jueves, 3 de octubre de 2013

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? : Genetics in Medicine : Nature Publishing Group

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? : Genetics in Medicine : Nature Publishing Group

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Journal name:
Genetics in Medicine
(2013)
DOI:
doi:10.1038/gim.2013.141
Received
Accepted
Published online

Abstract

Summary of recommendations:

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend prostate cancer antigen 3 (PCA3) testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination).
The EGAPP Working Group found insufficient evidence to recommend PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.
Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using PCA3 is deemed “low.” The EGAPP Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.
Based on the available evidence, the overall certainty of net health benefit is deemed “low.” The EGAPP Working Group discourages clinical use unless further evidence supports improved clinical outcomes.

Rationale:

It has been suggested that PCA3 testing in the general male population might lead to earlier diagnosis and management changes (e.g., earlier detection and earlier initiation or higher rates of medical interventions) that improve outcomes. EGAPP Working Group found no direct evidence to support this possibility, so we sought indirect evidence aimed at documenting the extent to which PCA3 testing alters prostate cancer diagnosis or management, alone and in combination with traditional clinical management factors, and the extent to which this testing improves health outcomes.

Analytic validity:

Assay-related evidence was deemed adequate for the PROGENSA PCA3 assay approved by the US Food and Drug Administration, available from Gen-Probe. Very few studies were available that investigated preanalytical effects, analytical performance, and diagnostic accuracy of other quantitative assays for PCA3.

Clinical validity:

Evidence on clinical validity was rated inadequate to derive any conclusions about performance of PCA3 testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer, or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination). Furthermore, there was little evidence to derive any conclusions about performance of PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.

Clinical utility:

No studies were available to provide direct evidence on the balance of benefits and harms related to PCA3 testing for diagnosis and management in the general male population. Evidence for other populations (e.g., high risk) was not evaluated in the review.

Contextual issues:

Early diagnosis of prostate cancer is central to minimizing morbidity and mortality. Prevention of prostate cancer mortality is a public health priority. Improvements in outcomes associated with PCA3 testing could have important impacts.
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Keywords:

diagnosis; genetic testing; management; PCA3; prostate cancer; recommendation

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Author information

Affiliations

  1. EGAPP Working Group: Chair: Ned Calonge, MD, MPH (Colorado Trust); Vice Chair: Roger D. Klein, MD, JD (Department of Molecular Pathology Cleveland Clinic Foundation); Members: Jonathan S. Berg, MD, PhD (Department of Genetics, UNC School of Medicine); Doug Campos-Outcalt, MD, MPA (Department of Family-Community Medicine, University of Arizona College of Medicine); Benjamin Djulbegovic, MD, PhD (Co-Director, Clinical & Translational Science Institute and Director, Center for Evidence–Based Medicine and Research, University of South Florida); Theodore Ganiats, MD (Department of Family and Preventive Medicine, University of California, San Diego); A. Cecile J.W. Janssens, PhD (Rollins School of Public Health, Emory University); Kenneth Offit, MD, MPH (Clinical Genetics Service, Memorial Sloan-Kettering Cancer Center): Stephen G. Pauker, MD, MACP, FACC, ABMH (Division of Clinical Decision Making, Informatics and Telemedicine, Department of Medicine, Tufts Medical Center); Margaret Piper, PhD, MPH (Blue Cross/Blue Shield Association Technology Evaluation Center); Carolyn Sue Richards, PhD, FACMG (Oregon Health & Science University); Ora L. Strickland, PhD, DSc (Hon.), RN, FAAN (Florida International University); Sean Tunis MD, MSc (Center for Medical Technology Policy); Marc S. Williams, MD (Genomic Medicine Institute, Geisinger Health System); and Doris Zallen, PhD (Department of Science and Technology in Society, Virginia Tech). Correspondence: ()

  2. This recommendation statement is a product of the independent EGAPP Working Group. Although the Centers for Disease Control and Prevention (CDC) provides support to the EGAPP Working Group, including staff support in the preparation of this document, recommendations made by the EGAPP Working Group should not be construed as official positions of the CDC or the US Department of Health and Human Services.

Consortia

  1. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group*

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