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

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.

Consensus-Based Guidelines for Acute Myeloid Leukemia Management in Gulf Cooperation Council Countries: Addressing Unmet Regional Needs and the Changing AML Landscape

“…61 Results showed that compared with the 7 + 3 regimen, there were no significant differences in CR, event-free survival, overall survival, and relapse-free survival. 61…”

“…The study examined patients 60 years and older who were exposed to various intensive chemotherapy regimens versus the 7 1 3 regimen. 61 Results showed that compared with the 7 1 3 regimen, there were no significant differences in CR, eventfree survival, overall survival, and relapse-free survival. 61 Most of the selected recommendations gained panel endorsement, with exceptions in the incorporation of cladribine to the 7 1 3 regimen.…”

“…61 Results showed that compared with the 7 1 3 regimen, there were no significant differences in CR, eventfree survival, overall survival, and relapse-free survival. 61 Most of the selected recommendations gained panel endorsement, with exceptions in the incorporation of cladribine to the 7 1 3 regimen. Divergence arose here because of concerns about observed heightened local populationspecific toxicity resulting from additional chemotherapy to the 7 1 3 regimen and different from that reported in clinical trials.…”

“…19 However, the panel recognizes the limitations of this recommendation. Recent findings from a 10-year German intergroup study conducted by Niederwieser et al 61 reported findings involving 1,079 patients with non-M3 AML with a median age range of 68-70 years. The study examined patients 60 years and older who were exposed to various intensive chemotherapy regimens versus the 7 + 3 regimen.…”