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Title: Sirolimus and secondary skin-cancer prevention in kidney transplantation
Author: Euvrard, Sylvie
Morelon, Emmanuel
Morelon, Lionel Rostaing
Goffin, Eric
Brocard, Anabelle
Tromme, Isabelle
Broeders, Nilufer
Marmol, Veronique del
Chatelet, Valérie
Dompmartin, Anne
Kessler, Michèle
Serra, Andreas L.
Hofbauer, Günther F.L.
Pouteil-Noble, Claire
Campistol Plana, Josep M.
Kanitakis, Jean
Roux, Adeline S.
Decullier, Evelyne
Dantal, Jacques
Cruzado, Josep Ma.
TUMORAPA Study Group
Keywords: Immunosupressors
Trasplantament renal
Càncer de pell
Ús terapèutic
Immunosupressive agents
Kidney transplantation
Skin cancer
Therapeutic use
Issue Date: 26-Jul-2012
Publisher: Massachusetts Medical Society
Abstract: 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 number, NCT00133887).
Note: Reproducció del document publicat a:
It is part of: New England Journal of Medicine, 2012, vol. 367, num. 4, p. 329-339
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ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Medicina)

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