Sorafenib联合化疗治疗进展期肾癌Ⅱ期临床研究

[目的]探讨Sorafenib联合吉西他滨、5-Fu治疗晚期肾细胞癌的疗效及安全性。[方法]入组转移性肾细胞癌患者19例，其中既往细胞因子治疗失败者15例。化疗方案采用吉西他滨1g／m^2，d1.8,5-Fu 400mg／m^2静脉推注d1，随后5-Fu 2．1g／m^2 46h化疗泵泵入，每4周为1个周期。同时Sorafenib治疗，400mg／次，口服，2次／d，持续使用至疾病进展或出现不可耐受的毒副反应。[结果]19例患者均可评价疗效。客观有效率37％（7／19），临床受益率79％（15／19）。6个月的PFS百分比为37％（7／19），并且该7例患者目前均无疾病进展。常见毒副作用为Ⅲ-Ⅳ度的骨髓抑制、Ⅱ度以上的手足综合征、Ⅱ度以上的胃肠道反应、Ⅱ度以上的皮疹、Ⅰ-Ⅱ度脱发、Ⅰ-Ⅱ度高血压。[结论]研究提示Sorafenib联合吉西他滨．5-Fu治疗晚期肾细胞癌表现出了较好的疗效和一定的安全性。

Phase Ⅱ Clinical Trial of Sorafenib in Combination Chemotherapy of Gemcitabine and 5-Fu in the Treatment for Advanced Renal Cell Carcinoma

[Purpose]To investigate the safety and effect of Sorafenib combined with gemcitabine plus 5-Fu for patients with advanced renal cell carcinoma. [Methods] Nineteen cases with metastatic renal cell carcinoma were eligible for this study, among them, 15 cases were failure of previous cytokine treatment. All the patients received gemcitabine （1g/m^2） on dl-.S, followed by 5-Fu bolus （400mg/m^2） on dl and 46h infusion （2.1g/m^2）, every 4 weeks as a cycle. At the same time, patients received oral Sorafenib （400mg, bid） until the disease progression or patients intolerance. [Results] Nineteen patients were evaluable for response and toxicity assessment. The overall response rate and clinical benifit were 37%（7/19）and 79%（15/19） respectively. The 6 months progression free survival was 37%（7/19）, and the 7 cases were still progression-free survival. The most common toxicity included neutropenia grade Ⅲ or Ⅳ, hand-foot syndrome grade Ⅱ or over, gastrointestinal tract toxicity grade Ⅱor over, rash grade Ⅱ or over, alopecia grade Ⅰor Ⅱ and hypertension grade Ⅰor Ⅱ. [Conclusion] The combination of Sorafenib, gemcitabine and 5-Fu is effective and safe for patients with advanced renal cell carcinoma.