Sirolimus for Secondary Prevention of Skin Cancer in Kidney Transplant Recipients: 5-Year Results.
Dantal J, Morelon E, et al.J Clin Oncol. 2018; 36(25):2612-2620.
Aims
To determine whether sirolimus-based immunosuppressive regimen reduces the occurrence of secondary skin cancers in a five year extension of the TUMORAPA randomised controlled trial*.
Interventions
Participants were randomised to either continue with calcineurin inhibitor–based therapy or convert to sirolimus.
Participants
120 calcineurin inhibitor–treated adult kidney transplant recipients with stable kidney function who had developed at least one invasive post-transplant cutaneous squamous cell carcinoma.
Outcomes
The primary outcome measured was survival, free of new cutaneous squamous cell carcinomas at 5 years. Secondary measured outcomes included the time of onset of new cutaneous squamous cell carcinomas, occurrence of other skin and nonskin malignancies, graft function, patient and graft survival, and the effect of the minimisation strategies on recurrence.
Follow-up
5 years
CET Conclusions
This manuscript reports the 5-year follow-up of the TUMORAPA study, where kidney transplant recipients with a previous diagnosis of squamous-cell skin cancer were randomised to either continue CNI-based immunosuppression or convert to sirolimus. In patients remaining on randomised therapy, survival free of recurrent SCC was longer and the number of new cancers was lower in the sirolimus group, with equivalent graft and patient survival. These findings were largely limited to patients switched after diagnosis of a single SCC – those with multiple previous SCCs appear to gain less benefit. Whilst these data suggest that sirolimus may be beneficial in this patient group, it should be noted that this was an on-protocol analysis. Given the poor tolerance of mTOR inhibitors, it is perhaps more useful to look to an intent-to-treat analysis to examine the likely overall benefit in a population. Also, the proportion of patients reaching 5-year follow-up was low at less than 50%.
Data analysis
Available case analysis
Quality notes
Previously assessed as *Euvrard S, et al. Sirolimus and secondary skin-cancer prevention in kidney transplantation. New England Journal of Medicine 2012; 367(4): 329-39.
Trial registration
Clinicaltrials.gov - NCT00133887 and EUDRACT 2005-004509-27