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Type: Journal article
Title: Sirolimus therapy after early cyclosporine withdrawal reduced the risk for cancer in adult renal transplantation
Author: Campistol, J.
Eris, J.
Oberbauer, R.
Friend, P.
Hutchison, B.
Morales, J.
Claesson, K.
Stallone, G.
Russ, G.
Rostaing, L.
Kreis, H.
Burke, J.
Brault, Y.
Scarola, J.
Neylan, J.
Citation: Journal of the American Society of Nephrology, 2006; 17(2):581-589
Publisher: Lippincott Williams & Wilkins
Issue Date: 2006
ISSN: 1046-6673
Statement of
Josep M. Campistol, Josette Eris, Rainer Oberbauer, Peter Friend, Brian Hutchison, José M. Morales, Kerstin Claesson, Giovanni Stallone, Graeme Russ, Lionel Rostaing, Henri Kreis, James T. Burke, Yves Brault, Joseph A. Scarola, John F. Neylan for the Rapamune Maintenance Regimen Study Group
Abstract: Sirolimus (SRL) is a mammalian target of rapamycin inhibitor that, in contrast to cyclosporine (CsA), has been shown to inhibit rather than promote cancers in experimental models. At 3 mo +/- 2 wk after renal transplantation, 430 of 525 enrolled patients were randomly assigned to remain on SRL-CsA-steroids (ST) or to have CsA withdrawn and SRL troughs increased two-fold (SRL-ST). Median times to first skin and nonskin malignancies were compared between treatments using a survival analysis. Mean annualized rates of skin malignancy were calculated, and the relative risk was determined using a Poisson model. Malignancy-free survival rates for nonskin malignancies were compared using Kaplan-Meier estimates and the log-rank test. At 5 yr, the median time to a first skin carcinoma was delayed (491 versus 1126 d; log-rank test, P = 0.007), and the risk for an event was significantly lower with SRL-ST therapy (relative risk SRL-ST to SRL-CsA-ST 0.346; 95% confidence interval 0.227 to 0.526; P < 0.001, intention-to-treat analysis). The relative risks for both basal and squamous cell carcinomas were significantly reduced. Kaplan-Meier estimates of nonskin cancer were 9.6 versus 4.0% (SRL-CsA-ST versus SRL-ST; P = 0.032, intention-to-treat analysis). Nonskin cancers included those of the lung, larynx, oropharynx, kidney, gastrointestinal tract, prostate, breast, thyroid, and cervix as well as glioma, liposarcoma, astrocytoma, leukemia, lymphoma, and Kaposi's sarcoma. Patients who received SRL-based, calcineurin inhibitor-free therapy after CsA withdrawal at month 3 had a reduced incidence of both skin and nonskin malignancies at 5 yr after renal transplantation compared with those who received SRL therapy combined with CsA. Longer follow-up and additional trials are needed to confirm these promising results.
Keywords: Humans
Immunosuppressive Agents
Disease-Free Survival
Drug Therapy, Combination
Kidney Transplantation
Drug Administration Schedule
Risk Assessment
Follow-Up Studies
Dose-Response Relationship, Drug
Description: © 2006 American Society of Nephrology
DOI: 10.1681/ASN.2005090993
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