Abstract 337P
Background
More than half of mPDAC patients are eligible for second-line chemotherapy, but the optimal continuum of care is still debated. To date, nal-IRI+5-FU/LV stands as the most novel and robust option in the second-line setting. The present study aimed to explore survival outcome of nal-IRI+5-FU/LV compared to other different second-line regimens in a real-world population of mPDAC patients previously treated with Gem-Nab.
Methods
This is a retrospective analysis including mPDAC patients consecutively treated between 2015 and 2018 at 39 Italian centers with second-line therapies after Gem-Nab failure. Survival analyses were performed using Kaplan-Meier method and log-rank test. Multivariate analysis was carried on by Cox regression.
Results
A total of 519 patients were enrolled, with 56% of males and a mean age of 66 years. In the overall population, second-line median PFS and OS were 3.8 (95%CI 3.7-4) and 6.8 months (95%CI 6.4-7.3), respectively. Nal-IRI+5-FU/LV was administered in 38.1% (n=198), FOLFIRI in 21.6% (n=112), FOLFOX or XELOX in 18.5% (n=96), FOLFIRINOX in 13.5% (n=70), and capecitabine in 8.3% (n=43) of cases. Median OS according to the different regimens was 9.1 months (95%CI 6.7-11.5) in the FOLFIRINOX subgroup, 7.5 months (95%CI 6.6-9.1) in nal-IRI+5-FU/LV, 6.7 months (95%CI 6.3-7.8) in FOLFIRI, 6.2 months (95%CI 5.5-7.1) in oxaliplatin-based doublet and 5.7 months (95%CI 5.3-6.8) in subjects receiving capecitabine (p<0.0005). At the multivariate analysis, a significant survival gain from second-line therapy correlated with partial response to the first-line, absence of liver metastases, improvement in performance status during the second-line, CA 19.9 < 1000 U/ml, low neutrophil/lymphocyte ratio and nal-IRI dose reduction.
Conclusions
In the absence of randomized trials, these real-world data might strengthen the role of nal-IRI+5-FU/LV as the optimal second-line option after Gem-Nab, being FOLFIRINOX feasible in only a small subgroup of patients. Further analyses are ongoing to validate a propensity score with main prognosticators to tailor the continuum of care of mPDAC.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.