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Transfusion independence after lenalidomide discontinuation in patients with del(5q) myelodysplastic neoplasm: a HARMONY Alliance study

Leukemia (2024)Cite this article

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Abstract

Lenalidomide (LEN) can induce red blood cell-transfusion independence (RBC-TI) in 60–70% of del(5q) myelodysplastic neoplasm (MDS) patients. Current recommendation is to continue LEN in responding patients until failure or progression, with likelihood of toxicity and a high cost for healthcare systems. This HARMONY Alliance study investigated the outcome of MDS del(5q) patients who discontinued LEN while RBC-transfusion independent. We enrolled 118 patients with IPSS-R low-intermediate risk. Seventy patients (59%) discontinued LEN for intolerance, 38 (32%) per their physician decision, nine (8%) per their own decision and one (1%) for unknown reasons. After a median follow-up of 49 months from discontinuation, 50/118 patients lost RBC-TI and 22/30 who underwent cytogenetic re-evaluation lost complete cytogenetic response. The median RBC-TI duration was 56 months. In multivariate analysis, RBC-TI duration after LEN discontinuation correlated with low transfusion burden before LEN therapy, treatment ≥ 12 LEN cycles, younger age and higher Hb level at LEN withdrawal. Forty-eight patients were re-treated with LEN for loss of response and 28 achieved again RBC-TI. These data show that stopping LEN therapy in MDS del(5q) patients who reached RBC-TI allows prolonged maintenance of TI in a large subset of patients.

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Fig. 1: Red blood cell transfusion independence (RBC-TI) duration after lenalidomide discontinuation.
Fig. 2: Event free survival (EFS) after lenalidomide discontinuation.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The Authors thank all the patients and families who participated in the study. The authors are fully responsible for all content and editorial decisions for this manuscript. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under HARMONY Grant Agreement n° 116026. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Program and EFPIA. E.C. was partially supported by “FPRC 5 per mille 2019 Ministero Salute, progetto IDEE” and “Italian Ministry of Health, Ricerca Corrente 2024”. M.D.C was partially supported by PI20/00970. V.S. was supported by AIRC IG-26537-2021 Investigator Research Grant.

Author information

Author notes

  1. These authors contributed equally: Elena Crisà, Valeria Santini

Authors and Affiliations

  1. Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy

    Elena Crisà

  2. Fondazione Sindromi Mielodisplastiche FISiM-ETS, Bologna, Italy

    Elena Crisà, Daniela Barraco, Anna Calvisi, Isabella Capodanno, Rosanna Ciancia, Monica Crugnola, Carlo Finelli, Claudio Fozza, Chiara Frairia, Giuseppe Pietrantuono, Antonella Poloni & Valeria Santini

  3. Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain

    Elvira Mora

  4. Department of Hematology, Oncology and Clinical Immunology, Universitätsklinik Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

    Ulrich Germing & Andrea Kündgen

  5. Hématologie clinique, hôpital Necker. Assistance publique hôpitaux de Paris (APHP), Paris, France

    Cecile Bally

  6. Hematology, Institute for Biomedical Research of Salamanca (IBSAL), University Hospital of Salamanca, Salamanca, Spain

    Maria Diez Campelo & Guillermo Sanz

  7. Hematology Research Unit Helsinki, University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland

    Mikko Myllymäki & Eva Hellstrom-Lindberg

  8. Department of Hematology M64 Karolinska University Hospital, Stockholm, Sweden

    Martin Jädersten

  9. Malignant Hematology Department, Moffitt Cancer Center, Tampa, FL, USA

    Rami Komrokji & Najla H. Al Ali

  10. Department of Hematology, Cellular Therapy,Hemostaseology and Infectiology, University Hospital Leipzig, Leipzig, Germany

