PB1945 EXPERIENCE OF THE ANDALUSIAN CHRONIC MYELOID LEUKEMIA GROUP (GALMC) IN THE DISCONTINUATION OF THE TYROSINE KINASE INHIBITOR TREATMENT OUTSIDE OF CLINICAL TRIALS

Background: Currently one of the most burning issues regarding the specific treatment of Chronic Myeloid Leukemia (CML) with Interleukin‐2‐inducible T‐cell kinases (ITKs) is whether in a percentage of patients who meet specific requirements treatment interruption could be attempted and maintain mole...

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Published in:	HemaSphere Vol. 3; no. S1; pp. 884 - n/a
Main Authors:	Alarcón‐Payer, C., Puerta Puerta, J.M., Jiménez Morales, A., Ramírez Sánchez, M.J., Montero Cuadrado, M.I., Mata Vázquez, M.I., Ferrer Chaves, C., Anguita Arance, M., Vera Goñi, J.A., García Pérez, M.J., Mellado Gázquez, Á., Moatassim de la Torre, Y., Hermosín Ramos, L., Jurado Chacón, M., López Garrido, P.
Format:	Journal Article
Language:	English
Published:	01-06-2019
Online Access:	Get full text
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Summary:	Background: Currently one of the most burning issues regarding the specific treatment of Chronic Myeloid Leukemia (CML) with Interleukin‐2‐inducible T‐cell kinases (ITKs) is whether in a percentage of patients who meet specific requirements treatment interruption could be attempted and maintain molecular relapse‐free survival without treatment restarting with the consequent reduction of side effects related to medication and the progressive increase in the quality of life of patients. Aims: To analyse molecular relapse‐free survival after suspension of Imatinib, Nilotinib or Dasatinib, which achieved and maintained a Molecular Response ≥ 4.5 log for at least 36 months. Methods: Multicenter prospective observational post‐authorization follow‐up study of patients with Chronic Phase Ph+ CML (CP‐CML). Inclusion criteria: minimum ITK treatment time of 5 years, no resistance to a previous ITK, no accelerated phase diagnosis or blast crisis and those who have achieved and maintained the Molecular Response ≥ 4.5 log for at least 36 months prior to treatment interruption. These patients were candidates for discontinuation of ITKs. Molecular monitoring of bcr‐abl oncogene levels was performed using the Real‐Time Reverse Polymerase Chain (RT‐PCR) technique with the GeneXpert automated system with a sensitivity of 5 log. Results: 71 patients with CP‐CML were discontinued. 51 discontinued Imatinib treatment, 7 discontinued dasatinib treatment and 12 discontinued Nilotinib treatment. The preliminary rates of Molecular Relapse Free Survival (MRFS) and Treatment Free Remission (TFR) are consistent with those obtained in the different clinical trials, and no progression to advanced stages of the disease has been reported. With a median follow‐up of 9 months, 78% remain without specific treatment with ITK for not having lost the major molecular response, (BCR ABL ≤ 0.1%) cut‐off point established in the study as a criterion for reintroduction of ITK treatment. Relapse occurred before 6 months of discontinued treatment with a median of 3 months. Summary/Conclusion: Discontinuation of treatment with ITKs translates into clinical benefit for patients with CP‐CML, as it would reduce treatment‐related side effects and improve quality of life.
ISSN:	2572-9241 2572-9241
DOI:	10.1097/01.HS9.0000566276.44891.74