Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Older Versus Younger Patients With Unresectable Pancreatic Cancer: The Multicenter NAPOLEON-2 Study

Asia Pac J Clin Oncol. 2025 Nov 4. doi: 10.1111/ajco.70041. Online ahead of print.

Abstract

Aim: Nanoliposomal irinotecan plus fluorouracil and folinic acid (NFF) has been used as a standard treatment for unresectable pancreatic cancer refractory to gemcitabine-based therapies. However, reports on the efficacy of NFF in older patients with pancreatic cancer, especially in those aged > 75 years, are limited. We retrospectively compared the efficacy and safety of NFF in older and younger patients.

Methods: We reviewed the clinical records of 161 consecutive patients with unresectable pancreatic cancer who were treated with NFF between June 2020 and May 2021. Patients ≥ 75 years old were classified as the older group. We compared the antitumor efficacy, safety, and survival of the older and younger groups. Geriatric nutritional risk index (GNRI) was used as a prognostic indicator in the older group.

Results: Overall, 26 and 135 patients were enrolled in the older and younger groups, respectively. The pretreatment characteristics of the two groups were not significantly different. Median overall survival and progression-free survival were 10.9 and 5.0 months, respectively, in the older group, versus 7.6 (p = 0.15) and 3.1 months (p = 0.29), respectively, in the younger group. There were no clinical differences in the adverse events or the overall response rates between the two groups. The older group with GNRI < 86 tended to have a shorter overall survival.

Conclusion: Older patients with pancreatic cancer may benefit from NFF to the same extent as younger patients without severe adverse events. GNRI needs further study as a predictor of NFF efficacy in older patients.

Keywords: GNRI; nanoliposomal irinotecan; older patient; pancreatic cancer; retrospective.