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.
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.
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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