Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia—A retrospective analysis

Publication date: September 2018
Source:European Journal of Cancer, Volume 100
Author(s): Uwe Pelzer, Lilianna Wislocka, Anja Jühling, Jana Striefler, Fritz Klein, Josefine Roemmler-Zehrer, Marianne Sinn, Tim Denecke, Marcus Bahra, Hanno Riess
IntroductionTreatment of patients with advanced pancreatic carcinoma (APC) and hyperbilirubinaemia is problematic because these patients were regularly excluded from clinical studies. Nanoparticle albumin–bound paclitaxel and gemcitabine (nab-P/G) is an evidence-based treatment for patients with APC. This retrospective study investigated the safety and efficacy of nab-P/G in patients with APC and cholestatic hyperbilirubinaemia.MethodsWe screened our prospective database for patients with APC treated with nab-P/G at total bilirubin levels of ≥1.2 mg/dl. Patients were assigned into three groups according to their bilirubin level (A: 1.2–3 mg/dl, B: >3–5 mg/dl, C: >5 mg/dl). Analyses with regard to safety and survival were performed.ResultsTwenty-nine of 168 patients screened between Dec 2013 and Dec 2015 fulfilled the inclusion criteria. Most patients (83%) were male; median age was 63 [41–79] years. Nab-P/G administrations in patients with an elevated bilirubin level (median, range) did not result in unexpected toxicities assessed by predefined (non-)haematological parameters. Median overall survival (mOS) for the whole group was 11.7 (95% confidence interval [CI]: 6.8–14.0) months; for A: 11.8 (95% CI: 6.5–16.5), B: 9.2 (95% CI: 1.1 – NA) months and C 11.8 (95% CI: 5.9–20.0] months (p = 0.843). Again, mOS from the first application of nab-P/G did not differ between the groups (p = 0.13).ConclusionNab-P/G administrations in our pts with cholestatic hyperbilirubinaemia suffering from APC were feasible and safe with respect to individualised dose administrations. A multicenter phase 1 trial in pts with hyperbilirubinaemia is started (AIO-PAK-0117) to confirm these findings in a prospective setting.



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