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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 < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)—P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks.
Highlights
Even though treatment of acute myeloid leukemia (AML) with curative intent is not standardized worldwide, it alwaysIn memory of Thomas Büchner—founder of the German Acute Myeloid Leukemia Cooperative Group (AML-CG).Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users.Extended author information available on the last page of the article involves intensive induction chemotherapy with the aim of reaching a complete remission (CR) and subsequent risk stratified post-remission therapy
136 (35%) patients belonged to the “older” age group ≥60 and were randomized between Sequential high-dose cytarabine and mitoxantrone (S-HAM) and double induction” (DI) with HAM(-HAM)
We found critical leukopenia of 29 days after S-HAM versus 46 days after standard DI in “younger” patients (P < 0.001) and 27 days versus 51 days in “older” patients, if the patients had received two cycles of HAM
Summary
Even though treatment of acute myeloid leukemia (AML) with curative intent is not standardized worldwide, it always. In memory of Thomas Büchner (born 1934 in Berlin—died 2016 in Münster)—founder of the German Acute Myeloid Leukemia Cooperative Group (AML-CG). Extended author information available on the last page of the article involves intensive induction chemotherapy with the aim of reaching a (morphologically) complete remission (CR) and subsequent risk stratified post-remission therapy. The increased knowledge of AML biology has not yet obviated the necessity for intensive cytotoxic chemotherapy. This is especially true for the initial induction phase where leukemia burden reduction by 3–4 logs and achievement of a complete (morphological) remission—following a prolonged period of deep aplasia—is the main goal
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