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Sirolimus and secondary skin-cancer prevention in kidney transplantation
Sylvie Euvrard1, Emmanuel Morelon, Lionel Rostaing
1Department of Dermatology, Hospices Civils de Lyon, Edouard Herriot Hospital Group, Lyon, France. sylvie.euvrard@numericable.fr
Background:
Transplant recipients in whom cutaneous squamous-cell carcinomas develop are at high risk for multiple subsequent skin cancers. Whether sirolimus is useful in the prevention of secondary skin cancer has not been assessed.
Methods:
In this multicenter trial, we randomly assigned transplant recipients who were taking calcineurin inhibitors and had at least one cutaneous squamous-cell carcinoma either to receive sirolimus as a substitute for calcineurin inhibitors (in 64 patients) or to maintain their initial treatment (in 56). The primary end point was survival free of squamous-cell carcinoma at 2 years. Secondary end points included the time until the onset of new squamous-cell carcinomas, occurrence of other skin tumors, graft function, and problems with sirolimus.
Results:
Survival free of cutaneous squamous-cell carcinoma was significantly longer in the sirolimus group than in the calcineurin-inhibitor group. Overall, new squamous-cell carcinomas developed in 14 patients (22%) in the sirolimus group (6 after withdrawal of sirolimus) and in 22 (39%) in the calcineurin-inhibitor group (median time until onset, 15 vs. 7 months; P=0.02), with a relative risk in the sirolimus group of 0.56 (95% confidence interval, 0.32 to 0.98). There were 60 serious adverse events in the sirolimus group, as compared with 14 such events in the calcineurin-inhibitor group (average, 0.938 vs. 0.250). There were twice as many serious adverse events in patients who had been converted to sirolimus with rapid protocols as in those with progressive protocols. In the sirolimus group, 23% of patients discontinued the drug because of adverse events. Graft function remained stable in the two study groups.
Conclusions:
Switching from calcineurin inhibitors to sirolimus had an antitumoral effect among kidney-transplant recipients with previous squamous-cell carcinoma. These observations may have implications concerning immunosuppressive treatment of patients with cutaneous squamous-cell carcinomas. (Funded by Hospices Civils de Lyon and others; TUMORAPA ClinicalTrials.gov number, NCT00133887.).
Insights
Switching from calcineurin inhibitors to sirolimus significantly reduced the risk of developing new squamous cell carcinomas in transplant recipients. However, sirolimus was associated with more adverse events, leading some patients to discontinue treatment.
Area of Science:
- Immunology
- Oncology
- Transplantation Medicine
Background:
- Transplant recipients with cutaneous squamous cell carcinoma (cSCC) face a high risk of developing multiple subsequent skin cancers.
- The efficacy of sirolimus in preventing secondary skin cancer in this population remains unassessed.
Purpose of the Study:
- To evaluate the effectiveness of sirolimus in preventing secondary cutaneous squamous cell carcinoma (cSCC) in transplant recipients.
- To compare sirolimus as a substitute for calcineurin inhibitors versus maintaining initial immunosuppressive therapy.
Main Methods:
- A multicenter trial randomly assigned transplant recipients with at least one cSCC to either receive sirolimus or maintain their calcineurin inhibitor treatment.
- The primary endpoint was 2-year survival free of cSCC.
- Secondary endpoints included time to new cSCC onset, other skin tumors, graft function, and sirolimus-related adverse events.
Main Results:
- Sirolimus significantly improved survival free of cSCC compared to calcineurin inhibitors (relative risk 0.56).
- New cSCCs developed in 22% of the sirolimus group versus 39% in the calcineurin-inhibitor group (median time to onset: 15 vs. 7 months, P=0.02).
- The sirolimus group experienced more serious adverse events (0.938 vs. 0.250), with 23% discontinuing due to adverse events; graft function remained stable.
Conclusions:
- Switching from calcineurin inhibitors to sirolimus demonstrated an antitumoral effect in kidney transplant recipients with a history of cSCC.
- These findings suggest potential implications for immunosuppressive strategies in managing transplant patients at high risk for cSCC.
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