晚期肾癌一线治疗的临床对照研究

Clinical controlled trial of first-line treatment for advanced kidney cancer

目的研究不同治疗方法对晚期肾癌患者一线治疗的疗效。方法通过前瞻性对照研究方法将2006--2011年收治的82例晚期肾癌患者分为3组，分别给予吉西他滨联合白细胞介素2（IL一2）（A组，n=30）、奥沙利铂联合卡培他滨化疗（B组，n=30）及单药索拉非尼治疗（C组，n=22）。结果76例患者有完整的数据资料，A、B、C组治疗总有效率分别为39．3％（11／28）、37．0％（10／27）、38．1％（8／21），差异无统计学意义（x。=0．029；P=0．986）；中位疾病无进展期（PFS）分别为9．1个月（95％CI：7．9～10．3个月）、7．5个月（95％CI：5．5～9．5个月）、10．9个月（95％CI：10．5～11．3个月），差异有统计学意义（P=0．013）；日均治疗费用分别为人民币490、498、501元，差异无统计学意义（P=1．240）。因毒性反应退出研究：A组2例，B组3例，C组0例。结论对于不能一线选择索拉非尼的晚期肾癌患者，奥沙利铂联合卡培他滨化疗可取得与吉西他滨联合IL-2治疗相似的早期疗效，而且在患者耐受度上也相似。

Objective To estimate the efficacies of different first-line treatments for advanced stage kidney cancer. Methods For this observation controlled trial, a total of 82 cases with advanced stage kidney cancer from 2006 to 2011 were recruited. They were divided into 3 groups and accepted gemcitabine plus interleukin-2 （IL-2） （ Group A）, oxaliplatin plus capecitabine （ Group B ） or sorafenib alone （ Group C ）. Results Among them, 76 patients had complete data. The overall response rates of A-C groups were 39. 3% （11/28）, 37.0% （10/27）and 38.1% （8/21）respectively. And there was no significant difference （ X2 = O. 029, P = 0. 986 ）. And their progression-free survival （ PFS ） rates were 9. 1 （ 95% CI： 7.9 - 10. 3 ） , 7.5 （ 95 % CI： 5.5 - 9. 5 ） and 10.9 （ 95 % CI： 10. 5 - 11.3 ） months respectively. And there were significant differences （P = 0. 013 ）. Average daily treatment costs were 490, 498 and 501 Chinese yuan respectively. And there was no significant difference （P = 1. 240 ）. Because of toxicity, 2 and 3 cases withdrew in Groups A and B respectively. Conclusion Gemeitabine plus IL-2 and oxaliplatin plus eapecitabine have similar early effieacies and tolerance profiles for the patients who can not accept sorafenib as first-line treatment.