Publications

Authors:

Melisi, Davide; Zecchetto, Camilla; Merz, Valeria; Malleo, Giuseppe; Landoni, Luca; Quinzii, Alberto; Casalino, Simona; Fazzini, Federica; Gaule, Marina; Pesoni, Camilla; Casetti, Luca; Esposito, Alessandro; Marchegiani, Giovanni; Piazzola, Cristiana; D'Onofrio, Mirko; de Robertis, Riccardo; Gabbrielli, Armando; Bernardoni, Laura; Crino, Stefano F; Pietrobono, Silvia; Luchini, Claudio; Aliberti, Camillo; Martignoni, Guido; Milleri, Stefano; Butturini, Giovanni; Scarpa, Aldo; Salvia, Roberto; Bassi, Claudio

Title:

Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: The open-label, multicenter, phase II nITRO trial

Year:

2024

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Format:

Elettronico

Referee:

No

Name of journal:

European Journal of Cancer

ISSN of journal:

0959-8049

N° Volume:

196

Number or Folder:

January

Page numbers:

1-7

Keyword:

Liposomal irinotecan; NALIRIFOX; Perioperative treatment; Resectable pancreatic ductal adenocarcinoma

Short description of contents:

Background: Upfront surgery followed by postoperative treatment is a commonly adopted treatment for resectable pancreatic ductal adenocarcinoma (rPDAC). However, the risk of positive surgical margins, the poor recovery that often impairs postoperative treatments, and the risk of recurrence might limit the outcome of this strategy. This study evaluated the safety and the activity of liposomal irinotecan 50 mg/m2 + 5-fluorouracil 2400 mg/m2 + leucovorin 400 mg/m2 + oxaliplatin 60 mg/m2 (NALIRIFOX) in the perioperative treatment of patients with rPDAC. Methods: Eligible patients had a rPDAC with < 180° interface with major veins' wall. Patients received 3 cycles before and 3 cycles after resection with NALIRIFOX, days 1 and 15 of a 28-day cycle. The primary endpoint was the proportion of patients undergoing an R0 resection. Results: 107 patients began preoperative treatment. Nine patients discontinued the treatment because of related or unrelated adverse events. Disease-control rate was 92.9%. 87 patients underwent surgical exploration, 11 had intraoperative evidence of metastatic disease, and 1 died for surgical complications. R0 resection rate was 65.3%. 49 patients completed the three postoperative cycles. The most common grade ≥ 3 adverse events were diarrhea and neutropenia. Median overall survival (OS) of ITT patients was 32.3 months (95% CI 27.8-44.3). Median disease-free and OS from surgery of resected patients were 19.3 (95% CI 12.6-34.1) and 40.3 months (95% CI 29-NA), respectively. Conclusion: Perioperative NALIRIFOX was manageable and active, and deserves further investigation in randomized trials comparing it with standard upfront surgery followed by adjuvant therapy.

Note:

Epub 2023 Nov 11

Product ID:

136395

Handle IRIS:

11562/1114887

Last Modified:

January 10, 2024

Bibliographic citation:

Melisi, Davide; Zecchetto, Camilla; Merz, Valeria; Malleo, Giuseppe; Landoni, Luca; Quinzii, Alberto; Casalino, Simona; Fazzini, Federica; Gaule, Marina; Pesoni, Camilla; Casetti, Luca; Esposito, Alessandro; Marchegiani, Giovanni; Piazzola, Cristiana; D'Onofrio, Mirko; de Robertis, Riccardo; Gabbrielli, Armando; Bernardoni, Laura; Crino, Stefano F; Pietrobono, Silvia; Luchini, Claudio; Aliberti, Camillo; Martignoni, Guido; Milleri, Stefano; Butturini, Giovanni; Scarpa, Aldo; Salvia, Roberto; Bassi, Claudio, Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: The open-label, multicenter, phase II nITRO trial «European Journal of Cancer» , vol. 196 , n. January , 2024 , pp. 1-7

Consulta la scheda completa presente nel repository istituzionale della Ricerca di Ateneo