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

doi:10.1016/j.ejca.2020.11.003

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

Research output: Journal article (peer-reviewed) › Journal article

21 Citations (Scopus)

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.

Original language	English
Pages (from-to)	101-112
Number of pages	12
Journal	European Journal of Cancer
Volume	143
DOIs	https://doi.org/10.1016/j.ejca.2020.11.003
Publication status	Published - Jan 2021

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Aged
Albumins/pharmacology
Antineoplastic Combined Chemotherapy Protocols/pharmacology
Deoxycytidine/analogs & derivatives
Female
Humans
Male
Paclitaxel/pharmacology
Pancreatic Neoplasms/drug therapy

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10.1016/j.ejca.2020.11.003

Cite this

Prager, G. W., Oehler, L., Gerger, A., Mlineritsch, B., Andel, J., Petzer, A., Wilthoner, K., Sliwa, T., Pichler, P., Winder, T., Heibl, S., Gruenberger, B., Laengle, F., Hubmann, E., Korger, M., Pecherstorfer, M., Djanani, A., Neumann, H.-J., Philipp-Abbrederis, K., ... Eisterer, W. (2021). Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study. European Journal of Cancer, 143, 101-112. https://doi.org/10.1016/j.ejca.2020.11.003

@article{b5f1bccfd93d4c9d9997a553a781c852,

title = "Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study",

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 = "Aged, Albumins/pharmacology, Antineoplastic Combined Chemotherapy Protocols/pharmacology, Deoxycytidine/analogs \& derivatives, Female, Humans, Male, Paclitaxel/pharmacology, Pancreatic Neoplasms/drug therapy",

author = "Prager, \{Gerald W\} and Leopold Oehler and Armin Gerger and Brigitte Mlineritsch and Johannes Andel and Andreas Petzer and Klaus Wilthoner and Thamer Sliwa and Petra Pichler and Thomas Winder and Sonja Heibl and Birgit Gruenberger and Friedrich Laengle and Eva Hubmann and Markus Korger and Martin Pecherstorfer and Angela Djanani and Hans-Joerg Neumann and Kathrin Philipp-Abbrederis and Ewald W{\"o}ll and Robert Trondl and Catharina Arnold-Schrauf and Wolfgang Eisterer",

note = "Publisher Copyright: {\textcopyright} 2020 The Authors",

year = "2021",

month = jan,

doi = "10.1016/j.ejca.2020.11.003",

language = "English",

volume = "143",

pages = "101--112",

journal = "European Journal of Cancer",

issn = "0959-8049",

publisher = "Elsevier Ltd.",

}

Prager, GW, Oehler, L, Gerger, A, Mlineritsch, B, Andel, J, Petzer, A, Wilthoner, K, Sliwa, T, Pichler, P, Winder, T, Heibl, S, Gruenberger, B, Laengle, F, Hubmann, E, Korger, M, Pecherstorfer, M, Djanani, A, Neumann, H-J, Philipp-Abbrederis, K, Wöll, E, Trondl, R, Arnold-Schrauf, C & Eisterer, W 2021, 'Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study', European Journal of Cancer, vol. 143, pp. 101-112. https://doi.org/10.1016/j.ejca.2020.11.003

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study. / Prager, Gerald W; Oehler, Leopold; Gerger, Armin et al.
In: European Journal of Cancer, Vol. 143, 01.2021, p. 101-112.

Research output: Journal article (peer-reviewed) › Journal article

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

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 - https://www.scopus.com/pages/publications/85097401696

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 -

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

Abstract

UN SDGs

Keywords

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