1. The CONVERT Trial Source: Alberú J, Pascoe MD, Campistol JM, et al. Lower malignancy rates in renal allograft recipients converted to sirolimus-based, calcineurin inhibitor-free immunotherapy: 24-month results from the CONVERT trial. Transplantation. 2011;92(3):303–310.

2. Background: There exists a correlation between immunosuppression and malignancy risk. Long-term immunosuppression leads to increase in the malignancy risk in recipients of renal allograft. This also leads to a significant increase in the overall morbidity and mortality.

3. Aim: To examine the malignancy rates in renal allograft recipients at 2 years after conversion to a sirolimus (SRL)-based, calcineurin inhibitor (CNI)-free regimen.

4. Methods: Study design: Open-label, randomized, multicenter study (the CONVERT trial). Patients: 830 patients randomly assigned to SRL conversion (n=555) or CNI continuation (n=275). Patients with the history of post-transplant lymphoproliferative disease or known/suspected malignancy within 5 years before screening were excluded. Skin and non-skin malignancies were reported, even with the discontinuation of the therapy. Exposure time to study drugs (i.e., number of events per 100 person- years of follow-up) was the basis of analysis of malignancy rates.

5. Results: Significantly lower total number of malignancies per 100 person-years of exposure was observed among SRL conversion patients compared to CNI continuation (2.1 vs 6.0, p<0.001) at 2 years. Significantly lower rates of the sub-set of non-melanoma skin carcinomas through 2 years post-conversion (1.2 vs 4.3, p<0.001) observed in patients undergoing SRL-based, CNI-free therapy. Non-significant difference in the rate of all other malignancies observed between the two treatment groups (p=0.058).

6. Conclusion: The event rate of malignancy at 2 years in renal allograft recipients is lower with SRL-based immunosuppression compared to CNI-based therapy. This difference in the rate of malignancy was primarily due to reduction in non- melanoma skin carcinoma rates.