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A BCR-ABL1 cutoff of 1.5% at 3 months, determined by the GeneXpert system, predicts an optimal response in patients with chronic myeloid leukemia

García-Gutiérrez, Valentín ; Gómez-Casares, María T ; Puerta, José M ; Alonso-Domínguez, Juan M ; Osorio, Santiago ; Hernández-Boluda, Juan C ; Collado, Rosa ; Ramírez, María J ; Ibáñez, Fátima ; Martín, María L ; Rodríguez-Gambarte, Juan D ; Martínez-Laperche, Carolina ; Gómez, Montse ; Fiallo, Dolly V ; Redondo, Sara ; Rodríguez, Alicia ; Ruiz-Nuño, Concepción ; Steegmann, Juan L ; Jiménez-Velasco, Antonio Speletas, Matthaios

PloS one, 2017-03, Vol.12 (3), p.e0173532-e0173532 [Periódico revisado por pares]

United States: Public Library of Science

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A BCR-ABL1 cutoff of 1.5% at 3 months, determined by the GeneXpert system, predicts an optimal response in patients with chronic myeloid leukemia
Autor: García-Gutiérrez, Valentín ; Gómez-Casares, María T ; Puerta, José M ; Alonso-Domínguez, Juan M ; Osorio, Santiago ; Hernández-Boluda, Juan C ; Collado, Rosa ; Ramírez, María J ; Ibáñez, Fátima ; Martín, María L ; Rodríguez-Gambarte, Juan D ; Martínez-Laperche, Carolina ; Gómez, Montse ; Fiallo, Dolly V ; Redondo, Sara ; Rodríguez, Alicia ; Ruiz-Nuño, Concepción ; Steegmann, Juan L ; Jiménez-Velasco, Antonio
Speletas, Matthaios
Assuntos: Adult ; Aged ; Automation ; BCR protein ; Biology and Life Sciences ; Biomarkers, Tumor - genetics ; Care and treatment ; Chromosomes ; Chronic myeloid leukemia ; Cohort Studies ; Cytogenetics ; Female ; Follow-Up Studies ; Fusion Proteins, bcr-abl - genetics ; Gene Rearrangement ; Hematology ; Humans ; Identification methods ; Laboratories ; Leukemia ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - diagnosis ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - genetics ; Male ; Medicine and Health Sciences ; Middle Aged ; Myeloid leukemia ; Neoplasm Staging ; Patients ; Polymerase chain reaction ; Polymerase Chain Reaction - methods ; Prognosis ; Protein Kinase Inhibitors - therapeutic use ; Research and Analysis Methods ; Standardization
É parte de: PloS one, 2017-03, Vol.12 (3), p.e0173532-e0173532
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
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Membership of the Spanish Group of Chronic Myeloid Leukemia (GELMC) is provided in the Acknowledgments.
Conceptualization: VGG MTGC JMP JLS AJV.Data curation: VGG JMP AJV.Formal analysis: VGG JMAD AJV.Funding acquisition: AJV.Investigation: VGG MTGC JLS AJV.Methodology: VGG MTGC JMAD AJV.Project administration: VGG JMP JLS AJV.Resources: VGG MTGC JMP JMAD SO JCHB RC MJR FI MLM JDRG CML MG DVF SR AR CRN JLS AJV.Software: VGG JMAD.Supervision: VGG MTGC JLS AJV.Validation: VGG JMP AJV.Visualization: VGG MTGC JLS AJV.Writing – original draft: VGG MTGC JLS AJV.Writing – review & editing: VGG MTGC JMP JMAD SO JCHB RC MJR FI MLM JDRG CML MG DVF SR AR CRN JLS AJV.
Competing Interests: Dr. García-Gutierrez has received a consultancy fee and research funding and has served as a member on the board of directors or advisory committees for Novartis, Bristol-Myers Squibb, Pfizer and Ariad. Dr. Steegmann has received a consultancy fee and honoraria and has received research funding and participated on the Speaker’s bureau for Novartis, Bristol-Myers Squibb, Pfizer and Ariad. The remaining authors have no conflicts of interest to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Descrição: In chronic myeloid leukemia (CML) patients, 3-month BCR-ABL1 levels have consistently been correlated with further outcomes. Monitoring molecular responses in CML using the GeneXpert (Cepheid) platform has shown an optimal correlation with standardized RQ-PCR (IS) when measuring BCR-ABL1 levels lower than 10%, as it is not accurate for values over 10%. The aim of the present study was to determine the predictive molecular value at three months on different outcome variables using the Xpert BCR-ABL1 MonitorTM assay (Xpert BCR-ABL1). We monitored 125 newly diagnosed consecutive CML patients in the chronic phase (CML-CP) using an automated method: Xpert BCR-ABL1. Only 5% of patients did not achieve an optimal response at 3 months, and the 10% BCR-ABL1 cutoff defined by RQ-PCR (IS) methods was unable to identify significant differences in the probabilities of achieving a complete cytogenetic response (CCyR) (50% vs. 87%, p = 0.1) or a major molecular response (MMR) (60% vs. 80%, p = 0.29) by 12 months. In contrast, a cutoff of 1.5% more accurately identified differences in the probabilities of achieving CCyR (98% vs. 54%, p<0.001) and MMR (88% vs. 56%, p<0.001) by 12 months, as well as probabilities of treatment changes (p = 0.005). Therefore, when using the Xpert BCR-ABL1 assay, a cutoff of 1.5% at 3 months could with high probability identify patients able to achieve an optimal response at 12 months.
Editor: United States: Public Library of Science
Idioma: Inglês

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A BCR-ABL1 cutoff of 1.5% at 3 months, determined by the GeneXpert system, predicts an optimal response in patients with chronic myeloid leukemia

United States: Public Library of Science

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