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Previous Volume 351:337-345 July 22, 2004 Number 4 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Perspective by Schrag, D. Editorial by Erlichman, C. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The epidermal growth factor receptor (EGFR), which participates in signaling pathways that are deregulated in cancer cells, commonly appears on colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We compared the efficacy of cetuximab in combination with irinotecan with that of cetuximab alone in metastatic colorectal cancer that was refractory to treatment with irinotecan.

Methods We randomly assigned 329 patients whose disease had progressed during or within three months after treatment with an irinotecan-based regimen to receive either cetuximab and irinotecan (at the same dose and schedule as in a prestudy regimen [218 patients]) or cetuximab monotherapy (111 patients). In cases of disease progression, the addition of irinotecan to cetuximab monotherapy was permitted. The patients were evaluated radiologically for tumor response and were also evaluated for the time to tumor progression, survival, and side effects of treatment.

Results The rate of response in the combination-therapy group was significantly higher than that in the monotherapy group (22.9 percent [95 percent confidence interval, 17.5 to 29.1 percent] vs. 10.8 percent [95 percent confidence interval, 5.7 to 18.1 percent], P=0.007). The median time to progression was significantly greater in the combination-therapy group (4.1 vs. 1.5 months, P<0.001 by the log-rank test). The median survival time was 8.6 months in the combination-therapy group and 6.9 months in the monotherapy group (P=0.48). Toxic effects were more frequent in the combination-therapy group, but their severity and incidence were similar to those that would be expected with irinotecan alone.

Conclusions Cetuximab has clinically significant activity when given alone or in combination with irinotecan in patients with irinotecan-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.

Full Text of this Article

Related Letters:

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.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:1575-1576, Oct 7, 2004. Correspondence

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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 26: 4200-4204 [Full Text]  
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• Laheru, D., Croghan, G., Bukowski, R., Rudek, M., Messersmith, W., Erlichman, C., Pelley, R., Jimeno, A., Donehower, R., Boni, J., Abbas, R., Martins, P., Zacharchuk, C., Hidalgo, M. (2008). A Phase I Study of EKB-569 in Combination with Capecitabine in Patients with Advanced Colorectal Cancer. Clin. Cancer Res. 14: 5602-5609 [Abstract] [Full Text]  
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• Adam, R., de Haas, R. J., Wicherts, D. A., Aloia, T. A., Delvart, V., Azoulay, D., Bismuth, H., Castaing, D. (2008). Is Hepatic Resection Justified After Chemotherapy in Patients With Colorectal Liver Metastases and Lymph Node Involvement?. JCO 26: 3672-3680 [Abstract] [Full Text]  
• Tijink, B. M., Laeremans, T., Budde, M., Walsum, M. S.-v., Dreier, T., de Haard, H. J., Leemans, C. R., van Dongen, G. A.M.S. (2008). Improved tumor targeting of anti-epidermal growth factor receptor Nanobodies through albumin binding: taking advantage of modular Nanobody technology. Molecular Cancer Therapeutics 7: 2288-2297 [Abstract] [Full Text]  
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• Sharma, R. I., Smith, T. A.D. (2008). Colorectal Tumor Cells Treated with 5-FU, Oxaliplatin, Irinotecan, and Cetuximab Exhibit Changes in 18F-FDG Incorporation Corresponding to Hexokinase Activity and Glucose Transport. JNM 49: 1386-1394 [Abstract] [Full Text]  
• 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 26: 3351-3357 [Abstract] [Full Text]  
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• Cohen, S. J., Punt, C. J.A., Iannotti, N., Saidman, B. H., Sabbath, K. D., Gabrail, N. Y., Picus, J., Morse, M., Mitchell, E., Miller, M. C., Doyle, G. V., Tissing, H., Terstappen, L. W.M.M., Meropol, N. J. (2008). Relationship of Circulating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients With Metastatic Colorectal Cancer. JCO 26: 3213-3221 [Abstract] [Full Text]  
• Shitara, K., Munakata, M., Muto, O., Sakata, Y. (2008). Metastatic Rectal Cancer Responding to Third-line Therapy Employing Bevacizumab After Failure of Oxaliplatin and Irinotecan: Case Report. Jpn J Clin Oncol 38: 493-496 [Abstract] [Full Text]  
• Sasaki, T., Nakamura, T., Rebhun, R. B., Cheng, H., Hale, K. S., Tsan, R. Z., Fidler, I. J., Langley, R. R. (2008). Modification of the Primary Tumor Microenvironment by Transforming Growth Factor {alpha}-Epidermal Growth Factor Receptor Signaling Promotes Metastasis in an Orthotopic Colon Cancer Model. Am. J. Pathol. 173: 205-216 [Abstract] [Full Text]  
• Borner, M., Koeberle, D., Von Moos, R., Saletti, P., Rauch, D., Hess, V., Trojan, A., Helbling, D., Pestalozzi, B., Caspar, C., Ruhstaller, T., Roth, A., Kappeler, A., Dietrich, D., Lanz, D., Mingrone, W., for the Swiss Group for Clinical Cancer Research (, (2008). Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol 19: 1288-1292 [Abstract] [Full Text]  
• Vincenzi, B., Santini, D., Galluzzo, S., Russo, A., Fulfaro, F., Silletta, M., Battistoni, F., Rocci, L., Zobel, B. B., Adamo, V., Dicuonzo, G., Tonini, G. (2008). Early Magnesium Reduction in Advanced Colorectal Cancer Patients Treated with Cetuximab Plus Irinotecan as Predictive Factor of Efficacy and Outcome. Clin. Cancer Res. 14: 4219-4224 [Abstract] [Full Text]  
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