PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT).

4022 Background: There is no current standard of care for APC after 1st line GEM. The CONKO3 study (ASCO 2008) reported a survival benefit with 2nd line oxaliplatin-5FU (OFF), but has not yet been validated. PANCREOX was initiated to evaluate the benefit of mFOLFOX6 vs infusional 5FU/LV in this setting. Methods: Pts with APC previously treated with GEM and ECOG PS <=2 were eligible. 108 pts were randomized. PFS was the primary endpoint in this Canadian, multicentre, open-label study. Secondary outcomes included OS and quality of life. Pts received mFOLFOX6 or infusional 5FU/LV until progression. Results: Pt characteristics, efficacy and quality of life results are shown in the Table. Duration of 1st line GEM was similar. More pts withdrew due to adverse events (AEs) in the mFOLFOX6 arm (20.4% vs 1.9%) and due to progression in the 5FU/LV arm (74.1% vs 50.0%). No difference was observed in PFS (median 3.1 vs 2.9 mos, p=0.99). OS was inferior in pts assigned to mFOLFOX6 (median 6.1 vs 9.9 mos, p=0.02). Use ...