Distinct safety profiles of albumin-bound nab-paclitaxel and paclitaxel in pancreatic cancer focusing on hematologic and hepatobiliary risks

Nab-paclitaxel (albumin-bound paclitaxel) and traditional paclitaxel are both used in pancreatic cancer treatment, but their adverse event (AE) profiles may differ due to formulation differences. This study compares the safety profiles of Nab-paclitaxel and paclitaxel using the FDA Adverse Event Reporting System (FAERS) database. FAERS data from Q1 2004 to Q2 2024 were analyzed using disproportionality methods, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), to detect significant AE signals. Adverse events were categorized by system organ classes, and key signals were identified and compared for each drug. Nab-paclitaxel was associated with a higher frequency of severe hematologic and hepatobiliary events, including neutropenia (ROR 44.63; PRR 23.86) and cholangitis (ROR 113.06). Additionally, Nab-paclitaxel had 539 reports of death (27.08%), while paclitaxel had 272 (9.68%). Paclitaxel was more frequently associated with infusion-related hypersensitivity reactions, with 172 cases of flushing and 116 hypersensitivity reactions. Time trends showed a steady increase in Nab-paclitaxel-related AEs, especially hematologic toxicities, suggesting greater risk accumulation over time. Nab-paclitaxel's nanoparticle formulation, while enhancing distribution and clearance properties, is linked to elevated hematologic and hepatic AEs in pancreatic cancer treatment, requiring vigilant patient monitoring.