Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML : The HOVON-SAKK-132 trial
(2021) In Blood Advances 5(4). p.1110-1121- 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 (15mg 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... (More)
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 (15mg 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% 6 2% standard error and overall survival, 54% 6 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML.
(Less)
- author
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Blood Advances
- volume
- 5
- issue
- 4
- pages
- 12 pages
- publisher
- American Society of Hematology
- external identifiers
-
- pmid:33616652
- scopus:85102657462
- ISSN
- 2473-9529
- DOI
- 10.1182/bloodadvances.2020003855
- language
- English
- LU publication?
- no
- id
- 8c9b8794-fefb-4c95-9bc5-bd929f4d33ec
- date added to LUP
- 2021-03-26 08:38:48
- date last changed
- 2024-04-18 04:25:15
@article{8c9b8794-fefb-4c95-9bc5-bd929f4d33ec,
abstract = {{<p>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 (15mg 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% 6 2% standard error and overall survival, 54% 6 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML.</p>}},
author = {{Löwenberg, Bob and Pabst, Thomas and Maertens, Johan and Gradowska, Patrycja and Biemond, Bart J. and Spertini, Olivier and Vellenga, Edo and Griskevicius, Laimonas and Tick, Lidwine W. and Jongen-Lavrencic, Mojca and Kooy, Marinus Van Marwijk and Vekemans, Marie Christiane and Van Der Velden, Walter J.F.M. and Beverloo, Berna and Michaux, Lucienne and Graux, Carlos and Deeren, Dries and Weerdt, Okke De and Esser, Joost W.J.Van and Bargetzi, Mario and Klein, Saskia K and Gadisseur, Alain and Westerweel, Peter E. and Veelken, Hendrik and Gregor, Michael and Silzle, Tobias and Lammeren-Venema, Dani Ëlle Van and Moors, Ine and Breems, Dimitri A. and Hoogendoorn, Mels and Legdeur, Marie Cecile J.C. and Fischer, Thomas and Kuball, Juergen and Cornelissen, Jan and Porkka, Kimmo and Juliusson, Gunnar and Meyer, Peter and Höglund, Martin and Gjertsen, Bjorn T. and Janssen, Jeroen J.W.M. and Huls, Gerwin and Passweg, Jakob and Cloos, Jacqueline and Valk, Peter J.M. and Elssen, Catharina H.M.J.Van and Manz, Markus G. and Floisand, Yngvar and Ossenkoppele, Gert J.}},
issn = {{2473-9529}},
language = {{eng}},
number = {{4}},
pages = {{1110--1121}},
publisher = {{American Society of Hematology}},
series = {{Blood Advances}},
title = {{Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML : The HOVON-SAKK-132 trial}},
url = {{http://dx.doi.org/10.1182/bloodadvances.2020003855}},
doi = {{10.1182/bloodadvances.2020003855}},
volume = {{5}},
year = {{2021}},
}