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

Details

Ressource 1Request a copy Sous embargo indéterminé.
State: Public
Version: author
License: Not specified
Serval ID
serval:BIB_F33C1F2838B7
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial.
Journal
Blood advances
Author(s)
Löwenberg B., Pabst T., Maertens J., Gradowska P., Biemond B.J., Spertini O., Vellenga E., Griskevicius L., Tick L.W., Jongen-Lavrencic M., van Marwijk Kooy M., Vekemans M.C., van der Velden WJFM, Beverloo B., Michaux L., Graux C., Deeren D., de Weerdt O., van Esser JWJ, Bargetzi M., Klein S.K., Gadisseur A., Westerweel P.E., Veelken H., Gregor M., Silzle T., van Lammeren-Venema D., Moors I., Breems D.A., Hoogendoorn M., Legdeur MJC, Fischer T., Kuball J., Cornelissen J., Porkka K., Juliusson G., Meyer P., Höglund M., Gjertsen B.T., Janssen JJWM, Huls G., Passweg J., Cloos J., Valk PJM, van Elssen CHMJ, Manz M.G., Floisand Y., Ossenkoppele G.J.
ISSN
2473-9537 (Electronic)
ISSN-L
2473-9529
Publication state
Published
Issued date
23/02/2021
Peer-reviewed
Oui
Volume
5
Number
4
Pages
1110-1121
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Lenalidomide, an antineoplastic and immunomodulatory drug, has therapeutic activity in acute myeloid leukemia (AML), but definitive studies about its therapeutic utility have been lacking. In a phase 3 study, we compared 2 induction regimens in newly diagnosed patients age 18 to 65 years with AML: idarubicine-cytarabine (cycle 1) and daunorubicin and intermediate-dose cytarabine (cycle 2) without or with lenalidomide (15 mg orally on days 1-21). One final consolidation cycle of chemotherapy or autologous stem cell transplantation (auto-SCT) or allogeneic SCT (allo-SCT) was provided according to a prognostic risk and minimal residual disease (MRD)-adapted approach. Event-free survival (EFS; primary end point) and other clinical end points were assessed. A second random assignment in patients in complete response or in complete response with incomplete hematologic recovery after cycle 3 or auto-SCT involved 6 cycles of maintenance with lenalidomide (10 mg on days 1-21) or observation. In all, 392 patients were randomly assigned to the control group, and 388 patients were randomly assigned to lenalidomide induction. At a median follow-up of 41 months, the study revealed no differences in outcome between the treatments (EFS, 44% ± 2% standard error and overall survival, 54% ± 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML. In relation to the previous Dutch-Belgian Hemato-Oncology Cooperative Group and Swiss Group for Clinical Cancer Research (HOVON-SAKK) studies that used a similar 3-cycle regimen but did not pursue an MRD-guided approach, these survival estimates compare markedly more favorably. MRD status after cycle 2 lost prognostic value in intermediate-risk AML in the risk-adjusted treatment context. Maintenance with lenalidomide showed no apparent effect on relapse probability in 88 patients randomly assigned for this part of the study.
Pubmed
Web of science
Open Access
Yes
Create date
01/03/2021 13:05
Last modification date
07/07/2021 6:37
Usage data