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Fractionated vs single-dose gemtuzumab ozogamicin with determinants of benefit in older patients with AML: the UK NCRI AML18 trial

•Fractionated compared with single-dose gemtuzumab increased response depth across most AML molecular groups without increasing toxicity.•Older patients with AML receiving fractionated gemtuzumab had improved survival when induction was consolidated by allograft. [Display omitted] Addition of gemtuz...

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Published in:Blood 2023-11, Vol.142 (20), p.1697-1707
Main Authors: Freeman, Sylvie D., Thomas, Abin, Thomas, Ian, Hills, Robert K., Vyas, Paresh, Gilkes, Amanda, Metzner, Marlen, Jakobsen, Niels Asger, Kennedy, Alison, Moore, Rachel, Almuina, Nuria Marquez, Burns, Sarah, King, Sophie, Andrew, Georgia, Gallagher, Kathleen M. E., Sellar, Rob S., Cahalin, Paul, Weber, Duruta, Dennis, Mike, Mehta, Priyanka, Knapper, Steven, Russell, Nigel H.
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Language:English
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Summary:•Fractionated compared with single-dose gemtuzumab increased response depth across most AML molecular groups without increasing toxicity.•Older patients with AML receiving fractionated gemtuzumab had improved survival when induction was consolidated by allograft. [Display omitted] Addition of gemtuzumab ozogamicin (GO) to induction chemotherapy improves outcomes in older patients with acute myeloid leukemia (AML), but it is uncertain whether a fractionated schedule provides additional benefit to a single dose. We randomized 852 older adults (median age, 68-years) with AML/high-risk myelodysplasia to GO on day 1 (GO1) or on days 1 and 4 (GO2) of course 1 induction. The median follow-up period was 50.2 months. Although complete remission (CR) rates after course 1 did not significantly differ between arms (GO2, 63%; GO1, 57%; odds ratio [OR], 0.78; P = .08), there were significantly more patients who achieved CR with a measurable residual disease (MRD)
ISSN:0006-4971
1528-0020
1528-0020
DOI:10.1182/blood.2023020630