3556 Background: EPIC is a randomized phase III study comparing cetuximab plus irinotecan to irinotecan in second-line metastatic, EGFR-expressing mCRC patients (pts) (target N=1,300 pts). Following an independent Data Safety Monitoring Board (DSMB) review of 400 pts., the pooled safety data was presented at ASCO 2005 (#3580). The DSMB has recently reviewed safety data on the first 800 patients. Methods: Patients with EGFR-expressing mCRC who had failed first-line oxaliplatin in combination with a fluoropyrimidine and an ECOG performance status ≤ 2 were randomized to either Arm A (cetuximab 400 mg/m2 followed by 250 mg/ m2 weekly and irinotecan 350 mg/ m2 q 3 weeks) or to Arm B (irinotecan 350 mg/ m2 q 3 weeks). A pooled safety analysis is presented. Results: Eight hundred patients were randomized from May 2003 to March 2005 in Europe, Australia, Asia, and the US: 309 women and 491 men, with a median age of 61 years (range 21–90) and ECOG performance status (PS) of: 0= 53%, 1= 42%, 2= 5%. Seventeen pts re...