期刊
EUROPEAN UROLOGY
卷 81, 期 4, 页码 337-346出版社
ELSEVIER
DOI: 10.1016/j.eururo.2021.12.007
关键词
Systematic review; Active surveillance; Localised prostate cancer; Consensus statements; Criteria for inclusion and eligibility; Monitoring and reclassification; Positive cores; Core involvement; Per-protocol or untriggered repeat biopsies; Clinical practice guidelines and recommendations
资金
- Astellas
- Ipsen
- Sanofi
- Janssen
- Roche
- European Association of Urology
- Bayer
- Pierre Fabre Oncologie
- Amgen
- AstraZeneca
- Bristol-Myers Squibb
- Celgene
- Dendreon
- Ferring
- GSK
- Incyte
- Janssen Cilag
- Merck
- MSD
- Novartis
- Pfizer
- Sanofi Aventis
- SeaGen
- Shionogi
- Synthon
- Takeda
- Teva/OncoGenex
- Cancer Australia
- Medical Research Council
- National Institute of Health Research (UK)
- Cancer Research UK
- Sir John Fisher Foundation
- Consilient Health
- SIOG
- ESMO
- Slaintecare
- Philips
- Google Inc.
This qualitative systematic review explores the criteria for recruitment, monitoring, and reclassification in active surveillance protocols for localized prostate cancer. The study found that a minority of protocols included the use of MRI, and it recommends improvements in biopsy strategies for protocols without mandatory MRI use.
Context: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa). Objective: To perform a qualitative systematic review (SR) to issue recommendations regarding inclusion of intermediate-risk disease, biopsy characteristics at inclusion and monitoring, and repeat biopsy strategy. Evidence acquisition: A protocol-driven, Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-adhering SR incorporating AS protocols published from January 1990 to October 2020 was performed. The main outcomes were criteria for inclusion of intermediate-risk disease, monitoring, reclassification, and repeat biopsy strategies (per protocol and/or triggered). Clinical effectiveness data were not assessed. Evidence synthesis: Of the 17 011 articles identified, 333 studies incorporating 375 AS protocols, recruiting 264 852 patients, were included. Only a minority of protocols included the use of magnetic resonance imaging (MRI) for recruitment (n = 17), follow-up (n = 47), and reclassification (n = 26). More than 50% of protocols included patients with intermediate or high-risk disease, whilst 44.1% of protocols excluded low-risk patients with more than three positive cores, and 39% of protocols excluded patients with core involvement (CI) >50% per core. Of the protocols, >= 80% mandated a confirmatory transrectal ultrasound biopsy; 72% (n = 189) of protocols mandated per-protocol repeat biopsies, with 20% performing this annually and 25% every 2 yr. Only 27 protocols (10.3%) mandated triggered biopsies, with 74% of these protocols defining progression or changes on MRI as triggers for repeat biopsy. Conclusions: For AS protocols in which the use of MRI is not mandatory or absent, we recommend the following: (1) AS can be considered in patients with low-volume International Society of Urological Pathology (ISUP) grade 2 (three or fewer positive cores and cancer involvement <= 50% CI per core) or another single element of intermediate-risk disease, and patients with ISUP 3 should be excluded; (2) per-protocol confirmatory prostate biopsies should be performed within 2 yr, and per-protocol surveillance repeat biopsies should be performed at least once every 3 yr for the first 10 yr; and (3) for patients with low-volume, low-risk disease at recruitment, if repeat systematic biopsies reveal more than three positive cores or maximum CI >50% per core, they should be monitored closely for evidence of adverse features (eg, upgrading); patients with ISUP 2 disease with increased core positivity and/or CI to similar thresholds should be reclassified. Patient summary: We examined the literature to issue new recommendations on active surveillance (AS) for managing localised prostate cancer. The recommendations include setting criteria for including men with more aggressive disease (intermediate-risk disease), setting thresholds for close monitoring of men with low-risk but more extensive disease, and determining when to perform repeat biopsies (within 2 yr and 3 yearly thereafter). (C) 2021 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology.
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