Journal article
Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial
European urology oncology, v 6(5), pp 477-483
Oct 2023
PMID: 37574391
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Prostate cancer (PCa) patients with pathogenic/likely pathogenic germline variants (PGVs) in cancer predisposition genes may be eligible for U.S. Food and Drug Administration-approved targeted therapies, clinical trials, or enhanced screening. Studies suggest that eligible patients are missing genetics-informed care due to restrictive testing criteria.
To establish the prevalence of actionable PGVs among prospectively accrued, unselected PCa patients, stratified by their guideline eligibility.
Consecutive, unselected PCa patients were enrolled at 15 sites in the USA from October 2019 to August 2021, and had multigene cancer panel testing.
Correlates between the prevalence of PGVs and clinician-reported demographic and clinical characteristics were examined.
Among 958 patients (median [quartiles] age at diagnosis 65 [60, 71] yr), 627 (65%) had low- or intermediate-risk disease (grade group 1, 2, or 3). A total of 77 PGVs in 17 genes were identified in 74 patients (7.7%, 95% confidence interval [CI] 6.2-9.6%). No significant difference was found in the prevalence of PGVs among patients who met the 2019 National Comprehensive Cancer Network Prostate criteria (8.8%, 43/486, 95% CI 6.6-12%) versus those who did not (6.6%, 31/472, 95% CI 4.6-9.2%; odds ratio 1.38, 95% CI 0.85-2.23), indicating that these criteria would miss 42% of patients (31/74, 95% CI 31-53%) with PGVs. The criteria were less effective at predicting PGVs in patients from under-represented populations. Most PGVs (81%, 60/74) were potentially clinically actionable. Limitations include the inability to stratify analyses based on individual ethnicity due to low numbers of non-White patients with PGVs.
Our results indicate that almost half of PCa patients with PGVs are missed by current testing guidelines. Comprehensive germline genetic testing should be offered to all patients with PCa.
One in 13 patients with prostate cancer carries an inherited variant that may be actionable for the patient's current care or prevention of future cancer, and could benefit from expanded testing criteria.
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Details
- Title
- Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial
- Creators
- Neal Shore - Carolina Urologic Research CenterMukaram Gazi - Urology AssociatesChristopher Pieczonka - SUNY Upstate Medical UniversitySean Heron - Advanced DermatologyRishi Modh - Advanced DermatologyDavid Cahn - Colorado Urology, Lakewood, CO, USALaurence H Belkoff - MidLantic Urology, Bala Cynwyd, PA, USAAaron Berger - Associated Urological Specialists, Chicago Ridge, IL, USABrian Mazzarella - Urology Austin, Austin, TX, USAJoseph Veys - Georgia UrologyCharles Idom - Georgia UrologyDavid Morris - Urology AssociatesGautam Jayram - Urology AssociatesAlexander Engelman - Tampa General HospitalRaviender Bukkapatnam - Florida Urology Partners, Tampa, FL, USAPaul Dato - Genesis HealthCareRichard Bevan-Thomas - Urology Partners, Arlington, TX, USARobert Cornell - DermSurgery AssociatesDavid R Wise - NYU Langone HealthMary Kay Hardwick - InvitaeRyan D Hernandez - University of California, San FranciscoSusan Rojahn - InvitaePaige Layman - InvitaeKathryn E Hatchell - InvitaeBrandie Heald - InvitaeRobert L NussbaumSarah M Nielsen - InvitaeEdward D Esplin - Invitae
- Publication Details
- European urology oncology, v 6(5), pp 477-483
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:001110479000001
- Scopus ID
- 2-s2.0-85197791305
- Other Identifier
- 991021916911104721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Oncology
- Urology & Nephrology