Mussai, F. et al. (2023) A randomised evaluation of low-dose Ara-C plus pegylated recombinant arginase BCT-100 versus low dose Ara-C in older unfit patients with acute myeloid leukaemia: results from the LI-1 trial. British Journal of Haematology, 200(5), pp. 573-578. (doi: 10.1111/bjh.18560) (PMID:36413792)
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Abstract
The survival of acute myeloid leukaemia (AML) patients aged over 60 has been suboptimal historically, whether they are treated using hypomethylating agents, low-dose cytarabine (LDAC) or venetoclax-based regimens. Progress is being made, however, for subgroups with favourable molecular or cytogenetic findings. Arginine metabolism plays a key role in AML pathophysiology. We report the only randomised study of LDAC with recombinant arginase BCT-100 versus LDAC alone in older AML patients unsuitable for intensive therapy. Eighty-three patients were randomised to the study. An overall response rate was seen in 19.5% (all complete remission [CR]) and 15% (7.5% each in CR and CR without evidence of adequate count recovery [CRi]) of patients in the LDAC+BCT-100 and LDAC arms respectively (odds ratio 0.73, confidence interval 0.23–2.33; p = 0.592). No significant difference in overall or median survival between treatment arms was seen. The addition of BCT-100 to LDAC was well tolerated.
| Item Type: | Articles |
|---|---|
| Keywords: | Arginase, AML, BCT‐100, cytarabine. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Burnett, Professor Alan and Copland, Professor Mhairi |
| Authors: | Mussai, F., De Santo, C., Cheng, P., Thomas, I. F., Ariti, C., Upton, L., Scarpa, U., Stavrou, V., Sydenham, M., Burnett, A. K., Knapper, S. K., Mehta, P., McMullin, M. F., Copland, M., Russell, N. H., and Dennis, M. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cancer Sciences |
| Journal Name: | British Journal of Haematology |
| Publisher: | Wiley |
| ISSN: | 0007-1048 |
| ISSN (Online): | 1365-2141 |
| Published Online: | 22 November 2022 |
| Copyright Holders: | Copyright © 2022 The Authors |
| First Published: | First published in British Journal of Haematology 200(5): 573-578 |
| Publisher Policy: | Reproduced under a Creative Commons License |
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