Two-year incidence of malignancy in sirolimus-treated renal transplant recipients: results from five multicenter studies

Clin Transplant. 2004 Aug;18(4):446-9. doi: 10.1111/j.1399-0012.2004.00188.x.


We examined the rates of malignancy at 2 yr after transplantation in renal allograft patients receiving sirolimus (SRL) in continuous combination with cyclosporine (CsA), SRL as base therapy or SRL maintenance therapy after early withdrawal of CsA. A total of 1295 patients were enrolled in two double-blind studies comparing SRL with azathioprine (AZA) or placebo administered in continuous regimens with CsA. In two other trials (n = 161), SRL given as base therapy was compared with CsA. In the fifth trial, patients were randomly assigned at 3 months to either remain on CsA + SRL therapy (n = 215) or to have CsA eliminated with SRL being continued in concentration-controlled doses (n = 215). At 2 yr after transplantation, patients receiving SRL in continuous combination with CsA had a significantly lower incidence of skin cancer compared with patients receiving placebo. Patients receiving SRL as base therapy had no malignancies compared with a 5% incidence in those receiving CsA. The incidence of malignancy was significantly lower in patients receiving concentration-controlled SRL with elimination of CsA compared with those who remained on CsA + SRL. Based on the currently available data, patients receiving SRL-based therapy without CsA or SRL maintenance therapy after early CsA withdrawal have lower rates of malignancy in the first 2 yr after renal transplantation. SRL immunotherapy may be beneficial in protecting renal transplant patients from skin cancer even when given in combination with CsA.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chemoprevention
  • Cyclosporine / adverse effects
  • Drug Therapy, Combination
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Incidence
  • Kidney Transplantation* / immunology
  • Multicenter Studies as Topic
  • Neoplasms / chemically induced*
  • Neoplasms / immunology
  • Neoplasms / prevention & control
  • Neoplasms, Second Primary / chemically induced
  • Neoplasms, Second Primary / epidemiology*
  • Neoplasms, Second Primary / immunology
  • Neoplasms, Second Primary / prevention & control
  • Retrospective Studies
  • Sirolimus / therapeutic use*
  • Skin Neoplasms / chemically induced
  • Skin Neoplasms / immunology


  • Immunosuppressive Agents
  • Cyclosporine
  • Sirolimus