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FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL

The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. Fir...

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Autores principales: Dartigeas, Caroline, Slama, Borhane, Doyle, Margaret, Tapprich, Christoph, Albrecht, Claire, Dupuis, Sandrine, Wapenaar, Robert, Schmidt-Hieber, Charlotte, Leblond, Veronique
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9492818/
https://www.ncbi.nlm.nih.gov/pubmed/36103041
http://dx.doi.org/10.1007/s44228-022-00015-5
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author Dartigeas, Caroline
Slama, Borhane
Doyle, Margaret
Tapprich, Christoph
Albrecht, Claire
Dupuis, Sandrine
Wapenaar, Robert
Schmidt-Hieber, Charlotte
Leblond, Veronique
author_facet Dartigeas, Caroline
Slama, Borhane
Doyle, Margaret
Tapprich, Christoph
Albrecht, Claire
Dupuis, Sandrine
Wapenaar, Robert
Schmidt-Hieber, Charlotte
Leblond, Veronique
author_sort Dartigeas, Caroline
collection PubMed
description The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. First-line CLL/SLL patients had del17p and/or TP53 mutations. In this interim analysis, the median follow-up time for patients with CLL/SLL and MCL was 17.7 and 15.1 months, respectively. In the effectiveness populations for CLL/SLL (n = 200) and MCL (n = 59), the median progression-free survival was not estimable and 12.4 months, respectively; the 12-month overall survival rates were 88.5% and 65.8%, respectively. Treatment-emergent adverse events of interest for patients with CLL/SLL (n = 202) and MCL (n = 59) included: infections and infestations (53.5% and 32.2%), major bleeding (5.0% and 5.1%), and atrial fibrillation (5.9% and 8.5%); 135 (66.8%) and 20 (33.9%) patients were continuing treatment at the time of data cutoff. Future analyses will report on longer-term follow-up (Trial registration: ClinicalTrials.gov, NCT03425591. Registered 1 February 2018—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03425591). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s44228-022-00015-5.
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spelling pubmed-94928182022-10-05 FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL Dartigeas, Caroline Slama, Borhane Doyle, Margaret Tapprich, Christoph Albrecht, Claire Dupuis, Sandrine Wapenaar, Robert Schmidt-Hieber, Charlotte Leblond, Veronique Clin Hematol Int Research Article The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in France. Patients were mostly relapsed/refractory with high-risk features. First-line CLL/SLL patients had del17p and/or TP53 mutations. In this interim analysis, the median follow-up time for patients with CLL/SLL and MCL was 17.7 and 15.1 months, respectively. In the effectiveness populations for CLL/SLL (n = 200) and MCL (n = 59), the median progression-free survival was not estimable and 12.4 months, respectively; the 12-month overall survival rates were 88.5% and 65.8%, respectively. Treatment-emergent adverse events of interest for patients with CLL/SLL (n = 202) and MCL (n = 59) included: infections and infestations (53.5% and 32.2%), major bleeding (5.0% and 5.1%), and atrial fibrillation (5.9% and 8.5%); 135 (66.8%) and 20 (33.9%) patients were continuing treatment at the time of data cutoff. Future analyses will report on longer-term follow-up (Trial registration: ClinicalTrials.gov, NCT03425591. Registered 1 February 2018—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03425591). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s44228-022-00015-5. Springer Netherlands 2022-09-14 /pmc/articles/PMC9492818/ /pubmed/36103041 http://dx.doi.org/10.1007/s44228-022-00015-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Research Article
Dartigeas, Caroline
Slama, Borhane
Doyle, Margaret
Tapprich, Christoph
Albrecht, Claire
Dupuis, Sandrine
Wapenaar, Robert
Schmidt-Hieber, Charlotte
Leblond, Veronique
FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title_full FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title_fullStr FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title_full_unstemmed FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title_short FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL
title_sort fire study: real-world effectiveness and safety of ibrutinib in clinical practice in patients with cll and mcl
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9492818/
https://www.ncbi.nlm.nih.gov/pubmed/36103041
http://dx.doi.org/10.1007/s44228-022-00015-5
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