Pizzocaro G, Piva L, Salvioni R, Di Fronzo G, Ronchi E, Miodini P
J Urol. 1986 Jan;135(1):18-21. doi: 10.1016/s0022-5347(17)45501-7.
From July 1, 1979 to June 30, 1983, 136 consecutive patients with category M0 renal cell cancer who had undergone transperitoneal radical nephrectomy at 5 centers entered a prospective randomized trial to compare 500 mg. adjuvant medroxyprogesterone 3 times a week for 1 year to no treatment. Sex steroid hormone receptors also were studied in the renal tumor and in the surrounding healthy parenchyma with the dextran-coated charcoal technique. After a median followup period of 3 years (range 13 to 60 months) 30 of 121 evaluable patients (24.8 per cent) experienced relapse, usually in the lung or bones. Relapses occurred in 15 of 58 evaluable patients in the adjuvant treatment group (25.8 per cent) and 15 of 63 evaluable controls (23.8 per cent). The disease recurred more frequently (35.1 per cent) in the 57 patients with no receptors in the tumor than in the 45 with at least 1 receptor (17.8 per cent). These results were independent of adjuvant therapy. After a median 3-year followup, adjuvant medroxyprogesterone acetate was of no therapeutic benefit in patients who had undergone radical nephrectomy and the side effects of the therapy were evident in more than 50 per cent of the patients.
1979年7月1日至1983年6月30日,5个中心连续136例M0期肾细胞癌患者接受了经腹根治性肾切除术,进入一项前瞻性随机试验,比较每周3次、每次500毫克辅助性甲羟孕酮治疗1年与不治疗的效果。还采用葡聚糖包被活性炭技术对肾肿瘤及周围健康实质组织中的性甾体激素受体进行了研究。中位随访期3年(范围13至60个月)后,121例可评估患者中有30例(24.8%)出现复发,通常为肺部或骨转移。辅助治疗组58例可评估患者中有15例(25.8%)复发,63例可评估对照组中有15例(23.8%)复发。肿瘤无受体的57例患者疾病复发更频繁(35.1%),而至少有1种受体的45例患者复发率为17.8%。这些结果与辅助治疗无关。中位随访3年后,辅助性醋酸甲羟孕酮对接受根治性肾切除术的患者无治疗益处,且超过50%的患者出现明显的治疗副作用。