Abstract 1677P
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.
Resources from the same session
1701P - Cancer premium: Explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland
Presenter: Miquel Serra-Burriel
Session: Poster session 22
1702P - Real-world evidence contributions to European medicines agency’s safety and efficacy evaluations of oncology targeted therapies between 2018-2022
Presenter: Jeroen W. G. Derksen
Session: Poster session 22
1703P - Value of molecular targets and genome-targeted cancer therapies FDA-approved, 2015-2022
Presenter: Ariadna Tibau
Session: Poster session 22
1704P - Clinical benefit of cancer drugs approved by the US food and drug administration based on appropriateness of control arm and its change over time
Presenter: Molto Consolacion
Session: Poster session 22
1705P - Therapeutic value of first vs supplemental indications of drugs in the US and Europe (2011-2020): Retrospective cohort study
Presenter: Kerstin Vokinger
Session: Poster session 22