학술논문
A phase II study of liposomal irinotecan with 5-fluorouracil, leucovorin and oxaliplatin in patients with resectable pancreatic cancer: the nITRO trial
Document Type
article
Author
Francesca Simionato; Camilla Zecchetto; Valeria Merz; Alessandro Cavaliere; Simona Casalino; Marina Gaule; Mirko D’Onofrio; Giuseppe Malleo; Luca Landoni; Alessandro Esposito; Giovanni Marchegiani; Luca Casetti; Massimiliano Tuveri; Salvatore Paiella; Filippo Scopelliti; Alessandro Giardino; Isabella Frigerio; Paolo Regi; Paola Capelli; Stefano Gobbo; Armando Gabbrielli; Laura Bernardoni; Vita Fedele; Irene Rossi; Cristiana Piazzola; Serena Giacomazzi; Martina Pasquato; Morena Gianfortone; Stefano Milleri; Michele Milella; Giovanni Butturini; Roberto Salvia; Claudio Bassi; Davide Melisi
Source
Therapeutic Advances in Medical Oncology, Vol 12 (2020)
Subject
Language
English
ISSN
1758-8359
17588359
17588359
Abstract
Background: Up-front surgery followed by postoperative chemotherapy remains the standard paradigm for the treatment of patients with resectable pancreatic cancer. However, the risk for positive surgical margins, the poor recovery after surgery that often impairs postoperative treatment, and the common metastatic relapse limit the overall clinical outcomes achieved with this strategy. Polychemotherapeutic combinations are valid options for postoperative treatment in patients with good performance status. liposomal irinotecan (Nal-IRI) is a novel nanoliposome formulation of irinotecan that accumulates in tumor-associated macrophages improving the therapeutic index of irinotecan and has been approved for the treatment of patients with metastatic pancreatic cancer after progression under gemcitabine-based therapy. Thus, it remains of the outmost urgency to investigate introduction of the most novel agents, such as nal-IRI, in perioperative approaches aimed at increasing the long-term effectiveness of surgery. Methods: The nITRO trial is a phase II, single-arm, open-label study to assess the safety and the activity of nal-IRI with fluorouracil/leucovorin (5-FU/LV) and oxaliplatin in the perioperative treatment of patients with resectable pancreatic cancer. The primary tumor must be resectable with no involvement of the major arteries and no involvement or