| Sirolimus and secondary skin-cancer prevention in kidney transplantation. | |
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MedLine Citation:
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PMID: 22830463 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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.). |
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Authors:
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Sylvie Euvrard; Emmanuel Morelon; Lionel Rostaing; Eric Goffin; Anabelle Brocard; Isabelle Tromme; Nilufer Broeders; Veronique del Marmol; Valérie Chatelet; Anne Dompmartin; Michèle Kessler; Andreas L Serra; Günther F L Hofbauer; Claire Pouteil-Noble; Josep M Campistol; Jean Kanitakis; Adeline S Roux; Evelyne Decullier; Jacques Dantal; |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 367 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2012 Jul |
Date Detail:
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Created Date: 2012-07-26 Completed Date: 2012-08-02 Revised Date: 2012-10-18 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 329-39 Citation Subset: AIM; IM |
Affiliation:
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Department of Dermatology, Hospices Civils de Lyon, Edouard Herriot Hospital Group, Lyon, France. sylvie.euvrard@numericable.fr |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00133887 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Calcineurin / antagonists & inhibitors* Carcinoma, Squamous Cell / prevention & control* Cyclosporine / adverse effects, therapeutic use Enzyme Inhibitors / adverse effects, therapeutic use Female Humans Immunosuppressive Agents / adverse effects, therapeutic use* Kidney Transplantation* Male Middle Aged Sirolimus / adverse effects, therapeutic use* Skin Neoplasms / prevention & control* Tacrolimus / adverse effects, therapeutic use |
| Chemical | |
Reg. No./Substance:
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0/Enzyme Inhibitors; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 53123-88-9/Sirolimus; 59865-13-3/Cyclosporine; EC 3.1.3.16/Calcineurin |
| Investigator | |
Investigator/Affiliation:
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Emmanuel Morelon / ; Maria Brunet / ; Cécile Chauvet / ; Sylvie Euvrard / ; Jean Kanitakis / ; Maria A Ocampo / ; Adeline L Roux / ; Evelyne Decullier / ; Claire Pouteil Noble / ; Jacques Dantal / ; Anabelle Brocard / ; Olivier Jumbou / ; Brigitte Dréno / ; Lionel Rostaing / ; Nassim Kamar / ; Eric Goffin / ; Djamila Chaib Eddour / ; Isabelle Tromme / ; Nilufer Broeders / ; Daniel Abramowicz / ; Veronique Del Marmol / ; Valérie Chatelet / ; Bruno Hurault de Ligny / ; Anne Dompmartin / ; Michèle Kessler / ; Fadia Doumat Batch / ; Andreas L Serra / ; Günther F L Hofbauer / ; Pierre Merville / ; Marie Beylot-Barry / ; Matthias Buchler / ; Laurent Machet / ; Bénédicte Janbon / ; Marie Thérèse Leccia / ; Stéphane Barbier / ; Guillaume Lair / ; Pascal Joly / ; Anne E Heng / ; Michel d'Incan / ; Christiane Mousson / ; Sophie Dalac-Rat / ; Marie France Mamzer-Bruneel / ; Céleste Lebbé / ; Michel Delahousse / ; Florence Cordoliani / ; Joseph Rivalan / ; Gilles Safa / ; Eric Alamartine / ; Frédéric Cambazard / ; Valérie Moal / ; Marie Hélène Munoz / ; Josep M Campistol / ; José-Manuel Mascaro / ; Maria Mir / ; Sonia Segura Tigell / ; Josep M Cruzado / ; Anna Jugglà Serra / ; Gabriel Bernal Blanco / ; Agueda Pulpillo / |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2012 Oct 18;367(16):1565; author reply 1565-6
[PMID:
23075186
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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