Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe

Muhammad Ahsan Javed, Georg Beyer, Nha Le, Alessio Vinci, Helen Wong, Daniel Palmer, Robert D Morgan, Angela Lamarca, Richard A Hubner, Juan W Valle, Salma Alam, Sumsur Chowdhury, Yuk Ting Ma, Livia Archibugi, Gabriele Capurso, Patrick Maisonneuve, Albrecht Neesse, Malin Sund, Marvin Schober, Sebastian Krug

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis. Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma (MPA). Randomized clinical trials evaluating intensified chemotherapies including FOLFIRINOX and nab-paclitaxel plus gemcitabine (NAB+GEM) have shown improvement in survival. Here, we have evaluated the efficacy of intensified chemotherapy versus gemcitabine monotherapy in real-life settings across Europe.

METHODS: A retrospective multi-center study including 1056 MPA patients, between 2012 and 2015, from nine centers in UK, Germany, Italy, Hungary and the Swedish registry was performed. Follow-up was at least 12 months. Cox proportional Harzards regression was used for uni- and multivariable evaluation of prognostic factors.

RESULTS: Of 1056 MPA patients, 1030 (98.7%) were assessable for survival analysis. Gemcitabine monotherapy was the most commonly used regimen (41.3%), compared to FOLFIRINOX (n = 204, 19.3%), NAB+GEM (n = 81, 7.7%) and other gemcitabine- or 5-FU-based regimens (n = 335, 31.7%). The median overall survival (OS) was: FOLFIRINOX 9.9 months (95%CI 8.4-12.6), NAB+GEM 7.9 months (95%CI 6.2-10.0), other combinations 8.5 months (95%CI 7.7-9.3) and gemcitabine monotherapy 4.9 months (95%CI 4.4-5.6). Compared to gemcitabine monotherapy, any combination of chemotherapeutics improved the survival with no significant difference between the intensified regimens. Multivariable analysis showed an association between treatment center, male gender, inoperability at diagnosis and performance status (ECOG 1-3) with poor prognosis.

CONCLUSION: Gemcitabine monotherapy was predominantly used in 2012-2015. Intensified chemotherapy improved OS in comparison to gemcitabine monotherapy. In real-life settings, the OS rates of different treatment approaches are lower than shown in randomized phase III trials.

Original languageEnglish
Pages (from-to)97-104
Number of pages8
JournalPancreatology
Volume19
Issue number1
DOIs
Publication statusPublished - Jan 2019

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gemcitabine
Adenocarcinoma
Drug Therapy
Survival
Hungary
Survival Analysis
Fluorouracil

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Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe. / Javed, Muhammad Ahsan; Beyer, Georg; Le, Nha; Vinci, Alessio; Wong, Helen; Palmer, Daniel; Morgan, Robert D; Lamarca, Angela; Hubner, Richard A; Valle, Juan W; Alam, Salma; Chowdhury, Sumsur; Ma, Yuk Ting; Archibugi, Livia; Capurso, Gabriele; Maisonneuve, Patrick; Neesse, Albrecht; Sund, Malin; Schober, Marvin; Krug, Sebastian.

In: Pancreatology, Vol. 19, No. 1, 01.2019, p. 97-104.

