Comparable relapse incidence after unrelated allogeneic stem cell transplantation with post‐transplant cyclophosphamide versus conventional anti‐graft versus host disease prophylaxis in patients with acute myeloid leukemia: A study on behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Author:

Nagler Arnon1ORCID,Ngoya Maud23,Galimard Jacques‐Emmanuel4,Labopin Myriam23,Blau Igor Wolfgang5,Kröger Nicolaus6,Gedde‐Dahl Tobias7,Schroeder Thomas8ORCID,Burns David9,Salmenniemi Urpu10,Rambaldi Alessandro11,Choi Goda12,Peffault de Latour Régis13ORCID,Vydra Jan14,Sengeloev Henrik15ORCID,Eder Matthias16,Mielke Stephan17,Forcade Edouard18,Kulagin Alexander19ORCID,Ciceri Fabio20,Mohty Mohamad23

Affiliation:

1. Division of Hematology Sheba Medical Center Tel Hashomer Israel

2. EBMT Paris Study Office, Department of Haematology Saint Antoine Hospital, INSERM UMR 938, Sorbonne University Paris France

3. Department of Haematology Saint Antoine Hospital, INSERM UMR 938, Sorbonne University Paris France

4. EBMT Statistical Unit Paris France

5. Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie Berlin Germany

6. University Hospital Eppendorf Hamburg Germany

7. Oslo University Hospital, Rikshospitalet Oslo Norway

8. University Hospital | Essen Essen Germany

9. University Hospital Birmingham NHSTrust Birmingham UK

10. HUCH Comprehensive Cancer Center Helsinki Finland

11. Department of Oncology and Hematology University of Milan and Azienda Socio‐Sanitaria Territoriale Papa Giovanni XXIII Piazza OMS Bergamo Italy

12. University Medical Center Groningen (UMCG) Groningen The Netherlands

13. Saint‐Louis Hospital, BMT Unit Paris France

14. Institute of Hematology and Blood Transfusion Prague Czech Republic

15. Rigshospitalet Herlev Denmark

16. Hannover Medical School Hannover Germany

17. Karolinska University Hospital Stockholm Sweden

18. CHU Bordeaux, Hopital Haut‐Leveque Pessac France

19. RM Gorbacheva Research Institute Pavlov University Petersburg Russia

20. IRCCS Ospedale San Raffaele Vita‐Salute San Raffaele University Milan Italy

Abstract

AbstractWe compared relapse incidence (RI) post‐unrelated transplantation with post‐transplant cyclophosphamide (PTCy) versus no PTCy graft‐versus‐host disease (GVHD) prophylaxis, in 7049 acute myeloid leukemia (AML) patients in remission, 707 with PTCy, and 6342 without (No PTCy). The patients in the PTCy group were younger, 52.7 versus 56.6 years (p < .001). There were more 9/10 donors in the PTCy group, 33.8% versus 16.4% (p < .001), and more received myeloablative conditioning, 61.7% versus 50.2% (p < .001). In the No PTCy group, 87.7% of patients received in vivo T‐cell depletion. Neutrophil and platelet engraftment were lower in the PTCy versus No PTCy group, 93.8% and 80.9% versus 97.6% and 92.6% (p < .001). RI was not significantly different in the PTCy versus the No PTCy group, hazard ratio (HR) of 1.11 (95% confidence interval [CI] 0.9–1.37) (p = .31). Acute GVHD grades II–IV and III–IV, were significantly lower in the PTCy versus the No PTCy group, HR of 0.74 (95% CI 0.59–0.92, p = .007) and HR = 0.56 (95% CI 0.38–0.83, p = .004), as were total and extensive chronic GVHD, HRs of 0.5 (95% CI 0.41–0.62, p < .001) and HR = 0.31 (95% CI 0.22–0.42, p < .001). Non‐relapse mortality (NRM) was significantly lower with PTCy versus the No PTCy group, HR of 0.67 (95% CI 0.5–0.91, p = .007). GVHD‐free, relapse‐free survival (GRFS) was higher in the PTCy versus the No PTCy group, HR of 0.69 (95% CI 0.59–0.81, p = .001). Leukemia‐free survival (LFS) and overall survival (OS) did not differ between the groups. In summary, we observed comparable RI, OS, and LFS, significantly lower incidences of GVHD and NRM, and significantly higher GRFS in AML patients undergoing unrelated donor‐hematopoietic stem cell transplantation with PTCy versus No PTCy GVHD prophylaxis.

Publisher

Wiley

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