Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis
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Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. / Pelzer, Uwe; Wislocka, Lilianna; Jühling, Anja; Striefler, Jana; Klein, Fritz; Roemmler-Zehrer, Josefine; Sinn, Marianne; Denecke, Tim; Bahra, Marcus; Riess, Hanno.
In: EUR J CANCER, Vol. 100, 09.2018, p. 85-93.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis
AU - Pelzer, Uwe
AU - Wislocka, Lilianna
AU - Jühling, Anja
AU - Striefler, Jana
AU - Klein, Fritz
AU - Roemmler-Zehrer, Josefine
AU - Sinn, Marianne
AU - Denecke, Tim
AU - Bahra, Marcus
AU - Riess, Hanno
N1 - Copyright © 2018 Elsevier Ltd. All rights reserved.
PY - 2018/9
Y1 - 2018/9
N2 - INTRODUCTION: Treatment 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.METHODS: We 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.RESULTS: Twenty-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).CONCLUSION: Nab-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.
AB - INTRODUCTION: Treatment 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.METHODS: We 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.RESULTS: Twenty-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).CONCLUSION: Nab-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.
KW - Adenocarcinoma/complications
KW - Adult
KW - Aged
KW - Albumins/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Cholestasis/diagnosis
KW - Databases, Factual
KW - Deoxycytidine/administration & dosage
KW - Feasibility Studies
KW - Female
KW - Humans
KW - Hyperbilirubinemia/diagnosis
KW - Male
KW - Middle Aged
KW - Paclitaxel/administration & dosage
KW - Pancreatic Neoplasms/complications
KW - Retrospective Studies
KW - Risk Factors
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1016/j.ejca.2018.06.001
DO - 10.1016/j.ejca.2018.06.001
M3 - SCORING: Journal article
C2 - 30014884
VL - 100
SP - 85
EP - 93
JO - EUR J CANCER
JF - EUR J CANCER
SN - 0959-8049
ER -