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

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Burnett, Alan K, Das Gupta, Emma, Knapper, Steve, Khwaja, Asim, Sweeney, Marion, Kjeldsen, Lars, Hawkins, Timothy, Betteridge, Sophie E, Cahalin, Paul, Clark, Richard E ORCID: 0000-0002-1261-3299 et al (show 2 more authors) , Hills, Robert K and Russel, Nigel H (2018) Addition of the mammalian target of rapamycin inhibitor, everolimus, to consolidation therapy in acute myeloid leukemia: experience from the UK NCRI AML17 trial. HAEMATOLOGICA, 103 (10). pp. 1654-1661.

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Official URL: http://dx.doi.org/10.3324/haematol.2018.189514

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
Uncontrolled Keywords:	UK NCRI AML Study Group, Humans, Disease-Free Survival, Survival Rate, Adolescent, Adult, Aged, Middle Aged, Female, Male, Leukemia, Myeloid, Acute, TOR Serine-Threonine Kinases, Consolidation Chemotherapy, Everolimus
Depositing User:	Symplectic Admin
Date Deposited:	02 Oct 2018 13:24
Last Modified:	19 Jan 2023 01:15
DOI:	10.3324/haematol.2018.189514
Open Access URL:	http://www.haematologica.org/content/103/10/1654.a...
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3027016