Sirolimus reduces post-transplant skin cancer risk

Lyon, France - Patients who have undergone kidney transplants are less likely to develop skin cancer when given sirolimus for immunosuppression than if they receive calcineurin inhibitors, a French study suggests.

The study, headed by researchers at Hospices Civils de Lyon, revealed that the risk of developing new squamous cell carcinomas was cut nearly in half in patients who received sirolimus compared with those whose therapy included cyclosporine or tacrolimus. The time it took the cutaneous tumors to develop also was longer in the sirolimus group (15 months versus seven months), MedPage Today reports.

To explore the effects of switching patients from a calcineurin inhibitor to sirolimus after a first invasive squamous cell carcinoma, investigators enrolled 120 patients in a phase 3, open-label trial in which the patients were randomly assigned to continue on cyclosporine or tacrolimus or to switch to sirolimus. Participants were evaluated quarterly over the two-year study. At enrollment, 86 patients were being given cyclosporine and 36 were on tacrolimus.

Nearly 71 percent of those receiving a calcineurin inhibitor developed new squamous cell tumors, compared with 47.6 percent in the sirolimus group.

Serious adverse events were seen in 60 patients on sirolimus and in 14 of those on a calcineurin inhibitor. The occurrence of an adverse event led to discontinuation in 23 percent of the patients on sirolimus.

“Although serious adverse events were significantly more frequent in the sirolimus group than in the calcineurin-inhibitor group, the number of cutaneous squamous-cell carcinomas was (significantly) lower,” the study authors wrote.

The study was published in the New England Journal of Medicine.

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