Background: Everolimus was recently introduced as a second-line treatment for renal cell carcinoma (RCC) and many other cancers. A few prospective studies have shown that serum creatinine levels are increased in a signifi cant proportion of patients r...
Background: Everolimus was recently introduced as a second-line treatment for renal cell carcinoma (RCC) and many other cancers. A few prospective studies have shown that serum creatinine levels are increased in a signifi cant proportion of patients receiving everolimus. We report the incidence, risk factors and clinical signifi cance of AKI associated with everolimus treatment in patients with cancer in the paper. Methods: We analyzed patients who received everolimus for more than 4 weeks as an anti-cancer therapy. AKI is defi ned as a greater than 1.5-fold increase in creatinine levels from baseline levels. Results: AKI developed in 21 (23%) RCC patients and none of the patients (N = 17) with other cancers showed AKI. Fourteen out of 21 were considered to be an everolimus- associated AKI. The incidence of AKI increased progressively as baseline eGFR decreased (10% in subjects with eGFR >90 mL/min/1.73 m2, 17% in with eGFR 60 - 90 mL/min/1.73 m2, 28% in eGFR 30 - 60 mL/min/1.73m2, and 100% in eGFR 15 - 30 mL/min/1.73 m2, P = 0.029 for trend). Baseline eGFR was an independent risk factor for development of everolimus-associated AKI (Hazard ratio per 10 mL/min/1.73 m2 increases, 0.70; P = 0.047). Nine out of 14 patients with everolimus-associated AKI continued with a reduced dose or after a short-term off period. Four out of 14 discontinued the drug because of progression of an underlying malignancy. Only one patient stopped the drug due to AKI. Conclusions: Our study suggests that AKI was a common adverse effect of everolimus treatment, especially in subjects with impaired renal function. However, AKI occurrence did not require discontinuation of the drug, and the treatment decision should be made through a multidisciplinary approach including the assessment of oncological benefi ts of everolimus and other therapeutic options.