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Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response

INTRODUCTION: Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clini...

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Autores principales: Ferreira, Amanda Pifano Soares, Seguro, Fernanda Salles, Abdo, Andre Ramires Neder, Santos, Fernanda Maria, Maciel, Felipe Vieira Rodrigues, Nardinelli, Luciana, Giorgi, Ricardo Rodrigues, Ruiz, Antonio Roberto Lancha, Ferreira, Milton Pifano Soares, Rego, Eduardo Magalhaes, Rocha, Vanderson, Bendit, Israel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10261248/
https://www.ncbi.nlm.nih.gov/pubmed/37052662
http://dx.doi.org/10.1007/s00277-023-05189-3
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author Ferreira, Amanda Pifano Soares
Seguro, Fernanda Salles
Abdo, Andre Ramires Neder
Santos, Fernanda Maria
Maciel, Felipe Vieira Rodrigues
Nardinelli, Luciana
Giorgi, Ricardo Rodrigues
Ruiz, Antonio Roberto Lancha
Ferreira, Milton Pifano Soares
Rego, Eduardo Magalhaes
Rocha, Vanderson
Bendit, Israel
author_facet Ferreira, Amanda Pifano Soares
Seguro, Fernanda Salles
Abdo, Andre Ramires Neder
Santos, Fernanda Maria
Maciel, Felipe Vieira Rodrigues
Nardinelli, Luciana
Giorgi, Ricardo Rodrigues
Ruiz, Antonio Roberto Lancha
Ferreira, Milton Pifano Soares
Rego, Eduardo Magalhaes
Rocha, Vanderson
Bendit, Israel
author_sort Ferreira, Amanda Pifano Soares
collection PubMed
description INTRODUCTION: Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clinical trials. Establishing whether these results can be reproduced or if caution is needed when extrapolating data to the general population with CML is essential. OBJECTIVES: To evaluate the molecular response (MR) in patients with chronic-phase CML (CML-CP) not included in clinical studies and correlate them with the responses obtained in clinical trials. METHODS: Between January 2007 and January 2017, 227 patients newly diagnosed with CML-CP treated with IM as first-line treatment were included. This study is an observational, retrospective, and single-center study. RESULTS: At a median follow-up time of 7.3 years, 60.3% of the 227 patients who started IM were still on IM. Early molecular response (EMR) at 3 and 6 months was achieved by 74.2% and 65%, respectively. The median time to a MMR was nine months. The MR4.0 and MR4.5 were 67.2% and 51.1%, respectively. The overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) of the patients who exclusively used IM were 91%, 91%, and 85.1%, respectively. CONCLUSION: The results presented are similar to those described in prospective and randomized trials, demonstrating that the outcomes are reproducible in the real world. EMR at 3 and 6 months reflects better long-term responses, including higher rates of deeper molecular responses. Considering treatment costs, the absence of literature evidence of an impact on overall survival demonstrated by first-line second-generation tyrosine kinase inhibitors (TKIs), and the global OS of 85.8%, imatinib mesylate (IM) is still an excellent therapeutic option.
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spelling pubmed-102612482023-06-15 Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response Ferreira, Amanda Pifano Soares Seguro, Fernanda Salles Abdo, Andre Ramires Neder Santos, Fernanda Maria Maciel, Felipe Vieira Rodrigues Nardinelli, Luciana Giorgi, Ricardo Rodrigues Ruiz, Antonio Roberto Lancha Ferreira, Milton Pifano Soares Rego, Eduardo Magalhaes Rocha, Vanderson Bendit, Israel Ann Hematol Original Article INTRODUCTION: Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clinical trials. Establishing whether these results can be reproduced or if caution is needed when extrapolating data to the general population with CML is essential. OBJECTIVES: To evaluate the molecular response (MR) in patients with chronic-phase CML (CML-CP) not included in clinical studies and correlate them with the responses obtained in clinical trials. METHODS: Between January 2007 and January 2017, 227 patients newly diagnosed with CML-CP treated with IM as first-line treatment were included. This study is an observational, retrospective, and single-center study. RESULTS: At a median follow-up time of 7.3 years, 60.3% of the 227 patients who started IM were still on IM. Early molecular response (EMR) at 3 and 6 months was achieved by 74.2% and 65%, respectively. The median time to a MMR was nine months. The MR4.0 and MR4.5 were 67.2% and 51.1%, respectively. The overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) of the patients who exclusively used IM were 91%, 91%, and 85.1%, respectively. CONCLUSION: The results presented are similar to those described in prospective and randomized trials, demonstrating that the outcomes are reproducible in the real world. EMR at 3 and 6 months reflects better long-term responses, including higher rates of deeper molecular responses. Considering treatment costs, the absence of literature evidence of an impact on overall survival demonstrated by first-line second-generation tyrosine kinase inhibitors (TKIs), and the global OS of 85.8%, imatinib mesylate (IM) is still an excellent therapeutic option. Springer Berlin Heidelberg 2023-04-13 2023 /pmc/articles/PMC10261248/ /pubmed/37052662 http://dx.doi.org/10.1007/s00277-023-05189-3 Text en © The Author(s) 2023, corrected publication 2023 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 Original Article
Ferreira, Amanda Pifano Soares
Seguro, Fernanda Salles
Abdo, Andre Ramires Neder
Santos, Fernanda Maria
Maciel, Felipe Vieira Rodrigues
Nardinelli, Luciana
Giorgi, Ricardo Rodrigues
Ruiz, Antonio Roberto Lancha
Ferreira, Milton Pifano Soares
Rego, Eduardo Magalhaes
Rocha, Vanderson
Bendit, Israel
Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title_full Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title_fullStr Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title_full_unstemmed Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title_short Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response
title_sort real-world imatinib mesylate treatment in patients with chronic myeloid leukemia: the importance of molecular monitoring and the early molecular response
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10261248/
https://www.ncbi.nlm.nih.gov/pubmed/37052662
http://dx.doi.org/10.1007/s00277-023-05189-3
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