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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(2007). PF00299804, an Irreversible Pan-ERBB Inhibitor, Is Effective in Lung Cancer Models with EGFR and ERBB2 Mutations that Are Resistant to Gefitinib. Cancer Res.
67: 11924-11932
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Solit, D. B., Santos, E., Pratilas, C. A., Lobo, J., Moroz, M., Cai, S., Blasberg, R., Sebolt-Leopold, J., Larson, S., Rosen, N.
(2007). 3'-Deoxy-3'-[18F]Fluorothymidine Positron Emission Tomography Is a Sensitive Method for Imaging the Response of BRAF-Dependent Tumors to MEK Inhibition. Cancer Res.
67: 11463-11469
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Thomas, F., Rochaix, P., Benlyazid, A., Sarini, J., Rives, M., Lefebvre, J. L., Allal, B. C., Courbon, F., Chatelut, E., Delord, J.-P.
(2007). Pilot Study of Neoadjuvant Treatment with Erlotinib in Nonmetastatic Head and Neck Squamous Cell Carcinoma. Clin. Cancer Res.
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Socinski, M. A., Stinchcombe, T. E.
(2007). Duration of First-Line Chemotherapy in Advanced Non Small-Cell Lung Cancer: Less Is More in the Era of Effective Subsequent Therapies. JCO
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Shi, Z., Peng, X.-X., Kim, I.-W., Shukla, S., Si, Q.-S., Robey, R. W., Bates, S. E., Shen, T., Ashby, C. R. Jr., Fu, L.-W., Ambudkar, S. V., Chen, Z.-S.
(2007). Erlotinib (Tarceva, OSI-774) Antagonizes ATP-Binding Cassette Subfamily B Member 1 and ATP-Binding Cassette Subfamily G Member 2 Mediated Drug Resistance. Cancer Res.
67: 11012-11020
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Yu, Z., Boggon, T. J., Kobayashi, S., Jin, C., Ma, P. C., Dowlati, A., Kern, J. A., Tenen, D. G., Halmos, B.
(2007). Resistance to an Irreversible Epidermal Growth Factor Receptor (EGFR) Inhibitor in EGFR-Mutant Lung Cancer Reveals Novel Treatment Strategies. Cancer Res.
67: 10417-10427
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Herbst, R. S., Davies, A. M., Natale, R. B., Dang, T. P., Schiller, J. H., Garland, L. L., Miller, V. A., Mendelson, D., Van den Abbeele, A. D., Melenevsky, Y., de Vries, D. J., Eberhard, D. A., Lyons, B., Lutzker, S. G., Johnson, B. E.
(2007). Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non Small Cell Lung Cancer. Clin. Cancer Res.
13: 6175-6181
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Karrison, T. G., Maitland, M. L., Stadler, W. M., Ratain, M. J.
(2007). Design of Phase II Cancer Trials Using a Continuous Endpoint of Change in Tumor Size: Application to a Study of Sorafenib and Erlotinib in Non Small-Cell Lung Cancer. JNCI J Natl Cancer Inst
99: 1455-1461
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Rubinstein, L. V., Dancey, J. E., Korn, E. L., Smith, M. A., Wright, J. J.
(2007). Early Average Change in Tumor Size in a Phase 2 Trial: Efficient Endpoint or False Promise?. JNCI J Natl Cancer Inst
99: 1422-1423
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Hsu, D. S., Balakumaran, B. S., Acharya, C. R., Vlahovic, V., Walters, K. S., Garman, K., Anders, C., Riedel, R. F., Lancaster, J., Harpole, D., Dressman, H. K., Nevins, J. R., Febbo, P. G., Potti, A.
(2007). Pharmacogenomic Strategies Provide a Rational Approach to the Treatment of Cisplatin-Resistant Patients With Advanced Cancer. JCO
25: 4350-4357
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Gross, N. D., Boyle, J. O., Du, B., Kekatpure, V. D., Lantowski, A., Thaler, H. T., Weksler, B. B., Subbaramaiah, K., Dannenberg, A. J.
(2007). Inhibition of Jun NH2-Terminal Kinases Suppresses the Growth of Experimental Head and Neck Squamous Cell Carcinoma. Clin. Cancer Res.
13: 5910-5917
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Wu, W., O'Reilly, M. S., Langley, R. R., Tsan, R. Z., Baker, C. H., Bekele, N., Tang, X. M., Onn, A., Fidler, I. J., Herbst, R. S.
(2007). Expression of epidermal growth factor (EGF)/transforming growth factor-{alpha} by human lung cancer cells determines their response to EGF receptor tyrosine kinase inhibition in the lungs of mice. Molecular Cancer Therapeutics
6: 2652-2663
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Gridelli, C., Maione, P., Rossi, A., De Marinis, F.
(2007). The Role of Bevacizumab in the Treatment of Non-Small Cell Lung Cancer: Current Indications and Future Developments. The Oncologist
12: 1183-1193
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Heymach, J. V., Johnson, B. E., Prager, D., Csada, E., Roubec, J., Pesek, M., Spasova, I., Belani, C. P., Bodrogi, I., Gadgeel, S., Kennedy, S. J., Hou, J., Herbst, R. S.
(2007). Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non Small-Cell Lung Cancer. JCO
25: 4270-4277
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Arnold, A. M., Seymour, L., Smylie, M., Ding, K., Ung, Y., Findlay, B., Lee, C. W., Djurfeldt, M., Whitehead, M., Ellis, P., Goss, G., Chan, A., Meharchand, J., Alam, Y., Gregg, R., Butts, C., Langmuir, P., Shepherd, F.
(2007). Phase II Study of Vandetanib or Placebo in Small-Cell Lung Cancer Patients After Complete or Partial Response to Induction Chemotherapy With or Without Radiation Therapy: National Cancer Institute of Canada Clinical Trials Group Study BR.20. JCO
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Harari, P. M., Allen, G. W., Bonner, J. A.
(2007). Biology of Interactions: Antiepidermal Growth Factor Receptor Agents. JCO
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Janne, P. A., von Pawel, J., Cohen, R. B., Crino, L., Butts, C. A., Olson, S. S., Eiseman, I. A., Chiappori, A. A., Yeap, B. Y., Lenehan, P. F., Dasse, K., Sheeran, M., Bonomi, P. D.
(2007). Multicenter, Randomized, Phase II Trial of CI-1033, an Irreversible Pan-ERBB Inhibitor, for Previously Treated Advanced Non Small-Cell Lung Cancer. JCO
25: 3936-3944
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Edwards, A., Li, J., Atadja, P., Bhalla, K., Haura, E. B.
(2007). Effect of the histone deacetylase inhibitor LBH589 against epidermal growth factor receptor dependent human lung cancer cells. Molecular Cancer Therapeutics
6: 2515-2524
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Alberts, W. M.
(2007). Introduction: Diagnosis and Management of Lung Cancer*: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition). Chest
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