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Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy
BACKGROUND: Recently, the combination of venetoclax plus a hypomethylating agent (HMA; azacitidine ordecitabine) or low‐dose cytarabine (LDAC) showed promise in Phase III trials in previously untreated AML. In France at the time of this study, venetoclax was not yet approved for AML and there were t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10067034/ https://www.ncbi.nlm.nih.gov/pubmed/36482507 http://dx.doi.org/10.1002/cam4.5459 |
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author | Laloi, Louise Billotey, Natacha Chaumard Dumas, Pierre‐Yves Paul, Franciane Villate, Alban Simand, Célestine Fornecker, Luc Puisset, Florent Bertoli, Sarah Simonet, Marion Boissard Laribi, Kamel Houyou, Dyhia Santagostino, Alberto Michel, Claire Guepin, Gabrielle Roth Guerineau, Elodie Tabrizi, Reza Hunault, Mathilde Giltat, Aurélien Kaphan, Eléonore Bulabois, Claude Cartet, Elodie Rocher, Clément Lachenal, Florence Morisset, Stéphane Récher, Christian Pigneux, Arnaud Belhabri, Amine Michallet, Mauricette Michallet, Anne‐Sophie |
author_facet | Laloi, Louise Billotey, Natacha Chaumard Dumas, Pierre‐Yves Paul, Franciane Villate, Alban Simand, Célestine Fornecker, Luc Puisset, Florent Bertoli, Sarah Simonet, Marion Boissard Laribi, Kamel Houyou, Dyhia Santagostino, Alberto Michel, Claire Guepin, Gabrielle Roth Guerineau, Elodie Tabrizi, Reza Hunault, Mathilde Giltat, Aurélien Kaphan, Eléonore Bulabois, Claude Cartet, Elodie Rocher, Clément Lachenal, Florence Morisset, Stéphane Récher, Christian Pigneux, Arnaud Belhabri, Amine Michallet, Mauricette Michallet, Anne‐Sophie |
author_sort | Laloi, Louise |
collection | PubMed |
description | BACKGROUND: Recently, the combination of venetoclax plus a hypomethylating agent (HMA; azacitidine ordecitabine) or low‐dose cytarabine (LDAC) showed promise in Phase III trials in previously untreated AML. In France at the time of this study, venetoclax was not yet approved for AML and there were therefore no formal usage recommendations. Here we report the first study in a French cohort that assessed venetoclax in combination with existing treatments for AML under real‐life conditions. METHOD: This retrospective, real‐life study collected data on venetoclax use and management in a French cohort with acute myeloid leukemia (AML) ineligible for intensive chemotherapy. RESULT: Of 118 patients, 81 were in second line/beyond (71.6% also hypomethylating agent [HMA]; 23.5% lowdose cytarabine [LDAC]) and 37 in first line. For venetoclax initiation, 57.3% underwent ramp up and 74.6% were hospitalized. Median venetoclax duration was 2.5 months (range 0.03‐16.2). With all treatment lines and regimens, most common grade 3/4 adverse events were hematologic (overall 96.4% of patients) and infections (57.1%). Dosage adjustments for drug interactions and safety varied between centers. In second‐line/beyond, median progression‐free survival was 4.0 months (95% confidence interval [CI] 2.7‐12.8) with venetoclax‐HMA and 3.4 months (1.3‐8.9) with venetoclax‐LDAC; overall response rate was 51.9% and 41.2%, respectively. Thus, we showed that venetoclax‐based treatment yields promising findings in patients with AML, but to address treatment complexity, practice harmonization is needed. |
format | Online Article Text |
id | pubmed-10067034 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-100670342023-04-03 Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy Laloi, Louise Billotey, Natacha Chaumard Dumas, Pierre‐Yves Paul, Franciane Villate, Alban Simand, Célestine Fornecker, Luc Puisset, Florent Bertoli, Sarah Simonet, Marion Boissard Laribi, Kamel Houyou, Dyhia Santagostino, Alberto Michel, Claire Guepin, Gabrielle Roth Guerineau, Elodie Tabrizi, Reza Hunault, Mathilde Giltat, Aurélien Kaphan, Eléonore Bulabois, Claude Cartet, Elodie Rocher, Clément Lachenal, Florence Morisset, Stéphane Récher, Christian Pigneux, Arnaud Belhabri, Amine Michallet, Mauricette Michallet, Anne‐Sophie Cancer Med BRIEF COMMUNICATION BACKGROUND: Recently, the combination of venetoclax plus a hypomethylating agent (HMA; azacitidine ordecitabine) or low‐dose cytarabine (LDAC) showed promise in Phase III trials in previously untreated AML. In France at the time of this study, venetoclax was not yet approved for AML and there were therefore no formal usage recommendations. Here we report the first study in a French cohort that assessed venetoclax in combination with existing treatments for AML under real‐life conditions. METHOD: This retrospective, real‐life study collected data on venetoclax use and management in a French cohort with acute myeloid leukemia (AML) ineligible for intensive chemotherapy. RESULT: Of 118 patients, 81 were in second line/beyond (71.6% also hypomethylating agent [HMA]; 23.5% lowdose cytarabine [LDAC]) and 37 in first line. For venetoclax initiation, 57.3% underwent ramp up and 74.6% were hospitalized. Median venetoclax duration was 2.5 months (range 0.03‐16.2). With all treatment lines and regimens, most common grade 3/4 adverse events were hematologic (overall 96.4% of patients) and infections (57.1%). Dosage adjustments for drug interactions and safety varied between centers. In second‐line/beyond, median progression‐free survival was 4.0 months (95% confidence interval [CI] 2.7‐12.8) with venetoclax‐HMA and 3.4 months (1.3‐8.9) with venetoclax‐LDAC; overall response rate was 51.9% and 41.2%, respectively. Thus, we showed that venetoclax‐based treatment yields promising findings in patients with AML, but to address treatment complexity, practice harmonization is needed. John Wiley and Sons Inc. 2022-12-08 /pmc/articles/PMC10067034/ /pubmed/36482507 http://dx.doi.org/10.1002/cam4.5459 Text en © 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | BRIEF COMMUNICATION Laloi, Louise Billotey, Natacha Chaumard Dumas, Pierre‐Yves Paul, Franciane Villate, Alban Simand, Célestine Fornecker, Luc Puisset, Florent Bertoli, Sarah Simonet, Marion Boissard Laribi, Kamel Houyou, Dyhia Santagostino, Alberto Michel, Claire Guepin, Gabrielle Roth Guerineau, Elodie Tabrizi, Reza Hunault, Mathilde Giltat, Aurélien Kaphan, Eléonore Bulabois, Claude Cartet, Elodie Rocher, Clément Lachenal, Florence Morisset, Stéphane Récher, Christian Pigneux, Arnaud Belhabri, Amine Michallet, Mauricette Michallet, Anne‐Sophie Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title | Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title_full | Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title_fullStr | Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title_full_unstemmed | Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title_short | Retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy |
title_sort | retrospective, real‐life study of venetoclax plus azacitidine or low‐dose cytarabine in french patients with acute myeloid leukemia ineligible for intensive chemotherapy |
topic | BRIEF COMMUNICATION |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10067034/ https://www.ncbi.nlm.nih.gov/pubmed/36482507 http://dx.doi.org/10.1002/cam4.5459 |
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