receptorinhibitor erlotinib prolongs survival in non–small-celllung cancer after the failure of first-line or second-line chemotherapy.
Methods Patients with stage IIIB or IV non–small-celllung cancer, with performance status from 0 to 3, were eligibleif they had received one or two prior chemotherapy regimens.The patients were stratified according to center, performancestatus, response to prior chemotherapy, number of prior regimens,and prior platinum-based therapy and were randomly assignedin a 2:1 ratio to receive oral erlotinib, at a dose of 150 mgdaily, or placebo.
Results The median age of the 731 patients who underwent randomizationwas 61.4 years; 49 percent had received two prior chemotherapyregimens, and 93 percent had received platinum-based chemotherapy.The response rate was 8.9 percent in the erlotinib group andless than 1 percent in the placebo group (P<0.001); the medianduration 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 toxiceffects.
Conclusions Erlotinib can prolong survival in patients withnon–small-cell lung cancer after first-line or second-linechemotherapy.
Source Information
From the Departments of Medical Oncology and Hematology (F.A.S.) and Radiation Oncology (A.B.), the University Health Network, Princess Margaret Hospital Site, and the University of Toronto (F.A.S., A.B.) — both in Toronto; the Instituto de Cancer Arnaldo Vieira de Carvalho, São Paulo (J.R.P.); the Oncological Institute Ion Chiricuta, Cluj-Napoca, Romania (T.C.); the Department of Medical Oncology, National Cancer Centre, Singapore (E.H.T.); the Department of Oncology, McGill University, Montreal (V.H.); the Faculty of Medicine, Chiangmai University, Chiangmai, Thailand (S.T.); the Confidence Medical Center, San Isidro, Argentina (D.C.); Pramongkutklao Hospital, Bangkok, Thailand (S.M.); Cross Cancer Institute, Edmonton, Alta., Canada (M.S.); the Instituto Nacional de Cancer, Praça da Cruz Vermelha, Rio de Janeiro, Brazil (R.M.); the Instituto Medico Alexander Fleming, Buenos Aires (M.K.); the Oncology Institute, Bucharest, Romania (M.D.); Hôtel Dieu Health Sciences Hospital, St. Catharines, Ont., Canada (B.F.); the National Cancer Institute of Canada Clinical Trials Group, Kingston, Ont., Canada (D.T., D.J., L.S.); and OSI Pharmaceuticals, Boulder, Colo. (G.C., P.S.).
Erlotinib in Lung Cancer
Nabhan C., Bitran J. D., Takano T., Ohe Y., Pao W., Ladanyi M., Miller V. A., the Lung Cancer Oncogenome Group , Shepherd F. A., Seymour L., Tsao M.-S., Kamel-Reid S., Shepherd F. A.
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N Engl J Med 2005;
353:1739-1741, Oct 20, 2005.
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