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

Biochemistry

Clinical & Medical Biochemistry

Author(s): Sobrero AF, Maurel J, Fehrenbacher L, Scheithauer W, Abubakr YA,

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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
  • DOI: 10.1200/JCO.2007.13.1193
  • This article was published in J Clin Oncol and referenced in Clinical & Medical Biochemistry

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