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

Niederwieser D, Lang T, Krahl R, Heinicke T, Maschmeyer G, Al-Ali HK, Schwind S, Jentzsch M, Cross M, Kahl C, Wolf HH, Sayer H, Schulze A, Dreger P, Hegenbart U, Krämer A, Junghanss C, Mügge LO, Hähling D, Hirt C, Späth C, Peter N, Opitz B, Florschütz A, Reifenrath K, Zojer N, Scholl S, Pönisch W, Heyn S, Vucinic V, Hochhaus A, Aul C, Giagounidis A, Balleisen L, Oldenkott B, Staib P, Kiehl M, Schütte W, Naumann R, Eimermacher H, Dörken B, Sauerland C, Lengfelder E, Hiddemann W, Wörmann B, Müller-Tidow C, Serve H, Schliemann C, Hehlmann R, Berdel WE, Pfirrmann M, Krug U, Hoffmann VS

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.