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Background

Cetuximab Plus Irinotecan for Metastatic Colorectal Cancer (mCRC): Safety Analysis of the first 800 Patients in a Randomized Phase III Trial (EPIC): Abstract #3556. Y.A. Abubakr, C. Eng, V. Pautret, J.Maurel, W. Scheithauer, H. Kroning, A. Zubel, M.P. Lutz, L. Wong, A. Sobrero. Background.

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  1. Cetuximab Plus Irinotecan for Metastatic Colorectal Cancer (mCRC): Safety Analysis of the first 800 Patients in a Randomized Phase III Trial (EPIC): Abstract #3556 Y.A. Abubakr, C. Eng, V. Pautret, J.Maurel, W. Scheithauer, H. Kroning, A. Zubel, M.P. Lutz, L. Wong, A. Sobrero

  2. Background • Cetuximab has been proven to be safe and effective as a single agent in refractory colorectal cancer patients with an 11% response rate. In addition, cetuximab in combination with irinotecan showed a 23% response rate in a mixed refractory population in which 45% of subjects had received 3 or more lines of treatment [Cunningham et al, 2004]. • These results provide a compelling rationale for combining irinotecan and cetuximab in an earlier and uniquely second-line treatment setting in this phase III study in order to evaluate effects on survival. • EPIC is a randomized phase III study comparing cetuximab plus irinotecan to irinotecan in 2nd-line metastatic, EGFR-expressing mCRC patients (pts) (target N=1300 pts). Following an independent Data Safety Monitoring Board (DSMB) review of 400 pts., the pooled safety data was presented at ASCO 2005 ( # 3580). • A pre-planned analysis of safety data of the first 800 patients was performed and is presented in a pooled fashion. An independent Data Safety Monitoring Board has intermittently reviewed the safety data. Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  3. Study design: Phase III, randomized, open label, multicenter study EGFR testing Cetuximab 400mg/m2 250mg/m2 loading dose weekly week #1 starting on of cycle #1 week #2 and Irinotecan 350mg/m2 every 3 weeks a Enrollment and Screening Randomization Post-Treatment follow-up Irinotecan 350mg/m2 every 3 weeks a * Randomization is stratified by study site and ECOG performance status (0-1, 2) Study Schema a or 300mg/m2 in patients > 70 years of age, with prior pelvic/abdominal radiation or ECOG of 2 Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  4. Patient Demographics Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  5. Total number of Cycles Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  6. Safety: Pooled Adverse Events of Interest Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  7. Pooled Adverse Events (N=783) Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

  8. Conclusion: • In this pooled analysis the incidence of the characteristic cetuximab and irinotecan toxicities does not seem to be increased as compared to reported incidences with Erbitux and Camptosar. • The combination of irinotecan every 3 weeks and weekly cetuximab appears to be a feasible and safe regimen. • The study completed its accrual of 1300 patients in February 2006. Efficacy results will be available in 2007. Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006

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