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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Hirsch, F. R., Varella-Garcia, M., Dziadziuszko, R., Xiao, Y., Gajapathy, S., Skokan, M., Lin, M., O'Neill, V., Bunn, P. A. Jr.
(2008). Fluorescence In situ Hybridization Subgroup Analysis of TRIBUTE, a Phase III Trial of Erlotinib Plus Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer. Clin. Cancer Res.
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Nogueira-Rodrigues, A., do Carmo, C. C., Viegas, C., Erlich, F., Camisao, C., Fontao, K., Lima, R., Herchenhorn, D., Martins, R. G., Moralez, G. M., Small, I. A., Ferreira, C. G.
(2008). Phase I Trial of Erlotinib Combined with Cisplatin and Radiotherapy for Patients with Locally Advanced Cervical Squamous Cell Cancer. Clin. Cancer Res.
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Herbst, R. S., Heymach, J. V., Lippman, S. M.
(2008). Lung Cancer. NEJM
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Schilsky, R. L., Gordon, G., Gilmer, T. M., Courtneidge, S. A., Matrisian, L. M., Grad, O., Nelson, W. G., on behalf of the Translational Research Working Gr,
(2008). The Translational Research Working Group Developmental Pathway for Anticancer Agents (Drugs or Biologics). Clin. Cancer Res.
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Maruyama, R., Nishiwaki, Y., Tamura, T., Yamamoto, N., Tsuboi, M., Nakagawa, K., Shinkai, T., Negoro, S., Imamura, F., Eguchi, K., Takeda, K., Inoue, A., Tomii, K., Harada, M., Masuda, N., Jiang, H., Itoh, Y., Ichinose, Y., Saijo, N., Fukuoka, M.
(2008). Phase III Study, V-15-32, of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non-Small-Cell Lung Cancer. JCO
26: 4244-4252
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Oza, A. M., Eisenhauer, E. A., Elit, L., Cutz, J.-C., Sakurada, A., Tsao, M. S., Hoskins, P. J., Biagi, J., Ghatage, P., Mazurka, J., Provencher, D., Dore, N., Dancey, J., Fyles, A.
(2008). Phase II Study of Erlotinib in Recurrent or Metastatic Endometrial Cancer: NCIC IND-148. JCO
26: 4319-4325
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Zhu, C.-Q., da Cunha Santos, G., Ding, K., Sakurada, A., Cutz, J.-C., Liu, N., Zhang, T., Marrano, P., Whitehead, M., Squire, J. A., Kamel-Reid, S., Seymour, L., Shepherd, F. A., Tsao, M.-S.
(2008). Role of KRAS and EGFR As Biomarkers of Response to Erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. JCO
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McFarlane, J., Riggins, J., Smith, T. J.
(2008). SPIKE$: A Six-Step Protocol for Delivering Bad News About the Cost of Medical Care. JCO
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Gravis, G., Bladou, F., Salem, N., Goncalves, A., Esterni, B., Walz, J., Bagattini, S., Marcy, M., Brunelle, S., Viens, P.
(2008). Results from a monocentric phase II trial of erlotinib in patients with metastatic prostate cancer. Ann Oncol
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Ling, Y.-H., Lin, R., Perez-Soler, R.
(2008). Erlotinib Induces Mitochondrial-Mediated Apoptosis in Human H3255 Non-Small-Cell Lung Cancer Cells with Epidermal Growth Factor ReceptorL858R Mutation through Mitochondrial Oxidative Phosphorylation-Dependent Activation of BAX and BAK. Mol. Pharmacol.
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Stinchcombe, T. E., Socinski, M. A.
(2008). Gefitinib in Advanced Non-Small Cell Lung Cancer: Does It Deserve a Second Chance?. The Oncologist
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Pino, M. S., Balsamo, M., Di Modugno, F., Mottolese, M., Alessio, M., Melucci, E., Milella, M., McConkey, D. J., Philippar, U., Gertler, F. B., Natali, P. G., Nistico, P.
(2008). Human Mena+11a Isoform Serves as a Marker of Epithelial Phenotype and Sensitivity to Epidermal Growth Factor Receptor Inhibition in Human Pancreatic Cancer Cell Lines. Clin. Cancer Res.
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Einhorn, L. H.
(2008). First-Line Chemotherapy for Non-Small-Cell Lung Cancer: Is There a Superior Regimen Based on Histology?. JCO
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Hoering, A., LeBlanc, M., Crowley, J. J.
(2008). Randomized Phase III Clinical Trial Designs for Targeted Agents. Clin. Cancer Res.
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Hirsch, F. R., Herbst, R. S., Olsen, C., Chansky, K., Crowley, J., Kelly, K., Franklin, W. A., Bunn, P. A. Jr, Varella-Garcia, M., Gandara, D. R.
(2008). Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non-Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy. JCO
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Fleming, I. N., Hogben, M., Frame, S., McClue, S. J., Green, S. R.
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Gumus, Z. H., Du, B., Kacker, A., Boyle, J. O., Bocker, J. M., Mukherjee, P., Subbaramaiah, K., Dannenberg, A. J., Weinstein, H.
(2008). Effects of Tobacco Smoke on Gene Expression and Cellular Pathways in a Cellular Model of Oral Leukoplakia. Cancer Prevention Research
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(2008). From Nihilism to Individualism: The Evolution of Lung Cancer Therapy. Am. J. Respir. Crit. Care Med.
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Ahn, M.-J., Park, B.-B., Ahn, J. S., Kim, S. W., Kim, H.-T., Lee, J. S., Kang, J. H., Cho, J. Y., Song, H. S., Park, S. H., Sohn, C. H., Shin, S. W., Choi, J. H., Ki, C.-S., Park, C. K., Holmes, A. J., Janne, P. A., Park, K.
(2008). Are There Any Ethnic Differences in Molecular Predictors of Erlotinib Efficacy in Advanced Non-Small Cell Lung Cancer?. Clin. Cancer Res.
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