Oral mucositis after tacrolimus/sirolimus or cyclosporine/methotrexate as graft-versus-host disease prophylaxis

Oral Dis. 2021 Jul;27(5):1217-1225. doi: 10.1111/odi.13663. Epub 2020 Oct 27.

Abstract

Objectives: To 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 methods: The 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.

Results: Eighty-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.

Conclusions: The 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.

Keywords: dental; graft-versus-host disease; haematopoietic stem cell transplantation; longitudinal; mucosa.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Cyclosporine / adverse effects
  • Graft vs Host Disease* / prevention & control
  • Hematopoietic Stem Cell Transplantation* / adverse effects
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Methotrexate / adverse effects
  • Sirolimus / adverse effects
  • Stomatitis* / chemically induced
  • Stomatitis* / prevention & control
  • Tacrolimus / adverse effects

Substances

  • Immunosuppressive Agents
  • Cyclosporine
  • Sirolimus
  • Tacrolimus
  • Methotrexate