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Background <p>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.</p> Methods <p>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.</p> Results <p>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 (<i>n</i> = 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 (<i>p</i> &lt; 10<sup>–3</sup>). Patients who had previously received irinotecan exhibited significantly lower OS compared with patients who were irinotecan-naïve (<i>p</i> &lt; 10<sup>–3</sup>).Our nomogram demonstrated excellent prediction of 6-month and 1-year survivals (<i>p</i> &lt; 10 <sup>−3</sup>).</p> Conclusions <p>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.</p> Trial registration <p>NCT06006728, Registration Date: August 23, 2023.</p>

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

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  • 发表日期：

    2025年11月28日

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  • Marie Decraecker,
  • Sophie Le Joncour,
  • Valérie Aurillac,
  • Maïté Sangnier,
  • Camille Ducerf,
  • Aude Berroneau,
  • Laetitia Rouleau,
  • David Tougeron,
  • Christophe Laplace,
  • Magali Madau,
  • Camille Dumon,
  • Herve Perrier,
  • Jean-Frédéric Blanc

摘要

Background

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.

Methods

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.

Results

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).

Conclusions

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.

Trial registration

NCT06006728, Registration Date: August 23, 2023.