Few data are available about sorafenib use in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis. No systematic review has been previously performed about this issue. The objective of the present review is to investigate pharmacokinetics and clinical outcomes of sorafenib in mRCC patients undergoing hemodialysis.
According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all the literature about mRCC dialysis patients receiving sorafenib, published from January 1946 to August 2015, was evaluated. Applying inclusion/exclusion criteria, 11 articles were selected for the analysis; 1 patient from our department was also included. The investigated outcomes were pharmacokinetics, toxicity, response rate, progression-free survival, and overall survival where available. A total of 36 patients were included. Median treatment duration was 6.0 months on overall population; median progression-free survival was 6.3 months (calculated on 19 patients); response rate was 22% (on 29 patients); median overall survival was 14.9 months (on 28 patients). Of note, 24 patients started sorafenib at reduced dose; 6 of 36 patients (17%) required dose reduction due to adverse events (AEs). Sorafenib treatment was discontinued in 7 patients (19%) because of AEs. Most of AEs were Grade 1-2; severe toxicities (Grade 4-5) included G4 anemia (1 case), G4 hypertension (1 case), G4 cerebellar hemorrhage (1 patient), and a case of G5 subarachnoid hemorrhage. This review confirmed the efficacy of sorafenib treatment in mRCC patients receiving hemodialysis. Nevertheless, drug toxicity seems to be increased in these patients, despite the initiation of therapy at reduced doses; therefore, sorafenib should be used with caution in dialysis patients.
Clinical genitourinary cancer. 2016 Jan 28 [Epub ahead of print]
Alessandro Leonetti, Melissa Bersanelli, Bruno Castagneto, Cristina Masini, Giovanni Di Meglio, Benedetta Pellegrino, Sebastiano Buti
Medical Oncology Unit, University Hospital of Parma, Parma, Italy., Medical Oncology Unit, University Hospital of Parma, Parma, Italy., Department of Oncology, San Giacomo Hospital Novi Ligure, Alessandria, Italy., Division of Medical Oncology, University Hospital of Modena, Modena, Italy., Medical Oncology Unit, Hospital of Bolzano, Bolzano, Italy., Medical Oncology Unit, University Hospital of Parma, Parma, Italy., Medical Oncology Unit, University Hospital of Parma, Parma, Italy.