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

G.J. Ossenkoppele; D.A. Breems; G. Stuessi; Y. van Norden; M. Bargetzi; B.J. Biemond; P.A. von dem Borne; Y. Chalandon; J. Cloos; D. Deeren; M. Fehr; B. Gjertsen; C. Graux; G. Huls; J.J.J.W. Janssen; A. Jaspers; M. Jongen-Lavrencic; E. de Jongh; S.K. Klein; M. van der Klift; M.V. Kooy; J. Maertens; L. Micheaux; M.W.M. van der Poel; A. van Rhenen; L. Tick; P. Valk; M.C. Vekemans; W.J.F.M. van der Velden; O. de Weerdt; T. Pabst; M. Manz; B. Lowenberg; V. Havelange; I. Moors; F. van Obberg; J.A. Maertens; B. Hodossy; S. Vansteenweghen; L. Lammertijn; A. Sonet; A. Triffet; J. Passweg; D. Heim; Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON); Swiss Group for Clinical Cancer Research (SAKK)

doi:10.1038/s41375-020-0725-0

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

G.J. Ossenkoppele^*, D.A. Breems, G. Stuessi, Y. van Norden, M. Bargetzi, B.J. Biemond, P.A. von dem Borne, Y. Chalandon, J. Cloos, D. Deeren, M. Fehr, B. Gjertsen, C. Graux, G. Huls, J.J.J.W. Janssen, A. Jaspers, M. Jongen-Lavrencic, E. de Jongh, S.K. Klein, M. van der KliftM.V. Kooy, J. Maertens, L. Micheaux, M.W.M. van der Poel, A. van Rhenen, L. Tick, P. Valk, M.C. Vekemans, W.J.F.M. van der Velden, O. de Weerdt, T. Pabst, M. Manz, B. Lowenberg, V. Havelange, I. Moors, F. van Obberg, J.A. Maertens, B. Hodossy, S. Vansteenweghen, L. Lammertijn, A. Sonet, A. Triffet, J. Passweg, D. Heim, Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON), Swiss Group for Clinical Cancer Research (SAKK)

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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. 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).

Original language	English
Pages (from-to)	1751-1759
Number of pages	9
Journal	Leukemia
Volume	34
Issue number	7
DOIs	https://doi.org/10.1038/s41375-020-0725-0
Publication status	Published - 1 Jul 2020

Keywords

acute myeloid-leukemia
adults
high-dose lenalidomide
therapy
THERAPY
ADULTS
ACUTE MYELOID-LEUKEMIA
HIGH-DOSE LENALIDOMIDE

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1 Erratum / corrigendum / retractions

Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS
Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K. & van der Klift, M. & 15 others, van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) & Swiss Group for Clinical Cancer Research (SAKK), Oct 2020, In: Leukemia. 34, 10, p. 2820-2820 1 p., 2820.
Research output: Contribution to journal › Erratum / corrigendum / retractions › Academic

Open Access

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Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., von dem Borne, P. A., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., ... Swiss Group for Clinical Cancer Research (SAKK) (2020). Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS. Leukemia, 34(7), 1751-1759. https://doi.org/10.1038/s41375-020-0725-0

@article{cc27e68083224302aa67107a6f3ccaa0,

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

abstract = "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. 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).",

keywords = "acute myeloid-leukemia, adults, high-dose lenalidomide, therapy, THERAPY, ADULTS, ACUTE MYELOID-LEUKEMIA, HIGH-DOSE LENALIDOMIDE",

