Abstract
ObjectivesTo determine whether treatment with tacrolimus plus sirolimus (Tac/Sir) as a prophylaxis for graft‐versus‐host disease worsens severe oral mucositis and delays healing compared to cyclosporine plus methotrexate (CsA/Mtx) following haematopoietic stem cell transplantation.Subjects and MethodsThe study comprised 141 patients: 73 randomized to receive Tac/Sir and 68 to receive CsA/Mtx. The oral mucositis assessment scale and toxicity grading according to WHO were used to assess the severity, peak and duration of oral mucositis from the day −3 to day 24 post‐transplant.ResultsEighty‐seven patients developed oral mucositis in the first 24 days post‐transplant. No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed. The peak oral mucositis score occurred on day 10 in both groups. Although oral mucositis scores had returned to baseline in the CsA/Mtx group on day 24 post‐transplant, no significant difference compared with the Tac/Sir group was found.ConclusionsThe introduction of tacrolimus/sirolimus as a graft‐versus‐host disease prophylaxis in haematopoietic stem cell transplantation increased neither the incidence nor severity of oral mucositis compared with cyclosporine/methotrexate. Furthermore, oral mucositis healing was not prolonged and followed the same time pattern as cyclosporine/methotrexate.
Highlights
Allogeneic haematopoietic stem cell transplantation (HSCT) is a curative treatment for otherwise lethal haematopoietic disorders (Goldstone & Rowe, 2009; Negrin, 2014; Sureda et al, 2015)
In the main clinical trial, patients were randomized in a prospective, open-label, phase III, multicentre trial comparing tacrolimus plus sirolimus (Tac/Sir) and cyclosporine and methotrexate (CsA/Mtx) as graft-versus-host disease (GVHD) prophylaxis in the setting of HSCT; they were enrolled at one centre in Stockholm, Sweden (September 2007 to January 2014), and one centre in Turku, Finland (January 2010 to December 2011)
The present study found that, as a GVHD prophylaxis of Oral mucositis (OM), Tac/ Sir following HSCT increased neither the incidence nor severity of OM compared with CsA/Mtx
Summary
Allogeneic haematopoietic stem cell transplantation (HSCT) is a curative treatment for otherwise lethal haematopoietic disorders (Goldstone & Rowe, 2009; Negrin, 2014; Sureda et al, 2015). Continual advancement in transplant procedures has steadily improved patient outcome over time, but graft-versus-host disease (GVHD) remains a serious complication of HSCT Both acute and chronic GVHD contribute significantly to morbidity and mortality after treatment (Deeg, 2007; Gooley et al, 2010; Remberger et al, 2011; Ziakas et al, 2014). Aside from HSCT, a high incidence of painful oral ulcers has been reported in the kidney transplant setting (van Gelder et al, 2003) These efforts to address GVHD, including new combinations of immunosuppressive drugs and new immunosuppressive strategies, confer a risk of new side effects. The aim of the present study, a substudy of the previous clinical trial, was to determine whether treatment with Tac/Sir as prophylaxis for GVHD worsens severe OM and delays healing compared to the standard regimen of CsA/Mtx
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