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Acute myeloid leukemia

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

Leukemia volume 34, pages 1751–1759 (2020)Cite this article

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A Correction to this article was published on 30 July 2020

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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).

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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.

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

D. A. Breems30, Havelange31, M-C Vekemans31, I. Moors32, F. van Obberg33, J. A. Maertens34, B. Hodossy35, S. Vansteenweghen35, L. Lammertijn35, D. Deeren36, C. Graux37, A. Sonet37, A. Triffet38, B. T. Gjertsen11, M. Bargetzi5, J. Passweg39, D. Heim39, San Giovanni40, Georg Stuessi40, T. Pabst28, D. Betticher41, Y. Chalandon42, O. Spertini43, M. Gregor44, U. Hess45, M. Fehr45, M. G. Manz46, S. K. Klein17, B. J. Biemond6, G J Ossenkoppele47, A. van de Loosdrecht47, J J W M Janssen47, J. W. J. van Esser48, M. Van der Klift48, R. E. Brouwer49, D. Van Lammeren-Venema50, M. D. Levin51, L. W. Tick52, M. C. J. C. Legdeur53, G. Huls54, E. Vellenga54, M. Hoogendoorn55, J. H. Veelken56, P. A. von dem Borne56, H. C. Schouten57, O. de Weerdt58, W. J. F. M. van der Velden59, J. Cornelissen15, M. Jongen-Lavrencic15, B. Wouters15, H. G. M. Raaijmakers15, B. Löwenberg15, J. Kuball60, A. Van Rhenen60, M. Van Marwijk Kooy61

