Early versus delayed hormonal therapy for prostate specific antigen only recurrence of prostate cancer after radical prostatectomy
Early versus delayed hormonal therapy for prostate specific antigen only recurrence of prostate cancer after radical prostatectomy
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DOI：
10.1097/01.ju.0000113794.34810.d0
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发表时间：
2004-03-01
影响因子：
6.6
通讯作者：
Soderdahl, D
中科院分区：
文献类型：
--
作者：
Moul, JW;Wu, HY;Soderdahl, D
目的：激素治疗（HT）是目前前列腺特异性抗原（PSA）复发（PSAR）全身治疗的主流，然而，几乎没有发表的文献将激素治疗与临床观察进行比较。本研究的目的是检查国防部前列腺疾病研究中心的观察性数据库，通过风险分层方法比较早期和延迟使用HT治疗根治性前列腺切除术后发生PSAR的男性的临床结果。材料和方法：数据库中5382名接受原发性根治性前列腺切除术（RP）的男性中，4967名患者在1988年至2002年12月期间接受了psa治疗。在这些患者中，1352名患有PSAR（术后PSA大于0.2 ng/ml）且术后随访超过6个月的男性被用作研究队列。这些患者进一步分为早期HT组（355例）和晚期HT组（997例），前者在PSA仅复发但临床转移前接受了HT治疗，后者在临床转移前或目前随访中未接受过HT治疗。主要终点是临床转移的发展。在1352例PSAR患者中，103例（7.6%）发生了临床转移。根据手术Gleason sum、PSA翻倍时间和复发时间对患者进行分层。采用单因素和多因素Cox比例风险模型评价早期和晚期HT对临床结局的影响。结果：病理Gleason sum大于7或PSA倍增时间小于12个月的患者早期HT与延迟临床转移相关（风险比= 2.12,p = 0.01）。然而，在整个队列中，早期HT对临床转移没有影响。种族、RP时年龄和诊断时PSA对无转移生存无影响（p < 0.05）。结论：回顾性观察性多中心数据库分析表明，仅在当前随访的高风险病例中，早期接受HT治疗的PSAR是延迟临床转移的独立预测因子。要解决这一重要问题，需要进行更长时间的随访和随机试验的进一步研究。
Purpose: Hormonal therapy (HT) is the current mainstay of systemic treatment for prostate specific antigen (PSA) only recurrence (PSAR), however, there is virtually no published literature comparing HT to observation in the clinical setting. The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational database to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach.Materials and Methods: Of 5,382 men in the database who underwent primary radical prostatectomy (RP), 4,967 patients were treated in the PSA-era between 1988 and December 2002. Of those patients 1,352 men who had PSAR (PSA after surgery greater than 0.2 ng/ml) and had postoperative followup greater than 6 months were used as the study cohort. These patients were further divided into an early HT group in which patients (355) received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients (997) who received no HT before clinical metastasis or by current followup. The primary end point was the development of clinical metastases. Of the 1,352 patients with PSAR clinical metastases developed in 103 (7.6%). Patients were also stratified by surgical Gleason sum, PSA doubling time and timing of recurrence. Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome.Results: Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less (Hazards ratio = 2.12, p = 0.01). However, in the overall cohort early HT did not impact clinical metastases. Race, age at RP and PSA at diagnosis had no effect on metastasis-free survival (p >0.05).Conclusions: The retrospective observational multicenter database analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current followup. Further study with longer followup and randomized trials are needed to address this important issue.