Redefining the use of a first-line FOLFIRINOX-like regimen in older patients with metastatic pancreatic cancer: Updated analysis.

700 Background: Prospective elderly-specific data for treating pancreatic cancer are scarce. First-line treatment with triplet chemotherapy (e.g., FOLFIRINOX) is often too toxic for older adults (OA). Interim analysis of this multicenter phase II trial evaluating the tolerability and efficacy of alternating FOLFOX and FOLFIRI (aFOLFIRINOX) in OA with metastatic pancreatic adenocarcinoma (mPDAC) indicated safety of the regimen. We now report updated study results including safety and survival endpoints. Methods: Eligible patients (n=37) ≥65 years old with measurable untreated mPDAC, ECOG PS 0-2, receive standard doses of FOLFOX alternating with FOLFIRI every 2 weeks for up to 6 months. Patients (pts) could continue treatment thereafter at the discretion of their physician. The primary endpoint was rate of treatment-limiting grade ≥3 adverse events (TLAE) per CTCAE v5.0 in the first 8 weeks of therapy. TLAE were defined as treatment-related grade 3 non-hematologic AE persisting > 2 weeks despite best supportive care, grade 3 anemia or thrombocytopenia, grade >3 neuropathy, any grade > 4 AE, or AE requiring treatment discontinuation. The study was powered to detect a 20% improvement in TLAE compared to FOLFIRINOX. Secondary endpoints included progression free & overall survival (PFS & OS), objective response rate (ORR). FACT-G and PROMIS-10 quality of life (QOL) surveys and geriatric assessments (GA) were collected. Results: 37 eligible pts enrolled: 19 male, 18 female; median age 75 (range 65-82); 31 pts had ECOG PS 0-1. The pre-specified primary endpoint was met - 24 pts (65%, 95% CI: 47%-80%) did not experience TLAE as defined above. 4 of 28 pts (14%) who received at least 1 full cycle of treatment had a TLAE, whereas 9 of 9 patients (100%) who received