Arthur Peyrottes, Michael Baboudjian, Romain Diamand, Quentin Ducrot, Cyril Vitard, Arthur Baudewyns, Olivier Windisch, Julien Anract, Charles Dariane, Thibault Tricard, Julien Sarkis, Yvanne Sadreux, Marco Oderda, Thibaut Long Depaquit, Alexandre De La Taille, Jonathan Olivier, Laurent Brureau, Olivier Rouviere, Sébastien Crouzet, Alain Ruffion, François Desgrandchamps, Matthieu Roumiguie, Morgan Rouprêt, Guillaume Ploussard, Gaelle Fiard
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This study aims to evaluate the outcomes of patients with PI-RADS 5 lesions managed with AS.</p><p><strong>Methods: </strong>We analyzed data from 126 patients treated at 16 centers in France, Italy, Switzerland, and Belgium, whose initial magnetic resonance imaging revealed at least one PI-RADS 5 lesion and who subsequently underwent AS. The primary endpoint was BCR-free survival. The secondary endpoints included metastasis-free survival, time to biopsy grade reclassification, and time to AS discontinuation, along with their predictors.</p><p><strong>Key findings and limitations: </strong>After a median follow-up of 36 mo after confirmatory biopsies (95% confidence interval [CI] 23-55), BCR was observed in five patients, with the median time not reached. The 5-yr BCR-free survival rate was 88% (95% CI 79-99%). No metastatic progression was reported. Seventeen patients experienced biopsy grade reclassification (median time not reached), and 55 patients discontinued AS. 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引用次数: 0
摘要
背景与目的：前列腺影像学报告与数据系统（PI-RADS） 5病变患者局部治疗后发生临床显著性前列腺癌（PCa）、囊外延伸和生化复发（BCR）的风险较高。当有针对性的活组织检查显示有良好风险的肿瘤时，对这些患者进行主动监测（AS）尤其具有挑战性。本研究旨在评估AS治疗PI-RADS 5病变患者的预后。方法：我们分析了来自法国、意大利、瑞士和比利时16个中心的126例患者的数据，这些患者最初的磁共振成像显示至少有一个PI-RADS 5病变，随后接受了AS。主要终点是无bcr生存期。次要终点包括无转移生存期、活检分级再分类时间、AS停药时间及其预测因子。主要发现和局限性：确诊活检后中位随访36个月（95%可信区间[CI] 23-55）， 5例患者观察到BCR，中位时间未达到。5年无bcr生存率为88% （95% CI 79-99%）。无转移进展报道。17例患者经历了活检分级重新分类（中位时间未达到），55例患者停止了AS。到AS停止的中位时间为55个月（95% CI 46个月-不适用）。5年AS无停药生存率为41% （95% CI 30.8-54.6%）。在多变量Cox回归分析中，基线前列腺特异性抗原密度和活检穿刺阳性百分比与活检分级重新分类、AS停药和BCR相关。结论和临床意义：在严格的监测下，对于PI-RADS 5病变和有利风险PCa患者，AS是一种安全的管理选择。局限性主要是本研究的回顾性设计固有的。
Are Patients with Prostate Imaging Reporting and Data System 5 Lesions Eligible for Active Surveillance? A Multicentric European Study.
Background and objective: Patients with Prostate Imaging Reporting and Data System (PI-RADS) 5 lesions are at a high risk of clinically significant prostate cancer (PCa), extracapsular extension, and biochemical recurrence (BCR) after local treatment. Managing these patients with active surveillance (AS) can be particularly challenging when targeted biopsies indicate favorable-risk tumors. This study aims to evaluate the outcomes of patients with PI-RADS 5 lesions managed with AS.
Methods: We analyzed data from 126 patients treated at 16 centers in France, Italy, Switzerland, and Belgium, whose initial magnetic resonance imaging revealed at least one PI-RADS 5 lesion and who subsequently underwent AS. The primary endpoint was BCR-free survival. The secondary endpoints included metastasis-free survival, time to biopsy grade reclassification, and time to AS discontinuation, along with their predictors.
Key findings and limitations: After a median follow-up of 36 mo after confirmatory biopsies (95% confidence interval [CI] 23-55), BCR was observed in five patients, with the median time not reached. The 5-yr BCR-free survival rate was 88% (95% CI 79-99%). No metastatic progression was reported. Seventeen patients experienced biopsy grade reclassification (median time not reached), and 55 patients discontinued AS. The median time to AS discontinuation was 55 mo (95% CI 46 mo-not applicable). The 5-yr AS discontinuation-free survival rate was 41% (95% CI 30.8-54.6%). On a multivariate Cox regression analysis, baseline prostate-specific antigen density and the percentage of positive biopsy cores were associated with biopsy grade reclassification, AS discontinuation, and BCR.
Conclusions and clinical implications: With strict monitoring, AS is a safe management option for patients with PI-RADS 5 lesions and favorable-risk PCa. Limitations are mainly inherent to the retrospective design of this study.
期刊介绍：
Journal Name: European Urology Oncology
Affiliation: Official Journal of the European Association of Urology
Focus:
First official publication of the EAU fully devoted to the study of genitourinary malignancies
Aims to deliver high-quality research
Content:
Includes original articles, opinion piece editorials, and invited reviews
Covers clinical, basic, and translational research
Publication Frequency: Six times a year in electronic format
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