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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Università Cattolica del Sacro Cuore
2023
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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. |
format | Online Article Text |
id | pubmed-10171205 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Università Cattolica del Sacro Cuore |
record_format | MEDLINE/PubMed |
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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