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 received no study therapy and are excluded from the analysis. A total of 3,629 chemotherapy cycles were administered to the 783 pts with a median of 4 cycles per pt (range 1-23). Four (0.5%) subjects experienced severe infusion reactions: 2 grade 3 and 2 grade 4, none were fatal. In this pooled analysis, 59 deaths occurred within 30 days of last study therapy: 45 disease-related, 5 study drug related, 6 due to other causes, and 3 with unknown etiology. A summary table of adverse events (AE's) is included.
CONCLUSIONS
The DSMB raised no concerns after reviewing the safety data from 800 pts. In this pooled analysis characteristic toxicities of cetuximab and irinotecan do not appear to be increased, incidences and severities are similar to the earlier safety report based on the initial 400 patients. The study is currently nearing completion of accrual. [Table: see text] [Table: see text].