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风险分层前列腺癌主动监测随访方案的前瞻性实施与早期结果

Prospective Implementation and Early Outcomes of a Risk-stratified Prostate Cancer Active Surveillance Follow-up Protocol.

作者信息

Thankapannair Vineetha, Keates Alexandra, Barrett Tristan, Gnanapragasam Vincent J

机构信息

Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

Cambridge Urology Translational Research and Clinical Trials Office, Cambridge Biomedical Campus, Addenbrooke's Hospital, Cambridge, UK.

出版信息

Eur Urol Open Sci. 2023 Jan 24;49:15-22. doi: 10.1016/j.euros.2022.12.013. eCollection 2023 Mar.

DOI:10.1016/j.euros.2022.12.013
PMID:36874604
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9975013/
Abstract

BACKGROUND

Active surveillance (AS) is a major management option for men with early prostate cancer. Current guidelines however advocate identical AS follow-up for all without considering different disease trajectories. We previously proposed a pragmatic three-tier STRATified CANcer Surveillance (STRATCANS) follow-up strategy based on different progression risks from clinic-pathological and imaging features.

OBJECTIVE

To report early outcomes from the implementation of the STRATCANS protocol in our centre.

DESIGN SETTING AND PARTICIPANTS

Men on AS were enrolled into a prospective stratified follow-up programme.

INTERVENTION

Three tiers of increasing follow-up intensity based on National Institute for Health and Care Excellence (NICE): Cambridge Prognostic Group (CPG) 1 or 2, prostate-specific antigen density, and magnetic resonance imaging (MRI) Likert score at entry.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Rates of progression to CPG ≥3, any pathological progression, AS attrition, and patient choice for treatment were assessed. Differences in progression were compared with chi-square statistics.

RESULTS AND LIMITATIONS

Data from 156 men (median age 67.3 yr) were analysed. Of these, 38.4% had CPG2 disease and 27.5% had grade group 2 disease at diagnosis. The median time on AS was 4 yr (interquartile range 3.2-4.9) and 1.5 yr on STRATCANS. Overall, 135/156 (86.5%) men remained on AS or converted to watchful waiting and 6/156 (3.8%) stopped AS by choice by the end of the evaluation period. Of the 156 patients, 66 (42.3%) were allocated to STRATCANS 1 (least intense follow-up), 61 (39.1%) to STRATCANS 2, and 29 (18.6%) to STRATCANS 3 (highest intensity). By increasing STRATCANS tier, progression rates to CPG ≥3 and any progression events were 0% and 4.6%, 3.4% and 8.6%, and 7.4% and 22.2%, respectively ( = 0.019). Modelling resource usage suggested potential reductions in appointments by 22% and MRI by 42% compared with current NICE guideline recommendations (first 12 months of AS). The study is limited by short follow-up, a relatively small cohort, and being single centre.

CONCLUSIONS

A simple risk-tiered AS strategy is possible with early outcomes supporting stratified follow-up intensity. STRATCANS implementation could de-escalate follow-up in men at a low risk of progression while husbanding resources for those who need closer follow-up.

PATIENT SUMMARY

We report a practical way to personalise follow-up for men on active surveillance for early prostate cancer. Our method may allow reductions in the follow-up burden for men at a low risk of disease change while maintaining vigilance for those at a higher risk.

摘要

背景

主动监测(AS)是早期前列腺癌男性患者的主要治疗选择。然而,目前的指南提倡对所有患者进行相同的AS随访,而不考虑不同的疾病发展轨迹。我们之前基于临床病理和影像学特征所提示的不同进展风险,提出了一种实用的三层分层癌症监测(STRATCANS)随访策略。

目的

报告在我们中心实施STRATCANS方案的早期结果。

设计、背景与参与者:接受AS的男性被纳入一项前瞻性分层随访计划。

干预措施

根据英国国家卫生与临床优化研究所(NICE)的标准,基于剑桥预后组(CPG)1或2、前列腺特异性抗原密度以及入组时的磁共振成像(MRI)李克特评分,分为三层,随访强度逐渐增加。

结果测量与统计分析

评估进展至CPG≥3的发生率、任何病理进展、AS失访率以及患者的治疗选择。采用卡方统计比较进展差异。

结果与局限性

分析了156名男性(中位年龄67.3岁)的数据。其中,38.4%在诊断时患有CPG2疾病,27.5%患有2级组疾病。AS的中位时间为4年(四分位间距3.2 - 4.9),STRATCANS为1.5年。总体而言,在评估期结束时,135/156(86.5%)的男性仍在接受AS或转为观察等待,6/156(3.8%)自行停止了AS。在156名患者中,66名(42.3%)被分配到STRATCANS 1(随访强度最低),61名(39.1%)被分配到STRATCANS 2,29名(18.6%)被分配到STRATCANS 3(随访强度最高)。随着STRATCANS层级的增加,进展至CPG≥3的发生率和任何进展事件的发生率分别为0%和4.6%、3.4%和8.6%、7.4%和22.2%(P = 0.019)。资源使用模型显示,与当前NICE指南建议(AS的前12个月)相比,预约次数可能减少22%,MRI检查减少42%。该研究受随访时间短、队列相对较小以及单中心的限制。

结论

一种简单的风险分层AS策略是可行的,早期结果支持分层随访强度。实施STRATCANS可以降低进展风险低的男性的随访强度,同时为需要更密切随访的男性节省资源。

患者总结

我们报告了一种为早期前列腺癌主动监测男性患者个性化随访的实用方法。我们的方法可能会减轻疾病变化风险低的男性的随访负担,同时对风险较高的男性保持警惕。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f808/9975013/30e78ed90dfd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f808/9975013/30e78ed90dfd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f808/9975013/30e78ed90dfd/gr1.jpg

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