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

for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and 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

for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK)

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

17 Citations (Scopus)

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/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).

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

Bibliographical 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:
© 2020, The Author(s), under exclusive licence to Springer Nature Limited.

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10.1038/s41375-020-0725-0

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@article{4b1aff2ce2cb405e8a8b55c872666769,

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/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).",

author = "{for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK)} and Ossenkoppele, {G. J.} and Breems, {D. A.} and G. Stuessi and {van Norden}, Y. and M. Bargetzi and Biemond, {B. J.} and {A von dem Borne}, P. and Y. Chalandon and J. Cloos and D. Deeren and M. Fehr and B. Gjertsen and C. Graux and G. Huls and Janssen, {J. J.W.M.} and A. Jaspers and M. Jongen-Lavrencic and {de Jongh}, E. and Klein, {S. K.} and {van der Klift}, M. and {van Marwijk Kooy}, M. and Maertens, {J. A.} and L. Micheaux and {van der Poel}, {M. W.M.} and {van Rhenen}, A. and L. Tick and P. Valk and Vekemans, {M. C.} and {van der Velden}, {W. J.F.M.} and {de Weerdt}, O. and T. Pabst and Manz, {M. G.} and B. L{\"o}wenberg and Breems, {D. A.} and Havelange and I. Moors and Klein, {S. K.} and Janssen, {J. J.W.M.} and {van Esser}, {J. W.J.} and {Van der Klift}, M. and Brouwer, {R. E.} and Levin, {M. D.} and E. Vellenga and M. Hoogendoorn and Schouten, {H. C.} and J. Cornelissen and M. Jongen-Lavrencic and B. Wouters and Raaijmakers, {H. G.M.} and B. L{\"o}wenberg",

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.",

year = "2020",

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

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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.

AU - Graux, C.

AU - Huls, G.

AU - Janssen, J. J.W.M.

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. A.

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. G.

AU - Löwenberg, B.

AU - Breems, D. A.

AU - Havelange,

AU - Moors, I.

AU - Klein, S. K.

AU - Janssen, J. J.W.M.

AU - van Esser, J. W.J.

AU - Van der Klift, M.

AU - Brouwer, R. E.

AU - Levin, M. D.

AU - Vellenga, E.

AU - Hoogendoorn, M.

AU - Schouten, H. C.

AU - Cornelissen, J.

AU - Jongen-Lavrencic, M.

AU - Wouters, B.

AU - Raaijmakers, H. G.M.

AU - Löwenberg, B.

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/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).

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DO - 10.1038/s41375-020-0725-0

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AN - SCOPUS:85078895571

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

Abstract

Bibliographical note

UN SDGs

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