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Repisalud author García-Gutiérrez, Valentín author Gómez-Casares, María T author Puerta, José M author Alonso-Domínguez, Juan M author Osorio, Santiago author Hernández-Boluda, Juan C author Collado, Rosa author Ramírez, María J author Ibáñez, Fátima author Martín, María L author Rodríguez-Gambarte, Juan D author Martínez-Laperche, Carolina author Gómez, Montse author Fiallo, Dolly V author Redondo, Sara author Rodríguez, Alicia author Ruiz-Nuño, Concepción author Steegmann, Juan L author Jiménez-Velasco, Antonio authoraffiliation [García-Gutiérrez,V; Rodríguez-Gambarte,JD] Hematology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Gómez-Casares,MT; Fiallo,DV] Hematology Department, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain. [Puerta,JM] Unidad de Gestión Clínica Hematología y Hemoterapia, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Alonso-Domínguez,JM] Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain. [Osorio,S; Martínez-Laperche,C; Redondo,S] Hematology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain. [Hernández-Boluda,JC; Gómez,M] Hematology Department, Hospital Clínico, Valencia, Spain. [Collado,R] Genetic Laboratory, Hematology Department, Consorcio Hospital General Universitario, Valencia, Spain. [Ramírez,MJ] Hematology Department, Hospital de Jerez de la Frontera, Cádiz, Spain. [Ibáñez,F] Hematology Department, Hospital San Pedro de Alcántara, Cáceres, Spain. [Martín,ML; Rodríguez,A] Hematology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Ruiz-Nuño,C; Jiménez-Velasco,A] Hematology Department, Hospital Regional Universitario de Málaga, IBIMA, Málaga, Spain. [Steegmann,JL] Hematology Department & IIS-IP, Hospital Universitario de la Princesa, Madrid, Spain. 2024-01-23T20:12:32Z 2024-01-23T20:12:32Z 2017-03-09 http://hdl.handle.net/10668/2631 http://hdl.handle.net/20.500.12105/17295 28278193 10.1371/journal.pone.0173532 1932-6203 PloS One 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. eng Humanos Leucemia mielógena crónica BCR-ABL positiva Leucemia mieloide de fase crónica Reacción en cadena de la polimerasa Probabilidad Estándares de referencia 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 research article