Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.

ABSTRACT: Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8?=?"dose-dense") and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21?=?"standard"). 387 evaluable patients were randomly assigned to S-HAM (N?=?203) and to standard double induction (N?=?184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P?=?0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P?=?0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)-P?

SUBMITTER: Braess J 

PROVIDER: S-EPMC6286323 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature