Schmitt B, Bennett C, Seidenfeld J, Samson D, Wilt T
Health Services Research & Development Program, VA Chicago Health Care System-Lakeside Division, 333 E. Huron Street, Chicago, Illinois 60611, USA.
Cochrane Database Syst Rev. 2000;1999(2):CD001526. doi: 10.1002/14651858.CD001526.
This systematic review assessed the effect of maximal androgen blockade (MAB) on survival when compared to castration (medical or surgical) alone for patients with advanced prostate cancer.
Randomized controlled trials were searched in general and specialized databases (MEDLINE, EMBASE, Cancerlit, Cochrane Library, VA Cochrane Prostate Disease register) and by reviewing bibliographies.
All published randomized trials were eligible for inclusion provided they (1) randomized men with advanced prostate cancer to receive a non-steroidal anti-androgen (NSAA) medication in addition to castration (medical or surgical) or to castration alone, and (2) reported overall survival, progression-free survival, cancer-specific survival, and/or adverse events. Eligibility was assessed by two independent reviewers.
Information on patients, interventions, and outcomes were extracted by two independent reviewers using a standardized form. The main outcome measure for comparing effectiveness was overall survival at 1, 2, and 5 years. Secondary outcome measures included progression-free survival and cancer-specific survival. The relationship of specific NSAA on outcome was evaluated. Additionally, the incidence of adverse effects was measured.
Twenty trials enrolling 6,320 patients were included. The pooled OR for overall survival was 1.03 (95% CI:0.85 to 1.25), 1.16 (95% CI:1.00 to 1.33), and 1.29 (95% CI:1.11 to 1.50) at 1, 2, and 5 years respectively. Overall survival was only significant at 5 years. The risk difference at 5 years was 0.048 (95% CI:0.02 to 0.077) and NNT at 5 years 20.8. Progression-free survival was improved only at 1 year follow-up (OR=1.38) and cancer-free survival was improved only at 5 years (OR=1.22). Adverse events occurred more frequently in those assigned to MAB and resulted in withdrawal in 10%. Quality of life was measured in only one study favored orchiectomy alone (less diarrhea and better emotional functioning in the first 6 months).
REVIEWER'S CONCLUSIONS: MAB produces a modest overall and cancer-specific survival at 5 years but is associated with increased adverse events and reduced quality of life.
本系统评价旨在评估与单纯去势（药物或手术）相比，最大雄激素阻断（MAB）对晚期前列腺癌患者生存率的影响。
在综合和专业数据库（MEDLINE、EMBASE、Cancerlit、Cochrane图书馆、VA Cochrane前列腺疾病注册库）中检索随机对照试验，并查阅参考文献。
所有已发表的随机试验均符合纳入条件，只要它们（1）将晚期前列腺癌男性随机分组，使其在去势（药物或手术）基础上接受非甾体类抗雄激素（NSAA）药物治疗，或仅接受去势治疗；（2）报告总生存期、无进展生存期、癌症特异性生存期和/或不良事件。由两名独立的评审员评估入选资格。
两名独立的评审员使用标准化表格提取有关患者、干预措施和结局的信息。比较有效性的主要结局指标是1年、2年和5年时的总生存期。次要结局指标包括无进展生存期和癌症特异性生存期。评估了特定NSAA与结局的关系。此外，还测量了不良反应的发生率。
纳入了20项试验，共6320例患者。1年、2年和5年时总生存期的合并OR分别为1.03（95%CI：0.85至1.25）、1.16（95%CI：1.00至1.33）和1.29（95%CI：1.11至1.50）。总生存期仅在5年时有显著差异。5年时的风险差为0.048（95%CI：0.02至0.077），5年时的需治疗人数为20.8。无进展生存期仅在1年随访时有所改善（OR = 1.38），无癌生存期仅在5年时有所改善（OR = 1.22）。接受MAB治疗的患者不良事件发生频率更高，10%的患者因此退出研究。仅在一项研究中对生活质量进行了测量，结果显示单纯睾丸切除术更具优势（前6个月腹泻更少，情绪功能更好）。
MAB在5年时可使总生存期和癌症特异性生存期略有提高，但与不良事件增加和生活质量下降相关。
