Efficacy and safety of sorafenib in advanced renal cell carcinoma patients: Results from a long-term study.

Sorafenib has been confirmed as an effective drug in advanced renal cell carcinoma (RCC). This study aimed to evaluate the long-term efficacy and safety of sorafenib in ethnic Chinese patients with advanced RCC, and to develop optimal treatment strategies for Asian patients. Between May 2006 and August 2011, 30 patients with advanced RCC were treated with sorafenib in the Oncology Center, Tongji Hospital. All 30 patients received continuous treatment with 400 mg of sorafenib orally twice daily until disease progression or intolerable toxicities or mortality occurred. Dose reduction to 600 mg daily or even less was required if toxicities of grade 3 or 4 occurred. Patients were assessed for tumor response, progression-free survival (PFS), overall survival (OS) and drug-related toxicities. The median follow-up time was 58 weeks (range, 12-270). Among the 30 patients, 1 patient had complete remission (CR 3.3%), 4 patients had partial remission (PR 13.3%), 19 patients had stable disease (SD 63.3%) and 6 patients had disease progression (PD 20%). The disease control rate (DCR, CR+PR+SD) was 80%, the median PFS time was 14 months, and the median OS time was 16 months. Only 1 patient discontinued sorafenib treatment permanently due to severe toxicities. Dose reduction or interruption was required in 12 patients (40%) who developed adverse events of grade 3 or 4. Seven of these patients tolerated the dose of 600 mg per day well, and experienced clinical benefit. The Kaplan-Meier method and log-rank test revealed that the Memorial Sloan-Kettering Cancer Center (MSKCC) status was a prognostic factor for PFS and OS in advanced RCC. The long-term efficacy and safety of sorafenib were confirmed in Chinese advanced RCC patients who showed an even greater benefit in PFS. The findings of this study indicate that a dose of 600 mg instead of 400 mg per day may be an optimal choice for Asian patients when a reduction of the initial dose is required.