A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients by Alan K. Burnett, Nigel H. Russell, Robert K. Hills, Jonathan Kell, Jamie Cavenagh, Lars Kjeldsen, Mary-Frances McMullin, Paul Cahalin, Mike Dennis, Lone Friis, Ian F. Thomas, Don Milligan, and Richard E. Clark Blood Volume 125(25):3878-3885 June 18, 2015 ©2015 by American Society of Hematology
Trial design of AML17. Trial design of AML17. Patients allocated either CEP-701 or everolimus post–course 1 carried this molecule forward into subsequent courses. *After closure of the CEP-701 randomization, patients were guided by risk score to either poor risk or not poor risk options. **After closure of the everolimus randomization, patients in this group received daunorubicin (DA) 50 mg alone. ***After closure of the D clofarabine arm, patients were recommended to receive FLAG-Ida (which was also the case if renal criteria were not met). Alan K. Burnett et al. Blood 2015;125:3878-3885 ©2015 by American Society of Hematology
CONSORT diagram for AML17 daunorubicin dose randomization. Alan K. Burnett et al. Blood 2015;125:3878-3885 ©2015 by American Society of Hematology
Nonhematologic toxicity after courses 1 and 2. Nonhematologic toxicity after courses 1 and 2. (A) Course 1: toxicity according to NCI CTCAE v.3.0. (B) Course 2. Alan K. Burnett et al. Blood 2015;125:3878-3885 ©2015 by American Society of Hematology
Outcomes after daunorubicin dose randomization. Outcomes after daunorubicin dose randomization. (A) Overall survival (OS); (B) cumulative incidence of relapse; (C) OS—favorable cytogenetics; (D) OS—intermediate cytogenetics; (E) OS—adverse cytogenetics; (F) survival censored at transplant. Alan K. Burnett et al. Blood 2015;125:3878-3885 ©2015 by American Society of Hematology