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Ossenkoppele, G.J.; Breems, D.A.; Stuessi, G.; Norden, Y. van; Bargetzi, M.; Biemond, B.J.; ... ; Swiss Grp Clinical Canc Res SAKK (2020)

Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Article / Letter to editor
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/m(2) 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...Show moreMore 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/m(2) 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).Show less
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Ossenkoppele, G.J.; Breems, D.A.; Stuessi, G.; Norden, Y. van; Bargetzi, M.; Biemond, B.J.; Borne, P.A. von dem; Chalandon, Y.; Cloos, J.; Deeren, D.; Fehr, M.; Gjertsen, B.; Graux, C.; Huls, G.; Janssen, J.J.J.W.; Jaspers, A.; Jongen-Lavrencic, M.; Jongh, E. de; Klein, S.K.; Klift, M. van der; Kooy, M.V.; Maertens, J.; Micheaux, L.; Poel, M.W.M. van der; Rhenen, A. van; Tick, L.; Valk, P.; Vekemans, M.C.; Velden, W.J.F.M. van der; Weerdt, O. de; Pabst, T.; Manz, M.; Lowenberg, B.; Havelange; Moors, I.; Obberg, F. van; Maertens, J.A.; Hodossy, B.; Vansteenweghen, S.; Lammertijn, L.; Sonet, A.; Triffet, A.; Gjertsen, B.T.; Passweg, J.; Heim, D.; Giovanni, S.; Betticher, D.; Spertini, O.; Gregor, M.; Hess, U.; Manz, M.G.; Loosdrecht, A. van de; Janssen, J.J.W.M.; Esser, J.W.J. van; Brouwer, R.E.; Lammeren-Venema, D. van; Levin, M.D.; Tick, L.W.; Legdeur, M.C.J.C.; Vellenga, E.; Hoogendoorn, M.; Veelken, J.H.; Schouten, H.C.; Cornelissen, J.; Wouters, B.; Raaijmakers, H.G.M.; Kuball, J.; Dutch-Belgian Hemato-Oncology; Swiss Grp Clinical Canc Res SAKK
Date
2020-02-04
Journal
Leukemia
Volume
34
Pages
1751 - 1759
DOI
doi:10.1038/s41375-020-0725-0
Link
https://www.nature.com/articles/s41375-020-0725-0