Verhagen Paul C M S, Wildhagen Mark F, Verkerk Annet M, Vjaters Egils, Pagi Hembo, Kukk Leonhard, Bratus Dejan, Fiala Richard, Bangma Chris H, Schröder Fritz H, Mickisch Gerald H J
Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands,
World J Urol. 2014 Oct;32(5):1287-94. doi: 10.1007/s00345-013-1206-0. Epub 2013 Nov 21.
To compare intermittent treatment (IT) versus continuous treatment (CT) using cyproterone acetate (CPA) in bone metastatic prostate cancer patients, we conducted an open-label, multicenter randomized trial. Continuous androgen deprivation therapy is the standard treatment in metastatic prostate cancer. Intermittent treatment might maintain efficacy while toxicity and costs are reduced.
Patients received CPA 100 mg tid in the prephase. Patients with a PSA decline of ≥ 90 % or PSA <4 ng/ml were randomized. If patients were progressive, LHRH analogues were added. Primary end point was time to PSA progression.
A total of 366 patients were recruited; 258 reached a good response after 3 or 6 months and were randomized. A total of 131 patients randomized to IT and 127 to CT. Patients on IT had an average of 1.7 episodes on CPA, before LHRH analogues were started. The mean time without treatment in IT was 463 days versus 422 days on treatment. There were statistical significant differences between IT and CT in 3 of the 5 functional scales of EORTC QLQ C 30; however, the clinical relevance of this finding appears modest. Symptom and potency scales showed significant advantages for IT. There were no differences in time to PSA progression on CPA, time to PSA and/or clinical progression on LHRH analogues and time to cancer-specific and overall survival.
IT by CPA is associated with less symptoms and modest advantages in QOL domains. There were no differences in time to PSA progression, clinical progression or survival.
为比较醋酸环丙孕酮（CPA）用于骨转移性前列腺癌患者的间歇性治疗（IT）与连续性治疗（CT），我们开展了一项开放标签、多中心随机试验。持续性雄激素剥夺疗法是转移性前列腺癌的标准治疗方法。间歇性治疗可能在维持疗效的同时降低毒性和成本。
患者在前期接受每日3次、每次100 mg的CPA治疗。前列腺特异性抗原（PSA）下降≥90%或PSA<4 ng/ml的患者被随机分组。如果患者病情进展，则加用促性腺激素释放激素（LHRH）类似物。主要终点为PSA进展时间。
共招募366例患者；258例在3或6个月后达到良好反应并被随机分组。共131例患者被随机分配至IT组，127例至CT组。在开始使用LHRH类似物之前，IT组患者平均接受1.7个周期的CPA治疗。IT组的平均无治疗时间为463天，而CT组的治疗时间为422天。在欧洲癌症研究与治疗组织（EORTC）QLQ C 30量表的5个功能量表中，有3个量表显示IT组和CT组之间存在统计学显著差异；然而，这一发现的临床相关性似乎不大。症状和性功能量表显示IT组具有显著优势。在CPA治疗期间的PSA进展时间、LHRH类似物治疗期间的PSA和/或临床进展时间以及癌症特异性生存时间和总生存时间方面，两组之间没有差异。
CPA间歇性治疗与较少的症状相关，并且在生活质量（QOL）方面具有一定优势。在PSA进展时间、临床进展或生存时间方面没有差异。
