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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer
New England Journal of Medicine, Volume 360, No. 14, Year 2009
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Description
Background: We investigated the efficacy of cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) as first-line treatment for metastatic colorectal cancer and sought associations between the mutation status of the KRAS gene in tumors and clinical response to cetuximab. Methods: We randomly assigned patients with epidermal growth factor receptor-positive colorectal cancer with unresectable metastases to receive FOLFIRI either alone or in combination with cetuximab. The primary end point was progression-free survival. Results: A total of 599 patients received cetuximab plus FOLFIRI, and 599 received FOLFIRI alone. The hazard ratio for progression-free survival in the cetuximab-FOLFIRI group as compared with the FOLFIRI group was 0.85 (95% confidence interval [CI], 0.72 to 0.99; P = 0.048). There was no significant difference in the overall survival between the two treatment groups (hazard ratio, 0.93; 95% CI, 0.81 to 1.07; P = 0.31). There was a significant interaction between treatment group and KRAS mutation status for tumor response (P = 0.03) but not for progression-free survival (P = 0.07) or overall survival (P = 0.44). The hazard ratio for progression-free survival among patients with wild-type-KRAS tumors was 0.68 (95% CI, 0.50 to 0.94), in favor of the cetuximab-FOLFIRI group. The following grade 3 or 4 adverse events were more frequent with cetuximab plus FOLFIRI than with FOLFIRI alone: skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, P<0.001), infusion-related reactions (in 2.5% vs. 0%, P<0.001), and diarrhea (in 15.7% vs. 10.5%, P = 0.008). Conclusions: First-line treatment with cetuximab plus FOLFIRI, as compared with FOLFIRI alone, reduced the risk of progression of metastatic colorectal cancer. The benefit of cetuximab was limited to patients with KRAS wild-type tumors. (ClinicalTrials.gov number, NCT00154102.) Copyright © 2009 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
van Cutsem, Éric J.D.G.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Köhne, Claus Henning
Germany, Oldenburg
Klinikum Oldenburg
Hitre, Erika
Hungary, Budapest
Országos Onkológiai Intézet Budapest
Załuski, Jerzy
Poland, Poznan
Wielkopolska Center of Oncology, Poznan
Chien, Chung Rong Chang
Taiwan, Taipei
Chang Gung Memorial Hospital
Makhson, Anatoly
Russian Federation, Moscow
Moscow City Oncology Hospital
D'Haens, Geert R.A.M.
Belgium, Bonheiden
Imelda Hospital
Pintér, Tamás
Hungary, Gyor
Petz Aladár County Teaching Hospital
Lim, Robert
Singapore, Singapore City
National University Hospital
Bodoky, G.
Hungary, Budapest
Szent Laszlo Hospital
Roh, Jae Kyung
South Korea, Seoul
Yonsei University College of Medicine
Folprecht, Gunnar
Germany, Dresden
Universitätsklinikum Carl Gustav Carus Dresden
Ruff, Paul W.
South Africa, Johannesburg
University of the Witwatersrand
Stroh, Christopher
Germany, Darmstadt
Merck Kgaa
Tejpar, Sabine
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Schlichting, Michael
Germany, Darmstadt
Merck Kgaa
Nippgen, Johannes
Germany, Darmstadt
Merck Kgaa
Rougier, Phillippe
France, Boulogne-billancourt
Hopital Ambroise Pare, Boulogne-billancourt
Statistics
Citations: 3,362
Authors: 18
Affiliations: 15
Identifiers
Doi:
10.1056/NEJMoa0805019
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Cancer
Environmental
Genetics And Genomics