Research output: Contribution to journalArticle

Javed, MA, Beyer, G, Le, N, Vinci, A, Wong, H, Palmer, D, Morgan, RD, Lamarca, A, Hubner, RA, Valle, JW, Alam, S, Chowdhury, S, Ma, YT, Archibugi, L, Capurso, G, Maisonneuve, P, Neesse, A, Sund, M, Schober, M & Krug, S 2019, 'Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe', Pancreatology, vol. 19, no. 1, pp. 97-104. https://doi.org/10.1016/j.pan.2018.10.003
Javed, Muhammad Ahsan ; Beyer, Georg ; Le, Nha ; Vinci, Alessio ; Wong, Helen ; Palmer, Daniel ; Morgan, Robert D ; Lamarca, Angela ; Hubner, Richard A ; Valle, Juan W ; Alam, Salma ; Chowdhury, Sumsur ; Ma, Yuk Ting ; Archibugi, Livia ; Capurso, Gabriele ; Maisonneuve, Patrick ; Neesse, Albrecht ; Sund, Malin ; Schober, Marvin ; Krug, Sebastian. / Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe. In: Pancreatology. 2019 ; Vol. 19, No. 1. pp. 97-104.
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title = "Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe",
abstract = "BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis. Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma (MPA). Randomized clinical trials evaluating intensified chemotherapies including FOLFIRINOX and nab-paclitaxel plus gemcitabine (NAB+GEM) have shown improvement in survival. Here, we have evaluated the efficacy of intensified chemotherapy versus gemcitabine monotherapy in real-life settings across Europe.METHODS: A retrospective multi-center study including 1056 MPA patients, between 2012 and 2015, from nine centers in UK, Germany, Italy, Hungary and the Swedish registry was performed. Follow-up was at least 12 months. Cox proportional Harzards regression was used for uni- and multivariable evaluation of prognostic factors.RESULTS: Of 1056 MPA patients, 1030 (98.7{\%}) were assessable for survival analysis. Gemcitabine monotherapy was the most commonly used regimen (41.3{\%}), compared to FOLFIRINOX (n = 204, 19.3{\%}), NAB+GEM (n = 81, 7.7{\%}) and other gemcitabine- or 5-FU-based regimens (n = 335, 31.7{\%}). The median overall survival (OS) was: FOLFIRINOX 9.9 months (95{\%}CI 8.4-12.6), NAB+GEM 7.9 months (95{\%}CI 6.2-10.0), other combinations 8.5 months (95{\%}CI 7.7-9.3) and gemcitabine monotherapy 4.9 months (95{\%}CI 4.4-5.6). Compared to gemcitabine monotherapy, any combination of chemotherapeutics improved the survival with no significant difference between the intensified regimens. Multivariable analysis showed an association between treatment center, male gender, inoperability at diagnosis and performance status (ECOG 1-3) with poor prognosis.CONCLUSION: Gemcitabine monotherapy was predominantly used in 2012-2015. Intensified chemotherapy improved OS in comparison to gemcitabine monotherapy. In real-life settings, the OS rates of different treatment approaches are lower than shown in randomized phase III trials.",
author = "Javed, {Muhammad Ahsan} and Georg Beyer and Nha Le and Alessio Vinci and Helen Wong and Daniel Palmer and Morgan, {Robert D} and Angela Lamarca and Hubner, {Richard A} and Valle, {Juan W} and Salma Alam and Sumsur Chowdhury and Ma, {Yuk Ting} and Livia Archibugi and Gabriele Capurso and Patrick Maisonneuve and Albrecht Neesse and Malin Sund and Marvin Schober and Sebastian Krug",
note = "Copyright {\circledC} 2018 IAP and EPC. All rights reserved.",
year = "2019",
month = "1",
doi = "10.1016/j.pan.2018.10.003",
language = "English",
volume = "19",
pages = "97--104",
journal = "Pancreatology",
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T1 - Impact of intensified chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical routine in Europe

AU - Javed, Muhammad Ahsan

AU - Beyer, Georg

AU - Le, Nha

AU - Vinci, Alessio

AU - Wong, Helen

AU - Palmer, Daniel

AU - Morgan, Robert D

AU - Lamarca, Angela

AU - Hubner, Richard A

AU - Valle, Juan W

AU - Alam, Salma

AU - Chowdhury, Sumsur

AU - Ma, Yuk Ting

AU - Archibugi, Livia

AU - Capurso, Gabriele

AU - Maisonneuve, Patrick

AU - Neesse, Albrecht

AU - Sund, Malin

AU - Schober, Marvin

AU - Krug, Sebastian

N1 - Copyright © 2018 IAP and EPC. All rights reserved.

