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 - Funding Information:
The authors thank the patients who participated in this trial. Medical writing support was provided by Ulrike Posch, Sciencewriting, Hatting, Austria, funded by Celgene, Celgene GmbH , Austria. Statistical analysis was performed by the company Clinical Trials Management (CTM), Vienna, Austria. Study monitoring was carried out by the company Raffeiner Studienmonitoring, Walding, Austria. Programming and service for the electronic case report form was provided by UNIDATA Geodesign GmbH, Vienna, Austria. Medical Dictionary for Regulatory Activities Terminology (MedDRA®) is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MedDRA® trademark is registered by IFPMA on behalf of ICH.
Funding Information:
The study (NCT02555813) was funded by Celgene GmbH, Austria. Celgene Europe B.V., Netherlands, is the marketing authorization holder of nab-paclitaxel in the EU.The authors thank the patients who participated in this trial. Medical writing support was provided by Ulrike Posch, Sciencewriting, Hatting, Austria, funded by Celgene, Celgene GmbH, Austria. Statistical analysis was performed by the company Clinical Trials Management (CTM), Vienna, Austria. Study monitoring was carried out by the company Raffeiner Studienmonitoring, Walding, Austria. Programming and service for the electronic case report form was provided by UNIDATA Geodesign GmbH, Vienna, Austria. Medical Dictionary for Regulatory Activities Terminology (MedDRA?) is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MedDRA? trademark is registered by IFPMA on behalf of ICH.
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 -