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主动监测经筛检发现前列腺癌男性的结局。哥德堡随机人群前列腺癌筛查试验的结果。

Outcome following active surveillance of men with screen-detected prostate cancer. Results from the Göteborg randomised population-based prostate cancer screening trial.

机构信息

Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Sweden.

出版信息

Eur Urol. 2013 Jan;63(1):101-7. doi: 10.1016/j.eururo.2012.08.066. Epub 2012 Sep 5.

DOI:10.1016/j.eururo.2012.08.066
PMID:22980443
Abstract

BACKGROUND

Active surveillance (AS) has emerged as a treatment strategy for reducing overtreatment of screen-detected, low-risk prostate cancer (PCa).

OBJECTIVE

To assess outcomes following AS of men with screen-detected PCa.

DESIGN, SETTING, AND PARTICIPANTS: Of the 968 men who were diagnosed with screen-detected PCa between 1995 and 2010 in the Göteborg randomised, population-based PCa screening trial, 439 were managed with AS and were included in this study. Median age at diagnosis was 65.4 yr of age, and median follow-up was 6.0 yr from diagnosis.

INTERVENTION

The study participants were followed at intervals of 3-12 mo and were recommended to switch to deferred active treatment in case of a progression in prostate-specific antigen, grade, or stage.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The end points-overall survival (OS), treatment-free survival, failure-free (no relapse after radical treatment) survival, and cancer-specific survival-were calculated for various risk groups (very low, low, intermediate, and high) with Kaplan-Meier estimates. A Cox proportional hazards model as well as a competing risk analysis were used to assess whether risk group or age at diagnosis was associated with failure after AS.

RESULTS AND LIMITATIONS

Forty-five per cent of all screen-detected PCa were managed with AS, and very low-risk and low-risk PCa constituted 60% of all screen-detected PCa. Thirty-seven per cent (162 of 439) switched from surveillance to deferred active treatment, and 39 men failed AS. The 10-yr OS, treatment-free survival, and failure-free survival were 81.1%, 45.4%, and 86.4%, respectively (Kaplan-Meier estimates). Men with low-, intermediate-, and high-risk tumours had a hazard ratio for failure of 2.1 (p=0.09), 3.6 (p=0.002), and 4.6 (p=0.15), respectively, compared to very low-risk tumours (Cox regression). Only one PCa death occurred, and one patient developed metastasis (both in the intermediate-risk group). The main limitation of this study is the relatively short follow-up.

CONCLUSIONS

A large proportion of men with screen-detected PCa can be managed with AS. AS appears safe for men with low-risk PCa.

摘要

背景

主动监测(AS)已成为减少筛查发现的低危前列腺癌(PCa)过度治疗的一种治疗策略。

目的

评估 AS 治疗筛查发现的 PCa 患者的结局。

设计、地点和参与者:在 1995 年至 2010 年期间,哥德堡随机、基于人群的前列腺癌筛查试验中诊断出 968 名筛查发现的 PCa 男性,其中 439 名接受 AS 治疗并纳入本研究。诊断时的中位年龄为 65.4 岁,中位随访时间为诊断后 6.0 年。

干预措施

研究参与者每 3-12 个月随访一次,并建议在前列腺特异性抗原、分级或分期进展时转为延迟主动治疗。

结局测量和统计分析

使用 Kaplan-Meier 估计值计算各种风险组(极低危、低危、中危和高危)的总生存(OS)、无治疗生存、无失败(根治性治疗后无复发)生存和癌症特异性生存。使用 Cox 比例风险模型和竞争风险分析评估风险组或诊断时年龄与 AS 后失败是否相关。

结果和局限性

45%的所有筛查发现的 PCa 采用 AS 治疗,极低危和低危 PCa 占所有筛查发现的 PCa 的 60%。37%(439 例中的 162 例)从监测转为延迟主动治疗,39 例患者 AS 失败。10 年 OS、无治疗生存和无失败生存分别为 81.1%、45.4%和 86.4%(Kaplan-Meier 估计值)。低危、中危和高危肿瘤患者的失败风险比分别为 2.1(p=0.09)、3.6(p=0.002)和 4.6(p=0.15),与极低危肿瘤相比(Cox 回归)。仅发生 1 例 PCa 死亡和 1 例转移(均发生在中危组)。本研究的主要局限性是随访时间相对较短。

结论

很大一部分筛查发现的 PCa 男性可以采用 AS 治疗。AS 似乎对低危 PCa 患者是安全的。

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