Kriegmair M, Oberneder R, Hofstetter A
Department of Urology, University of Munich, Germany.
Urology. 1995 May;45(5):758-62. doi: 10.1016/S0090-4295(99)80079-X.
Since the beginning of the 1980s, when gene technology provided sufficient amounts of cytokines, numerous Phase II studies in metastatic renal cell carcinoma were carried out mostly with interferon alfa (IFN-alpha) and interleukin-2 (IL-2). So far, no randomized prospective trials including untreated control groups have been reported. We present a prospective study comparing IFN-alpha and vinblastine (VBL) versus medroxyprogesterone acetate (MPA).
Immunochemotherapy schedule consists of IFN-alpha 8 million U/day subcutaneously for 3 days per week and VBL 0.1 mg/kg body weight intravenously at 3-week intervals. MPA was administrated intramuscularly at a dosage of 500 mg/week. The response rates, toxicities, and actuarial overall survival were analyzed.
The overall response rate in 41 patients receiving IFN-alpha and VBL treatment was 20.5% (95% confidence interval, 9% to 33%). Four patients reached a complete and 5 patients reached a partial remission. No remissions were observed in 35 patients of the control group. A statistically significant survival benefit for the IFN-alpha and VBL group could not be demonstrated. Excluding fever, mild to moderate toxicities were observed. About one third of patients refused the proposed schedule due to general malaise and fatigue.
A survival benefit or a favorable outcome of patients with metastatic renal cell carcinoma, treated with IFN-alpha and VBL, could not be demonstrated. As judged from this analysis, IFN-alpha and VBL therapy does not sufficiently meet the requirements of a palliative treatment of renal cell carcinoma.
自20世纪80年代初基因技术能够提供足够数量的细胞因子以来，针对转移性肾细胞癌开展了大量的II期研究，主要使用的是α干扰素（IFN-α）和白细胞介素-2（IL-2）。迄今为止，尚未有包含未治疗对照组的随机前瞻性试验报告。我们开展了一项前瞻性研究，比较IFN-α与长春碱（VBL）联合用药和醋酸甲羟孕酮（MPA）的疗效。
免疫化疗方案为：IFN-α皮下注射，800万单位/天，每周3天；VBL静脉注射，0.1毫克/千克体重，每3周1次。MPA肌肉注射，剂量为500毫克/周。分析缓解率、毒性反应及精算总生存率。
41例接受IFN-α与VBL联合治疗的患者总缓解率为20.5%（95%置信区间为9%至33%）。4例患者达到完全缓解，5例患者达到部分缓解。对照组35例患者未观察到缓解病例。IFN-α与VBL联合治疗组未显示出有统计学意义的生存获益。除发热外，观察到轻度至中度毒性反应。约三分之一的患者因全身不适和疲劳拒绝了拟定的治疗方案。
未证明IFN-α与VBL联合治疗能使转移性肾细胞癌患者获得生存获益或良好结局。从本分析判断，IFN-α与VBL联合治疗不足以满足肾细胞癌姑息治疗的需求。
