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).

Abstract

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 of post-progression therapy was significantly higher in the 5FU/LV arm (25% vs 6.8%, p<0.05). Increased toxicity was observed with the addition of oxaliplatin in 2nd line APC with grade 3/4 possibly-related AEs occurring in 63% of mFOLFOX6 pts and 11% of 5FU/LV pts. No treatment related deaths. Conclusions: No benefit was observed with the addition of oxaliplatin to infusional 5FU/LV in GEM-treated 2nd line APC. PFS was similar and OS was inferior with mFOLFOX6. Given the proven benefit of FOLFIRINOX in untreated APC (ACCORD 11), these results suggest that the opportunity for use of oxaliplatin-based CT would be primarily in the 1st-line setting. Funding: Sanofi Canada. Clinical trial information: NCT01121848. Variables Statistic mFOLFOX6 n=54 5FU/LV n=54 HR (95% CI) P Age Median (y) 65 67 0.36 Duration of advanced disease Median (mos) 7.9 5.7 0.20 Stage (%) Locally advanced 7.4 5.6 0.70 Metastatic 92.6 94.4 ECOG (%) 0 13.0 18.9 0.22 1 75.9 75.5 2 11.1 5.7 PFS Median (mos) 3.1 2.9 1.00 (0.66-1.53) 0.99 OS Median (mos) 6.1 9.9 1.78 (1.08-2.93) 0.02 ORR (%) 13.2 8.5 0.36 EORTC-QLQ-C30 Time to definite deterioration > 10 pts (days) 65 92 1.47 (0.74-29.4 0.27