Details

Autor(en) / Beteiligte

• Niederwieser, Dietger
• Lang, Thomas
• Krahl, Rainer
• Heinicke, Thomas
• Maschmeyer, Georg
• Al-Ali, Haifa Kathrin
• Schwind, Sebastian
• Jentzsch, Madlen
• Cross, Michael
• Kahl, Christoph
• Wolf, Hans-Heinrich
• Sayer, Herbert
• Schulze, Antje
• Dreger, Peter
• Hegenbart, Ute
• Krämer, Alwin
• Junghanss, Christian
• Mügge, Lars-Olof
• Hähling, Detlev
• Hirt, Carsten
• Späth, Christian
• Peter, Norma
• Opitz, Bernhard
• Florschütz, Axel
• Reifenrath, Kolja
• Zojer, Niklas
• Scholl, Sebastian
• Pönisch, Wolfram
• Heyn, Simone
• Vucinic, Vladan
• Hochhaus, Andreas
• Aul, Carlo
• Giagounidis, Aristoteles
• Balleisen, Leopold
• Oldenkott, Bernd
• Staib, Peter
• Kiehl, Michael
• Schütte, Wolfgang
• Naumann, Ralph
• Eimermacher, Hartmut
• Dörken, Bernd
• Sauerland, Cristina
• Lengfelder, Eva
• Hiddemann, Wolfgang
• Wörmann, Bernhard
• Müller-Tidow, Carsten
• Serve, Hubert
• Schliemann, Christoph
• Hehlmann, Rüdiger
• Berdel, Wolfgang E.
• Pfirrmann, Markus
• Krug, Utz
• Hoffmann, Verena S.

Titel

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

Ist Teil von

• Annals of hematology, 2023-03, Vol.102 (3), p.547-561

Ort / Verlag

Berlin/Heidelberg: Springer Berlin Heidelberg

Erscheinungsjahr

2023

Link zum Volltext

Quelle

SpringerLink (Online service)

Beschreibungen/Notizen

• 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.