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  • Löwenberg, BobErasmus Univ Med Ctr MC, Rotterdam, Netherlands.;Erasmus MC Canc Inst, Rotterdam, Netherlands. (author)

Addition of lenalidomide to intensive treatment in younger and middle-aged adults with newly diagnosed AML : the HOVON-SAKK-132 trial

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-02-22
  • American Society of Hematology,2021
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-440998
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-440998URI
  • https://doi.org/10.1182/bloodadvances.2020003855DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Lenalidomide, an antineoplastic and immunomodulatory drug, has therapeutic activity in acute myeloid leukemia (AML), but definitive studies about its therapeutic utility have been lacking. In a phase 3 study, we compared 2 induction regimens in newly diagnosed patients age 18 to 65 years with AML: idarubicine-cytarabine (cycle 1) and daunorubicin and intermediate-dose cytarabine (cycle 2) without or with lenalidomide (15 mg orally on days 1-21). One final consolidation cycle of chemotherapy or autologous stem cell transplantation (auto-SCT) or allogeneic SCT (allo-SCT) was provided according to a prognostic risk and minimal residual disease (MRD)-adapted approach. Event-free survival (EFS; primary end point) and other clinical end points were assessed. A second random assignment in patients in complete response or in complete response with incomplete hematologic recovery after cycle 3 or auto-SCT involved 6 cycles of maintenance with lenalidomide (10 mg on days 1-21) or observation. In all, 392 patients were randomly assigned to the control group, and 388 patients were randomly assigned to lenalidomide induction. At a median follow-up of 41 months, the study revealed no differences in outcome between the treatments (EFS, 44% +/- 2% standard error and overall survival, 54% = 2% at 4 years for both arms) although in an exploratory post hoc analysis, a lenalidomide benefit was suggested in SRSF2-mutant AML. In relation to the previous Dutch-Belgian Hemato-Oncology Cooperative Group and Swiss Group for Clinical Cancer Research (HOVON-SAKK) studies that used a similar 3-cycle regimen but did not pursue an MRD-guided approach, these survival estimates compare markedly more favorably. MRD status after cycle 2 lost prognostic value in intermediate-risk AML in the risk-adjusted treatment context. Maintenance with lenalidomide showed no apparent effect on relapse probability in 88 patients randomly assigned for this part of the study.

