Journal Article

The role of nanoliposomal irinotecan plus fluorouracil/leucovorin in the continuum of care of patients with metastatic pancreatic ductal adenocarcinoma

Spadi, Rosella, Casalino, Simona, Vaccaro, Vanja, Zichi, Clizia, Scartozzi, Mario, Noventa, Silvia, Milella, Michele, Pinto, Carmine, Satolli, Maria Antonietta, Fasano, Morena, Antonuzzo, Lorenzo, Merz, Valeria, Zaniboni, Alberto, Procaccio, Letizia, De Toni, Chiara, Giordano, Guido, De Vita, Ferdinando, Giommoni, Elisa, Bergamo, Francesca, Lonardi, Sara, Melisi, Davide, Zecchetto, Camilla, Pretta, Andrea, Barsotti, Giulia

2023

Overview

Background The NAPOLI‐I trial showed better outcome of nanoliposomal irinotecan (nal‐IRI) plus 5‐fluorouracil/leucovorin (5‐FU/LV) compared to 5‐FU/LV in patients with advanced pancreatic ductal adenocarcinoma cancer (advPDAC) progressed to gemcitabine‐based therapy. This study aims to explore the real‐world efficacy and safety of 5‐FU/LV‐nal‐IRI. Methods This is a retrospective multicenter analysis including advPDAC patients receiving 5‐FU/LV‐nal‐IRI after failure of gemcitabine‐based therapy. Survival analyses were performed using Kaplan–Meier method, univariate and multivariate analyses by Cox regression. Results A total of 296 patients (median age 64.4 years, ECOG PS ≥1 in 56% of cases) were treated at 11 Italian institutions between 2016 and 2018. 34% of them underwent primary tumor resection, and 79% received gemcitabine‐nabpaclitaxel as first line. 5‐FU/LV‐nal‐IRI was administered as second‐line in 73% of cases. Objective response and disease control rate were 12% and 41%, respectively. Treatment was well tolerated with dose reductions in 50% of patients but no one permanent discontinuation; the commonest grade ≥3 toxicities were neutropenia (14%) and diarrhea (12%). Median PFS and OS from 5‐FU/LV‐nal‐IRI initiation was 3.2 and 7.1 months, respectively. Conclusions These real‐world data confirm the 5‐FU/LV‐nal‐IRI efficacy and safety in advPDAC patients progressed to gemcitabine‐based therapy, with outcomes comparable to NAPOLI‐1, even in a less‐selected population and with more modern therapeutic algorithm.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: 5-Fluorouracil / Adenocarcinoma / Adenocarcinoma - drug therapy / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Body mass index / Camptothecin / Chemotherapy / Continuity of Patient Care / Diarrhea / Disease control / FDA approval / Fluorouracil - adverse effects / Gemcitabine / Humans / Irinotecan / Leucovorin - adverse effects / Medical prognosis / Metastases / Metastasis / Middle Aged / Multivariate analysis / Neutropenia / Pancreas / Pancreatic cancer / Pancreatic Neoplasms / Pancreatic Neoplasms - pathology / Patients / Response rates