Background: The phase III MPACT trial demonstrated the superiority of gemcitabine
(Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients
with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to
evaluate the effect of Gem/Nab-P in routine clinical practice.
Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline
treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre
retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive
markers, were performed.
Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance
status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13)
and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and
stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control
rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia,
5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients.
No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3%
of the patients.
Conclusion: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine
and Nab-paclitaxel in metastatic PDAC in a real-life population.