EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. - Archive ouverte HAL Access content directly
Journal Articles Journal of Clinical Oncology Year : 2008

EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer.

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Alberto F. Sobrero
  • Function : Author
Joan Maurel
  • Function : Author
Louis Fehrenbacher
  • Function : Author
Werner Scheithauer
  • Function : Author
Yousif A. Abubakr
  • Function : Author
Manfred P. Lutz
  • Function : Author
M Eugenia Vega-Villegas
  • Function : Author
Cathy Eng
  • Function : Author
Ernst U. Steinhauer
  • Function : Author
Jana Prausova
  • Function : Author
Heinz-Josef Lenz
  • Function : Author
Gary Middleton
  • Function : Author
Hendrik Kröning
  • Function : Author
Gabriele Luppi
  • Function : Author
Oliver Kisker
  • Function : Author
Angela Zubel
  • Function : Author
Christiane Langer
  • Function : Author
Justin Kopit
  • Function : Author
Howard A. Burris
  • Function : Author

Abstract

PURPOSE: To determine whether adding cetuximab to irinotecan prolongs survival in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin. PATIENTS AND METHODS: This multicenter, open-label, phase III study randomly assigned 1,298 patients with epidermal growth factor receptor-expressing mCRC who had experienced first-line fluoropyrimidine and oxaliplatin treatment failure to cetuximab (400 mg/m(2) day 1 followed by 250 mg/m(2) weekly) plus irinotecan (350 mg/m(2) every 3 weeks) or irinotecan alone. Primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), response rate (RR), and quality of life (QOL). RESULTS: Median OS was comparable between treatments: 10.7 months (95% CI, 9.6 to 11.3) with cetuximab/irinotecan and 10.0 months (95% CI, 9.1 to 11.3) with irinotecan alone (hazard ratio [HR], 0.975; 95% CI, 0.854 to 1.114; P = .71). This lack of difference may have been due to post-trial therapy: 46.9% of patients assigned to irinotecan eventually received cetuximab (87.2% of those who did, received it with irinotecan). Cetuximab added to irinotecan significantly improved PFS (median, 4.0 v 2.6 months; HR, 0.692; 95% CI, 0.617 to 0.776; P
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Dates and versions

inserm-00484211 , version 1 (23-05-2010)

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Alberto F. Sobrero, Joan Maurel, Louis Fehrenbacher, Werner Scheithauer, Yousif A. Abubakr, et al.. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer.. Journal of Clinical Oncology, 2008, 26 (14), pp.2311-9. ⟨10.1200/JCO.2007.13.1193⟩. ⟨inserm-00484211⟩

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