TY - JOUR
T1 - Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: The HOVON-SAKK-132 trial
AU - Löwenberg, Bob
AU - Pabst, Thomas
AU - Maertens, Johan
AU - Gradowska, Patrycja
AU - Biemond, Bart J.
AU - Spertini, Olivier
AU - Vellenga, Edo
AU - Griskevicius, Laimonas
AU - Tick, Lidwine W.
AU - Jongen-Lavrencic, Mojca
AU - Kooy, Marinus Van Marwijk
AU - Vekemans, Marie-Christiane
AU - van der Velden, Walter J. F. M.
AU - Beverloo, Berna
AU - Michaux, Lucienne
AU - Graux, Carlos
AU - Deeren, Dries
AU - Weerdt, Okke De
AU - Esser, Joost W. J. Van
AU - Klein, Mario Bargetzi Saskia K.
AU - Gadisseur, Alain
AU - Westerweel, Peter E.
AU - Veelken, Hendrik
AU - Gregor, Michael
AU - Silzle, Tobias
AU - Lammeren-Venema, Dani Ëlle Van
AU - Moors, Ine
AU - Breems, Dimitri A.
AU - Hoogendoorn, Mels
AU - Legdeur, Marie-Cecile J. C.
AU - Fischer, Thomas
AU - Kuball, Juergen
AU - Porkka, Jan Cornelissen Kimmo
AU - Juliusson, Gunnar
AU - Meyer, Peter
AU - Höglund, Martin
AU - Gjertsen, Bjorn T.
AU - Janssen, Jeroen J. W. M.
AU - Huls, Gerwin
AU - Passweg, Jakob
AU - Cloos, Jacqueline
AU - Valk, Peter J. M.
AU - Elssen, Catharina H. M. J. Van
AU - Manz, Markus G.
AU - Floisand, Yngvar
AU - Ossenkoppele, Gert J.
N1 - Publisher Copyright: © 2021 by The American Society of Hematology 1110.
PY - 2021/2/23
Y1 - 2021/2/23
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85102657462&partnerID=8YFLogxK
U2 - https://doi.org/10.1182/bloodadvances.2020003855
DO - https://doi.org/10.1182/bloodadvances.2020003855
M3 - Article
C2 - 33616652
SN - 2473-9529
VL - 5
SP - 1110
EP - 1121
JO - BLOOD ADVANCES
JF - BLOOD ADVANCES
IS - 4
ER -