PY - 2019/1

Y1 - 2019/1

N2 - BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis. Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma (MPA). Randomized clinical trials evaluating intensified chemotherapies including FOLFIRINOX and nab-paclitaxel plus gemcitabine (NAB+GEM) have shown improvement in survival. Here, we have evaluated the efficacy of intensified chemotherapy versus gemcitabine monotherapy in real-life settings across Europe.METHODS: A retrospective multi-center study including 1056 MPA patients, between 2012 and 2015, from nine centers in UK, Germany, Italy, Hungary and the Swedish registry was performed. Follow-up was at least 12 months. Cox proportional Harzards regression was used for uni- and multivariable evaluation of prognostic factors.RESULTS: Of 1056 MPA patients, 1030 (98.7%) were assessable for survival analysis. Gemcitabine monotherapy was the most commonly used regimen (41.3%), compared to FOLFIRINOX (n = 204, 19.3%), NAB+GEM (n = 81, 7.7%) and other gemcitabine- or 5-FU-based regimens (n = 335, 31.7%). The median overall survival (OS) was: FOLFIRINOX 9.9 months (95%CI 8.4-12.6), NAB+GEM 7.9 months (95%CI 6.2-10.0), other combinations 8.5 months (95%CI 7.7-9.3) and gemcitabine monotherapy 4.9 months (95%CI 4.4-5.6). Compared to gemcitabine monotherapy, any combination of chemotherapeutics improved the survival with no significant difference between the intensified regimens. Multivariable analysis showed an association between treatment center, male gender, inoperability at diagnosis and performance status (ECOG 1-3) with poor prognosis.CONCLUSION: Gemcitabine monotherapy was predominantly used in 2012-2015. Intensified chemotherapy improved OS in comparison to gemcitabine monotherapy. In real-life settings, the OS rates of different treatment approaches are lower than shown in randomized phase III trials.

AB - BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis. Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma (MPA). Randomized clinical trials evaluating intensified chemotherapies including FOLFIRINOX and nab-paclitaxel plus gemcitabine (NAB+GEM) have shown improvement in survival. Here, we have evaluated the efficacy of intensified chemotherapy versus gemcitabine monotherapy in real-life settings across Europe.METHODS: A retrospective multi-center study including 1056 MPA patients, between 2012 and 2015, from nine centers in UK, Germany, Italy, Hungary and the Swedish registry was performed. Follow-up was at least 12 months. Cox proportional Harzards regression was used for uni- and multivariable evaluation of prognostic factors.RESULTS: Of 1056 MPA patients, 1030 (98.7%) were assessable for survival analysis. Gemcitabine monotherapy was the most commonly used regimen (41.3%), compared to FOLFIRINOX (n = 204, 19.3%), NAB+GEM (n = 81, 7.7%) and other gemcitabine- or 5-FU-based regimens (n = 335, 31.7%). The median overall survival (OS) was: FOLFIRINOX 9.9 months (95%CI 8.4-12.6), NAB+GEM 7.9 months (95%CI 6.2-10.0), other combinations 8.5 months (95%CI 7.7-9.3) and gemcitabine monotherapy 4.9 months (95%CI 4.4-5.6). Compared to gemcitabine monotherapy, any combination of chemotherapeutics improved the survival with no significant difference between the intensified regimens. Multivariable analysis showed an association between treatment center, male gender, inoperability at diagnosis and performance status (ECOG 1-3) with poor prognosis.CONCLUSION: Gemcitabine monotherapy was predominantly used in 2012-2015. Intensified chemotherapy improved OS in comparison to gemcitabine monotherapy. In real-life settings, the OS rates of different treatment approaches are lower than shown in randomized phase III trials.

U2 - 10.1016/j.pan.2018.10.003

DO - 10.1016/j.pan.2018.10.003

M3 - Article

C2 - 30529068

VL - 19

SP - 97

EP - 104

JO - Pancreatology

JF - Pancreatology

SN - 1424-3903

IS - 1

ER -