Department of Urology, Erasmus MC, Rotterdam, The Netherlands.
BJU Int. 2012 Dec;110(11):1672-7. doi: 10.1111/j.1464-410X.2012.11434.x. Epub 2012 Aug 29.
Study Type--Therapy (outcomes) Level of Evidence 2b. What's known on the subject? and What does the study add? Active surveillance aims to reduce overtreatment by selecting patients with low risk prostate cancer (PCa) based on favourable disease characteristics. However, most studies on active surveillance do not have long-term results available; in particular, data on patients with intermediate risk disease are lacking. Our findings demonstrate that withholding radical treatment in men with low or intermediate risk screen-detected localized PCa leads to a substantial delay or even avoidance of radical treatment in a majority of men. Favourable disease-specific outcomes confirm the feasibility of active surveillance for low risk PCa and also support a role for active surveillance in selected patients with intermediate risk PCa.
• To assess the longer-term feasibility of active surveillance, we aimed to evaluate outcomes of patients with screen-detected localized prostate cancer (PCa) who initially elected to withhold radical treatment for either low or intermediate risk disease.
• All men underwent screening for PCa in the Rotterdam and Helsinki arms of the European Randomized Study of Screening for Prostate Cancer (ERSPC); eligible men were diagnosed with PCa prior to the establishment of the ERSPC-affiliated Prostate Cancer Research International: Active Surveillance (PRIAS) study (1994-2007) and were initially expectantly managed in the absence of a fixed follow-up protocol. • Low risk PCa was defined as clinical stage T1/T2, PSA ≤ 10 ng/mL, PSA density < 0.2 ng/mL/mL, Gleason ≤ 6 and maximum two positive biopsy cores, whereas PSA 10-20 ng/mL, Gleason score 7 and three positive biopsy cores were considered intermediate risk features. • Disease-specific, overall and treatment-free survival were analysed using the Kaplan-Meier and competing risks methods.
• In all, 509 patients with PCa were eligible, of whom 381 were considered low risk and 128 intermediate risk. • During a median follow-up of 7.4 years, a total of 221 patients (43.4%) switched to deferred treatment after a median of 2.6 years. • The calculated 10-year disease-specific survival rates were 99.1% and 96.1% for low and intermediate risk patients, respectively (P = 0.44), and for overall survival 79.0% and 64.5%, respectively (P = 0.003). • Competing risks analysis showed similar results.
• Withholding radical treatment in men with low to intermediate risk screen-detected PCa leads to a substantial delay or even avoidance of radical treatment and its potential side-effects in a majority of patients. • Disease-specific outcomes at 7.4 years of follow-up are favourable in low as well as intermediate risk patients. • This confirms the feasibility of active surveillance according to contemporary criteria, and also suggests a potential role for active surveillance in selected men with intermediate risk features.
• 为了评估主动监测的长期可行性，我们旨在评估最初选择为低危或中危疾病保留根治性治疗的筛查发现局限性前列腺癌（PCa）患者的结局。
• 所有男性均在欧洲前列腺癌筛查随机研究（ERSPC）的鹿特丹和赫尔辛基部分接受 PCa 筛查；符合条件的男性在 ERSPC 相关前列腺癌研究国际：主动监测（PRIAS）研究成立之前（1994-2007 年）被诊断为 PCa，并且在没有固定随访方案的情况下最初接受期待治疗。• 低危 PCa 定义为临床分期 T1/T2、PSA≤10ng/mL、PSA 密度<0.2ng/mL/ml、Gleason≤6 和最多两个阳性活检核心，而 PSA 10-20ng/mL、Gleason 评分 7 和三个阳性活检核心则被认为是中危特征。• 使用 Kaplan-Meier 和竞争风险方法分析疾病特异性、总体和无治疗生存情况。
• 共有 509 名 PCa 患者符合条件，其中 381 名患者被认为是低危，128 名患者是中危。• 在中位随访 7.4 年期间，中位随访 2.6 年后，共有 221 名患者（43.4%）转为延迟治疗。• 低危和中危患者的 10 年疾病特异性生存率分别计算为 99.1%和 96.1%（P=0.44），总生存率分别为 79.0%和 64.5%（P=0.003）。• 竞争风险分析得出了类似的结果。
• 在低危至中危筛查发现的 PCa 男性中，保留根治性治疗会导致大多数患者的根治性治疗以及其潜在副作用的大量延迟甚至避免。• 在中位随访 7.4 年时，低危和中危患者的疾病特异性结局均较好。• 这证实了根据当代标准进行主动监测的可行性，并且还表明主动监测在具有中危特征的特定男性中可能具有作用。
