Background and aim: The inhibitor of the mammalian target of rapamycin (mTOR) everolimus (EVR) has shown anti-proliferative effects in experimental and clinical models. We investigated whether liver transplant (LT) recipients on EVR-based immunosuppression had comparable outcome in terms of the incidence of new-onset post-transplant malignancies (NOPTM) vs. patients receiving calcineurin inhibitors (CNI).

Materials and methods: This was a retrospective analysis of a single-center, prospectively collected database. Between January 1996 and December 2013, 1,510 LT procedures were performed on 1,437 patients. A total of 243 patients received EVR for reasons other than de novo or recurrent malignancies and were compared against 1,182 patients on CNI-based immunosuppression (total data set = 1,425 patients). Data were censored until occurrence of NOPTM, death, lost to follow-up or as of November 2014.

Results: At a median follow-up of 1,740 days (range 1-6,510), a total of 43 NOPTM was observed (3.01%). Two (0.8%) NOPTM were observed in the EVR group (median follow-up 1,050 days; range 7-2,880) and consisted of 1 skin cancer and 1 post-transplant lymphoproliferative disease (PTLD). Forty-one (3.4%) NOPTM were observed in patients on CNI (median follow-up 3,121 days; range 1-6,510) and consisted of 11 skin cancers, 7 PTLD, and 23 solid organ malignancies (EVR vs. CNI, p = 0.031). Being older at transplantation, a history of higher CNI exposure, an Epstein-Barr virus negative status at transplantation, and no exposure to EVR were all independent risk factors for NOPTM.

Conclusions: EVR utilization was associated with a reduced risk for NOPTM after LT. To the best of our knowledge, this is the first evidence to be reported for EVR-based immunosuppressive regimens.

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