Sirolimus Prevents Secondary SCC in Kidney Transplant Recipients

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(ChemotherapyAdvisor) – Recipients of kidney transplants who develop squamous cell carcinoma (SCC) can prevent secondary skin cancers by switching from calcineurin inhibitors to sirolimus, which had an antitumoral effect, investigators reported in the New England Journal of Medicine July 26, 2012.

“The data suggest that the earlier the conversion occurs after an initial diagnosis of cutaneous SCC, the greater the efficacy,” Sylvie Euvrard, MD, of Hospices Civils de Lyon, Edouard Herriot Hospital Group, Lyon, France, reported on behalf of members of the TUMORAPA Study Group. Skin cancers affect more than 50% of organ-transplant recipients over the course of their lives.

The multicenter trial randomly assigned transplant recipients who had at least one cutaneous SCC while taking calcineurin inhibitors either to remain on therapy (n=56) or to switch to sirolimus in lieu of calcineurin inhibitors (n=64).

The sirolimus group had a significantly longer survival free of cutaneous SCC compared with the calcineurin-inhibitor group. At 2 years, new SCC had developed in 14 patients (22%) in the sirolimus group (6 after withdrawal of sirolimus) and in 22 (39%) of those in the calcineurin-inhibitor group.

Median time until onset of SCC was 15 months in the sirolimus arm vs. 7 months in the calcineurin-inhibitor arm (RR 0.56 [95% CI, 0.32–0.98]; P=0.02).

The sirolimus arm had more serious adverse events (AEs) than the calcineurin-inhibitor arm, 60 vs 14. Among patients converted to sirolimus with rapid protocols, twice as many AEs occurred than in those converted with progressive protocols. In the sirolimus group, 23% of patients discontinued the drug due to AEs. Graft function remained stable in both treatment arms.


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