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Converting to Sirolimus From Calcineurin Inhibitors Reduces Risk of Skin Cancer in Kidney Transplant Patients: Presented at Renal Week 2009

By Kristina Rebelo

SAN DIEGO -- October 31, 2009 -- Kidney transplant patients, a group with a known high risk for nonmelanoma skin cancer (NMSC), demonstrate a significantly lower rate of NMSC by converting from calcineurin inhibitors (CNI) to sirolimus (SRL), according to a study released here at the American Society of Nephrology (ASN) Renal Week 2009.

The study -- conducted in Australia, New Zealand, and the United States -- comprised 86 kidney transplant patients, all of whom had a history of NMSC. Eligibility criteria included transplant at least 1 year out, glomerular filtration rate of at least 40 mL/min, proteinuria of no more than 500 mg/day, and an NMSC diagnosis within the past 3 years.

"The downside to transplantation, in spite of the lifesaving nature of it, is that all patients are on immunosuppressant drugs, and are more prone to cancer," explained lead investigator, Graeme Russ, MD, Queen Elizabeth Hospital, Woodville, South Australia, speaking here at a news conference on October 29. "An immunosuppressive drug that prevents rejection effectively, but is associated with lower rates of cancer, will be of significant advantage to transplant recipients."

Baseline demographics were similar between groups.

Participants were randomised (1:1) to either convert from CNI to SRL or to continue with CNI; they were stratified based on the number of NMSC lesions (0 to 5 vs 6 to 20) in the previous 12 months. Studies have shown that the incidence of skin cancer in solid-organ transplant recipients is up to 200-fold that of age-matched controls because of the necessary use of immunosuppressive drugs.

The primary endpoint was the number of new biopsy-confirmed NMSC lesions per patient-year.

The data demonstrated that the yearly rate of NMSC and proportion of patients with new NMSC was significantly lower in SRL patients, as were rates of squamous cell carcinoma. Biopsy-confirmed acute rejection was 0 in the SRL group and 1 in the CNI group. Overall, new skin cancers developed in 56% of the SRL group compared with 81% of those who remained on the standard immunosuppressant.

Discontinuations due to adverse events were higher among the SRL patients (46.2% vs 0%, P < .001); reported AEs were nonetheless consistent with the known safety profile of SRL. Treatment-emergent AEs were 97.4% and 85.1% in SRL and CNI groups, respectively (P = .067).

"With the number of side effects from the SRL, it comes down to the individual patients, and what they can tolerate," Dr. Russ concluded.

Funding for this study was provided by Wyeth Pharmaceuticals.

[Presentation title: Kidney Transplant Recipients at High Risk for Non-Melanoma Skin Cancer (NMSC) May Benefit From Conversion to Sirolimus Versus Continuation of Calcineurin Inhibitors. Abstract SA-FC350]

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