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Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients

Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the...

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Autores principales: Berton, Dominique, Floquet, Anne, Lescaut, Willy, Baron, Gabriel, Kaminsky, Marie-Christine, Toussaint, Philippe, Largillier, Rémy, Savoye, Aude-Marie, Alexandre, Jérôme, Delbaldo, Catherine, Malaurie, Emmanuelle, Barletta, Hugues, Bosacki, Claire, Garnier-Tixidre, Claire, Follana, Philippe, Laharie-Mineur, Hortense, Briac Levache, Charles, Valenza, Bruno, Dechartres, Agnès, Mollon-Grange, Delphine, Selle, Frédéric
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8489574/
https://www.ncbi.nlm.nih.gov/pubmed/34616296
http://dx.doi.org/10.3389/fphar.2021.711813
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author Berton, Dominique
Floquet, Anne
Lescaut, Willy
Baron, Gabriel
Kaminsky, Marie-Christine
Toussaint, Philippe
Largillier, Rémy
Savoye, Aude-Marie
Alexandre, Jérôme
Delbaldo, Catherine
Malaurie, Emmanuelle
Barletta, Hugues
Bosacki, Claire
Garnier-Tixidre, Claire
Follana, Philippe
Laharie-Mineur, Hortense
Briac Levache, Charles
Valenza, Bruno
Dechartres, Agnès
Mollon-Grange, Delphine
Selle, Frédéric
author_facet Berton, Dominique
Floquet, Anne
Lescaut, Willy
Baron, Gabriel
Kaminsky, Marie-Christine
Toussaint, Philippe
Largillier, Rémy
Savoye, Aude-Marie
Alexandre, Jérôme
Delbaldo, Catherine
Malaurie, Emmanuelle
Barletta, Hugues
Bosacki, Claire
Garnier-Tixidre, Claire
Follana, Philippe
Laharie-Mineur, Hortense
Briac Levache, Charles
Valenza, Bruno
Dechartres, Agnès
Mollon-Grange, Delphine
Selle, Frédéric
author_sort Berton, Dominique
collection PubMed
description Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real-world setting. Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab-containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front-line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co-medications, follow-up and monitoring, progression-free survival, and treatment at recurrence. In this non-interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease. Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment-related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression-free survival was 17.4 (95% CI, 16.4–19.1) months. The 3-year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin. Discussion: Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule. Clinical Trial Registration:ClinicalTrials.gov, Identifier NCT01832415.
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spelling pubmed-84895742021-10-05 Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients Berton, Dominique Floquet, Anne Lescaut, Willy Baron, Gabriel Kaminsky, Marie-Christine Toussaint, Philippe Largillier, Rémy Savoye, Aude-Marie Alexandre, Jérôme Delbaldo, Catherine Malaurie, Emmanuelle Barletta, Hugues Bosacki, Claire Garnier-Tixidre, Claire Follana, Philippe Laharie-Mineur, Hortense Briac Levache, Charles Valenza, Bruno Dechartres, Agnès Mollon-Grange, Delphine Selle, Frédéric Front Pharmacol Pharmacology Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real-world setting. Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab-containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front-line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co-medications, follow-up and monitoring, progression-free survival, and treatment at recurrence. In this non-interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease. Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment-related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression-free survival was 17.4 (95% CI, 16.4–19.1) months. The 3-year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin. Discussion: Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule. Clinical Trial Registration:ClinicalTrials.gov, Identifier NCT01832415. Frontiers Media S.A. 2021-09-20 /pmc/articles/PMC8489574/ /pubmed/34616296 http://dx.doi.org/10.3389/fphar.2021.711813 Text en Copyright © 2021 Berton, Floquet, Lescaut, Baron, Kaminsky, Toussaint, Largillier, Savoye, Alexandre, Delbaldo, Malaurie, Barletta, Bosacki, Garnier-Tixidre, Follana, Laharie-Mineur, Briac Levache, Valenza, Dechartres, Mollon-Grange and Selle. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Berton, Dominique
Floquet, Anne
Lescaut, Willy
Baron, Gabriel
Kaminsky, Marie-Christine
Toussaint, Philippe
Largillier, Rémy
Savoye, Aude-Marie
Alexandre, Jérôme
Delbaldo, Catherine
Malaurie, Emmanuelle
Barletta, Hugues
Bosacki, Claire
Garnier-Tixidre, Claire
Follana, Philippe
Laharie-Mineur, Hortense
Briac Levache, Charles
Valenza, Bruno
Dechartres, Agnès
Mollon-Grange, Delphine
Selle, Frédéric
Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title_full Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title_fullStr Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title_full_unstemmed Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title_short Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients
title_sort real-world experience of bevacizumab as first-line treatment for ovarian cancer: the gineco encourage cohort of 468 french patients
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8489574/
https://www.ncbi.nlm.nih.gov/pubmed/34616296
http://dx.doi.org/10.3389/fphar.2021.711813
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