BERLIN, Feb. 9 /PRNewswire/ -- A new study published in this month’s issue of the Journal of the American Society of Nephrology shows that the risk of cancer in kidney transplant recipients was reduced by more than 50% at five years post transplantation in those patients who were treated with sirolimus following withdrawal of cyclosporine at three months.
Cancer is now the second most common cause of premature death in kidney transplant recipients with an incidence of up to 10 times that seen in the general population. To date this risk has largely been considered to be due to overall immunosuppression as a class effect of the drugs used.
“Post transplant malignancies are a major cause of morbidity and death associated with maintenance immunosuppression following organ transplantation,” said Dr Josep Campistol, Director of the Clinical Institute of Nephrology and Urology, of the Hospital Clinic de Barcelona. “The findings of this study are enormously important for transplant patients, not least because cancer is the second most common cause of premature death in these patients.”
He continued: “Notably this study demonstrates that sirolimus can delay the appearance and/or decrease the frequency of malignancy in these patients. Longer follow up and additional trials are therefore needed to confirm what are already promising results.”
Details of the study
In this analysis of the Rapamune Maintenance Study, 430 kidney transplant patients were randomly assigned to remain on sirolimus (SRL), cyclosporine (CsA) and steroids (ST) or to have cyclosporine withdrawn.
Skin carcinoma
Any skin cancer also included melanoma, Bowen’s disease, and non-specified skin cancers.
Intention-to-treat (ITT) analyses of any skin carcinoma are given below: * At 5 years, with regard to any skin carcinoma there were fewer lesions with cyclosporine withdrawal, 109 vs 39 (SRL-CsA-ST vs SRL-ST), and the mean annualized rates were lower, 107.7 vs 35.8 (SRL-CsA-ST vs SRL-ST). * The time to development of first skin carcinoma was delayed with cyclosporine withdrawal (median time to first skin carcinoma was 491 vs 1126 days; P = 0.007). * The relative risk of any skin carcinoma was 65% lower in those patients in whom cyclosporine was withdrawn (relative risk SRL-ST to SRL-CsA-ST 0.346; 95% confidence interval 0.227 to 0.556; P < 0.001). * The relative risk of both of the most common forms of skin carcinoma (basal cell and squamous cell carcinomas) were significantly lower with SRL+ST. Non-skin cancers
Non-skin cancers observed in the study were: lung, larynx, oropharynx, kidney, gastrointestinal tract, prostate, breast, thyroid and cervix as well as glioma, lipsosarcoma, astrocytoma, leukaemia, lymphoma and Kaposis’s Sarcoma.
The number of non-skin malignancies recorded in the patients maintained on cyclosporine was 18 compared with only 8 in the group who had cyclosporine withdrawn. Non-skin malignancy-free survival rate was higher with cyclosporine withdrawal, 90.38% vs 95.99% (SRL-CsA-ST vs SRL-ST). P = 0.032, ITT analysis.
Offering kidney transplant recipients a sirolimus-based therapy may give patients an opportunity to reduce their risk of developing cancer after a successful kidney transplant.
This analysis is one of a series of data reviews conducted of the Rapamune Maintenance Regimen study.
Barcelona
Hospital Clinic de
CONTACT: Dr Josep Campistol, Director of the Clinical Institute ofNephrology and Urology, Hospital Clinic de Barcelona, Tel:+44-20-8948-8388/ +44-7768-646430, info@pressoffice.biz
