Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial

Summary Background The optimum post-remission treatment (PRT) in acute myeloid leukaemia (AML) is still a matter of debate. Consolidation treatments include chemotherapy with high-dose cytarabine, or allogeneic or autologous haemopoietic stem cell transplantation (HSCT). In a post-hoc analysis of the AML96 trial ( NCT00180115 ), our aim was to differentiate groups of patients according to the treatments that would provide them optimum benefit. Methods In the multicentre AML96 trial, 586 patients (aged 15–60 years) with AML—excluding those with t(8;21)—who were in complete remission after double induction treatment were consolidated with allogeneic HSCT, autologous HSCT, or chemotherapy containing high-dose cytarabine in a priority-based and risk-adapted manner. We assessed the association between potentially prognostic variables and overall survival after complete remission by use of a stratified Cox regression analysis. With the significant variables of the resulting model, we developed a PRT score in 452 patients with a complete dataset. This score was then validated by use of data from 407 patients from the AML2003 trial ( NCT00180102 ). Findings Age, percentage of CD34-positive blasts, FLT3-ITD mutant-to-wild-type ratio, cytogenetic risk, and de-novo or secondary AML were identified as independent prognostic factors, and included in the PRT score. The PRT score separated patients in AML96 into three groups: favourable (n=190; 3-year survival 68%, 95% CI 60–74), intermediate (n=198; 49%, 42–56), and unfavourable (n=64; 20%, 12–31). All pair-wise comparisons of two of three PRT score groups were significant in the log-rank test (p