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    Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
    (Mattioli 1885, 2023) Dogu, Mehmet Hilmi; Tekgunduz, Ali Irfan Emre; Deveci, Burak; Korkmaz, Gulten; Comert, Melda; Sevindik, Omur Gokmen; Yokus, Osman
    Background And Objectives: Gilteritinib (XOSPATA (R), 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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    A Real-Life Turkish Experience of Ruxolitinib in Polycythemia Vera
    (Galenos Publ House, 2023) Serin, Istemi; Dogu, Mehmet Hilmi; Ekinci, Omer; Cagliyan, Gulsum Akgun; Basturk, Abdulkadir; Aras, Merih Reis; Demircioglu, Sinan
    Introduction: Ruxolitinib is a small -molecule inhibitor of the JAK1/2 pathway. This study aimed to reveal the results and side-effect profile of the use of ruxolitinib as a treatment option in polycythemia vera (PV). Methods: A total of 34 patients with PV from 18 different centers were included in the study. The evaluation of the response under treatment with ruxolitinib was determined as a reduction in spleen volume (splenomegaly size: >= 35%) by imaging and control of hematocrit levels (<= 45%) compared to baseline. Results: While the number of patients in which a reduction in spleen volume and hematocrit control was achieved was 19 (55.9%) at 3 months of treatment, it was 21 (61.8%) at 6 months. Additionally, while the number of side effects was negatively correlated with the reduction in spleen volume (Spearman's rho: -0.365, p=0.034), a decrease in the hematocrit level was positively correlated (Spearman's rho: 0.75, p=0.029). Those without a reduction in spleen volume experienced more constipation (chi-square: 5.988, Fisher's exact test: p=0.033). Conclusion: This study shed light on the use of ruxolitinib in PV and the importance of splenomegaly on studies planned with larger patient groups.