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Lookup NU author(s): Professor Graham Jackson
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.Lenalidomide is an effective maintenance agent for patients with myeloma, prolonging first remission and, in transplant eligible patients, improving overall survival (OS) compared to observation. The ‘Myeloma XI’ trial, for newly diagnosed patients, aimed to evaluate whether the addition of the histone deacetylase inhibitor vorinostat to the lenalidomide maintenance backbone could improve outcomes further. Patients included in this analysis were randomised to maintenance therapy with lenalidomide alone (10 mg/day on days 1–21 of each 28-day cycle), or in combination with vorinostat (300 mg/day on day 1–7 and 15–21 of each 28-day cycle) with treatment continuing until unacceptable toxicity or progressive disease. There was no significant difference in median progression-free survival between those receiving lenalidomide-vorinostat or lenalidomide alone, 34 and 40 months respectively (hazard ratio [HR] 1.18, 95% confidence interval [CI] 0.96–1.44, p = 0.109). There was also no significant difference in median OS, not estimable and 75 months respectively (HR 0.99, 95% CI 0.76–1.29, p = 0.929). Subgroup analysis demonstrated no statistically significant heterogeneity in outcomes. Combination lenalidomide-vorinostat appeared to be poorly tolerated with more dose modifications, fewer cycles of maintenance therapy delivered and higher rates of discontinuation due to toxicity than lenalidomide alone. The trial did not meet its primary end-point, there was no benefit from the addition of vorinostat to lenalidomide maintenance.
Author(s): Jenner MW, Pawlyn C, Davies FE, Menzies T, Hockaday A, Olivier C, Jones JR, Karunanithi K, Lindsay J, Kishore B, Cook G, Drayson MT, Kaiser MF, Owen RG, Gregory W, Cairns DA, Morgan G, Jackson GH
Publication type: Article
Publication status: Published
Journal: British Journal of Haematology
Year: 2023
Volume: 201
Issue: 2
Pages: 267-279
Print publication date: 05/04/2023
Online publication date: 21/12/2022
Acceptance date: 28/11/2022
Date deposited: 09/01/2023
ISSN (print): 0007-1048
ISSN (electronic): 1365-2141
Publisher: John Wiley and Sons Inc
URL: https://doi.org/10.1111/bjh.18600
DOI: 10.1111/bjh.18600
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