Two-year randomized controlled prospective trial converting treatment of stable renal transplant recipients with cutaneous invasive squamous cell carcinomas to sirolimus.
Hoogendijk-van den Akker JM, Harden PN, et al.Journal of Clinical Oncology. 2013; 31(10): 1317-1323
Aims
To investigate whether the conversion from standard immunosuppression to sirolimus-based immunosuppression decreases the rate of new invasive squamous cell carcinomas (SCC).
Interventions
Following the withdrawal of purine antagonist or calcineurin inhibitors the conversion group were administered sirolimus. The control group immunosuppressive regimen did not change during the study period.
Participants
155 first or second kidney transplant recipients >12 months post transplant with stable graft function, aged ≥18 years. No acute rejection episodes for at least 12 weeks before randomisation and recipients were on calcineurin inhibitors, azathioprine, mycophenolate and/or steroids.
Outcomes
The primary outcome included the development of cutaneous invasive SCC. The secondary outcomes included incidence, severity, and reversibility of biopsy-confirmed acute rejection episodes, patient and graft survival, and renal function.
Follow-up
2 years.
CET Conclusions
The author’s findings were in contrast to some previous studies in that they were not able to show a benefit at two years in converting renal transplant recipients to sirolimus with respect to their squamous cell cancer free survival. It should also be noted that there were a large number of withdrawals from side effects of the mTOR inhibitors.
Data analysis
Available case analysis
Trial registration
ISRCTN98226084