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Addition of the mammalian target of rapamycin inhibitor, Everolimus, to consolidation therapy in acute myeloid leukaemia: experience from the UK NCRI AML17 trial

Burnett, Alan K, Das Gupta, Emma, Knapper, Steve, Khwaja, Asim, Sweeney, Marion, Kjeldsen, Lars, Hawkins, Timothy, Betteridge, Sophie E., Cahalin, Paul, Clark, Richard E., Hills, Robert K. and Russell, Nigel H. 2018. Addition of the mammalian target of rapamycin inhibitor, Everolimus, to consolidation therapy in acute myeloid leukaemia: experience from the UK NCRI AML17 trial. Haematologica 103 (10) , pp. 1654-1661. 10.3324/haematol.2018.189514

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Abstract

As part of the UK NCRI AML17 trial, adult patients with acute myeloid leukemia in remission could be randomized to receive the mammalian target of rapamycin inhibitor everolimus, sequentially with post-induction chemotherapy. Three hundred and thirty-nine patients were randomised (2:1) to receive everolimus or not for a maximum of 84 days between chemotherapy courses. The primary endpoint was relapse-free survival. At 5 years there was no difference in relapse-free survival [29% versus 40%; odds ratio 1.19 (0.9-1.59) P=0.2], cumulative incidence of relapse [60% versus 54%: odds ratio 1.12 (0.82-1.52): P=0.5] or overall survival [45% versus 58%: odds ratio 1.3 (0.94-1.81): P=0.11]. The independent Data Monitoring Committee advised study termination after randomization of 339 of the intended 600 patients because of excess mortality in the everolimus arm without any evidence of beneficial disease control. The delivery of the everolimus dose was variable, but there was no evidence of clinical benefit in patients with adequate dose delivery compared with no treatment. This study suggests that the addition of mammalian target of rapamycin inhibition to chemotherapy provides no benefit.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Centre for Trials Research (CNTRR)
Publisher: Ferrata Storti Foundation
ISSN: 0390-6078
Funders: Cancer Research UK
Date of First Compliant Deposit: 12 July 2018
Date of Acceptance: 4 July 2018
Last Modified: 29 May 2019 23:28
URI: http://orca-mwe.cf.ac.uk/id/eprint/113163

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