2026-04-17T14:40:30Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/57772025-09-30T02:08:08Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Blanc, Jean-Frédéric
author
Wang-Gillam, Andrea
author
Chen, Li-Tzong
author
Siveke, Jens T.
author
Mirakhur, Beloo
author
Macarulla Mercadé, Teresa
2021-03-19T12:33:13Z2021-03-19T12:33:13Z2019-05-01
Irinotecan liposomal; Pacients grans; Càncer de pàncreesIrinotecán liposomal; Pacientes mayores; Cáncer de páncreasLiposomal irinotecan; Older patients; Pancreatic cancerObjectives
Pancreatic cancer is a highly lethal disease predominantly affecting older patients. Characterization of outcomes in these patients may help optimise treatment decisions. The global, phase 3 NAPOLI-1 trial ( NCT01494506 ) demonstrated an overall survival (OS) benefit with liposomal irinotecan and 5-flurouracil/leucovorin (nal-IRI + 5-FU/LV) versus 5-FU/LV. This subgroup analysis explored impact of age on outcomes in NAPOLI-1 patients, and nal-IRI + 5-FU/LV efficacy and safety in older patients.
Materials and Methods
This exploratory, post-hoc analysis of the NAPOLI-1 trial included patients aged ≥eighteen years (no upper limit) with metastatic pancreatic adenocarcinoma that had progressed on gemcitabine-based therapy. Patients were stratified by age (cut-offs at 65, 70, and 75 years); OS and progression-free survival (PFS) were estimated by Kaplan-Meier analysis.
Results
Of 417 randomized patients, 192 (46%), 110 (26%) and 43 (10%) were aged ≥65, ≥70 and ≥ 75 years, respectively. Mortality risk and risk of disease progression were similar in older and younger patients independent of treatment (HRs for median [m]OS/mPFS comparisons were 0.88/0.95 [<65 versus ≥65 years], 0.89/0.88 [<70 versus ≥70 years] and 1.04/0.98 [<75 versus ≥75 years]; P > .25). Reduced mortality/morbidity risk with nal-IRI + 5-FU/LV in older subgroups was in line with the wider population. No additional toxicities with nal-IRI + 5-FU/LV were observed in older patients: 86% of patients ≥75 years versus 69% <75 years required a dose delay or reduction due to toxicities (43% versus 32% dose reductions).
Discussion
Results suggest that older patients with metastatic pancreatic adenocarcinoma that progressed on prior gemcitabine-based treatment can benefit from second-line therapy, supporting nal-IRI + 5-FU/LV treatment in older patients.The NAPOLI-1 trial (ClinicalTrials.govidentifier: NCT01494506) was sponsored by Merrimack Pharmaceuticals, Inc., Cambridge, MA, USA; Medical writing support was provided by Laura McMahon of Physicians World Europe GmbH, Mannheim, Germany, and funded by Shire International, Zug, Switzerland. Correction and publication costs were funded by Global Medical Affairs, Servier, Suresnes, France.
Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess
Pàncrees - Càncer
Metàstasi
Medicaments - Administració
DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms
CHEMICALS AND DRUGS::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidinones::Uracil::Fluorouracil
Other subheadings::Other subheadings::Other subheadings::/administration & dosage
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas
COMPUESTOS QUÍMICOS Y DROGAS::compuestos heterocíclicos::compuestos heterocíclicos de 1 anillo::pirimidinas::pirimidinonas::uracilo::fluorouracilo
Otros calificadores::Otros calificadores::Otros calificadores::/administración & dosificación
ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica
Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion