Simple SummaryThe available chemotherapeutic regimens for metastatic pancreatic ductal adenocarcinoma (mPDAC) in Romania include FOLFIRINOX (FFX), gemcitabine-based regimens (GB), and gemcitabine monotherapy (Gem). The purpose of our study was to compare the efficacy of FFX, GB, and Gem in patients with mPDAC in real-world scenarios. Our research revealed that the overall survival (OS) of patients receiving FFX or GB was comparable, twice as long as that of patients receiving Gem, and the progression-free survival (PFS) was highest for patients receiving FFX as first-line chemotherapy (L1). Male gender, Eastern Cooperative Oncology Group Performance (ECOG-PS) 0/1, the FFX regimen, and neutrophil-to-lymphocyte ratio (NLR) > 4.15 were all independently linked to a longer OS. L1 with FFX improved both OS and PFS for second-line chemotherapy (L2).AbstractPurpose: To assess the efficacy of FOLFIRINOX(FFX), gemcitabine-based regimens (GB), and gemcitabine monotherapy (Gem) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Methods: This is a retrospective study that included 83 patients with mPDAC treated with first-line chemotherapy (L1) with either FFX, GB or Gem between 2015 and 2017. Progression-free survival (PFS) for L1 and second-line chemotherapy (L2) (PFS-L1 and PFS-L2) and overall survival (OS) were estimated using the Kaplan–Meier method. Results: Median PFS-L1 for FFX, GB and Gem groups was 9 months (95% (Confidence Interval) CI 2.76–15.24), 5 months (95%CI 3.44–6.56), and 5 months (95%CI 3.76–6.24), respectively (p= 0.04). OS was 14 months (95%CI 11.16–16.85), 12 months (95%CI: 9.44–11.56), and 7 months (95%CI: 5.7–8.3) for patients treated with FFX, GB, and Gem, respectively (p= 0.0001). ECOG-PS (0/1) (Hazard Ratio (HR) 6.74,p= 0.002), age > 70 years (HR 0.25,p= 0.04), body tumors (HR 2.8,p= 0.048), CA19–9 > 39 U/mL (HR 0.26,p= 0.02), and neutrophil-to-lymphocyte ratio (NLR) > 4.15 (HR 6.76,p= 0.001) were independent prognostic factors for PFS-L1. Male gender (HR 3.02,p= 0.026), ECOG-PS (0/1) (HR 4.21,p= 0.003), L1 with FFX (HR 0.255,p= 0.007), and NLR > 4.15 (HR 2.65,p= 0.04) were independent prognostic factors of OS. PFS-L2 (HR 6.91,p= 0.013) and OS-L2 (HR 6.95,p= 0.037) were significantly higher in patients first treated with FFX. Conclusions: The OS of patients who receive FFX or GB is comparable. The best PFS-L1 belongs to the FFX group. Male gender, ECOG-PS 0/1, the FFX regimen, and NLR > 4.15 were independent predictors of OS. PFS-L2 and OS-L2 were favorably impacted by L1 with FFX.