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  • Pabst, ThomasInselspital Bern, Bern, Switzerland. (author)
  • Maertens, JohanUniv Hosp Gasthuisberg, Leuven, Belgium. (author)
  • Gradowska, PatrycjaErasmus MC Canc Inst, Dutch Belgian Hematooncol Cooperat Grp Data Ctr, Rotterdam, Netherlands. (author)
  • Biemond, Bart J.Amsterdam Univ Med Ctr, Amsterdam, Netherlands. (author)
  • Spertini, OlivierUniv Lausanne UNIL, Lausanne Univ Hosp, Ctr Hosp Univ Vaudois, Lausanne, Switzerland. (author)
  • Vellenga, EdoUniv Groningen, Univ Med Ctr, Groningen, Netherlands. (author)
  • Griskevicius, LaimonasVilnius Univ Hosp, Santaros Klin, Vilnius, Lithuania.;Vilnius Univ, Vilnius, Lithuania. (author)
  • Tick, Lidwine W.Maxima Med Ctr, Eindhoven, Netherlands. (author)
  • Jongen-Lavrencic, MojcaErasmus Univ Med Ctr MC, Rotterdam, Netherlands.;Erasmus MC Canc Inst, Rotterdam, Netherlands. (author)
  • Kooy, Marinus van MarwijkIsala Hosp, Zwolle, Netherlands. (author)
  • Vekemans, Marie-ChristianeUniv Hosp St Luc, Brussels, Belgium. (author)
  • van der Velden, Walter J. F. M.Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands. (author)
  • Beverloo, BernaErasmus Univ MC, Dept Clin Genet, Rotterdam, Netherlands. (author)
  • Michaux, LucienneKatholieke Univ Leuven, Ctr Human Genet, Leuven, Belgium.;Univ Hosp Leuven, Leuven, Belgium. (author)
  • Graux, CarlosUniv Catholique Louvain Namur Godinne, Yvoir, Belgium. (author)
  • Deeren, DriesAZ Delta, Roeselare, Belgium. (author)
  • de Weerdt, OkkeSt Antonius Hosp, Nieuwegein, Netherlands. (author)
  • van Esser, Joost W. J.Amphia Hosp, Breda, Netherlands. (author)
  • Bargetzi, MarioKantonsspittal, Aarau, Switzerland. (author)
  • Klein, Saskia K.Meander Med Ctr, Amersfoort, Netherlands. (author)
  • Gadisseur, AlainUniv Hosp Antwerpen, Edegem, Belgium. (author)
  • Westerweel, Peter E.Albert Schweitzer Hosp, Dordrecht, Netherlands. (author)
  • Veelken, HendrikUniv Med Ctr, Leiden, Netherlands. (author)
  • Gregor, MichaelLuzerner Kantonsspittal, Luzern, Switzerland. (author)
  • Silzle, TobiasKantonsspittal, St Gallen, Switzerland. (author)
  • Van Lammeren-Venema, DanielleHaga Hosp, The Hague, Netherlands. (author)
  • Moors, IneUniv Hosp, Ghent, Belgium. (author)
  • Breems, Dimitri A.Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium. (author)
  • Hoogendoorn, MelsMed Spectrum Leeuwarden, Leeuwarden, Netherlands. (author)
  • Legdeur, Marie-Cecile J. C.Med Spectrum Twente, Enschede, Netherlands. (author)
  • Fischer, ThomasOtto von Guericke Univ Hosp Magdeburg, Magdeburg, Germany. (author)
  • Kuball, JuergenUniv Med Ctr Utrecht, Utrecht, Netherlands. (author)
  • Cornelissen, JanErasmus Univ Med Ctr MC, Rotterdam, Netherlands.;Erasmus MC Canc Inst, Rotterdam, Netherlands. (author)
  • Porkka, KimmoHelsinki Univ Hosp Canc Ctr, Helsinki, Finland. (author)
  • Juliusson, GunnarSkanes Univ Hosp, Lund, Sweden. (author)
  • Meyer, PeterStavanger Univ Hosp Rogaland, Stavanger, Norway. (author)
  • Höglund, MartinUppsala universitet,Hematologi(Swepub:uu)martinhl (author)
  • Gjertsen, Bjorn T.Haukeland Hosp, Bergen, Norway. (author)
  • Janssen, Jeroen J. W. M.Amsterdam Vrije Univ, Med Ctr, Amsterdam, Netherlands. (author)
  • Huls, GerwinUniv Groningen, Univ Med Ctr, Groningen, Netherlands. (author)
  • Passweg, JakobUniv Hosp, Basel, Switzerland. (author)
  • Cloos, JacquelineAmsterdam Vrije Univ, Med Ctr, Amsterdam, Netherlands. (author)
  • Valk, Peter J. M.Erasmus Univ Med Ctr MC, Rotterdam, Netherlands.;Erasmus MC Canc Inst, Rotterdam, Netherlands. (author)
  • van Elssen, Catharina H. M. J.Univ Med Ctr, Maastricht, Netherlands. (author)
  • Manz, Markus G.Univ Hosp, Zurich, Switzerland. (author)
  • Floisand, YngvarOslo Univ Hosp, Oslo, Norway. (author)
  • Ossenkoppele, Gert J.Amsterdam Vrije Univ, Med Ctr, Amsterdam, Netherlands. (author)
  • Erasmus Univ Med Ctr MC, Rotterdam, Netherlands.;Erasmus MC Canc Inst, Rotterdam, Netherlands.Inselspital Bern, Bern, Switzerland. (creator_code:org_t)

Related titles

  • In:Blood Advances: American Society of Hematology5:4, s. 1110-11212473-95292473-9537

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