Tolerability of everolimus-based immunosuppression in maintenance liver transplant recipients

The aim of this study was to evaluate the tolerability of the conversion from calcineurin inhibitor (CNI) to everolimus (ERL) in maintenance liver transplant (LT) recipients.

From January 2005 to March 2008, ERL was introduced after LT as maintenance immunosuppressive therapy because of (i) de novo or recurrent cancer after LT, (ii) pre-existing liver carcinoma on the liver explant or (iii) CNI toxicity. CNI dosage was progressively reduced until discontinuation.

The study population included 94 patients, of mean age 57 ± 10. The mean delay between LT and ERL introduction was 5 ± 5 yr. After a mean follow-up of 12 ± 7 months, 70% of the patients did present at least one side effect. The mean trough level of ERL was 6 μg/L at the end of follow-up. Main side effects included hyperlipidemia (37%), dermatitis (19%), mucositis (15%), and proteinuria (18%). Biopsy-proven acute rejection occurred in 9% of patients. Global ERL discontinuation rate was 21% (16% because of side effects).

The results of our experience indicate that conversion to ERL is associated with adverse effects in 70% of patients leading to drug discontinuation in 16% (and amenable to dose reduction in the remainders). Longer follow-up periods are necessary to capture the impact of ERL fully on renal function and survival in cancer patients.