Cancer Medicine (Jul 2023)

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

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

DOI
https://doi.org/10.1002/cam4.6111
Journal volume & issue
Vol. 12, no. 13
pp. 14337 – 14345

Abstract

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Abstract 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.