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
© 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:200 |
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| Enthalten in: |
British journal of haematology - 200(2023), 5 vom: 22. März, Seite 573-578 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mussai, Francis [VerfasserIn] |
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| Links: |
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| Themen: |
04079A1RDZ |
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| Anmerkungen: |
Date Completed 22.02.2023 Date Revised 10.02.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/bjh.18560 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM349269114 |
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| 100 | 1 | |a Mussai, Francis |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a 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 |b Results from the LI-1 trial |
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| 500 | |a Date Revised 10.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a AML | |
| 650 | 4 | |a BCT-100 | |
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| 700 | 1 | |a De Santo, Carmela |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Ian F |e verfasserin |4 aut | |
| 700 | 1 | |a Ariti, Cono |e verfasserin |4 aut | |
| 700 | 1 | |a Upton, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Scarpa, Ugo |e verfasserin |4 aut | |
| 700 | 1 | |a Stavrou, Victoria |e verfasserin |4 aut | |
| 700 | 1 | |a Sydenham, Mia |e verfasserin |4 aut | |
| 700 | 1 | |a Burnett, Alan K |e verfasserin |4 aut | |
| 700 | 1 | |a Knapper, Steven K |e verfasserin |4 aut | |
| 700 | 1 | |a Mehta, Priyanka |e verfasserin |4 aut | |
| 700 | 1 | |a McMullin, Mary F |e verfasserin |4 aut | |
| 700 | 1 | |a Copland, Mhairi |e verfasserin |4 aut | |
| 700 | 1 | |a Russell, Nigel H |e verfasserin |4 aut | |
| 700 | 1 | |a Dennis, Mike |e verfasserin |4 aut | |
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