Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer
David Cunningham, M.D., Yves Humblet, M.D., Ph.D., Salvatore Siena, M.D., David Khayat, M.D., Ph.D., Harry Bleiberg, M.D., Ph.D., Armando Santoro, M.D., Danny Bets, M.Sc., Matthias Mueser, M.D., Andreas Harstrick, M.D., Chris Verslype, M.D., Ph.D., Ian Chau, M.B., B.S., and Eric Van Cutsem, M.D., Ph.D.
Background The epidermal growth factor receptor (EGFR), whichparticipates in signaling pathways that are deregulated in cancercells, commonly appears on colorectal-cancer cells. Cetuximabis a monoclonal antibody that specifically blocks the EGFR.We compared the efficacy of cetuximab in combination with irinotecanwith that of cetuximab alone in metastatic colorectal cancerthat was refractory to treatment with irinotecan.
Methods We randomly assigned 329 patients whose disease hadprogressed during or within three months after treatment withan irinotecan-based regimen to receive either cetuximab andirinotecan (at the same dose and schedule as in a prestudy regimen[218 patients]) or cetuximab monotherapy (111 patients). Incases of disease progression, the addition of irinotecan tocetuximab monotherapy was permitted. The patients were evaluatedradiologically for tumor response and were also evaluated forthe time to tumor progression, survival, and side effects oftreatment.
Results The rate of response in the combination-therapy groupwas significantly higher than that in the monotherapy group(22.9 percent [95 percent confidence interval, 17.5 to 29.1percent] vs. 10.8 percent [95 percent confidence interval, 5.7to 18.1 percent], P=0.007). The median time to progression wassignificantly greater in the combination-therapy group (4.1vs. 1.5 months, P<0.001 by the log-rank test). The mediansurvival time was 8.6 months in the combination-therapy groupand 6.9 months in the monotherapy group (P=0.48). Toxic effectswere more frequent in the combination-therapy group, but theirseverity and incidence were similar to those that would be expectedwith irinotecan alone.
Conclusions Cetuximab has clinically significant activity whengiven alone or in combination with irinotecan in patients withirinotecan-refractory colorectal cancer.
Source Information
From the Royal Marsden Hospital, London and Surrey, United Kingdom (D.C., I.C.); Saint-Luc University Hospital, Université Catholique de Louvain, Brussels (Y.H.); Ospedale Niguarda Ca' Granda, Milan (S.S.); Hôpital Salpêtrière, Paris (D.K.); Institut Jules Bordet, Brussels (H.B.); Istituto Clinico Humanitas, Rozzano-Milano, Italy (A.S.); Merck, Amsterdam (D.B.); Merck, Darmstadt, Germany (M.M., A.H.); and University Hospital Gasthuisberg, Leuven, Belgium (C.V., E.C.).
Address reprint requests to Dr. Cunningham at the Department of Medicine, Royal Marsden Hospital, Downs Rd., Sutton, Surrey SM2 5PT, United Kingdom, or at david.cunningham{at}icr.ac.uk.
Cetuximab in Colon Cancer
Holmer A. F., Martin M. J., Costa A. F., Sander G. B., Picon P. D., Schrag D., Chau I., Cunningham D.
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N Engl J Med 2004;
351:1575-1576, Oct 7, 2004.
Correspondence
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Butts, C. A., Bodkin, D., Middleman, E. L., Englund, C. W., Ellison, D., Alam, Y., Kreisman, H., Graze, P., Maher, J., Ross, H. J., Ellis, P. M., McNulty, W., Kaplan, E., Pautret, V., Weber, M. R., Shepherd, F. A.
(2007). Randomized Phase II Study of Gemcitabine Plus Cisplatin or Carboplatin, With or Without Cetuximab, As First-Line Therapy for Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer. JCO
25: 5777-5784
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Liepe, K., Brogsitter, C., Leonhard, J., Wunderlich, G., Hliscs, R., Pinkert, J., Folprecht, G., Kotzerke, J.
(2007). Feasibility of High Activity Rhenium-188-Microsphere in Hepatic Radioembolization. Jpn J Clin Oncol
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Prewett, M., Deevi, D. S., Bassi, R., Fan, F., Ellis, L. M., Hicklin, D. J., Tonra, J. R.
(2007). Tumors Established with Cell Lines Selected for Oxaliplatin Resistance Respond to Oxaliplatin if Combined with Cetuximab. Clin. Cancer Res.
13: 7432-7440
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Gallerani, E., Ciriolo, M., Rossini, C., Cavalli, F.
(2007). Axillary Apocrine Carcinoma With Brain Metastases. JCO
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Scope, A., Agero, A. L. C., Dusza, S. W., Myskowski, P. L., Lieb, J. A., Saltz, L., Kemeny, N. E., Halpern, A. C.
