844P - Efficacy and Safety of Sorafenib in Japanese Patients on Hemodialysis with Metastatic Renal Cell Carcinoma

Abstract

ABSTRACT Aim: We investigated the efficacy and safty of sorafenib in paients on hemodialysis (HD) with metastatic renal cell carcinoma (mRCC). Methods: Eighteen patiens undergoing HD were treated with sorafenib as the first therapy for mRCC at our hospital between August 2008 and February 2014. Medical reords of these patients were retrospectively reviewed. Sorafenib was initially administered at 200 mg daily, and was increased up to a maintenance dose of 400-600 mg daily. Results: All patients were male, and the median age was 62.5 years. Thirteen patients (72.2%) were classified as the intermediate risk group, and the other 5 patients into a poor risk group, according to the Memorial Sloan-Kettering Cancer Center (MSKCC) risk model. Sixteen patients (88.9%) had four or more metstases, and 7 patiens (38.9%) had metastases in two or more organs. Of 14 patients who underwent prior nephrectomy, 8 patients (44.4%) were pathologically diagnosed with non-clear cell carcinoma. The mean duration of sorafenib therapy was 8 months. Five patients (27.8%) received 600 mg daily, 8 patients (44.4%) 400 mg daily, and 5 patients (27.8%) 200 mg daily as a maintenance dose. Sorafenib was discontinued due to progressive disease in 7 patinets (38.9%) and due to serious adverse events (AEs) (>grade3) in 6 patients (33.3%), including heart faiure in two (11.1%), anorexia in two (11.1%), subarachnoid hemorrhage in one (5.6%), interstitial pneumonia in one (5.6%), sepsis in one (5.6%), and syncope in one (5.6%). Median progression free survival was 6.3 months and median over all survival (OS) was 14.2 months. Multivariate analysis showed pretreatment elevated CRP (CRP > 5.0 mg/dl) as the only independent predictor for poor OS (CRP > 5.0: HR = 46.5, 95%CI 3.4-1518.5, p = 0.0033). The median OS of 6 patients (33.3%) with elevated CRP was 4.2 months, whereas that of 12 patients with non-elevated CRP was 14.7 months (p Conclusions: In this study, many paients had unfavorable clinical features such as MSKCC poor risk and multple metastases in multiple organs. Sorafenib treatment in patients with mRCC on HD appears to be feasible, but careful monitoring is needed because of a proclivity for higher incidence of serious AEs even with a reduced dose. Other treatment should be considered in patients with pretreatment elevated CRP whose prognosis may be poor under treatment with sorafenib. Disclosure: All authors have declared no conflicts of interest.