Goldenberg SL, Gleave ME, Taylor D, Bruchovsky N
Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
Mol Urol. 1999;3(3):287-292.
This report reviews the long-term follow-up of a prospective Phase II evaluation of intermittent androgen suppression in the treatment of prostate cancer. A total of 87 patients have been entered in this protocol. At the time of this report, 50 men have been followed for a minimum of 3 years. Treatment was initiated with combined androgen blockade and continued for at least 6 months until a serum PSA nadir was observed. Medication was then withheld until the serum PSA increased to mean values between 10 and 20 ng/mL. This cycle of treatment and no treatment was repeated until the regulation of PSA became androgen independent. The total time in the study ranges from 40 to 126 months, with a mean of 65.5 months. The off-treatment period in the first cycle for the men with long-term follow-up was associated with an improvement in the sense of well-being and recovery of libido and potency in men who reported normal or near-normal sexual function before the start of therapy. The average time off therapy (percentage time off therapy) for cycles 1, 2, 3, and 4 was 15 months (54%), 10 months (48%), 8 months (45%), and 7 months (40%), respectively. The study group included 9 patients treated because of a rising PSA concentration after radiation therapy for locally advanced cancer. These patients have been off therapy for an average of 22 and 13 months in treatment cycles 1 and 2, respectively. Six patients with rising PSA values after radical prostatectomy and with follow-up exceeding 36 months have been off therapy for an average of 19 and 11 months in treatment cycles 1 and 2, respectively. Of the 87 patients, 23 have had their disease progress to androgen independence at a median of 32 months of treatment, and 13 have died cancer-specific deaths at a median of 48 months. Prostate cancer is amenable to control by intermittent androgen suppression. This approach affords an improved quality of life when the patient is off therapy, with reduced toxicity and costs. Phase II trials suggest that there is not a negative impact on patient outcome. Randomized protocols are currently in progress to determine whether survival is affected in a beneficial or adverse way by such treatment in men with locally recurrent or metastatic cancer.
本报告回顾了一项关于间歇性雄激素抑制治疗前列腺癌的前瞻性II期评估的长期随访情况。共有87名患者纳入该方案。在撰写本报告时，50名男性已接受至少3年的随访。治疗始于联合雄激素阻断，并持续至少6个月，直至观察到血清前列腺特异性抗原（PSA）最低点。然后停用药物，直到血清PSA升高至10至20 ng/mL的平均值。这种治疗和不治疗的周期重复进行，直到PSA的调节变得不依赖雄激素。研究总时间为40至126个月，平均为65.5个月。在长期随访的男性中，第一个周期的非治疗期与幸福感改善以及性欲和性功能恢复相关，这些男性在治疗开始前报告性功能正常或接近正常。第1、2、3和4周期的平均非治疗时间（非治疗时间百分比）分别为15个月（54%）、10个月（48%）、8个月（45%）和7个月（40%）。研究组包括9名因局部晚期癌症放疗后PSA浓度升高而接受治疗的患者。这些患者在第1和第2治疗周期的平均非治疗时间分别为22个月和13个月。6名根治性前列腺切除术后PSA值升高且随访超过36个月的患者在第1和第2治疗周期的平均非治疗时间分别为19个月和11个月。在87名患者中，23名患者的疾病在治疗中位32个月时进展为雄激素非依赖性，13名患者在中位48个月时死于癌症相关死亡。前列腺癌可通过间歇性雄激素抑制得到控制。这种方法在患者停止治疗时可提高生活质量，同时降低毒性和成本。II期试验表明，对患者预后没有负面影响。目前正在进行随机试验方案，以确定这种治疗对局部复发或转移性癌症男性患者的生存是产生有益还是不利影响。
