OBJECTIVES: 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 75years); 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>/=75years, 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 >/=65years], 0.89/0.88 [<70 versus >/=70years] and 1.04/0.98 [<75 versus >/=75years]; 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 >/=75years versus 69% <75years 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.
Date:
2019-05
Relation:
Journal of Geriatric Oncology. 2019 May;10(3):427-435.
