Phase Ⅱ study of sorafenib as first line treatment in patients with metastatic renal cell carcinoma

VernacularTitle:索拉非尼一线治疗晚期转移性肾癌的Ⅱ期临床研究
Author: Chuanliang CUI ; Jianhui MA ; Jun GUO ; Aiping ZHOU ; Jinwan WANG
Publication Type:Journal Article
Keywords: Carcinoma,renal cell; Neoplasm metastasis; First-line treatment; Clinical tri-als,phase Ⅱ; Sorafenib
From: Chinese Journal of Urology 2009;30(1):15-17
CountryChina
Language:Chinese
Abstract: Objective To evaluate the safety and efficacy of sorafenib as first line treatment in patients with metastatic renal cell carcinoma. Methods Eleven patients with metastatic renal cell carcinoma after radical nephrectomy and 1 patient with locally advanced renal cell carcinoma and unre-sectable primary renal tumor were eligible for this study. The regimen was oral intake of sorafenib (400 mg twice daily) until the disease progression or toxicity becoming intolerable. Results All pa-tients were evaluable for response and toxicity assessment. The overall objective response rate and dis-ease control rate were 25%(3/12) and 83%(10/12, 3 partial responses and 7 disease stabilizations). The actuarial 6-month progression-free survival was 83% (10/12), while the median survival time was 16 months. The most common adverse effects included hand-foot skin reaction, rash, alopecia and hy-pertension. Conclusion Sorafenib is effective and safe as first line treatment for patients with meta-static renal cell carcinoma.