Observational studyBMC cancer2025
Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer.
Observational study in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06006728 (Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Who cites it
1 citing paper in PubMed.
- Photodynamic Priming and Minocycline Overcome Chemoresistance by Reprogramming the Pancreatic Tumor Immune Microenvironment In Vivo.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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.
methodsWe 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.
resultsA 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).
conclusionsNal-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.
trial registrationNCT06006728, Registration Date: August 23, 2023.
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