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.
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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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Baselga, J., Tabernero, J.
(2007). Combined Antiangiogenesis and Antiepidermal Growth Factor Receptor Targeting in the Treatment of Cancer: Hold Back, We Are Not There Yet. JCO
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Ekman, S., Bergqvist, M., Heldin, C.-H., Lennartsson, J.
(2007). Activation of Growth Factor Receptors in Esophageal Cancer Implications for Therapy. The Oncologist
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Scartozzi, M., Bearzi, I., Pierantoni, C., Mandolesi, A., Loupakis, F., Zaniboni, A., Catalano, V., Quadri, A., Zorzi, F., Berardi, R., Biscotti, T., Labianca, R., Falcone, A., Cascinu, S.
(2007). Nuclear Factor-kB Tumor Expression Predicts Response and Survival in Irinotecan-Refractory Metastatic Colorectal Cancer Treated With Cetuximab-Irinotecan Therapy. JCO
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Tang, Y., Lou, J., Alpaugh, R. K., Robinson, M. K., Marks, J. D., Weiner, L. M.
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(2007). High Incidence of Cetuximab-Related Infusion Reactions in Tennessee and North Carolina and the Association With Atopic History. JCO
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Zhang, W., Gordon, M., Schultheis, A. M., Yang, D. Y., Nagashima, F., Azuma, M., Chang, H.-M., Borucka, E., Lurje, G., Sherrod, A. E., Iqbal, S., Groshen, S., Lenz, H.-J.
(2007). FCGR2A and FCGR3A Polymorphisms Associated With Clinical Outcome of Epidermal Growth Factor Receptor Expressing Metastatic Colorectal Cancer Patients Treated With Single-Agent Cetuximab. JCO
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Zhang, W., Press, O. A., Haiman, C. A., Yang, D. Y., Gordon, M. A., Fazzone, W., El-khoueiry, A., Iqbal, S., Sherrod, A. E., Lurje, G., Lenz, H.-J.
(2007). Association of Methylenetetrahydrofolate Reductase Gene Polymorphisms and Sex-Specific Survival in Patients With Metastatic Colon Cancer. JCO
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Dy, G. K., Krook, J. E., Green, E. M., Sargent, D. J., Delaunoit, T., Morton, R. F., Fuchs, C. S., Ramanathan, R. K., Williamson, S. K., Findlay, B. P., Pockaj, B. A., Sticca, R. P., Alberts, S. R., Pitot, H. C. IV, Goldberg, R. M.
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de Gramont, A., Buyse, M., Abrahantes, J. C., Burzykowski, T., Quinaux, E., Cervantes, A., Figer, A., Lledo, G., Flesch, M., Mineur, L., Carola, E., Etienne, P.-L., Rivera, F., Chirivella, I., Perez-Staub, N., Louvet, C., Andre, T., Tabah-Fisch, I., Tournigand, C.
(2007). Reintroduction of Oxaliplatin Is Associated With Improved Survival in Advanced Colorectal Cancer. JCO
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Khambata-Ford, S., Garrett, C. R., Meropol, N. J., Basik, M., Harbison, C. T., Wu, S., Wong, T. W., Huang, X., Takimoto, C. H., Godwin, A. K., Tan, B. R., Krishnamurthi, S. S., Burris, H. A. III, Poplin, E. A., Hidalgo, M., Baselga, J., Clark, E. A., Mauro, D. J.
(2007). Expression of Epiregulin and Amphiregulin and K-ras Mutation Status Predict Disease Control in Metastatic Colorectal Cancer Patients Treated With Cetuximab. JCO
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Sartore-Bianchi, A., Moroni, M., Veronese, S., Carnaghi, C., Bajetta, E., Luppi, G., Sobrero, A., Barone, C., Cascinu, S., Colucci, G., Cortesi, E., Nichelatti, M., Gambacorta, M., Siena, S.
(2007). Epidermal Growth Factor Receptor Gene Copy Number and Clinical Outcome of Metastatic Colorectal Cancer Treated With Panitumumab. JCO
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Damiano, V., Caputo, R., Garofalo, S., Bianco, R., Rosa, R., Merola, G., Gelardi, T., Racioppi, L., Fontanini, G., De Placido, S., Kandimalla, E. R., Agrawal, S., Ciardiello, F., Tortora, G.
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Meyerhardt, J., Stuart, K, Fuchs, C., Zhu, A., Earle, C., Bhargava, P, Blaszkowsky, L, Enzinger, P, Mayer, R., Battu, S, Lawrence, C, Ryan, D.
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