局部进展期肾癌术后靶向辅助治疗的初步研究

The Preliminary Study of Targeted Drugs as Postoperative Adjuvant Therapy for Locally Advanced Renal Cell Carcinoma

目的:探讨使用两种靶向药物(索拉非尼和舒尼替尼)术后辅助治疗局部进展期肾癌的临床疗效。方法:2008年5月～2010年8月期间先后有12例局部进展期肾癌患者入组,肾根治性切除术后随机给予索拉非尼(A组)或舒尼替尼(B组)进行辅助治疗。随访6～36个月,观察临床疗效。结果:A组6例,平均年龄(62.5±8.5)岁,肾癌根治术预后评分为(7.7±1.4)分,术后开始服药时间为(5.4±1.8)周,PFS为(16.9±12.2)个月。其中1例患者使用索拉非尼6个月后,由于原位及腹壁出现转移灶而退出该研究。B组6例,平均年龄(42.8±8.2)岁,Mayo评分为(7.2±1.5)分,术后开始服药时间为(4.1±1.8)周,无疾病进展生存期(PFS)为(13.7±4.1)个月。结论:对于手术可切除的局部进展期肾癌,术后给予靶向药物辅助治疗,有一定的疗效,长期疗效有待进一步研究证实。

Objective.To evaluate the safety and efficacy of targeted agent （Sorafenib or Sunitinib） as adjuvant therapy for locally advanced renal cell carcinoma （RCC）. Methods.. Twelve patients with locally advanced RCC were enrolled according to the inclusion criteria from May in 2008 to August in 2010. They underwent radical nephrec- tomy and were randomly administered Sorafenib （Group A） or Sunitinib （Group B） with informed consent. The efficacy and side effects were observed with at least 1 year follow-up. Results： Six patients were enrolled in Group A,with the average age （62.5±8.5） years old,Mayo score （7.7±1.4） points,drug administered time （5.4±1. 8） weeks postoperatively,progression free survival （16.9±12.2） months. One case in Group A was discontinued at the sixth month adjuvant therapy for the metastasis on abominable wall and in situ. Other six patients were enrolled in Group B, with the average age （42.8 ± 8.2） years old, Mayo score （ 7.2 ±1.5） points, drug administered time （4.1 ±1.8） weeks postoperatively, progression free survival （13.7 ± 4.1） months. No recurrence or metastasis was detected through imaging examination in Group B. Conclusions： The adjuvant therapy for advanced RCC postoperatively with targeted drugs is potentially effective and well tolerated. Results of associated trials are eagerly awaited,as they will determine the role of targeted drug in the adjuvant therapy.