(2007). Randomized Double-Blind Trial of Prophylactic Oral Minocycline and Topical Tazarotene for Cetuximab-Associated Acne-Like Eruption. JCO
25: 5390-5396
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Korita, P. V., Wakai, T., Shirai, Y., Sakata, J., Takizawa, K., Cruz, P. V., Ajioka, Y., Hatakeyama, K.
(2007). Intrahepatic Lymphatic Invasion Independently Predicts Poor Survival and Recurrences after Hepatectomy in Patients with Colorectal Carcinoma Liver Metastases. Ann. Surg. Oncol.
14: 3472-3480
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Gallagher, D. J., Capanu, M., Raggio, G., Kemeny, N.
(2007). Hepatic arterial infusion plus systemic irinotecan in patients with unresectable hepatic metastases from colorectal cancer previously treated with systemic oxaliplatin: a retrospective analysis. Ann Oncol
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Widakowich, C., de Castro, G. Jr., de Azambuja, E., Dinh, P., Awada, A.
(2007). Review: Side Effects of Approved Molecular Targeted Therapies in Solid Cancers. The Oncologist
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Mahmood, I., Green, M. D.
(2007). Drug Interaction Studies of Therapeutic Proteins or Monoclonal Antibodies. J Clin Pharmacol
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Buyse, M., Burzykowski, T., Carroll, K., Michiels, S., Sargent, D. J., Miller, L. L., Elfring, G. L., Pignon, J.-P., Piedbois, P.
(2007). Progression-Free Survival Is a Surrogate for Survival in Advanced Colorectal Cancer. JCO
25: 5218-5224
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Tabernero, J., Van Cutsem, E., Diaz-Rubio, E., Cervantes, A., Humblet, Y., Andre, T., Van Laethem, J.-L., Soulie, P., Casado, E., Verslype, C., Valera, J. S., Tortora, G., Ciardiello, F., Kisker, O., de Gramont, A.
(2007). Phase II Trial of Cetuximab in Combination With Fluorouracil, Leucovorin, and Oxaliplatin in the First-Line Treatment of Metastatic Colorectal Cancer. JCO
25: 5225-5232
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Jonker, D. J., O'Callaghan, C. J., Karapetis, C. S., Zalcberg, J. R., Tu, D., Au, H.-J., Berry, S. R., Krahn, M., Price, T., Simes, R. J., Tebbutt, N. C., van Hazel, G., Wierzbicki, R., Langer, C., Moore, M. J.
(2007). Cetuximab for the Treatment of Colorectal Cancer. NEJM
357: 2040-2048
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Martin, E. S., Tonon, G., Sinha, R., Xiao, Y., Feng, B., Kimmelman, A. C., Protopopov, A., Ivanova, E., Brennan, C., Montgomery, K., Kucherlapati, R., Bailey, G., Redston, M., Chin, L., DePinho, R. A.
(2007). Common and Distinct Genomic Events in Sporadic Colorectal Cancer and Diverse Cancer Types. Cancer Res.
67: 10736-10743
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Ratain, M. J., Glassman, R. H.
(2007). Biomarkers in Phase I Oncology Trials: Signal, Noise, or Expensive Distraction?. Clin. Cancer Res.
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Grothey, A.
(2007). Biological Therapy and Other Novel Therapies in Early-Stage Disease: Are They Appropriate?. Clin. Cancer Res.
13: 6909s-6912s
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Benson, A. B. III
(2007). New Approaches to Assessing and Treating Early-Stage Colon and Rectal Cancers: Cooperative Group Strategies for Assessing Optimal Approaches in Early-Stage Disease. Clin. Cancer Res.
13: 6913s-6920s
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Roda, J. M., Joshi, T., Butchar, J. P., McAlees, J. W., Lehman, A., Tridandapani, S., Carson, W. E. III
(2007). The Activation of Natural Killer Cell Effector Functions by Cetuximab-Coated, Epidermal Growth Factor Receptor Positive Tumor Cells is Enhanced By Cytokines. Clin. Cancer Res.
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Adam, R., Aloia, T., Levi, F., Wicherts, D. A., de Haas, R. J., Paule, B., Bralet, M.-P., Bouchahda, M., Machover, D., Ducreux, M., Castagne, V., Azoulay, D., Castaing, D.
(2007). Hepatic Resection After Rescue Cetuximab Treatment for Colorectal Liver Metastases Previously Refractory to Conventional Systemic Therapy. JCO
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Saltz, L. B., Lenz, H.-J., Kindler, H. L., Hochster, H. S., Wadler, S., Hoff, P. M., Kemeny, N. E., Hollywood, E. M., Gonen, M., Quinones, M., Morse, M., Chen, H. X.
(2007). Randomized Phase II Trial of Cetuximab, Bevacizumab, and Irinotecan Compared With Cetuximab and Bevacizumab Alone in Irinotecan-Refractory Colorectal Cancer: The BOND-2 Study. JCO
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