Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high‐risk acute myeloid leukaemia ineligible for intensive chemotherapy

Summary Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD)...

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Bibliographic Details
Published in:British journal of haematology 2022-01, Vol.196 (2), p.368-373
Main Authors: Loke, Justin, Metzner, Marlen, Boucher, Rebecca, Jackson, Aimee, Hopkins, Louise, Pavlu, Jiri, Tholouli, Eleni, Drummond, Mark, Peniket, Andy, Bishop, Rebecca, Fox, Sonia, Vyas, Paresh, Craddock, Charles
Format: Article
Language:English
Subjects:
acute myeloid leukaemia
Acute myeloid leukemia
Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Azacitidine - administration & dosage
Chemotherapy
Clinical Decision-Making
clinical trial
Cytogenetic Analysis
Depsipeptides - administration & dosage
Disease Management
Disease Susceptibility
early phase
Female
Hematology
Histone deacetylase
Humans
hypomethylating agent
Leukemia
Leukemia, Myeloid, Acute - diagnosis
Leukemia, Myeloid, Acute - drug therapy
Leukemia, Myeloid, Acute - etiology
Male
Molecular Targeted Therapy
Prognosis
refractory
relapsed
Remission
Treatment Outcome
Young Adult
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Summary:Summary Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next‐generation sequencing studies demonstrated important insights into therapy resistance.
ISSN:0007-1048
1365-2141
1365-2141
DOI:10.1111/bjh.17823