Phase III study (20050181) of panitumumab (pmab) with FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): Pooled safety results

摘要: 4064 Background: Pmab is a fully human anti-EGFr monoclonal antibody (MAb) with activity as single agent in refractory mCRC. Study 20050181 the first global, phase III trial investigating an MAb combined FOLFIRI 2nd-line tx for pts Methods: This randomized, multicenter, study pt eligibility criteria that include: histologically/cytologically- confirmed adenocarcinoma of colon or rectum metastatic disease; only 1 prior fluoropyrimidine-based chemotherapy regimen mCRC; ECOG performance status (PS) 0 to 2. No EGFr staining required inclusion. Pts are randomized 1:1 receive 6.0 mg/kg Q2W + (Pmab+FOLFIRI) alone (FOLFIRI). Co-primary endpoints progression-free survival and overall survival. Secondary include objective response rate, time progression, duration response, safety. will be investigated by pts’ KRAS mutational both arms poten...