Samson David J, Seidenfeld Jerome, Schmitt Brian, Hasselblad Vic, Albertsen Peter C, Bennett Charles L, Wilt Timothy J, Aronson Naomi
Technology Evaluation Center, Blue Cross and Blue Shield Association, Washington, DC 20005, USA.
Cancer. 2002 Jul 15;95(2):361-76. doi: 10.1002/cncr.10647.
The current systematic review and meta-analysis compared monotherapy and combined androgen blockade in the treatment of men with advanced prostate carcinoma. Outcomes of interest included overall, cancer specific, and progression-free survival; time to treatment failure; adverse events; and quality of life.
The literature search identified randomized trials comparing monotherapy (orchiectomy and luteinizing hormone-releasing hormone [LHRH] agonists) with combination therapy using orchiectomy or a LHRH agonist plus a nonsteroidal or steroidal antiandrogen. Dual independent review occurred. The meta-analysis used a random effects model.
Twenty-one trials compared survival after monotherapy with survival after combined androgen blockade (n = 6871 patients). The meta-analysis found no statistically significant difference in survival at 2 years between patients treated with combined androgen blockade and those treated with monotherapy (20 trials; hazard ratio [HR] = 0.970; 95% confidence interval [95% CI], 0.866-1.087). The authors determined a statistically significant difference in survival at 5 years that favored combined androgen blockade (10 trials; HR = 0.871; 95% CI, 0.805-0.942). For the subgroup of patients with a good prognosis, there was no statistically significant difference in survival. Adverse effects leading to withdrawal from therapy occurred more often with combined androgen blockade. To the authors' knowledge there is little evidence published to date comparing the effects of combined androgen blockade and monotherapy on quality of life, but the single randomized trial that adequately addressed this outcome reported an advantage for monotherapy over combined androgen blockade.
A thorough examination of the usefulness of combined androgen blockade must balance the modest increase in expected survival observed at 5 years against the increased risk of adverse effects and the potential for adversely affecting the patient's overall quality of life.
当前的系统评价和荟萃分析比较了单一疗法与联合雄激素阻断疗法在治疗晚期前列腺癌男性患者中的效果。感兴趣的结局包括总生存期、癌症特异性生存期和无进展生存期;治疗失败时间;不良事件;以及生活质量。
文献检索确定了比较单一疗法(睾丸切除术和促黄体生成素释放激素[LHRH]激动剂)与联合疗法(使用睾丸切除术或LHRH激动剂加非甾体或甾体抗雄激素)的随机试验。进行了双人独立评审。荟萃分析采用随机效应模型。
21项试验比较了单一疗法后的生存率与联合雄激素阻断疗法后的生存率(n = 6871例患者)。荟萃分析发现,联合雄激素阻断疗法治疗的患者与单一疗法治疗的患者在2年生存率上无统计学显著差异(20项试验;风险比[HR]=0.970;95%置信区间[95%CI],0.866 - 1.087)。作者确定在5年生存率上存在统计学显著差异,联合雄激素阻断疗法更具优势(10项试验;HR = 0.871;95%CI,0.805 - 0.942)。对于预后良好的患者亚组,生存率无统计学显著差异。联合雄激素阻断疗法导致因不良反应而退出治疗的情况更常见。据作者所知,迄今为止几乎没有证据比较联合雄激素阻断疗法和单一疗法对生活质量的影响,但唯一充分探讨该结局的随机试验报告单一疗法优于联合雄激素阻断疗法。
对联合雄激素阻断疗法有效性的全面评估必须权衡5年时观察到的预期生存率的适度提高与不良反应风险增加以及可能对患者总体生活质量产生的不利影响。