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Randomized evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients

Dennis, Mike, Thomas, Ian F., Ariti, Cono ORCID:, Upton, Laura, Burnett, Alan K., Gilkes, Amanda, Radia, Rohini, Hemmaway, Claire, Mehta, Priyanka, Knapper, Steven ORCID:, Clark, Richard E., Copland, Mhairi, Russell, Nigel and Hills, Robert K. 2021. Randomized evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Advances 5 (24) , pp. 5621-5625. 10.1182/bloodadvances.2021005038

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Survival for older patients with acute myeloid leukemia (AML) unsuitable for intensive chemotherapy is unsatisfactory. Standard nonintensive therapies have low response rates and only extend life by a few months. Quizartinib is an oral Fms-like tyrosine kinase 3 (FLT3) inhibitor with reported activity in wild-type patients. As part of the AML LI trial, we undertook a randomized evaluation of low-dose ara-C (LDAC) with or without quizartinib in patients not fit for intensive chemotherapy. Overall, survival was not improved (202 patients), but in the 27 FLT3-ITD patients, the addition of quizartinib to LDAC improved response (P 5 .05) with complete remission/complete remission with incomplete haematological recovery for quizartinib 1 LDAC in 5/13 (38%) vs 0/14 (0%) in patients receiving LDAC alone. Overall survival (OS) in these FLT3-ITD1 patients was also significantly improved at 2 years for quizartinib 1 LDAC (hazard ratio 0.36; 95% confidence intervals: 0.16, 0.85, P 5 .04). Median OS was 13.7 months compared with 4.2 months with LDAC alone. This is the first report of an FLT3-targeted therapy added to standard nonintensive chemotherapy that has improved survival in this population. Quizartinib merits consideration for future triplet-based treatment approaches. This trial was registered at www.clinicaltrials. gov as ISRCTN #ISRCTN40571019 and EUDRACT @2011-000749-19.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Centre for Trials Research (CNTRR)
Additional Information: Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only non commercial, non derivative use with attribution
Publisher: American Society of Hematology
ISSN: 2473-9529
Date of First Compliant Deposit: 18 February 2022
Date of Acceptance: 2 August 2021
Last Modified: 12 May 2023 17:06

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