Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study
Gerald W Prager, Leopold Oehler, Armin Gerger, Brigitte Mlineritsch, Johannes Andel, Andreas Petzer, Klaus Wilthoner, Thamer Sliwa, Petra Pichler, Thomas Winder, Sonja Heibl, Birgit Gruenberger, Friedrich Laengle, Eva Hubmann, Markus Korger, Martin Pecherstorfer, Angela Djanani, Hans-Joerg Neumann, Kathrin Philipp-Abbrederis, Ewald Wöll, Robert Trondl, Catharina Arnold-Schrauf, Wolfgang Eisterer, Gerald W Prager, Leopold Oehler, Armin Gerger, Brigitte Mlineritsch, Johannes Andel, Andreas Petzer, Klaus Wilthoner, Thamer Sliwa, Petra Pichler, Thomas Winder, Sonja Heibl, Birgit Gruenberger, Friedrich Laengle, Eva Hubmann, Markus Korger, Martin Pecherstorfer, Angela Djanani, Hans-Joerg Neumann, Kathrin Philipp-Abbrederis, Ewald Wöll, Robert Trondl, Catharina Arnold-Schrauf, Wolfgang Eisterer
Abstract
Background: Pancreatic cancer (PC) ranks among the deadliest malignancies worldwide. In the MPACT study, first-line nab-paclitaxel plus gemcitabine (nab-P/G) demonstrated activity (median overall survival [OS], 8.7 months) and tolerability in patients with metastatic PC (mPC). However, the clinical evidence of nab-P/G in the elderly (>70 years), who account for the majority of patients with mPC, is limited. This is the first prospective, multicentre, non-interventional study evaluating the tolerability and effectiveness of nab-P/G in younger (≤70 years) versus elderly (>70 years) patients with mPC in the daily clinical routine.
Methods: Eligible patients with mPC were treated with nab-P/G and observed until disease progression or unacceptable toxicity. The primary objectives were safety and tolerability of nab-P/G, and the secondary objectives were efficacy and real-life dosing.
Results: A total of 317 patients with mPC (median age, 70 years) were recruited, of which 299, aged ≤70 (n = 162) and >70 (n = 137) years, were eligible for analysis. Baseline characteristics and the safety profile were comparable between the groups. However, fatigue (22.8% versus 13.0%) and decreased appetite (8.8% versus 1.2%) were more frequent in elderly patients. Younger versus elderly patients equally benefited in terms of objective response rate (36% versus 48%), median progression-free survival (5.6 versus 5.5 months; hazard ratio [HR] = 1.03; p = 0.81) and OS (10.6 versus 10.2 months; HR = 0.89; p = 0.4). In addition, the median treatment duration (5 versus 4 cycles), relative dose intensity (70% versus 74%) or reasons for treatment discontinuation were similar. Most patients (56.2% versus 47.4%) benefited from a second-line therapy.
Conclusion: This prospective real-world analysis confirms the feasibility and tolerability of nab-P/G treatment and reveals OS data similar for younger patients and elderly patients aged >70 years. CLINICALTRIALS.
Gov registration: NCT02555813.
Austrian nis registry: NIS005071.
Keywords: Albumin-bound paclitaxel; Austria (MeSH); Duration of therapy; Gemcitabine; Pancreatic cancer; Progression-free survival; Prospective study; Survival rate.
Conflict of interest statement
Conflict of interest statement G.W.P. is a member of advisory board meetings/symposia for Merck Serono, Roche, Amgen, Sanofi, Lilly, Servier, Taiho, Bayer, Halozyme, BMS, Celgene, Shire and Terumo. S.H. is a member of advisory board meetings for Celgene. R.T. and C.A.-S. are employees of Celgene GmbH, Austria. All other authors declare no conflict of interest.
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed