Preliminary report of dosage-escalated sorafenib in patients with metastatic renal cell carcinoma / 中华泌尿外科杂志

ABSTRACT

Objective To evaluate the safety and efficacy of dosage-escalated sorafenib in pa-tients with metastatic renal cell carcinoma. Methods Twelve male patients and 4 female patients with median age of 53 (37-71 years) were included in this study. They were with refractory meta-static renal-clear-cell carcinoma and received sorafenib from 800 mg/d to 1200mg/d or 1800 mg/d gradually until intolerable or disease progression occurred. Overall response rate, toxicity and progres-sion free survival (PFS) were recorded and analyzed. Results The median follow-up was 11 months (9-16 months). The overall rate of objective response and disease control rate were 44%(7/16)and 81%(13/16), respectively. Serious adverse effects (≥Grade Ⅲ) included hand-foot skin reaction (25%, 4/16), mucositis (19%, 3/16), diarrhea (19%, 3/16), hypertension (12%, 2/16) and my-elosuppression (12%, 2/16). PFS for high risk patient was 9.2 months at the end of this study. Conclusions The dosage-escalated sorafenib could obtain a high response rate and prolong PFS of high-risk patients. The toxicities are tolerable for metastatic renal cell carcinoma patients treated with sorafenib.