Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer

In the randomized NAPOLI-1 trial, nanoliposomal irinotecan (Nal-Iri) combined with fluorouracil and folinic acid provided considerable survival increase for patients with metastatic pancreatic ductal adenocarcinomas who had received gemcitabine-based therapy. However, patients included in clinical trials often differ from those encountered in practice. A real-world study was required to assess the efficacy and safety of Nal-Iri in patients with poor prognoses for whom quality of life preservation was essential. We conducted an observational, retrospective national multicenter phase 4 study of patients with advanced pancreatic cancers treated using Nal-Iri combined with fluorouracil and folinic acid in clinical practice. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan–Meier method. We used a nomogram validated from a concordance index of eight clinicobiological variables to predict OS. A total of 58 patients with advanced pancreatic adenocarcinomas who received Nal-Iri combined with fluorouracil and folinic acid in three medical centers between March 2020 and September 2022 were included. The median duration of Nal-Iri treatment was 3.6 (range 1.9–8.8) months. The median follow-up time from the start of first-line treatment was 26.2 (16.5–44.8) months. Of all patients, 20.7% received Nal-Iri in a second-line setting, but most (n = 37 patients; 63.8%) received Nal-Iri in a third-line setting. Forty-two patients (72.4%) had previously been treated with irinotecan. The median OS from the time of Nal-Iri initiation was 6.0 (2.6–13.1) months, and the median PFS was 2.1 (1.7–2.6) months. Patients who received Nal-Iri in a second-line setting exhibited significantly better OS than patients who received Nal-Iri in a third-line setting or later (p < 10–3). Patients who had previously received irinotecan exhibited significantly lower OS compared with patients who were irinotecan-naïve (p < 10–3).Our nomogram demonstrated excellent prediction of 6-month and 1-year survivals (p < 10 −3). Nal-Iri combined with fluorouracil and folinic acid was particularly effective in second-line settings and irinotecan non-pre-treated patients. The nomogram demonstrated excellent prediction of survival under real-world conditions. NCT06006728, Registration Date: August 23, 2023.