Two-Year Randomized Controlled Prospective Trial Converting Treatment of Stable Renal Transplant Recipients With Cutaneous Invasive Squamous Cell Carcinomas to Sirolimus
- 1 April 2013
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 31 (10), 1317-1323
- https://doi.org/10.1200/jco.2012.45.6376
Abstract
In light of the significant morbidity and mortality of cutaneous invasive squamous cell carcinomas (SCCs) in renal transplant recipients, we investigated whether conversion to sirolimus-based immunosuppression from standard immunosuppression could diminish the recurrence rate of these skin cancers. In a 2-year randomized controlled trial, 155 renal transplant recipients with at least one biopsy-confirmed SCC were stratified according to age (< 55 v ≥ 55 years) and number of previous SCCs (one to nine v ≥ 10) and randomly assigned to conversion to sirolimus (n = 74) or continuation of their original immunosuppression (n = 81). Development of a new SCC within 2 years after random assignment was the primary end point. After 2 years of follow-up, the risk reduction of new SCCs in the multivariable analysis was not significant, with a hazard ratio (HR) of 0.76 (95% CI, 0.48 to 1.2; P = .255), compared with a non–sirolimus-based regimen. After the first year, there was a significant 50% risk reduction, with an HR of 0.50 (95% CI, 0.28 to 0.90; P = .021) for all patients together and an HR of 0.11 (95% CI, 0.01 to 0.94; P = .044) for patients with only one previous SCC. The tumor burden of SCC was reduced during the 2-year follow-up period in those receiving sirolimus (0.82 v 1.38 per year; HR, 0.51; 95% CI, 0.32 to 0.82; P = .006) if adjusted for the number of previous SCCs and age. Twenty-nine patients stopped taking sirolimus because of various adverse events. Conversion to sirolimus-based immunosuppression failed to show a benefit in terms of SCC-free survival at 2 years.Keywords
This publication has 30 references indexed in Scilit:
- A Case–Control Study of Betapapillomavirus Infection and Cutaneous Squamous Cell Carcinoma in Organ Transplant RecipientsAmerican Journal of Transplantation, 2011
- Incidence of cancer in kidney-transplant recipients: A long-term cohort study in a single centerCancer Epidemiology, 2011
- Subsequent Squamous- and Basal-Cell Carcinomas in Kidney-Transplant Recipients After the First Skin Cancer: Cumulative Incidence and Risk FactorsTransplantation, 2010
- Seven-Year Prospective Study of Nonmelanoma Skin Cancer Incidence in U.K. Renal Transplant RecipientsTransplantation, 2007
- Cancer Incidence Among Canadian Kidney Transplant RecipientsAmerican Journal of Transplantation, 2007
- Cancer Incidence Before and After Kidney TransplantationJama-Journal Of The American Medical Association, 2006
- Subsequent Skin Cancers in Kidney and Heart Transplant Recipients after the First Squamous Cell CarcinomaTransplantation, 2006
- Clinicopathologic features of skin cancer in organ transplant recipients: A retrospective case-control seriesJournal of the American Academy of Dermatology, 2006
- Skin Cancers after Organ TransplantationThe New England Journal of Medicine, 2003
- INCIDENCE OF SKIN CANCER AFTER RENAL TRANSPLANTATION IN THE NETHERLANDSTransplantation, 1990