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Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia

Acute myeloid leukemia (AML) patients aged ≥60 years tolerate standard induction chemotherapy poorly. Therapy with azacitidine at a dose of 75 mg/m(2)/day for 7 days appears to be better tolerated, and is approved by the Food and Drug Administration (FDA) for the treatment of elderly AML patients wi...

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Autores principales: Sadashiv, Santhosh K, Hilton, Christie, Khan, Cyrus, Rossetti, James M, Benjamin, Heather L, Fazal, Salman, Sahovic, Entezam, Shadduck, Richard K, Lister, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4298384/
https://www.ncbi.nlm.nih.gov/pubmed/25132519
http://dx.doi.org/10.1002/cam4.321
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author Sadashiv, Santhosh K
Hilton, Christie
Khan, Cyrus
Rossetti, James M
Benjamin, Heather L
Fazal, Salman
Sahovic, Entezam
Shadduck, Richard K
Lister, John
author_facet Sadashiv, Santhosh K
Hilton, Christie
Khan, Cyrus
Rossetti, James M
Benjamin, Heather L
Fazal, Salman
Sahovic, Entezam
Shadduck, Richard K
Lister, John
author_sort Sadashiv, Santhosh K
collection PubMed
description Acute myeloid leukemia (AML) patients aged ≥60 years tolerate standard induction chemotherapy poorly. Therapy with azacitidine at a dose of 75 mg/m(2)/day for 7 days appears to be better tolerated, and is approved by the Food and Drug Administration (FDA) for the treatment of elderly AML patients with bone marrow (BM) blast counts of 20–30%. Here, we report the results of a prospective, phase 2, open-label study that evaluated the tolerability and efficacy of a 5-day regimen of single-agent subcutaneous azacitidine 100 mg/m(2)/day administered every 28 days in 15 elderly patients with newly diagnosed AML, 14 of whom had BM blast counts >30%. The overall response rate was 47%. Complete remission, partial remission, and hematologic improvement were achieved by 20, 13, and 13% of patients, respectively. Median overall survival was 355 days for the entire cohort, and 532 days for responders. Median time to best response was 95 days, and median treatment duration was 198 days (range = 13–724 days). Grade 3–4 hematologic toxicities comprised predominantly febrile neutropenia (40%) and thrombocytopenia (20%). Febrile neutropenia was the most common cause of hospitalization. Nonhematologic toxicities, consisting of injection-site skin reactions and fatigue (Grades 1–2), occurred in 73% (n = 11) of patients. No treatment-related deaths occurred during the study. The dose and schedule of therapy remained constant in all but four patients. The findings of this study suggest that administration of subcutaneous azacitidine 100 mg/m(2)/day for 5 days every 28 days is a feasible, well-tolerated, and effective alternative to standard induction chemotherapy in elderly patients with AML.
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spelling pubmed-42983842015-01-22 Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia Sadashiv, Santhosh K Hilton, Christie Khan, Cyrus Rossetti, James M Benjamin, Heather L Fazal, Salman Sahovic, Entezam Shadduck, Richard K Lister, John Cancer Med Clinical Cancer Research Acute myeloid leukemia (AML) patients aged ≥60 years tolerate standard induction chemotherapy poorly. Therapy with azacitidine at a dose of 75 mg/m(2)/day for 7 days appears to be better tolerated, and is approved by the Food and Drug Administration (FDA) for the treatment of elderly AML patients with bone marrow (BM) blast counts of 20–30%. Here, we report the results of a prospective, phase 2, open-label study that evaluated the tolerability and efficacy of a 5-day regimen of single-agent subcutaneous azacitidine 100 mg/m(2)/day administered every 28 days in 15 elderly patients with newly diagnosed AML, 14 of whom had BM blast counts >30%. The overall response rate was 47%. Complete remission, partial remission, and hematologic improvement were achieved by 20, 13, and 13% of patients, respectively. Median overall survival was 355 days for the entire cohort, and 532 days for responders. Median time to best response was 95 days, and median treatment duration was 198 days (range = 13–724 days). Grade 3–4 hematologic toxicities comprised predominantly febrile neutropenia (40%) and thrombocytopenia (20%). Febrile neutropenia was the most common cause of hospitalization. Nonhematologic toxicities, consisting of injection-site skin reactions and fatigue (Grades 1–2), occurred in 73% (n = 11) of patients. No treatment-related deaths occurred during the study. The dose and schedule of therapy remained constant in all but four patients. The findings of this study suggest that administration of subcutaneous azacitidine 100 mg/m(2)/day for 5 days every 28 days is a feasible, well-tolerated, and effective alternative to standard induction chemotherapy in elderly patients with AML. Blackwell Publishing Ltd 2014-12 2014-08-16 /pmc/articles/PMC4298384/ /pubmed/25132519 http://dx.doi.org/10.1002/cam4.321 Text en © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by/3.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Cancer Research
Sadashiv, Santhosh K
Hilton, Christie
Khan, Cyrus
Rossetti, James M
Benjamin, Heather L
Fazal, Salman
Sahovic, Entezam
Shadduck, Richard K
Lister, John
Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title_full Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title_fullStr Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title_full_unstemmed Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title_short Efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
title_sort efficacy and tolerability of treatment with azacitidine for 5 days in elderly patients with acute myeloid leukemia
topic Clinical Cancer Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4298384/
https://www.ncbi.nlm.nih.gov/pubmed/25132519
http://dx.doi.org/10.1002/cam4.321
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