In:
European Journal of Haematology, Wiley, Vol. 100, No. 5 ( 2018-05), p. 395-402
Abstract:
Although a number of studies were published on the efficacy of post‐transplantation cyclophosphamide ( PTC y) for graft‐versus‐host disease ( GVHD ) prophylaxis, no large studies prospectively evaluated this strategy in related, unrelated, and haploidentical grafts. Methods In this study, GVHD prophylaxis for 57 matched bone marrow ( MBM ) grafts consisted of single‐agent PTC y, for 88 matched PBSC grafts ( MPBSC ) consisted of PTC y, tacrolimus, and mycophenolate mofetil ( MMF ) 30 mg/kg, and for 55 mismatched grafts ( MMG s) consisted of PTC y, tacrolimus and MMF 45 mg/kg. Results The study met the primary endpoint to demonstrate equivalent rates of acute GVHD grade II ‐ IV (11%, 17%,19%, P = .46), III ‐ IV (7%, 2%, 6%, P = .41), and moderate and severe chronic GVHD (22%, 11%, 15%, P = .23). There was also no differences in non‐relapse mortality (11% vs 15% vs 17%, P = .75), overall survival (63% vs 71% vs 56%, P = .72), event‐free‐survival (51% vs 66% vs 48%, P = .32) for MBM , MPBSC , and MMG groups, respectively. Toxicity was comparable between groups except higher incidence of nephrotoxicity in combination arms ( P = .0005) and higher incidence of graft failures in MMG group ( P = .004). Conclusion The suggested risk‐adapted PTC y‐based prophylaxis is feasible and is associated with low GVHD incidence and mortality in all types of grafts. The study was registered on clinicaltrials.gov ( NCT 02294552).
Type of Medium:
Online Resource
ISSN:
0902-4441
,
1600-0609
DOI:
10.1111/ejh.2018.100.issue-5
Language:
English
Publisher:
Wiley
Publication Date:
2018
detail.hit.zdb_id:
2027114-1
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