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The EPIC trial evaluates the safety of combining cetuximab and irinotecan in second-line treatment for metastatic colorectal cancer (mCRC) patients, specifically those expressing EGFR. In a pooled analysis of the first 800 patients, this Phase III randomized trial suggests the combination is feasible and safe, with adverse events consistent with prior reports of cetuximab and irinotecan monotherapies. The study completed enrollment of 1,300 patients and will provide efficacy results in 2007, requesting to define the therapeutic potential of this regimen.
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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 • 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
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
Patient Demographics Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006
Total number of Cycles Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006
Safety: Pooled Adverse Events of Interest Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006
Pooled Adverse Events (N=783) Abubakr, Eng, Pautret, et al: ASCO, #3556, 2006
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
