Safety and efficacy of sorafenib in elderly patients (pts) ≥65 years: A subset analysis from the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) Expanded Access Program in North America

Abstract

5045 Background: Sorafenib, an orally active multikinase inhibitor, has been approved by the US Food and Drug Administration for the treatment of advanced RCC. Prior to the drug’s approval for RCC, the North American ARCCS expanded access program was initiated to make sorafenib available to patients (pts) who were not eligible for or did not have access to sorafenib clinical trials in the United States and Canada. Because sorafenib is likely to be used in elderly pts with advanced RCC, we evaluated its safety and efficacy profile in a subset of pts ≥65 years (yrs) who enrolled in the ARCCS program. Methods: Eligible pts were ≥15 yrs of age with advanced RCC, Eastern Cooperative Oncology Group performance status of 0–2 (with waivers granted for pts with status 3–4), and adequate prior therapy of brain metastases. Major exclusion criteria included treatment with other investigational drugs in the 4 weeks prior to enrollment; life expectancy <2 months; active coronary artery disease, ischemia or hypertension...