Impact of prior chemotherapy on nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer: a retrospective analysis of data from the multicenter NAPOLEON-2 study

Background: Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen for patients with unresectable or recurrent pancreatic cancer (urPC) after gemcitabine-based chemotherapy. However, little is known about the clinical impact of previous chemotherapy on the effects of NFF in the real world. Objectives: We retrospectively evaluated whether the efficacy and safety of NFF differed depending on the history of prior chemotherapy among urPC patients receiving NFF. Design: This study was conducted using the real-world data of Japanese patients with urPC who received NFF in the multicenter NAPOLEON-2 study. Methods: We compared the efficacy and adverse events (AEs) after NFF initiation between previous irinotecan users and non-users, fluorouracil users and non-users, and platinum users and non-users. We also investigated whether the treatment duration of gemcitabine plus nab-paclitaxel (GnP) influenced the efficacy of NFF among patients treated with NFF as a second-line therapy after GnP. Results: Overall, 161 patients were enrolled, all of whom had previously received gemcitabine. In the efficacy analysis between irinotecan users and non-users, the median overall survival (OS) was 9.2 and 8.0 months, respectively (hazard ratio (HR) 0.88; p = 0.66). For fluorouracil, the median OS was 9.1 months for users and 7.6 months for non-users (HR 0.98; p = 0.93). For platinum, the median OS was 9.1 months for users and 8.0 months for non-users (HR 0.88; p = 0.67). There was no clinical difference in AEs between irinotecan users and non-users, which affected ⩾10% of patients in both groups. The median OS in the group with previous GnP for ⩾7.8 months was 9.5 months, while it was 4.8 months in the group with GnP for <7.8 months (HR 0.50; p < 0.01). Conclusion: NFF may be effective and tolerable, even in patients previously treated with irinotecan-, fluorouracil-, or platinum-based chemotherapy, in the real world.