Real-World Evidence of the Efficacy and Safety of Second-Line Therapy After Gemcitabine and Nab-Paclitaxel for Patients with Metastatic Pancreatic Cancer.

Background

Metastatic pancreatic cancer (mPC) is an aggressive disease with high morbidity and mortality, and long-term survival rates remain poor. New therapeutic options that demonstrate statistically significant improvements in overall survival (OS) and progression-free survival (PFS) are still being sought. Although many first-line (FL) treatment studies exist in the literature, there are almost no prospective studies on second-line (SL) therapy.

Methods

The aim of this clinical study was to retrospectively analyze the medical history of 251 patients diagnosed with mPC, treated first-line (FL) with GEM-NAB between February 2017 and January 2025. After disease progression, 109 patients received SL treatment. We also present a multivariate analysis based on routinely collected data (demographic, clinical, and laboratory parameters) evaluating their impact on OS and PFS.

Results

The median age was 66 years (range 37-84 years). The median PFS was 2.33 months (95% CI 1.69-2.97). Specifically, the mPFS was 4.1 months (95% CI 1.31-6.90) for FOLFIRINOX; 2.8 months (95% CI 2.30-3.30) for FOLFIRI; 2.37 months (95% CI 1.66-3.08) for NALIRI; 1.47 months (95% CI 1.18-1.75) for FOLFOX 6; and 0.93 months (95% CI 0.00-2.64) for GEM-cisplatin. The median OS was 5.03 months (95% CI 3.75-6.31). Seven patients achieved a partial response (overall response rate 6%). The most frequent adverse events (AEs) included anemia, fatigue, peripheral neuropathy, neutropenia, and thrombocytopenia.

Conclusions

As a result, SL treatments were compared, and some statistically significant difference was found between them in PFS time for chemotherapy FOLFIRINOX and GEM + cisplatin. The most frequent AEs occurred during treatment with FOLFIRINOX chemotherapy.