生物化疗联合沙利度胺治疗晚期肾癌的临床观察

The clinical observation of the therapeutic effect of biochemotherapy and thalidomide on advanced renal carcinoma.

目的 观察生物化疗加沙利度胺对晚期肾癌的治疗作用。方法 选取病理证实均为肾细胞癌的晚期肾癌后患者61例。分两组：①对照组23例行生物化疗；②实验组38例行生物化疗加沙利度胺治疗。所有病人均行病肾姑息切除术或肾动脉栓塞术，术后1—2周开始生物化疗。生物化疗方法：IL-2200万U／次，3次／周皮下注射；IFN-2a300万u／次，3次／周皮下注射；IL-2和IFN-2a均用42周。5-FU500mg加入5％葡萄糖液500ml缓慢静脉滴注（4—6h），第1-5天。21d为1周期，共4-6周期。沙利度胺用法为400mg／d，分2次口服，服用1年或至病情进展。结果 近期疗效两组均无CR病例。对照组PR5例，有效率（CR＋PR）21．7％；实验组PR18例，有效率（CR＋PR）47．4％，两组差异有显著性（P〈0．05）。两组未见严重不良反应发生。疾病进展期对照组4．7个月，平均5．2个月，实验组6-9个月，平均7个月。随访12个月对照组成活11例，1年生存率为43．4％；实验组成活19例，1年生存率为50％。随访24个月，对照组5例生存。生存率17．4％；实验组7例生存，生存率18．4％，两组差异无显著性（P〉0．05）。结论 生物化疗加沙利度胺对晚期肾癌的治疗与生物化疗相比，能提高近期疗效和延长疾病进展时间，对1年和2年生存率无差别。

Objective To evaluate the effect of biochmothetapy （recombinant interferon-2α,recombinant interleukin-2 plus 5- fluovouracil） plus thalidomide in the advanced renal cell canclnoma （RCC） ;Methods Overall 61 patients with advanced RCC underwent pallative nephrectomy or renal arterial embollzation. These cases were assigned to 2 groups, ① biochemotherapy group included 23 case, they were treated with subcutaneous interferon-2α （ IFN-2a）, interleukin-2 （ IL-21,5-fluourouracil （ 5-FU） ; ② biochemotherapy plus thalidomide group included 38 cases. The biochemotherapic courses consisted of IFN-2a （3×10^6U3times/w）. IL-2 （2×10^6U 3 times/ w） and 5-FU （500mg per day, continuous infusion for 5 days tin a 21-day cycle, total 4 to 6 cycles）, the IFN-2a and the IL-2 wcre totally used fo 42 weeks. Thalidomide was continuously administered at a dose of 400 mg twice daffy orally for one year or advantage of disease. The main outcome measure was the response rate and toxin responas;secondary outcomes were disease progressed time and overall survival rate. Results The overall response rate was 21.7 percent （no case complete response and 5 case partial response） in the biochemotherapy group and 47.4 percent （no case complete response and 18 ease partial response） in the biochemothcrapy plus thalidomide group （ P 〈 0.05） .There were not severely slde-effect in both groups.The median time to disease progression was 5.2 months in the biocbcmotherapy group and 7 months in the biocbcmotherapy plus thalidomide group. There was no significant difference in one-year and two-year survival rate in both groups （43.4 percent versus 50 percent for one-year survival rate, 17.4 percent versus 18.4 percent for two-year survival rate）.Conclusion Both groups did not show significant effect on one-year and two-year survival rate in those patients, but the biochemotherapy and thalidomide group lengthened disease progressed time and advanced the overall response rate.