索拉非尼一线治疗晚期转移性肾癌的Ⅱ期临床研究

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

目的评价索拉非尼一线治疗晚期转移性肾癌的疗效及安全性。方法转移性肾透明细胞癌患者12例，其中根治性肾切除术后出现复发或转移者11例，肿瘤侵及临近器官，原发灶无法手术切除者1例。均为初次治疗。12例均经病理检查证实为肾透明细胞癌。治疗方案：索拉非尼400mg，每日2次，持续使用至疾病进展或出现不可耐受的不良反应。结果12例患者均可评价疗效。部分缓解3例，疾病稳定7例，疾病进展2例。客观反应率25％（3／12），疾病控制率83％（10／12）。中位无进展生存期12（1～24）个月，中位生存期16（3～24）个月，6个月无进展生存率83％（10／12），1年生存率为50％（6／12）。不良反应：食欲下降7例、脱发5例、乏力5例、腹泻5例、皮疹5例、手足皮肤反应4例、高血压4例、心悸3例、黏膜出血3例、声嘶1例、肾功能损害1例。通过对症治疗，不良反应基本可以控制并耐受。结论索拉非尼一线治疗转移性肾癌可取得较高的疾病控制率，无进展生存、总生存期均明显延长，不良反应可控制。

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 unresectable 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 patients were evaluable for response and toxicity assessment. The overall objective response rate and disease 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 hypertension. Conclusion Sorafenib is effective and safe as first line treatment for patients with metastatic renal cell carcinoma.