A phase II study of neoadjuvant FOLFOX4 and cetuximab (C) in patients with locally advanced rectal adenocarcinoma (RA).

Abstract

e14122 Background: For resectable RA, 5-fluorouracil (5FU) with radiotherapy (RT) has been used commonly in the neoadjuvant setting. In metastatic colorectal cancer (CRC), C and FOLFOX4 as first-line treatment has shown promising results (Bokemeyer et al, JCO 2009). This phase II study was to investigate the down-staging rate (DSR) of C and FOLFOX4 as neoadjuvant chemotherapy (CT) for resectable, locally advanced RA. Methods: Eligible patients had resectable RA, T3/4 or any T with N1/2 staged by transrectal ultrasound (TRUS), no prior pelvic RT, and no prior anticancer therapy for CRC. Patients received FOLFOX4 and C 400 mg/m2 D1 followed by 250 mg/m2 weekly in a 28-day cycle for 2 cycles. TRUS was done before and after 2 cycles. In patients achieving partial response (PR) by RECIST criteria, 2 further cycles were given before total mesorectal excision, followed by 2 additional cycles of CT. RT with infusional 5FU was given neoadjuvantly in patients who did not achieve PR or adjuvantly in those with patho...