# Long-term survival in patients with pancreatic cancer treated with second-line liposomal irinotecan plus 5-fluorouracil/leucovorin: observations from Korea, Italy, and Germany

## TL;DR

This study examines long-term survival in pancreatic cancer patients treated with a specific drug combination in real-world settings across Korea, Italy, and Germany.

## Contribution

The study evaluates the real-world applicability of prognostic factors identified in a clinical trial for pancreatic cancer treatment.

## Key findings

- High CA19-9 levels and low N/L ratio were associated with long-term survival in real-world data.
- Factors like albumin levels and BMI showed inconsistent associations with survival across studies.
- Age and prior treatment lines, not included in the original nomogram, may influence long-term survival.

## Abstract

Pancreatic cancer (PAC) is an aggressive disease with poor clinical outcomes. Liposomal irinotecan in combination with 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) is the only approved therapy for metastatic PAC following gemcitabine-based therapy, based on the survival benefit demonstrated in the phase III NAPOLI-1 trial. Factors associated with long-term survival in this trial included age ≤65 years, Karnofsky performance status (KPS) ≥90, neutrophil-to-lymphocyte (N/L) ratio ≤5, carbohydrate antigen (CA) 19-9 <59-times the upper limit of normal (ULN), and no liver metastases. Using real-world data from studies conducted in Korea, Italy, and Germany, this review aims to assess the suitability of prognostic factors identified in the NAPOLI-1 trial nomogram. In these real-world studies, a high CA19-9 level and a low N/L ratio were associated with long-term survival in patients treated with nal-IRI+5-FU/LV. The impact of albumin levels, body mass index (BMI), liver metastasis, and KPS on survival identified from the NAPOLI-1 trial was confirmed in some real-world analyses but not consistently. Factors such as patient age and number of previous lines of treatment that were not identified in the NAPOLI-1 nomogram may be associated with long-term survival with nal-IRI+5-FU/LV in the real-world. In conclusion, this review has shown that while prognostic factors are useful for patient stratification, their predictive value on the efficacy of nal-IRI+5-FU/LV is low, thus this treatment may also result in long-term survival in patients with apparently unfavorable characteristics.

•nal-IRI+5-FU/LV is an approved treatment of metastatic pancreatic cancer (mPAC) following gemcitabine-based therapy.•NAPOLI-1 investigated nal-IRI+5-FU/LV in mPAC and factors associated with long-term survival were identified in a nomogram.•This review assesses the impact of these prognostic factors in the real-world in Korea, Italy and Germany.•A high CA19-9 level and a low N/L ratio were associated with long-term survival in the real-world.•Other factors, such as albumin levels and BMI, were confirmed in some of the real-world studies, but not consistently.

nal-IRI+5-FU/LV is an approved treatment of metastatic pancreatic cancer (mPAC) following gemcitabine-based therapy.

NAPOLI-1 investigated nal-IRI+5-FU/LV in mPAC and factors associated with long-term survival were identified in a nomogram.

This review assesses the impact of these prognostic factors in the real-world in Korea, Italy and Germany.

A high CA19-9 level and a low N/L ratio were associated with long-term survival in the real-world.

Other factors, such as albumin levels and BMI, were confirmed in some of the real-world studies, but not consistently.