Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries

Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess...

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Main Authors: Katja A. Oppelt, Josephina G. Kuiper, Ylenia Ingrasciotta, Valentina Ientile, Ron M. C. Herings, Michele Tari, Gianluca Trifirò, Ulrike Haug
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-03-01
Series:Frontiers in Oncology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2021.630456/full
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spelling doaj-9d14946394834ea08de389b1eabf0e072021-03-05T06:25:34ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2021-03-011110.3389/fonc.2021.630456630456Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European CountriesKatja A. Oppelt0Josephina G. Kuiper1Ylenia Ingrasciotta2Valentina Ientile3Ron M. C. Herings4Michele Tari5Gianluca Trifirò6Ulrike Haug7Ulrike Haug8Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, GermanyPHARMO Institute for Drug Outcomes Research, Utrecht, NetherlandsDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, ItalyDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, ItalyPHARMO Institute for Drug Outcomes Research, Utrecht, NetherlandsCaserta Local Health Unit, Caserta, ItalyDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, ItalyDepartment of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, GermanyFaculty of Human and Health Sciences, University of Bremen, Bremen, GermanyIntroduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival.Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72–93%) and 2014 (63–85%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51–77%), 56% (30–80%), and 61% (58–63%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity.Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions.https://www.frontiersin.org/articles/10.3389/fonc.2021.630456/fullcolorectal cancerbiologicssurvivalEuropereal-world data
collection DOAJ
language English
format Article
sources DOAJ
author Katja A. Oppelt
Josephina G. Kuiper
Ylenia Ingrasciotta
Valentina Ientile
Ron M. C. Herings
Michele Tari
Gianluca Trifirò
Ulrike Haug
Ulrike Haug
spellingShingle Katja A. Oppelt
Josephina G. Kuiper
Ylenia Ingrasciotta
Valentina Ientile
Ron M. C. Herings
Michele Tari
Gianluca Trifirò
Ulrike Haug
Ulrike Haug
Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
Frontiers in Oncology
colorectal cancer
biologics
survival
Europe
real-world data
author_facet Katja A. Oppelt
Josephina G. Kuiper
Ylenia Ingrasciotta
Valentina Ientile
Ron M. C. Herings
Michele Tari
Gianluca Trifirò
Ulrike Haug
Ulrike Haug
author_sort Katja A. Oppelt
title Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
title_short Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
title_full Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
title_fullStr Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
title_full_unstemmed Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
title_sort characteristics and absolute survival of metastatic colorectal cancer patients treated with biologics: a real-world data analysis from three european countries
publisher Frontiers Media S.A.
series Frontiers in Oncology
issn 2234-943X
publishDate 2021-03-01
description Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival.Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72–93%) and 2014 (63–85%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51–77%), 56% (30–80%), and 61% (58–63%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity.Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions.
topic colorectal cancer
biologics
survival
Europe
real-world data
url https://www.frontiersin.org/articles/10.3389/fonc.2021.630456/full
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