Different treatment strategies versus a common standard arm (CSA) in patients with newly diagnosed AML over the age of 60 years: a randomized German inter-group study.
Ann Hematol
; 102(3): 547-561, 2023 Mar.
Article
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| MEDLINE
| ID: mdl-36695874
ABSTRACT
A randomized inter-group trial comparing more intensive treatment strategies to a common standard arm 3 + 7 (CSA) was conducted in patients with non-M3 AML. Untreated patients ≥ 60 years were allocated to the CSA (n = 132) or to the study group arms (n = 1154) of the AMLCG (TAD/HAM versus HAM/HAM ± G-CSF followed by TAD and maintenance) and the OSHO (intermediate-dose ara-C/mitoxantrone followed by ara-C/mitoxantrone). Median age of the 1147 eligible patients was 69 (range 60-87) years. CR/CRi status at 90 days was not significantly different between the CSA (54% (95%CI 45-64)) and the study group arms (53% (95%CI 47-60) and 59% (95%CI 58-63)). The five-year event-free survival (EFS) probability (primary endpoint) was 6.2% (95%CI 2.7-14.0) in the CSA, 7.6% (95%CI 4.5-12.8) in study group A and 11.1% (95%CI 9.0-13.7) in B. The 5-year OS was 17.2% (95%CI 11.0-26.9), 17.0% (95%CI 2.0-23.9), and 19.5% (95%CI 16.7-22.8) in CSA, study group A and B, respectively. Neither study group differed significantly from the CSA regarding EFS, OS, or relapse-free survival. In multivariate analyses, allocation to the treatment strategy was not significantly associated with the time-to-event endpoints. The evaluation of more intensive treatment strategies did not show clinically relevant outcome differences when compared to CSA.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Leucemia Mieloide Aguda
/
Mitoxantrona
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Prognostic_studies
Límite:
Aged
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Aged80
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Humans
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Middle aged
Idioma:
En
Revista:
Ann Hematol
Asunto de la revista:
HEMATOLOGIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Alemania