Early conversion from a cyclosporine (CsA) regimen to a sirolimus regimen results in similar patient and graft survival but better renal function and fewer malignancies at 30 months after kidney transplantation.
These results, looking at early conversion from CsA to sirolimus 12 weeks after kidney transplantation, are part of the Concept study recently published in the American Journal of Transplantation (2009;9:1115-1123) and presented here at the American Transplant Congress 2009: The Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.
"Previous studies have demonstrated a positive impact of sirolimus use on renal function at 1 year post-transplantation," Yvon Lebranchu, MD, from the University François Rabelais in Tours, France, told meeting attendees.
The Concept study initially randomized 235 patients receiving kidney transplantation. All patients were first treated with daclizumab, mycophenolate mofetil, CsA, and steroids.
At week 12, 2 groups from the original patient population (n = 192) were randomized either to maintain CsA immunosuppression (n = 97) or to switch to sirolimus (n = 95). The number of enrolled patients had declined to 152 at 30 months (71 in the sirolimus group and 81 in the CsA group).
Year 1 results showed a superior glomerular filtration rate (GFR) and Modification of Diet in Renal Disease score in the sirolimus group, compared with the CsA group (64.4 vs 56.2 mL/min per 1.73 m2).
Benefit Maintained at 30 Months
"At 30 months, we still saw a difference in GFR in favor of sirolimus, with an on-treatment GFR of 64.4 mL/min per 1.73 m2 for sirolimus vs 53.8 mL/min per 1.73 m2 for cyclosporine," said Dr. Lebranchu. "So, the benefit in renal function is maintained to 30 months."
Dr. Lebranchu highlighted the different rates of cancers in the 2 groups at the 30-month mark. One person in the sirolimus group developed a malignancy, as did 6 in the CsA group.
"The difference between the 2 groups in terms of malignancy is not significant, but I have shown that the difference tended to worsen progressively in time through 30 months," Dr. Lebranchu told Medscape Transplantation. "These are intermediate results at 30 months and I speculate that, at the final results at 4 years, there will probably be a difference in terms of malignancy, with less malignancy in the sirolimus groups."
Dr. Lebranchu explained that the rate of malignancy related to transplantation increased with time in the CsA group. "It is not a problem in the first 12 months, but after 2, 3, 5, 10 years, it starts to be. So we see here after 30 months that the percentage of malignancy is less in the sirolimus group, and I think this is an important point," he said.
"This study showed there was continued long-term benefit in terms of renal function without any adverse events, such as proven rejections," session comoderator Todd Pesavento, MD, from Ohio State University College of Medicine, Division of Nephrology in Columbus, told Medscape Transplantation. "The maintenance of improved renal function is very important."
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