Author information

Authors and Affiliations

  1. Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands

    G. J. Ossenkoppele, J. Cloos & J. J. J. W. Janssen

  2. Netwerk Antwerpen, Antwerp, Belgium

    D. A. Breems

  3. Bellinzona-IOSI, Bellinzona, Switzerland

    G. Stuessi

  4. HOVON Data Center, Erasmus MC- Department of Hematology, Rotterdam, The Netherlands

    Y. van Norden

  5. Aarau- Kantonsspital, Aarau, Switzerland

    M. Bargetzi & M. Bargetzi

  6. Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands

    B. J. Biemond & B. J. Biemond

  7. Leiden University Medical Center, Leiden, Netherlands

    P. A von dem Borne

  8. University Hospital and University of Geneva, Genève, Switzerland

    Y. Chalandon

  9. Roeselare-AZ Delta, Roeselare, Belgium

    D. Deeren

  10. St Gallen-Kantonnsspital, St. Gallen, Switzerland

    M. Fehr

  11. Haukeland University Hospital, Bergen (N), Norway

    B. Gjertsen & B. T. Gjertsen

  12. Yvoir-MontGodinne, Yvoir, Belgium

    C. Graux

  13. University Medical Center, Groningen, Netherlands

    G. Huls

  14. Hôpital Citadelle, Liège (B), Belgium

    A. Jaspers, P. Valk & B. Löwenberg

  15. Erasmus University Medical Center, Rotterdam, Netherlands

    M. Jongen-Lavrencic, J. Cornelissen, M. Jongen-Lavrencic, B. Wouters, H. G. M. Raaijmakers & B. Löwenberg

  16. Dordrecht ASZ, Dordrecht, Netherlands

    E. de Jongh

  17. Meander Medical Center, Amersfoort, Netherlands

    S. K. Klein & S. K. Klein

  18. Amphia-Breda, Breda, Netherlands

    M. van der Klift

  19. Isala Hospital, Zwolle, Netherlands

    M. van Marwijk Kooy

  20. Hospital Gasthuisberg, Leuven (B), Belgium

    J. Maertens

  21. Center for Human Genetics, KU Leuven and University Hospitals Leuven, Leuven, Belgium

    L. Michaux

  22. Maastricht University Medical Center, Maastricht, Netherlands

    M. W. M. van der Poel

  23. UMC Utrecht, Utrecht, Netherlands

    A. van Rhenen

  24. MaximaMC Eindhoven, Eindhoven, Netherlands

    L. Tick

  25. Hôpital St Luc, Bruxelles, Belgium

    M. C. Vekemans

  26. Radboudumc Nijmegen, Nijmegen, Netherlands

    W. J. F. M. van der Velden

  27. St Antonius Hospital, Nieuwegein, Netherlands

    O. de Weerdt

  28. Department of Oncology, University Hospital, Inselspital and University of Bern, Bern, Switzerland

    T. Pabst & T. Pabst

  29. University Hospital, Zurich, Switzerland

    M. Manz

  30. Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium

    D. A. Breems

  31. Hôpital St. LucV, Brussels, Belgium

    Havelange & M-C Vekemans

  32. UZ Gent, Gent, Belgium

    I. Moors

  33. Hôpital. St Paul Jolimont, Haine, Belgium

    F. van Obberg

  34. UZ Gasthuisberg, Leuven, Belgium

    J. A. Maertens

  35. Citadelle, Liege, Belgium

    B. Hodossy, S. Vansteenweghen & L. Lammertijn

  36. AZ Delta, Roeselare, Belgium

    D. Deeren

  37. CHU UCLNamur (Godinne), Yvoir, Belgium

    C. Graux & A. Sonet

  38. Charleroi-CHU, Charleroi, Belgium

    A. Triffet

  39. University Hospital, Basel, Switzerland

    J. Passweg & D. Heim

  40. Ospedale San Giovanni, Bellinzona, Switzerland

    San Giovanni & Georg Stuessi

  41. Kantonsspital, Fribourg, Switzerland

    D. Betticher

  42. University Hospital (HUG), Geneva, Switzerland

    Y. Chalandon

  43. University Hospital, Lausanne, Switzerland

    O. Spertini

  44. Kantonsspital, Luzern, Switzerland

    M. Gregor

  45. Kantonsspital, St. Gallen, Switzerland

    U. Hess & M. Fehr

  46. University Hospital, Zurich, Switzerland

    M. G. Manz

  47. University Medical Center, location VUMC, Amsterdam, Netherlands

    G J Ossenkoppele, A. van de Loosdrecht & J J W M Janssen

  48. Amphia, Breda, Netherlands

    J. W. J. van Esser & M. Van der Klift

  49. RDGG, Delft, Netherlands

    R. E. Brouwer

  50. Hagaziekenhuis, The Hague, Netherlands

    D. Van Lammeren-Venema

  51. ASZ, Dordrecht, Netherlands

    M. D. Levin

  52. Maxima MC, Eindhoven, Netherlands

    L. W. Tick

  53. Medisch Spectrum Twente, Enschede, Netherlands

    M. C. J. C. Legdeur

  54. UMCG, Groningen, Netherlands

    G. Huls & E. Vellenga

  55. MCL, Heerlen, Leeuwarden, Netherlands

    M. Hoogendoorn

  56. LUMC, Leiden, Netherlands

    J. H. Veelken & P. A. von dem Borne

  57. MUMC, Maastricht, Netherlands

    H. C. Schouten

  58. St. Antonius Hospital, Nieuwegein, Netherlands

    O. de Weerdt

  59. Radboudumc, Nijmegen, Netherlands

    W. J. F. M. van der Velden

  60. University Hospital Utrecht, Utrecht, Netherlands

    J. Kuball & A. Van Rhenen

  61. Isala, Zwolle, the Netherlands

    M. Van Marwijk Kooy

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  1. G. J. Ossenkoppele
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Consortia

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

  • D. A. Breems
  • ,  Havelange
  • , M-C Vekemans
  • , I. Moors
  • , F. van Obberg
  • , J. A. Maertens
  • , B. Hodossy
  • , S. Vansteenweghen
  • , L. Lammertijn
  • , D. Deeren
  • , C. Graux
  • , A. Sonet
  • , A. Triffet
  • , B. T. Gjertsen
  • , M. Bargetzi
  • , J. Passweg
  • , D. Heim
  • , San Giovanni
  • , Georg Stuessi
  • , T. Pabst
  • , D. Betticher
  • , Y. Chalandon
  • , O. Spertini
  • , M. Gregor
  • , U. Hess
  • , M. Fehr
  • , M. G. Manz
  • , S. K. Klein
  • , B. J. Biemond
  • , G J Ossenkoppele
  • , A. van de Loosdrecht
  • , J J W M Janssen
  • , J. W. J. van Esser
  • , M. Van der Klift
  • , R. E. Brouwer
  • , D. Van Lammeren-Venema
  • , M. D. Levin
  • , L. W. Tick
  • , M. C. J. C. Legdeur
  • , G. Huls
  • , E. Vellenga
  • , M. Hoogendoorn
  • , J. H. Veelken
  • , P. A. von dem Borne
  • , H. C. Schouten
  • , O. de Weerdt
  • , W. J. F. M. van der Velden
  • , J. Cornelissen
  • , M. Jongen-Lavrencic
  • , B. Wouters
  • , H. G. M. Raaijmakers
  • , B. Löwenberg
  • , J. Kuball
  • , A. Van Rhenen
  •  & M. Van Marwijk Kooy

Corresponding author

Correspondence to G. J. Ossenkoppele.

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Members of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) are listed below Acknowledgements

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Ossenkoppele, G.J., Breems, D.A., Stuessi, G. et al. Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS. Leukemia 34, 1751–1759 (2020). https://doi.org/10.1038/s41375-020-0725-0

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