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Determinants of lenalidomide response with or without erythropoiesis-stimulating agents in myelodysplastic syndromes: the HOVON89 trial.
van de Loosdrecht, A A; Cremers, E M P; Alhan, C; Duetz, C; In 't Hout, F E M; Visser-Wisselaar, H A; Chitu, D A; Verbrugge, A; Cunha, S M; Ossenkoppele, G J; Janssen, J J W M; Klein, S K; Vellenga, E; Huls, G A; Muus, P; Langemeijer, S M C; de Greef, G E; Te Boekhorst, P A W; Raaijmakers, M H G; van Marwijk Kooy, M; Legdeur, M C; Wegman, J J; Deenik, W; de Weerdt, O; van Maanen-Lamme, T M; Jobse, P; van Kampen, R J W; Beeker, A; Wijermans, P W; Biemond, B J; Tanis, B C; van Esser, J W J; Schaar, C G; Noordzij-Nooteboom, H S; Jacobs, E M G; de Graaf, A O; Jongen-Lavrencic, M; Stevens-Kroef, M J P L; Westers, T M; Jansen, J H.
Afiliación
  • van de Loosdrecht AA; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands. a.vandeloosdrecht@amsterdamumc.nl.
  • Cremers EMP; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Alhan C; Department of Laboratory Medicine - Laboratory of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Duetz C; Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • In 't Hout FEM; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Visser-Wisselaar HA; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Chitu DA; Department of Laboratory Medicine - Laboratory of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Verbrugge A; Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Cunha SM; HOVON Foundation, Rotterdam, The Netherlands.
  • Ossenkoppele GJ; HOVON Foundation, Rotterdam, The Netherlands.
  • Janssen JJWM; Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
  • Klein SK; HOVON Foundation, Rotterdam, The Netherlands.
  • Vellenga E; HOVON Foundation, Rotterdam, The Netherlands.
  • Huls GA; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Muus P; Department of Hematology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, The Netherlands.
  • Langemeijer SMC; Department of Hematology, Meander Medisch Centrum, Amersfoort, The Netherlands.
  • de Greef GE; Department of Hematology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • Te Boekhorst PAW; Department of Hematology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • Raaijmakers MHG; Department of Hematology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • van Marwijk Kooy M; Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Legdeur MC; Department of Haematology, St. James University Hospital, Leeds, UK.
  • Wegman JJ; Department of Laboratory Medicine - Laboratory of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Deenik W; Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • de Weerdt O; Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
  • van Maanen-Lamme TM; Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
  • Jobse P; Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
  • van Kampen RJW; Department of Hematology, Isala Ziekenhuis, Zwolle, The Netherlands.
  • Beeker A; Department of Hematology, Medisch Spectrum Twente, Enschede, The Netherlands.
  • Wijermans PW; Department of Hematology, Deventer Ziekenhuis, Deventer, The Netherlands.
  • Biemond BJ; Department of Hematology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.
  • Tanis BC; Department of Internal Medicine, Tergooi Ziekenhuis, Hilversum, The Netherlands.
  • van Esser JWJ; Department of Internal Medicine, Rijnstate, Arnhem, the Netherlands.
  • Schaar CG; Department of Internal Medicine, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
  • Noordzij-Nooteboom HS; Department of Internal Medicine, Dijklander Ziekenhuis, Hoorn, The Netherlands.
  • Jacobs EMG; Department of Internal Medicine, Admiraal de Ruyter Ziekenhuis, Goes, The Netherlands.
  • de Graaf AO; Department of Internal Medicine, Zuyderland Ziekenhuis, Geleen, The Netherlands.
  • Jongen-Lavrencic M; Department of Hematology, Spaarne Gasthuis, Hoofddorp, The Netherlands.
  • Stevens-Kroef MJPL; Department of Hematology, Haaglanden Ziekenhuis, Den Haag, The Netherlands.
  • Westers TM; Department of Hematology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.
  • Jansen JH; Department of Internal Medicine, Groene Hart Ziekenhuis, Gouda, The Netherlands.
Leukemia ; 38(4): 840-850, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38297135
ABSTRACT
A randomized phase-II study was performed in low/int-1 risk MDS (IPSS) to study efficacy and safety of lenalidomide without (arm A) or with (arm B) ESA/G-CSF. In arm B, patients without erythroid response (HI-E) after 4 cycles received ESA; G-CSF was added if no HI-E was obtained by cycle 9. HI-E served as primary endpoint. Flow cytometry and next-generation sequencing were performed to identify predictors of response. The final evaluation comprised 184 patients; 84% non-del(5q), 16% isolated del(5q); median follow-up 70.7 months. In arm A and B, 39 and 41% of patients achieved HI-E; median time-to-HI-E 3.2 months for both arms, median duration of-HI-E 9.8 months. HI-E was significantly lower in non-del(5q) vs. del(5q) 32% vs. 80%. The same accounted for transfusion independency-at-week 24 (16% vs. 67%), but similar in both arms. Apart from presence of del(5q), high percentages of bone marrow lymphocytes and progenitor B-cells, a low number of mutations, absence of ring sideroblasts, and SF3B1 mutations predicted HI-E. In conclusion, lenalidomide induced HI-E in patients with non-del(5q) and del(5q) MDS without additional effect of ESA/G-CSF. The identified predictors of response may guide application of lenalidomide in lower-risk MDS in the era of precision medicine. (EudraCT 2008-002195-10).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndromes Mielodisplásicos / Hematínicos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans Idioma: En Revista: Leukemia Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndromes Mielodisplásicos / Hematínicos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans Idioma: En Revista: Leukemia Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido