Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial

摘要: Lenalidomide, an antineoplastic and immunomodulatory drug, has therapeutic activity in acute myeloid leukemia (AML), but definitive studies about its utility have been lacking. In a phase 3 study, we compared 2 induction regimens newly diagnosed patients age 18 to 65 years with AML: idarubicine-cytarabine (cycle 1) daunorubicin intermediate-dose cytarabine 2) without or lenalidomide (15 mg orally on days 1-21). One final consolidation cycle of chemotherapy autologous stem cell transplantation (auto-SCT) allogeneic SCT (allo-SCT) was provided according prognostic risk minimal residual disease (MRD)-adapted approach. Event-free survival (EFS; primary end point) other clinical points were assessed. A second random assignment complete response incomplete hematologic recovery after auto-SCT involved 6 cycles maintenance (10 1-21) observation. all, 392 randomly assigned the control group, 388 induction. At median follow-up 41 months, study revealed no differences outcome between treatments (EFS, 44% ± 2% standard error overall survival, 54% at 4 for both arms) although exploratory post hoc analysis, benefit suggested SRSF2-mutant AML. relation previous Dutch-Belgian Hemato-Oncology Cooperative Group Swiss Clinical Cancer Research (HOVON-SAKK) that used similar 3-cycle regimen did not pursue MRD-guided approach, these estimates compare markedly more favorably. MRD status lost value intermediate-risk AML risk-adjusted treatment context. Maintenance showed apparent effect relapse probability 88 this part study.