    Uwe Platzbecker & Anne Sophie Kubasch

  11. Clinics of Hematology and Medical Oncology, University Medical Center Göttingen, Göttingen, Germany

    Detlef Haase & Christina Ganster

  12. Department of Hematology and Oncology, University Hospital Mannheim, Heidelberg University, Heidelberg, Germany

    Wolf-Karsten Hofmann

  13. Dipartimento di Ematologia - ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi, Varese, Italy

    Daniela Barraco

  14. Hematology Department. Hospital Son Llatzer, Mallorca, Spain

    Juan José Bargay

  15. Hematology Department. Hospital Central de Asturias, Oviedo, Spain

    Teresa Bernal

  16. Hematology Department. Hospital Clinico Universitario de Salamanca, Salamanca, Spain

    Felix López Cadenas

  17. UOC Ematologia CTMO, Osp San Francesco Nuoro, Nuoro, Italy

    Anna Calvisi

  18. SOC Ematologia Azienda USL-IRCSS di Reggio Emilia, Reggio Emilia, Italy

    Isabella Capodanno

  19. Hematology-University Hospital Città della Salute e della Scienza, Turin, Italy

    Marco Cerrano

  20. Hematology- Hospital Città della Salute e della Scienza, Turin, Italy

    Marco Cerrano & Chiara Frairia

  21. IRCCS Centro di Riferimento Oncologico (CRO) di Aviano (Pordenone), Aviano, Italy

    Rosanna Ciancia

  22. Hematology Unit and BMT center University Hospital of Parma, Parma, Italy

    Monica Crugnola

  23. IRCCS Azienda Ospedaliero-Universitaria di Bologna, Institute of Hematology “Seràgnoli”, Bologna, Italy

    Carlo Finelli

  24. Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy

    Claudio Fozza

  25. Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland

    Ebeling Freja

  26. Hematology Department. Hospital Gemans Trias i Pujol, Badalona, Spain

    Maria Jose Jimenez

  27. Unità Operativa Complessa (UOC) Ematologia, Ospedale Belcolle, Viterbo and Division of Cellular Biotechnology and Hematology, Sapienza University, Rome, Italy

    Roberto Latagliata

  28. Hematology Department. Hopital Unversitario Virgen de las Nieves, Granada, Spain

    Francisca Hernandez Mohedo

  29. Hematology Department. Hospital Universitario Vall D’Hebron, Barcelona, Spain

    Antonieta Molero

  30. Hematology Department. Hospital de Cruces, Barakaldo, Spain

    Miriam Vara Pampliega

  31. Hematology Department. Hospital Universitario Reina Sofia, Cordoba, Spain

    Clara Aparicio Perez

  32. IRCCS CROB, Referral Cancer Center of Basilicata, Rionero In Vulture, Italy

    Giuseppe Pietrantuono

  33. Hematology, Università Politecnica Marche - AOU Marche, Ancona, Italy

    Antonella Poloni

  34. Hematology Department. ICO Duran i Reynals, L’Hospitalet de LLobregat, LLobregat, Spain

    Helena Pomares

  35. Valle Recasens. Hematology Department. Hospital Miguel Servent, Zaragoza, Spain

    Valle Recasens

  36. Division of Hematology, Luzerner Kantonsspital-in association with University Luzern, Luzern, Switzerland

    Axel Rüfer

  37. Department of Health Sciences - Section of Biostatistics University of Genoa, Genova, Italy

    Alessio Signori

  38. Service d’Hématologie Séniors, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France

    Pierre Fenaux

  39. CIBERONC, ISCIII, Madrid, Spain

    Guillermo Sanz

  40. MDS Unit, Hematology, DMSC, AOU Careggi, University of Florence, Florence, Italy

    Valeria Santini

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  1. Elena Crisà
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  2. Elvira Mora
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  44. Valeria Santini
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Contributions

E.C. designed the study, collected and analyzed data, performed statistical analysis and wrote the paper; V.S. designed the study, discussed and analyzed results and wrote the paper; A.S. performed statistical analysis and wrote statistical methods of the paper; all the authors treated the patients, collected data, reviewed and approved the manuscript.

Corresponding authors

Correspondence to Elena Crisà or Valeria Santini.

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Competing interests

U.P. declares honoraria and research support from BMS, Curis, Amgen, Abbvie, Novartis. P.F declares honoraria and research support from BMS. M.D.C. declares honoraria from BMS, Novartis, Keros, Blueprint Medicines, GSK, Agios, Hemavan, Syros, Curis, Astex/Otsuka; U.G. declares honoraria from BMS, Novartis and research support from BMS, Novartis, Abbvie, Jazz. C.F. declares honoraria from Sobi and research support from Sanofi, Amgen, BMS. R.K declares honoraria from Abbvie, BMS, DSI, Geron, Janssen, Jazz, Pharma Essentia, Rigel, Servio, Sobi, Sumitomo Pharma. C.F. declares honoraria from Novartis, Takeda, BMS and research support from BMS. G.S. declares honoraria from BMS, Chugai Pharma, AstraZeneca, GSK, Novartis, ExCellThera and research support from Novartis, BMS, Janssen, Takeda, Amgen, Menarini, Bayer, Pfizer. M.C. declares honoraria from Insight, Novartis, Servier, Abbvie, Janssen, Jazz, Astellas, Otsuka, Italfarmaco and Amgen. D.H. declares honoraria and research support from BMS. VS. declares honoraria from Abbvie, BMS, CTI, Curis, Keros, Geron, Novartis, Syros, Servier, travel grant from Jazz and Janssen. All the other authors have no COI to declare.

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Crisà, E., Mora, E., Germing, U. et al. Transfusion independence after lenalidomide discontinuation in patients with del(5q) myelodysplastic neoplasm: a HARMONY Alliance study. Leukemia (2024). https://doi.org/10.1038/s41375-024-02360-1

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