TY - JOUR
T1 - Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer
T2 - Analysis of a multicentre, prospective, non-interventional study
AU - Prager, Gerald W
AU - Oehler, Leopold
AU - Gerger, Armin
AU - Mlineritsch, Brigitte
AU - Andel, Johannes
AU - Petzer, Andreas
AU - Wilthoner, Klaus
AU - Sliwa, Thamer
AU - Pichler, Petra
AU - Winder, Thomas
AU - Heibl, Sonja
AU - Gruenberger, Birgit
AU - Laengle, Friedrich
AU - Hubmann, Eva
AU - Korger, Markus
AU - Pecherstorfer, Martin
AU - Djanani, Angela
AU - Neumann, Hans-Joerg
AU - Philipp-Abbrederis, Kathrin
AU - Wöll, Ewald
AU - Trondl, Robert
AU - Arnold-Schrauf, Catharina
AU - Eisterer, Wolfgang
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Aged
KW - Albumins/pharmacology
KW - Antineoplastic Combined Chemotherapy Protocols/pharmacology
KW - Deoxycytidine/analogs & derivatives
KW - Female
KW - Humans
KW - Male
KW - Paclitaxel/pharmacology
KW - Pancreatic Neoplasms/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=85097401696&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2020.11.003
DO - 10.1016/j.ejca.2020.11.003
M3 - Journal article
C2 - 33296830
SN - 0959-8049
VL - 143
SP - 101
EP - 112
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -