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 anirinotecan-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. Copyright 2004 Massachusetts Medical Society
RCT Entities:
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. Copyright 2004 Massachusetts Medical Society
Authors: John J Tentler; Sujatha Nallapareddy; Aik Choon Tan; Anna Spreafico; Todd M Pitts; M Pia Morelli; Heather M Selby; Maria I Kachaeva; Sara A Flanigan; Gillian N Kulikowski; Stephen Leong; John J Arcaroli; Wells A Messersmith; S Gail Eckhardt Journal: Mol Cancer Ther Date: 2010-10-05 Impact factor: 6.261
Authors: M Ponz-Sarvisé; J Rodríguez; A Viudez; A Chopitea; A Calvo; J García-Foncillas; I Gil-Bazo Journal: World J Gastroenterol Date: 2007-11-28 Impact factor: 5.742
Authors: J Rodriguez; R Zarate; E Bandres; A Viudez; A Chopitea; J García-Foncillas; I Gil-Bazo Journal: World J Gastroenterol Date: 2007-11-28 Impact factor: 5.742
Authors: Yasmine Touil; Wassila Igoudjil; Matthieu Corvaisier; Anne-Frédérique Dessein; Jérôme Vandomme; Didier Monté; Laurence Stechly; Nicolas Skrypek; Carole Langlois; Georges Grard; Guillaume Millet; Emmanuelle Leteurtre; Patrick Dumont; Stéphanie Truant; François-René Pruvot; Mohamed Hebbar; Fan Fan; Lee M Ellis; Pierre Formstecher; Isabelle Van Seuningen; Christian Gespach; Renata Polakowska; Guillemette Huet Journal: Clin Cancer Res Date: 2013-12-09 Impact factor: 12.531