Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial

Sylvie D. Freeman; Abin Thomas; Ian Thomas; Robert K. Hills; Paresh Vyas; Amanda Gilkes; Marlen Metzner; Niels Asger Jakobsen; Alison Kennedy; Amy Moore; Nuria Marquez Almuina; Sarah Burns; Sophie King; Georgia Andrew; Kathleen M.E. Gallagher; Rob S. Sellar; Paul Cahalin; Duruta Weber; Mike Dennis; Priyanka Mehta; Steven Knapper; Nigel H. Russell

doi:10.1182/blood.2023020630

Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial

Sylvie D. Freeman, Abin Thomas, Ian Thomas, Robert K. Hills, Paresh Vyas, Amanda Gilkes, Marlen Metzner, Niels Asger Jakobsen, Alison Kennedy, Amy Moore, Nuria Marquez Almuina, Sarah Burns, Sophie King, Georgia Andrew, Kathleen M.E. Gallagher, Rob S. Sellar, Paul Cahalin, Duruta Weber, Mike Dennis, Priyanka MehtaSteven Knapper, Nigel H. Russell^*

^*Corresponding author for this work

Immunology and Immunotherapy

Research output: Contribution to journal › Article › peer-review

Abstract

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 randomised 852 older adults (median age 68yrs) with AML/high risk myelodysplasia to GO on day 1 (GO1), or on days 1 and 4 (GO2) of course-1 induction. Median follow-up was 50.2 months. While complete remission rates post course 1 did not significantly differ between arms (GO2 63%, GO1 57%, OR 0.78 (0.59-1.03), P=0.08), there were significantly more patients who achieved CR with MRD

Original language	English
Article number	blood.2023020630
Journal	Blood
Early online date	18 Aug 2023
DOIs	https://doi.org/10.1182/blood.2023020630
Publication status	E-pub ahead of print - 18 Aug 2023

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10.1182/blood.2023020630Licence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

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Freeman, S. D., Thomas, A., Thomas, I., Hills, R. K., Vyas, P., Gilkes, A., Metzner, M., Jakobsen, N. A., Kennedy, A., Moore, A., Almuina, N. M., Burns, S., King, S., Andrew, G., Gallagher, K. M. E., Sellar, R. S., Cahalin, P., Weber, D., Dennis, M., ... Russell, N. H. (2023). Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial. Blood, Article blood.2023020630. Advance online publication. https://doi.org/10.1182/blood.2023020630

@article{7b0733f202714e1dada032c95fdf7abb,

title = "Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial",

abstract = "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 randomised 852 older adults (median age 68yrs) with AML/high risk myelodysplasia to GO on day 1 (GO1), or on days 1 and 4 (GO2) of course-1 induction. Median follow-up was 50.2 months. While complete remission rates post course 1 did not significantly differ between arms (GO2 63%, GO1 57%, OR 0.78 (0.59-1.03), P=0.08), there were significantly more patients who achieved CR with MRD",

author = "Freeman, {Sylvie D.} and Abin Thomas and Ian Thomas and Hills, {Robert K.} and Paresh Vyas and Amanda Gilkes and Marlen Metzner and Jakobsen, {Niels Asger} and Alison Kennedy and Amy Moore and Almuina, {Nuria Marquez} and Sarah Burns and Sophie King and Georgia Andrew and Gallagher, {Kathleen M.E.} and Sellar, {Rob S.} and Paul Cahalin and Duruta Weber and Mike Dennis and Priyanka Mehta and Steven Knapper and Russell, {Nigel H.}",

year = "2023",

month = aug,

day = "18",

doi = "10.1182/blood.2023020630",

language = "English",

journal = "Blood",

issn = "0006-4971",

publisher = "American Society of Hematology",

}

Freeman, SD, Thomas, A, Thomas, I, Hills, RK, Vyas, P, Gilkes, A, Metzner, M, Jakobsen, NA, Kennedy, A, Moore, A, Almuina, NM, Burns, S, King, S, Andrew, G, Gallagher, KME, Sellar, RS, Cahalin, P, Weber, D, Dennis, M, Mehta, P, Knapper, S & Russell, NH 2023, 'Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial', Blood. https://doi.org/10.1182/blood.2023020630

TY - JOUR

T1 - Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML

T2 - UK NCRI AML18 Trial

AU - Freeman, Sylvie D.

AU - Thomas, Abin

AU - Thomas, Ian

AU - Hills, Robert K.

AU - Vyas, Paresh

AU - Gilkes, Amanda

AU - Metzner, Marlen

AU - Jakobsen, Niels Asger

AU - Kennedy, Alison

AU - Moore, Amy

AU - Almuina, Nuria Marquez

AU - Burns, Sarah

AU - King, Sophie

AU - Andrew, Georgia

AU - Gallagher, Kathleen M.E.

AU - Sellar, Rob S.

AU - Cahalin, Paul

AU - Weber, Duruta

AU - Dennis, Mike

AU - Mehta, Priyanka

AU - Knapper, Steven

AU - Russell, Nigel H.

PY - 2023/8/18

Y1 - 2023/8/18

N2 - 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 randomised 852 older adults (median age 68yrs) with AML/high risk myelodysplasia to GO on day 1 (GO1), or on days 1 and 4 (GO2) of course-1 induction. Median follow-up was 50.2 months. While complete remission rates post course 1 did not significantly differ between arms (GO2 63%, GO1 57%, OR 0.78 (0.59-1.03), P=0.08), there were significantly more patients who achieved CR with MRD

AB - 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 randomised 852 older adults (median age 68yrs) with AML/high risk myelodysplasia to GO on day 1 (GO1), or on days 1 and 4 (GO2) of course-1 induction. Median follow-up was 50.2 months. While complete remission rates post course 1 did not significantly differ between arms (GO2 63%, GO1 57%, OR 0.78 (0.59-1.03), P=0.08), there were significantly more patients who achieved CR with MRD

U2 - 10.1182/blood.2023020630

DO - 10.1182/blood.2023020630

M3 - Article

SN - 0006-4971

JO - Blood

JF - Blood

M1 - blood.2023020630

ER -

Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial

Abstract

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