Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy
Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy
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DOI：
10.1016/s1470-2045(06)70700-8
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发表时间：
2006-06-01
期刊：
影响因子：
51.1
通讯作者：
Trump, Donald
中科院分区：
文献类型：
--
作者：
Messing, Edward M.;Manola, Judith;Trump, Donald
背景 前列腺癌雄激素剥夺治疗（ADT）的适当时机存在争议。我们的目的是确定对于接受根治性前列腺切除术和盆腔淋巴结切除术的淋巴结阳性前列腺癌患者，与仅在疾病进展时接受 ADT 的患者相比，立即 ADT 是否可以延长患者的生存期。方法 1988-93 年，来自美国 36 个机构的符合条件的患者被随机分配接受立即 ADT (n = 47) 或观察 (n = 51)，并在检测到远处转移或有症状时给予 ADT复发。第一年每 3 个月对患者进行一次随访，此后每 6 个月对患者进行一次随访。主要终点是无进展生存期；次要终点是总体生存率和疾病特异性生存率。分析是按意向治疗进行的。为了确保治疗组具有可比性，我们对载玻片进行了回顾性中央病理学审查，并对可用样本的格里森评分进行了重新分级。该试验早于临床试验注册的要求。结果在中位随访时间为 11.9 年（存活患者的范围为 9.7-14.5）时，接受立即 ADT 治疗的男性的总体生存率显着提高（风险比 1.84 [95% CI 1.01-3.35]，p = 0.04），前列腺癌特异性生存率（4.09 [1.76-9.49]，p） = 0.0004）和无进展生存期（3.42 [1.96-5.98]，p < 0.0001）。在收到的 49 张组织病理学载玻片中（19 张立即 ADT，30 张观察），16 张从原始格里森评分降级（组间
Background Appropriate timing of androgen deprivation treatment (ADT) for prostate cancer is controversial. Our aim Was to determine whether immediate ADT extends survival in men with node-positive prostate cancer who have undergone radical prostatectomy and pelvic lymphadenectomy compared with those who received ADT only once disease progressed.Methods Eligible patients from 36 institutes in the USA were randomly assigned in 1988-93 to receive immediate ADT (n = 47) or to be observed (n = 51), with ADT to be given on detection of distant metastases or symptomatic recurrences. Patients were followed up every 3 months for the first year and every 6 months thereafter. The primary endpoint was progression-free survival; secondary endpoints were overall and disease-specific survival. Analysis was by intention to treat. To ensure that the treatment groups were comparable, we did a retrospective central pathology review of slides and regraded the Gleason scores for available samples. This trial predates the requirement for clinical trial registration.Findings At median follow-up of 11.9 years (range 9.7-14.5 for surviving patients), men assigned immediate ADT had a significant improvement in overall survival (hazard ratio 1.84 [95% CI 1.01-3.35], p = 0.04), prostate-cancer-specific survival (4.09 [1.76-9.49], p = 0.0004), and progression-free survival (3.42 [1.96-5.98], p < 0.0001). Of 49 histopathology slides received (19 immediate ADT, 30 observation), 16 were downgraded from the original Gleason score (between groups