Denis L J, Carnelro de Moura J L, Bono A, Sylvester R, Whelan P, Newling D, Depauw M
Department of Urology, AZ Middelheim, Antwerp-Vrije Universiteit Brussels, Belgium.
Urology. 1993 Aug;42(2):119-29; discussion 129-30. doi: 10.1016/0090-4295(93)90634-m.
Maximal androgen blockade (MAB), the eradication of the effects of adrenal androgens on prostate cancer cells after castration, has been used with differing success in the treatment of prostatic carcinoma. The aim of this randomized phase III study was to compare the efficacy and side effects of bilateral orchiectomy versus a combination of a luteinizing hormone-releasing hormone agonist (LHRH-A) depot formulation, goserelin acetate (3.6 mg s.c. once every four weeks), and flutamide (250 mg three times daily), in patients with metastatic cancer. Treatment usually continued until disease progression (or for a minimum of three months). Efficacy was assessed by response, time to disease progression, and duration of survival. Clinical evaluations, standard laboratory tests, and imaging examinations were carried out regularly. A total of 327 patients were entered in this study. There was a difference in response only for prostatic acid phosphatase (PAP) with a more frequent decrease of the serum values to normal in the serum in patients assigned to MAB treatment. The MAB treatment, however, proved significantly better for time to subjective progression, time to objective progression, time to first (subjective and objective) progression, and duration of survival. The most frequent side effects for both treatments included hot flushes and gynecomastia. In conclusion, significant time to progression and survival benefits are achieved by adding flutamide to an LHRH-A regimen, probably improving the quality of life of patients with metastatic cancer.
最大雄激素阻断（MAB），即去势后消除肾上腺雄激素对前列腺癌细胞的作用，在前列腺癌治疗中的应用效果各异。这项随机III期研究的目的是比较双侧睾丸切除术与促黄体生成素释放激素激动剂（LHRH-A）长效制剂醋酸戈舍瑞林（3.6毫克皮下注射，每四周一次）和氟他胺（250毫克，每日三次）联合用药，对转移性癌症患者的疗效和副作用。治疗通常持续至疾病进展（或至少三个月）。通过反应、疾病进展时间和生存时间评估疗效。定期进行临床评估、标准实验室检查和影像学检查。本研究共纳入327例患者。仅前列腺酸性磷酸酶（PAP）的反应存在差异，接受MAB治疗的患者血清值降至正常的情况更频繁。然而，MAB治疗在主观进展时间、客观进展时间、首次（主观和客观）进展时间和生存时间方面明显更好。两种治疗最常见的副作用包括潮热和乳腺增生。总之，在LHRH-A方案中添加氟他胺可显著延长疾病进展时间并提高生存率，可能改善转移性癌症患者的生活质量。
