1677P - Pancreatic enzyme replacement therapy improves survival in patients receiving nab-paclitaxel plus gemcitabine as first-line treatment for advanced pancreatic adenocarcinoma

Background

Pancreatic ductal adenocarcinoma (PDAC) is one of the big killers with a 5-year-survival rate of less than 2% in metastatic disease. Limited treatment options and early clinical deterioration often affect outcome. Exocrine pancreatic insufficiency (EPI) is often underestimated in patients with advanced PDAC and a large proportion of patients (60-80%) does not receive pancreatic enzyme replacement therapy (PERT). This study aims to optimize the clinical selection of patients with advanced PDAC treated with gemcitabine/nabpaclitaxel and to develop models to predict benefit from first-line therapy and duration of second-line therapy.

Methods

In this observational study we prospectively enrolled patients with advanced PDAC treated with gemcitabine/nabpaclitaxel as first-line therapy at the Medical Oncology Unit of Careggi University Hospital from 2015 to 2022. Clinical and laboratory data were collected and associated with survival outcomes, duration of second-line therapy and treatment exposure.

Results

A total of 107 patients were enrolled, 54 (50.5%) were women and 53 (49.5%) were men. Disease stage was classified as locally advanced in 42 (39.3%) and metastatic in 65 (60.7%). Median progression-free survival (PFS) was 5.6 months and median overall survival (OS) was 7.4 months. Among the baseline clinical variables, a trend towards a worse prognosis was observed in patients with a high tumor burden (OS p=0.065). Overall, 66.0% of patients received PERT at baseline or within 3 months from first-line treatment start. PERT-users had a significantly longer OS than non-PERT-users (9.5 months vs 5.5 months, respectively, HR 95%CI 2,1 [1,2-3,7], p=0.008). In addition, the probability to receive a second-line treatment for at least 2 months was higher in the PERT-user group than in the non-PERT-user group (X-squared=7.6558, p-value=0.005659).

Conclusions

The clinical management of patients with advanced PDAC is challenging and requires a multidisciplinary strategy to prevent EPI-related symptoms and optimize treatment adherence. PERT could play a crucial role in preventing weight loss, maintaining dose intensity and improving survival.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.