重组人血管内皮抑制素联合吉西他滨和替吉奥方案治疗晚期肾癌的临床观察

Clinical observation on rh-Endostin combined with GS regimen in advanced renal Cell carcinoma

目的观察重组人血管内皮抑素注射液(恩度)联合吉西他滨(Gemcitabine)和替吉奥(S-1)方案治疗晚期肾癌的的近期疗效和安全性。方法将63例经病理组织学或细胞学检查确诊晚期肾癌患者随机分成2组,试验组(30例):采用恩度联合吉西他滨和替吉奥方案治疗;对照组(33例):采用单纯吉西他滨联合替吉奥化疗。4个周期后按照WHO标准评价近期疗效,参考KPS评分以及患者临床症状缓解情况评价患者的生活质量(QoL);按照WHO抗癌药物毒性反应分度标准评价毒性反应。结果试验组和对照组的客观有效率(RR)分别为70.0%和45.5%(P<0.05),临床受益率(CBR)分别为96.7%和75.8%(P<0.05);QoL改善稳定率为96.7%(29/30)和84.9%(28/33)(P>0.05);在血液学及非血液学毒性主要有中性粒细胞减少、血小板减少、恶心、呕吐、乏力、心律失常、过敏,Ⅲ级以上毒性反应发生率试验组和对照组分别为73.3%和57.6%(P>0.05);两组治疗后生活质量差异不显著(P>0.05)。结论恩度联合吉西他滨和替吉奥方案治疗晚期肾癌,近期疗效有所提高,不良反应没有增加,安全性较好。

Objective To investigate the short-term efficacy, safety and toxicities and tolerance of GS regimen combined with or without Endostar for advanced Renal Cell Carcinoma （RCC）. Methods A total of 63 patients were randomly divided into trial group （30 cases） and control group（ 33 cases）. In the trial group, the patients received endostar combined with GS regimen. In the control group, the patients received only GS regimen. The efficacy was evaluated according to RECIST criteria, quality of life （QOL） was evaluated by karnofsky. The safety was evaluated according to NCICTC 3.0 version criteria. Results The overall response rate was 70. 0% in the trial group and 45.5% in the control group respectively （P 〈 0. 05 ）. The clinical benefit rate was 96. 7% in the trial group and 75.8% in control group （ P 〈 0. 05 ）. The rates of improved and stabled QoL were 96. 7% and 84. 9% （ P 〉 0. 05 ） respectively. The main toxicities were marrow suppression and gastrointestinal symptoms. The total incidence of side effects in treatment group was higher than that of the control group, but no significance existed （P 〉 0. 05）. Condusion Endostar combined with GS regimen is effective for local advanced Renal Cell Carcinoma and can improve the quality of life. Also it is low toxic and tolerable. It may be worthy of further clinical investigation.