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20%～30%肾癌患者确诊时已出现转移,局限性肾癌患者术后也有20%～40%发生转移。传统化疗、放疗及糖皮质激素治疗均不能有效防止肾癌进展,转移性肾癌患者的预后较差,IL-2和IFN-α是目前仅有的免疫治疗方法,但疗效有限。近来,随着对肿瘤血管生成的有关机制的关注,针对以受体和调控血管生成信号分子为靶点的新药开发日渐成熟。首个口服多激酶抑制剂sorafenib,以丝氨酸-苏氨酸和受体酪氨酸激酶为作用靶点,抑制肿瘤细胞的增殖和肿瘤血管的形成。Ⅲ期临床研究显示,与安慰剂相比,本品可使患者无进展生存期延长1倍。本品于2005年12月经美国FDA快速审获批准用于晚期肾癌的治疗。
20% ~ 30% of patients with renal cell carcinoma have been diagnosed with metastasis, localized renal cell carcinoma patients also have 20% to 40% of the transfer. Traditional chemotherapy, radiotherapy and glucocorticoid therapy can not effectively prevent the progression of renal cell carcinoma, and the prognosis of patients with metastatic renal cell carcinoma is poor. IL-2 and IFN-α are the only immunotherapy methods currently available, but the curative effect is limited. Recently, with the focus on the mechanisms involved in tumor angiogenesis, development of new drugs targeting receptors and regulatory signaling molecules has matured. The first oral multikinase inhibitor, sorafenib, targets serine-threonine and receptor tyrosine kinases and inhibits tumor cell proliferation and tumor blood vessel formation. Phase III clinical studies show that compared with placebo, this product can prolong the progression-free survival of patients doubled. This product was quickly approved by the FDA in December 2005 for the treatment of advanced renal cell carcinoma.