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.
| Original language | English |
|---|---|
| Journal | Leukemia |
| Volume | 32 |
| Issue number | 12 |
| Pages (from-to) | 2558-2571 |
| Number of pages | 14 |
| ISSN | 0887-6924 |
| DOIs | |
| Publication status | Published - 01.12.2018 |
Funding
Conflict of interest Jan Braess has received research funding from Amgen and Janssen. Eva Elisabeth Lengfelder has received travel & accommodation expenses from Teva and Novartis. Ullrich Graeven has received honoraria from Amgen, Roche, Bayer, Sanofi, AbbVie, Servier, and Boehringer; has a consulting or advisory role in Baxalta, Servier, Roche, and Novartis; and has received travel & accommodation expenses from Merck and Sanofi. Dirk Behringer has a consulting or advisory role in Roche and BMS. Gero Massenkeil has received honoraria from Sanofi; has a consulting or advisory role in Sanofi; and is in speakers’ bureau in Sanofi. Stefan Bohlander has received honoraria from Roche. Wolfgang Hiddemann has received honoraria from Roche, Gilead, and Janssen; is in speakers’ bureau in Roche, Gilead, and Janssen; has received research funding from Amgen, Roche, Gilead, and Janssen; has received travel & accommodation expenses from Amgen, Roche, Gilead, and Janssen. All other authors declare that they have no conflict of interest.
