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Comparison of mycophenolate mofetil and calcineurin inhibitor versus calcineurin inhibitor-based graft-versus-host-disease prophylaxis for matched unrelated donor transplant in acute myeloid leukemia. A study from the ALWP of the EBMT

Bone Marrow Transplantation volume 56, pages 1077–1085 (2021)Cite this article

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Abstract

The association of Cyclosporine A (CsA) and mycophenolate mofetil (MMF) has increased in the setting of reduced intensity conditioning (RIC). Nevertheless, the use of CsA or CsA+MMF has not been reported in a large and uniform cohort. We analyzed 497 patients with acute myeloid leukemia in complete remission (CR) who underwent matched unrelated donor (MUD) hematopoietic stem cell transplantation (HSCT). All patients received a fludarabine busulfan RIC regimen and anti-thymocyte globulin (ATG) with either CsA alone or in combination with MMF. The cumulative incidence (CI) of grade II–IV acute GvHD was 27% (95% CI 21–33%) for CsA and 33% (95% CI 27–38%) for CsA+MMF (p = 0.25). The 2-year CI of chronic GvHD was 38% (95% CI 31–45%) and 33% (95% CI 28–39%) for the CsA and the CsA+MMF group, respectively (p = 0.26). On multivariate analysis, no statistically significant differences with respect to relapse incidence (RI), non-relapse mortality (NRM), leukemia-free survival (LFS), overall survival (OS), acute and chronic GvHD were found between the two groups, also when conducting a subgroup analysis in peripheral blood stem cells (PBSC) recipients. Our results support the importance of randomized trial to identify patients who could benefit from the addition of MMF in MUD HSCT.

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Fig. 1: Acute GvHD.
Fig. 2: Chronic GvHD.
Fig. 3: Cumulative incidence of NRM, RI, LFS and OS.
Fig. 4: GRFS.

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Acknowledgements

The authors thank all the EBMT transplant centers that have contributed data in this study.

Author information

Authors and Affiliations

  1. Sorbonne University, Service d’Hématologie Clinique et Thérapie cellulaire, Hôpital Saint-Antoine, INSERM UMRs 938, Paris, France

    Annalisa Paviglianiti, Myriam Labopin & Mohamad Mohty

  2. Programme de Transplantation & Thérapie Cellulaire, Centre de Recherche en Cancérologie de Marseille, Institut Paoli Calmettes, Marseille, France

    Didier Blaise

  3. Hopital St. Louis, Department of Hematology – BMT, Paris, France

    Gerard Socié

  4. CHU Grenoble Alpes - Université Grenoble Alpes, Service d’Hématologie, Grenoble, France

    Claude Eric Bulabois

  5. Hopital de Hautepierre, CHU de Strasbourg, Service Hématologie adulte, F-67200, Strasbourg, France

    Bruno Lioure

  6. CHU Lapeyronie, Département d’Hématologie Clinique, Montpellier, France

    Patrice Ceballos

  7. Charité Universitaetsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik m. S. Hämatologie/Onkologie, Berlin, Germany

    Igor Wolfgang Blau

  8. C.H.R.U de Brest, Service Onco-Hematologie, Brest, France

    Gaelle Guillerm

  9. University Hospital Gasthuisberg, Department of Hematology, Leuven, Belgium

    Johan Maertens

  10. CHU Nantes, Département d’Hématologie, Nantes, France

    Patrice Chevallier

  11. CHU - Institut Universitaire du Cancer Toulouse, Oncopole, I.U.C.T-O, Toulouse, France

    Anne Huynh

  12. CHRU Limoges Service d’Hématologie Clinique, Limoges, France

    Pascal Turlure

  13. Hopital Jean Minjoz, Service d’Hématologie, Besancon, France

    Eric Deconinck

  14. CHU Bordeaux, Service d’hematologie et thérapie Cellulaire, F-, 33000, Bordeaux, France

    Edouard Forcade

  15. Chaim Sheba Medical Center, Tel-Hashomer, Tel-Aviv University, Tel-Aviv, Israel

    Arnon Nagler

  16. Acute Leukemia Working Party Office, Paris, France

    Arnon Nagler

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  1. Annalisa Paviglianiti
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Contributions

AP and MM designed the study, AP, MM, and AN wrote the manuscript, ML performed the statistical analysis, DB, GS, CEB, BL, PC, IWB, GG, JM, PC, AH, PT, ED, EF, and AN provided cases for the study. All authors edited and approved the final version of the manuscript.

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Correspondence to Annalisa Paviglianiti.

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Paviglianiti, A., Labopin, M., Blaise, D. et al. Comparison of mycophenolate mofetil and calcineurin inhibitor versus calcineurin inhibitor-based graft-versus-host-disease prophylaxis for matched unrelated donor transplant in acute myeloid leukemia. A study from the ALWP of the EBMT. Bone Marrow Transplant 56, 1077–1085 (2021). https://doi.org/10.1038/s41409-020-01155-z

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