author = "G.J. Ossenkoppele and D.A. Breems and G. Stuessi and {van Norden}, Y. and M. Bargetzi and B.J. Biemond and {von dem Borne}, P.A. and Y. Chalandon and J. Cloos and D. Deeren and M. Fehr and B. Gjertsen and C. Graux and G. Huls and J.J.J.W. Janssen and A. Jaspers and M. Jongen-Lavrencic and {de Jongh}, E. and S.K. Klein and {van der Klift}, M. and M.V. Kooy and J. Maertens and L. Micheaux and {van der Poel}, M.W.M. and {van Rhenen}, A. and L. Tick and P. Valk and M.C. Vekemans and {van der Velden}, W.J.F.M. and {de Weerdt}, O. and T. Pabst and M. Manz and B. Lowenberg and V. Havelange and I. Moors and {van Obberg}, F. and J.A. Maertens and B. Hodossy and S. Vansteenweghen and L. Lammertijn and A. Sonet and A. Triffet and J. Passweg and D. Heim and {Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON)} and {Swiss Group for Clinical Cancer Research (SAKK)}",

note = "Funding Information: Acknowledgements The authors thanks the local and central data managers as well as the HOVON Datacenter Trial team. Dutch Cancer Foundation for financial support. Celgene for free drug supply and financial support to conduct the study. Publisher Copyright: {\textcopyright} 2020, The Author(s), under exclusive licence to Springer Nature Limited.",

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month = jul,

day = "1",

doi = "10.1038/s41375-020-0725-0",

language = "English",

volume = "34",

pages = "1751--1759",

journal = "Leukemia",

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publisher = "Nature Publishing Group",

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Ossenkoppele, GJ, Breems, DA, Stuessi, G, van Norden, Y, Bargetzi, M, Biemond, BJ, von dem Borne, PA, Chalandon, Y, Cloos, J, Deeren, D, Fehr, M, Gjertsen, B, Graux, C, Huls, G, Janssen, JJJW, Jaspers, A, Jongen-Lavrencic, M, de Jongh, E, Klein, SK, van der Klift, M, Kooy, MV, Maertens, J, Micheaux, L, van der Poel, MWM, van Rhenen, A, Tick, L, Valk, P, Vekemans, MC, van der Velden, WJFM, de Weerdt, O, Pabst, T, Manz, M, Lowenberg, B, Havelange, V, Moors, I, van Obberg, F, Maertens, JA, Hodossy, B, Vansteenweghen, S, Lammertijn, L, Sonet, A, Triffet, A, Passweg, J, Heim, D, Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) & Swiss Group for Clinical Cancer Research (SAKK) 2020, 'Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS', Leukemia, vol. 34, no. 7, pp. 1751-1759. https://doi.org/10.1038/s41375-020-0725-0

TY - JOUR

T1 - Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

AU - Ossenkoppele, G.J.

AU - Breems, D.A.

AU - Stuessi, G.

AU - van Norden, Y.

AU - Bargetzi, M.

AU - Biemond, B.J.

AU - von dem Borne, P.A.

AU - Chalandon, Y.

AU - Cloos, J.

AU - Deeren, D.

AU - Fehr, M.

AU - Gjertsen, B.

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 - Kooy, M.V.

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 - Lowenberg, B.

AU - Havelange, V.

AU - Moors, I.

AU - van Obberg, F.

AU - Maertens, J.A.

AU - Hodossy, B.

AU - Vansteenweghen, S.

AU - Lammertijn, L.

AU - Sonet, A.

AU - Triffet, A.

AU - Passweg, J.

AU - Heim, D.

AU - Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON)

AU - Swiss Group for Clinical Cancer Research (SAKK)

N1 - Funding Information: Acknowledgements The authors thanks the local and central data managers as well as the HOVON Datacenter Trial team. Dutch Cancer Foundation for financial support. Celgene for free drug supply and financial support to conduct the study. Publisher Copyright: © 2020, The Author(s), under exclusive licence to Springer Nature Limited.

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/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).

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/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).

KW - acute myeloid-leukemia

KW - adults

KW - high-dose lenalidomide

KW - therapy

KW - THERAPY

KW - ADULTS

KW - ACUTE MYELOID-LEUKEMIA

KW - HIGH-DOSE LENALIDOMIDE

U2 - 10.1038/s41375-020-0725-0

DO - 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 -

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

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

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