NALIRIFOX vs FOLFIRINOX vs gemcitabine plus nab-paclitaxel as first-line treatment of advanced pancreatic cancer: An individual patient data pooled analysis of phase 3 registration trials.

• DOI: 10.1200/jco.2023.41.16_suppl.e16262
• Publication Date: 2023-06-04T15:38:35Z
• Authors: Federico Nichetti; Simone Rota; Eleonora Gusmaroli; Chiara Carlotta P...; Andrea Franza; Filippo G. De Braud; Maria Di Bartolomeo; Monica Niger
• Keywords: FOLFIRINOX; Regimen; Progression-free survival

e16262 Background: The NAPOLI-3 trial showed the superiority of NALIRIFOX regimen over combination gemcitabine and nab-Paclitaxel (GemNabP) as first-line treatment (1LTx) advanced pancreatic cancer (PDAC), thus being candidate a reference in this setting. However, comparison with FOLFIRINOX has not yet been performed. Methods: We performed pooled analysis phase III trials that defined FOLFIRINOX, GemNabP optimal 1LTx options PDAC. Individual patient outcomes were retrieved from Kaplan Meier plots each trial, analysed after assessment data reconstruction accuracy. Progression free survival (PFS) overall (OS) compared between three different arms, using Cox proportional hazard models including random effect variable to account for inter-trial variability. Overall response rates (ORR) Grade 3 or 4 (G3/4) toxicity also compared. Results: A total 1372 patients treated (n=171, 12), (n=383, 28) (n=818, 60) included. Median PFS was significantly longer (7.4 months) [6.4 months, HR 1.48 (95% CI 1.21 - 1.82), p<.001] [5.6 1.45 1.24 1.70), p = p<.001]. provided higher ORR [42% vs 32% (FOLFIRINOX) 29% (GemNabP), associated poorer OS [9.2 1.25 1.07 1.46), p=0.005], while no significant difference observed [11.1 1.12, 0.88 1.43), p=0.344] (11.1 months). Among G3/4 events, diarrhea [p<.001] lower peripheral neuropathy, thrombocytopenia neutropenia [p<.001], though febrile occurrence [p=0.158]. Conclusions: may provide superior PDAC, gastrointestinal toxicities FOLFIRINOX. Careful selection, drug costs consideration direct is warranted. [Table: see text]