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Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results

BACKGROUND AND OBJECTIVES: Gilteritinib (XOSPATA®, Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute mye...

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Autores principales: Dogu, Mehmet Hilmi, Tekgunduz, Ali Irfan Emre, Deveci, Burak, Korkmaz, Gulten, Comert, Melda, Sevindik, Omur Gokmen, Yokus, Osman, Serin, Istemi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Università Cattolica del Sacro Cuore 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10171205/
https://www.ncbi.nlm.nih.gov/pubmed/37180209
http://dx.doi.org/10.4084/MJHID.2023.031
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author Dogu, Mehmet Hilmi
Tekgunduz, Ali Irfan Emre
Deveci, Burak
Korkmaz, Gulten
Comert, Melda
Sevindik, Omur Gokmen
Yokus, Osman
Serin, Istemi
author_facet Dogu, Mehmet Hilmi
Tekgunduz, Ali Irfan Emre
Deveci, Burak
Korkmaz, Gulten
Comert, Melda
Sevindik, Omur Gokmen
Yokus, Osman
Serin, Istemi
author_sort Dogu, Mehmet Hilmi
collection PubMed
description BACKGROUND AND OBJECTIVES: Gilteritinib (XOSPATA®, Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. OBJECTIVES: This research aimed to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program held in Turkey in April 2020 (NCT03409081). RESULTS: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. Patients with peripheral edema had a 10.47 (95% CI: 1.64–66.82) times higher risk of death than those without peripheral edema (p<0.05). CONCLUSION: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema.
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spelling pubmed-101712052023-05-11 Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results Dogu, Mehmet Hilmi Tekgunduz, Ali Irfan Emre Deveci, Burak Korkmaz, Gulten Comert, Melda Sevindik, Omur Gokmen Yokus, Osman Serin, Istemi Mediterr J Hematol Infect Dis Original Article BACKGROUND AND OBJECTIVES: Gilteritinib (XOSPATA®, Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. OBJECTIVES: This research aimed to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program held in Turkey in April 2020 (NCT03409081). RESULTS: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. Patients with peripheral edema had a 10.47 (95% CI: 1.64–66.82) times higher risk of death than those without peripheral edema (p<0.05). CONCLUSION: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema. Università Cattolica del Sacro Cuore 2023-05-01 /pmc/articles/PMC10171205/ /pubmed/37180209 http://dx.doi.org/10.4084/MJHID.2023.031 Text en https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Dogu, Mehmet Hilmi
Tekgunduz, Ali Irfan Emre
Deveci, Burak
Korkmaz, Gulten
Comert, Melda
Sevindik, Omur Gokmen
Yokus, Osman
Serin, Istemi
Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title_full Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title_fullStr Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title_full_unstemmed Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title_short Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
title_sort gilteritinib (xospata®) in turkey: early access program results
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10171205/
https://www.ncbi.nlm.nih.gov/pubmed/37180209
http://dx.doi.org/10.4084/MJHID.2023.031
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