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

Loke J., Metzner M., Boucher R., Jackson A., Hopkins L., Pavlu J., Tholouli E., Drummond M., Peniket A., Bishop R., Fox S., Vyas P., Craddock C.

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.

DOI

10.1111/bjh.17823

Type

Journal article

Publication Date

2022-01-01T00:00:00+00:00

Volume

196

Pages

368 - 373

Total pages

5

Keywords

acute myeloid leukaemia, clinical trial, early phase, hypomethylating agent, refractory, relapsed, Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Azacitidine, Clinical Decision-Making, Cytogenetic Analysis, Depsipeptides, Disease Management, Disease Susceptibility, Female, Humans, Leukemia, Myeloid, Acute, Male, Molecular Targeted Therapy, Prognosis, Treatment Outcome, Young Adult

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