Long-term follow-up of a prospective randomized trial comparing CYA and MTX with CYA and mycophenolate mofetil for GVHD prophylaxis in myeloablative sibling donor hematopoietic cell transplantation

Cyclosporine in combination with mycophenolate mofetil versus methotrexate for graft versus host disease prevention in myeloablative HLA‐identical sibling donor allogeneic hematopoietic cell transplantation

“…We previously reported similar incidence of acute GVHD and survival with faster hematopoietic recovery and a decrease in the incidence and severity of mucositis in a small prospective randomized trial comparing CSA and MMF with CSA and MTX in myeloablative MSD HCT [12,13]. We subsequently reported on our experience with CSA and MMF compared to CSA and MTX in a retrospective analysis spanning from 1999 to 2007, again demonstrating reductions in mucositis, time to engraftment, length of stay, as well as risk of chronic GVHD, without difference in survival or relapse [14].…”

“…Although a few small studies have demonstrated the feasibility, favorable toxicity, and comparable efficacy of MMF and a calcineurin inhibitor compared to MTX in myeloablative transplants [10][11][12][13], more recent large studies [18,19] have called into question the efficacy of MMF. We thus undertook this current retrospective study to evaluate our experience with MMF in sibling donor transplant compared to MTX.…”

HIV-1 remission following CCR5Δ32/Δ32 haematopoietic stem-cell transplantation

“…The GvHD prophylaxis was very similar and utilized standard regimens (CsA + MMF versus CsA + MTX) that in randomized studies have shown similar outcomes. 24 In both cases there was probable mild GvHD, which may have contributed to the loss of HIV-infected cells. Finally, both achieved and maintained full-donor chimerism in peripheral blood that might have contributed to reduced reservoir size 23,25 .…”

Mycophenolate mofetil administered every 8 hours in combination with tacrolimus is efficacious in the prophylaxis of acute graft versus host disease in childhood, adolescent, and young adult allogeneic stem cell transplantation recipients

“…During the last two decades, MMF has been increasingly used in combination with a calcineurin inhibitor in alloSCT recipients to replace MTX . One prospective randomized and several retrospective adult trials with HLA identical sibling alloSCTs have demonstrated no difference between CSA/MTX versus CSA/MMF in terms of aGVHD and chronic GVHD (cGVHD), relapse rate, and overall survival (OS); however, decreased mucositis in the MMF arm has been a common observation . In a phase II randomized trial in adults comparing tacrolimus/MMF to tacrolimus/MTX for aGVHD prophylaxis found similar incidence of grade II–IV aGVHD but less severe mucositis, narcotic analgesia requirement, parenteral nutrition, and earlier hospital discharge with the tacrolimus/MMF arm .…”

“…[10][11][12][13] One prospective randomized and several retrospective adult trials with HLA identical sibling alloSCTs have demonstrated no difference between CSA/MTX versus CSA/MMF in terms of aGVHD and chronic GVHD (cGVHD), relapse rate, and overall survival (OS); however, decreased mucositis in the MMF arm has been a common observation. [14][15][16][17] In a phase II randomized trial in adults comparing tacrolimus/MMF to tacrolimus/MTX for aGVHD prophylaxis found similar incidence of grade II-IV aGVHD but less severe mucositis, narcotic analgesia requirement, parenteral nutrition, and earlier hospital discharge with the tacrolimus/MMF arm. 18 Optimal dosing and monitoring of MMF and its metabolites has been a subject of extensive debate in the alloSCT literature.…”