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Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: the HOVON-SAKK-132 trial
- Source :
- Blood Adv, Blood advances, 5(4), 1110-1121. American Society of Hematology, Blood advances, Blood, 5(4), 1110-1121. American Society of Hematology, Löwenberg, B, Pabst, T, Maertens, J, Gradowska, P, Biemond, B J, Spertini, O, Vellenga, E, Griskevicius, L, Tick, L W, Jongen-Lavrencic, M, Kooy, M V M, Vekemans, M-C, van der Velden, W J F M, Beverloo, B, Michaux, L, Graux, C, Deeren, D, Weerdt, O D, Esser, J W J V, Klein, M B S K, Gadisseur, A, Westerweel, P E, Veelken, H, Gregor, M, Silzle, T, Lammeren-Venema, D Ë V, Moors, I, Breems, D A, Hoogendoorn, M, Legdeur, M-C J C, Fischer, T, Kuball, J, Porkka, J C K, Juliusson, G, Meyer, P, Höglund, M, Gjertsen, B T, Janssen, J J W M, Huls, G, Passweg, J, Cloos, J, Valk, P J M, Elssen, C H M J V, Manz, M G, Floisand, Y & Ossenkoppele, G J 2021, ' Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML: The HOVON-SAKK-132 trial ', Blood, vol. 5, no. 4, pp. 1110-1121 . https://doi.org/10.1182/bloodadvances.2020003855, BLOOD ADVANCES, Blood Advances, 5(4), 1110-1121. AMER SOC HEMATOLOGY, Blood Advances, 5, 1110-1121, Blood advances, 5(4), 1110-1121. The American Society of Hematology, Blood advances, Vol. 5, no. 4, p. 1110-1121 (2021), Blood Advances, 5, 4, pp. 1110-1121, Blood, 5(4), 1110-1121. AMER SOC HEMATOLOGY, Blood advances, Washington : American Society of Hematology, 2021, vol. 5, no. 4, p. 1110-1121
- Publication Year :
- 2020
-
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. ispartof: BLOOD ADVANCES vol:5 issue:4 pages:1110-1121 ispartof: location:United States status: published
- Subjects :
- Oncology
Clinical Trials and Observations
Phases of clinical research
0302 clinical medicine
Autologous stem-cell transplantation
hemic and lymphatic diseases
Medicine and Health Sciences
ELDERLY-PATIENTS
Lenalidomide
LENALIDOMIDE
Remission Induction
Hematopoietic Stem Cell Transplantation
Hematology
Middle Aged
Chemotherapy regimen
3. Good health
CYTARABINE
Leukemia, Myeloid, Acute
030220 oncology & carcinogenesis
Life Sciences & Biomedicine
medicine.drug
Adult
medicine.medical_specialty
Adolescent
HIGH-DOSE LENALIDOMIDE
MINIMAL RESIDUAL DISEASE
ACUTE MYELOID-LEUKEMIA
Transplantation, Autologous
03 medical and health sciences
Young Adult
All institutes and research themes of the Radboud University Medical Center
SEQUENTIAL AZACITIDINE
Internal medicine
AZACITIDINE PLUS LENALIDOMIDE
AZACITIDINE PLUS
medicine
Humans
COMBINATION
Aged
Science & Technology
business.industry
Minimal residual disease
Transplantation
Regimen
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
Cytarabine
Human medicine
business
030215 immunology
Subjects
Details
- ISSN :
- 24739537, 11101121, 24739529, and 00064971
- Volume :
- 5
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Blood advances
- Accession number :
- edsair.doi.dedup.....67b667f8652f65ff1c599befd9584961