Efficacy and safety of sorafenib for advanced renal cell carcinoma: real-world data of patients with renal impairment

We retrospectively analysed the efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with renal impairment.

Patients were divided into two groups by an estimated glomerular filtration rate (eGFR) cut-off of 45 mL/min/1. 73 m2. Background factors considered to affect prognosis were well balanced by propensity score matching between the groups. Demographics, dose modification, adverse events, tumour response, progression-free survival, and renal function (eGFR) were evaluated.

Among 935 and 2008 patients with an eGFR of <45 and ≥45, respectively, 613 pairs were matched. The mean starting dose was significantly lower in patients with an eGFR of <45; however, the mean daily dose, median treatment duration, progression-free survival, and tumour response were similar between the groups. In terms of safety, no significant differences were found in serious adverse events, although cytopaenia (16.6% vs 10.6%) and renal dysfunction (4.4% vs 0.7%) were higher in patients with an eGFR of <45 than ≥45 in all adverse events. There were also no differences in dose modification, including dose reduction, dose interruption, and treatment discontinuation.

Throughout the 12-month observation period, sorafenib in patients with an eGFR of <45 and ≥45 showed similar safety and efficacy, and treatment was continued without affecting renal function.

Oncotarget. 2018 Apr 10*** epublish ***

Katsunori Tatsugami, Mototsugu Oya, Koki Kabu, Hideyuki Akaza

Department of Urology, Graduate School of Medical Science, Kyushu University, Higashi-ku, Fukuoka City 812-8582, Japan., Department of Urology, Keio University School of Medicine, Shinjuku-ku, Tokyo 160-8582, Japan., Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Chiyoda-ku, Tokyo 100-8265, Japan., Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies/Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Meguro-ku, Tokyo 153-8904, Japan.