Transplant outcomes after CPX-351 vs 7 + 3 in older adults with newly diagnosed high-risk and/or secondary AML
Geoffrey L. Uy, Laura F. Newell, Tara L. Lin, Stuart L. Goldberg, Matthew J. Wieduwilt, Robert J. Ryan, Stefan Faderl, Jeffrey E. Lancet
Abstract
Vyxeos; Europe: Vyxeos liposomal) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio. 1 CPX-351 is approved for newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes in adults and pediatric patients aged $1 year in the United States and in adults in Europe. In a phase 3 study in older adults with newly diagnosed, high-risk/secondary AML, CPX-351 improved overall survival (OS), complete remission (CR) rate, allogeneic hematopoietic cell transplantation (alloHCT) rate, and OS landmarked from the alloHCT date vs conventional 7 1 3 (cytarabine/daunorubicin). Here, we performed detailed analyses of outcomes after alloHCT following CPX-351 vs 7 1 3 in the phase 3 study, with 5 years of follow-up. Details of this multicenter, randomized, open-label, phase 3 study have been described previously. riefly, patients aged 60 to 75 years with newly diagnosed, high-risk/secondary AML were randomized 1:1 to receive up to 2 induction cycles of CPX-351 (100 U/m 2 [daunorubicin 44 mg/m 2 plus cytarabine 100 mg/m 2 ] via 90-minute infusion on days 1, 3, and 5 [second induction: days 1 and 3]) or 7 1 3 (cytarabine 100 mg/m 2 per day continuous infusion for 7 days plus daunorubicin 60 mg/m 2 on days 1-3 [second induction: 5 1 2 schedule]) followed by up to 2 postremission consolidation cycles with CPX-351 65 U/m 2 or 5 1 2, respectively. Patients were stratified by age and AML subtype (Table alloHCT was allowed at the physician's discretion. The protocol was amended to collect additional alloHCT-specific information and outcomes, including cumulative incidence of relapse, nonrelapse mortality (NRM), and acute and chronic graft-versus-host disease (GVHD).