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. T. 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. Van Marwijk 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. Löwenberg, for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK)

Research output: Contribution to journalArticleAcademicpeer-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/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 languageEnglish
Number of pages9
JournalLeukemia
Volume34
Issue number7
DOIs
Publication statusE-pub ahead of print - 1 Jan 2020

Cite this

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., ... for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) and 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). https://doi.org/10.1038/s41375-020-0725-0