TY - JOUR
T1 - Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS
AU - for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK)
AU - Ossenkoppele, G. J.
AU - Breems, D. A.
AU - Stuessi, G.
AU - van Norden, Y.
AU - Bargetzi, M.
AU - Biemond, B. J.
AU - A von dem Borne, P.
AU - Chalandon, Y.
AU - Cloos, J.
AU - Deeren, D.
AU - Fehr, M.
AU - Gjertsen, B. T.
AU - Graux, C.
AU - Huls, G.
AU - Janssen, J. J.J.W.
AU - Jaspers, A.
AU - Jongen-Lavrencic, M.
AU - de Jongh, E.
AU - Klein, S. K.
AU - Van der Klift, M.
AU - Van Marwijk Kooy, M.
AU - Maertens, J.
AU - Micheaux, L.
AU - van der Poel, M. W.M.
AU - Van Rhenen, A.
AU - Tick, L.
AU - Valk, P.
AU - Vekemans, M. C.
AU - van der Velden, W. J.F.M.
AU - de Weerdt, O.
AU - Pabst, T.
AU - Manz, M.
AU - Löwenberg, B.
AU - Havelange, Violaine
AU - Moors, I.
AU - van Obberg, F.
AU - Hodossy, B.
AU - Vansteenweghen, S.
AU - Lammertijn, L.
AU - Sonet, A.
AU - Triffet, A.
AU - Passweg, J.
AU - Heim, D.
AU - Giovanni, San
AU - Betticher, D.
AU - Spertini, O.
AU - Gregor, M.
AU - Hess, U.
AU - van de Loosdrecht, A.
AU - Schouten, H. C.
AU - Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK)
PY - 2020/7/1
Y1 - 2020/7/1
N2 - More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (“3 + 7”) with or without lenalidomide at a dose of 20 mg/day 1–21. In the second cycle, patients received cytarabine 1000 mg/m2 twice daily on days 1–6 with or without lenalidomide (20 mg/day 1–21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).
AB - More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (“3 + 7”) with or without lenalidomide at a dose of 20 mg/day 1–21. In the second cycle, patients received cytarabine 1000 mg/m2 twice daily on days 1–6 with or without lenalidomide (20 mg/day 1–21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).
UR - http://www.scopus.com/inward/record.url?scp=85078895571&partnerID=8YFLogxK
U2 - https://doi.org/10.1038/s41375-020-0725-0
DO - https://doi.org/10.1038/s41375-020-0725-0
M3 - Article
C2 - 32020044
SN - 0887-6924
VL - 34
SP - 1751
EP - 1759
JO - Leukemia
JF - Leukemia
IS - 7
ER -