Cyclophosphamide-tacrolimus-mycophenolate mofetil for post- HSCT GVHD prophylaxis

Bolaños-Meade J, Hamadani M, Wu J, et al. Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis. New England Journal of Medicine. 2023; (doi: 10.1056/NEJMoa2215943).

A Phase III trial found that cyclophosphamide-tacrolimus-mycophenolate mofetil therapy led to greater relapse-free survival without graft-versus-host-disease (GVHD) among patients undergoing allogeneic human leukocyte antigen (HLA)-matched hematopoietic stem-cell transplantation (HSCT) compared with standard prophylaxis. For the study, adult patients with hematologic cancers were randomized to receive an experimental prophylaxis consisting of cyclophosphamide-tacrolimus-mycophenolate mofetil or standard prophylaxis with tacrolimus–methotrexate. Following reduced-intensity conditioning, patients received HSCT from an HLA-matched related donor or a matched or 7/8 mismatched unrelated donor. GVHD-free, relapse-free survival was much higher among the 214 patients in the experimental-prophylaxis cohort vs. the 217 patients in the standard-prophylaxis group. At 1 year, the adjusted GVHD-free, relapse-free survival rates for the experimental and standard-prophylaxis groups were 52.7% and 34.9%, respectively. Less severe acute or chronic GVHD appeared to be more common among the experimental-prophylaxis group at 1 year, with an increased incidence of immunosuppression-free survival. Neither cohort differed significantly in terms of overall and disease-free survival, relapse, transplantation-related death, and engraftment.

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Tags: GVHD, Cellular therapy, HSCT, Transplant, Graft versus host disease, cell therapy, graft-versus-host

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