Maximum androgen-blockade with medical or surgical castration in advanced prostate cancer: A meta-analysis of nine published randomized controlled trials and 4128 patients using flutamide
Maximum androgen-blockade with medical or surgical castration in advanced prostate cancer: A meta-analysis of nine published randomized controlled trials and 4128 patients using flutamide
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DOI：
10.1038/sj.pcan.4500265
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发表时间：
1999-01-01
影响因子：
4.8
通讯作者：
Ross, SD
中科院分区：
文献类型：
--
作者：
Bennett, CL;Tosteson, TD;Ross, SD
最近西南肿瘤组（SWOG）发表了他们的转移性前列腺癌临床试验结果，结论是睾丸切除术和氟他胺作为最大雄激素阻断（MAB）治疗与单独睾丸切除术相比，不能显著提高生存率（NCI 0105）， 1989年同一合作组发表的报告表明，与单独的leuprolide相比，leuprolide和氟他胺联合MAB治疗比单独的leuprolide提高了24%的生存率（NCI 0036）。临床医生很可能尚未确定氟他胺联合药物或手术去势的临床获益可能性。为了更好地描述这一重要的治疗决策，我们通过对1989年至1998年报告/进行的最新研究信息的荟萃分析，评估了单克隆抗体联合氟他胺治疗的生存获益。所有经同行评审的已发表的随机对照试验，比较氟他胺加促黄体激素释放激素（LhRH）激动剂或睾丸切除术作为单克隆抗体治疗联合LhRH或单独睾丸切除术。该研究的主要目的是形成风险比的综合估计和置信区间（通过阉割与MAB比较中生存的相对风险（RR）来衡量），总结氟他胺治疗对总生存的影响。如果可能，使用直接提取的对数风险比估计值（1项研究）；如果没有，则使用基于对数秩检验报告的p值的RR估计（7项研究）或基于重建的治疗组年生命表的离散比例风险近似（1项研究）。这些分析包括了9项涉及4128名晚期前列腺癌患者的研究。汇总估计显示，氟他胺作为单克隆抗体治疗的总生存率提高10%（相对风险(RR)= 0.90, 95%可信区间= 0.79,1.00）。目前可获得的来自随机试验的最新证据显示，与传统去势相比，氟他胺作为单抗治疗的总生存率提高了10%，几乎与最近发表的西南肿瘤组研究（NCI 0105）报告的估计相同。
With the recent Southwest Oncology Group (SWOG) publication of their metastatic prostate cancer clinical trial results, which concluded that orchiectomy and flutamide as maximal androgen blockade (MAB) therapy vs orchiectomy alone does not significantly improve survival (NCI 0105), and the 1989 publication from the same cooperative group indicating a 24% improvement in survival for MAB therapy with leuprolide and flutamide versus leuprolide alone (NCI 0036), clinicians may well be undecided about the likelihood of clinical benefits with flutamide in combination with medical or surgical castration. To better characterize this important therapeutic decision, we assessed the survival benefit of MAB therapy with flutamide through a meta-analysis of up-to-date information from studies reported/conducted from 1989 through 1998.All peer-reviewed published randomized controlled trials comparing treatment with flutamide plus either lutenizing hormone releasing hormone (LhRH) agonists or orchiectomy as MAB treatment with LhRH or orchiectomy alone were included. The primary objective of the study was to form a combined estimate and confidence interval for the hazard ratio (as measured by the relative risk (RR) of survival in a comparison of castration vs MAB) summarizing the effect of flutamide treatment on overall survival. Directly extracted estimates of the log hazard ratio were used if available (1 study); if not, either an estimate of the RR based on a reported P-value from a log rank test (7 studies) or a discrete proportional hazards approximation based on reconstructed annual life tables for the treatment arms (1 study) were used.Nine studies with 4128 patients with advanced prostate cancer were included in these analyses. Pooled estimates demonstrated a 10% improvement in overall survival with flutamide as MAB therapy (relative risk (RR)= 0.90, 95% Confidence interval = 0.79, 1.00).The currently available updated evidence from randomized trials shows a 10% benefit in overall survival with flutamide as MAB therapy in comparison to conventional castration, almost identical to the estimate reported in the recently published Southwest Oncology Group Study (NCI 0105).