The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) expanded access trial: Subset analysis of patients (pts) with brain metastases (BM)

15506 Background: Sorafenib (SOR) was demonstrated to be safe and effective in a phase III trial of previously treated RCC pts; however, pts with BM were excluded. BM occur in 5–10% of RCC pts, and generally portend a poor prognosis. Safety and efficacy of SOR in this pt population was therefore explored in a subset analysis of ARCCS, a community-based expanded access program. Methods: Pts received SOR 400 mg bid in this open-label, nonrandomized trial if they were =15 years old with advanced RCC and had ECOG PS of 0–2. Pts with BM were included but required to have some prior local therapy for their brain lesions. Prior treatment did not have to be successful, and pts whose BM had been surgically removed were also eligible for this protocol. BM were excluded as target lesions for RECIST unless they were the only lesions being followed. Major exclusion criteria included treatment with other investigational drugs within 4 wks of enrollment; life expectancy <2 mos; active coronary artery disease, ischemia, or hypertension; and severe renal impairment requiring dialysis. The primary endpoints were safety and efficacy (per investigator assessed RECIST criteria). Results: Of 2,488 ARCCS pts valid for safety, 65 (2.6%) had been previously treated for BM: 72.3% male with median age 59.5 yrs. 99% had =1 prior therapy for non-brain disease including 81.5 % radiotherapy, 78.5% nephrectomy and 47.7% prior systemic therapy. Grade 3 adverse events (AE) occurring >2% in this subset were fatigue and seizure (6.2% each) and hand-foot skin reaction, diarrhea, hemoglobin, mucositis, dehydration, vomiting, hyperglycemia, and thrombosis (3.1% each). In the total ARCCS population vs the BM subset, Grade 3 AEs were 35.2% vs 26.2% and Grade 4 AEs were 6.1% vs 9%. There were no CNS-related bleeding events in pts with BM. Of the 47 pts evaluable for response, partial response was reported in 2 (4%), stable disease in 33 (70%), and progressive disease in 12 (26%). Conclusions: The toxicity and efficacy of SOR in pts with brain mets in ARCCS were comparable to those observed in the whole study population. Of note, SOR was well tolerated in this study with no reports of cerebral hemorrhagic events. [Table: see text]

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