O-0005 FOLFIRI.3 Alternating with Gemcitabine in Patients with Untreated Metastatic Pancreatic Adenocarcinoma: The Randomized Multicenter Ageo Phase II Trial Firgem

ABSTRACT Introduction CPT-11 showed modest activity and tolerability in metastatic pancreatic adenocarcinoma (MPA). We developed a new strategy to improve efficacy and tolerability of CPT-11 based regimen in MPA patients (pts). Methods Chemotherapy-naive pts with histologically proven MPA, bilirubin levels Results Between 2007 and 2011, 98 pts were enrolled (males: 59, median age: 62 years, PS 0: 32%). Median follow-up was 23 months. Grade 3-4 toxicities per pts (%) in arm A/B were diarrhea 13/0, nausea-vomiting 11/4, neutropenia 51/25, and febrile neutropenia 4/0. No toxic death occurred. Response rate were 40 and 11% as disease control rate (CR + PR + SD) were 73 and 52% in arm A and B, respectively. The primary endpoint of the trial was met with rate of PFS at 6 months of 48% (95% CI: 33-63) in arm A while in arm B PFS was 30% (95% CI: 17 - 44). One year PFS was 23% (95%CI: 11.5-36) and 11% (95% CI: 4-21), respectively. Conclusion FIRGEM strategy is feasible and efficient with a manageable toxicity profile in good condition pts with MPA. A phase III trial comparing this strategy with the FOLFIRINOX triplet therapy focusing on quality of life should now be performed.