# Safety and Efficacy of Concomitant Administration of Nanoliposomal Irinotecan + 5‐Fluorouracil/Levo‐Leucovorin for Pancreatic Cancer

## TL;DR

This study compares the safety and effectiveness of two ways to administer cancer drugs for pancreatic cancer and finds that a faster method may be just as safe and effective.

## Contribution

The study provides new evidence that concomitant administration of nal-IRI and Levo-LV is as safe and effective as sequential administration.

## Key findings

- No significant difference in Grade 3 or higher adverse events between the two administration methods.
- Concomitant administration reduced infusion time by nearly 50% compared to sequential administration.
- Concomitant administration showed a trend toward improved overall survival, though not statistically significant.

## Abstract

Nanoliposomal irinotecan (nal‐IRI) plus 5‐fluorouracil (5‐FU)/levo‐leucovorin (Levo‐LV) therapy is recommended as the standard of care for unresectable locally advanced (UR‐LA) and metastatic pancreatic cancer after failure of gemcitabine‐containing regimens. Although the concomitant administration of nal‐IRI and Levo‐LV benefits from a reduced hospital stay, nal‐IRI is usually administered after Levo‐LV owing to insufficient data on compatibility reactions. This study aimed to compare the safety and efficacy of the sequential and concomitant administration of nal‐IRI and Levo‐LV.

Data of patients with UR‐LA or metastatic pancreatic cancer who received nal‐IRI plus 5‐FU/Levo‐LV between 2020 and 2023 at Shizuoka Cancer Center were retrospectively collected. Patients were classified into the sequential administration group (Group S) and concomitant administration group (Group C) to compare adverse events, infusion time, and survival. Univariate and multivariate analyses were performed to identify independent prognostic factors in each group.

A total of 94 patients were included (44 in Group S and 50 in Group C). There was no significant difference in the incidence of Grade 3 or higher adverse events between the two groups. The median total infusion times for nal‐IRI plus 5‐FU/Levo‐LV in Groups S and C were 271 and 149 min, respectively (p < 0.001). Overall survival estimates were 5.6 months (95% confidence interval [CI] 3.78–8.57) in Group S and 8.4 months (95% CI 6.77–10.3) in Group C (unstratified HR 0.65, 95% CI 0.42–1.02; p = 0.058). In the multivariate analysis for PFS and OS, the method of administration was not identified as an independent prognostic factor. Concomitant administration of Levo‐LV with nal‐IRI may not increase adverse events or impact efficacy while reducing infusion time.

Concomitant administration of Levo‐LV with nal‐IRI may not increase adverse events or impact efficacy compared to sequential administration.