Lurdes Y.T. Inoue, PhD; Daniel W. Lin, MD; Lisa F. Newcomb, PhD; Amy S. Leonardson, MS; Donna Ankerst, PhD; Roman Gulati, MS; H. Ballentine Carter, MD; Bruce J. Trock, PhD; Peter R. Carroll, MD; Matthew R. Cooperberg, MD; Janet E. Cowan, MA; Laurence H. Klotz, MD; Alexandre Mamedov, PhD; David F. Penson, MD; Ruth Etzioni, PhD
Disclaimer: The contents are solely the responsibility of the authors and do not necessarily represent the official views of the funders or sponsors.
Financial Support: By National Cancer Institute awards R01 CA183570 for the Prostate Modeling to Identify Surveillance Strategies (PROMISS) consortium (all authors), R01 CA160239 for statistical methods to study cancer recurrence using longitudinal multistate models (Dr. Inoue), P50 CA097186 as part of the Pacific Northwest Prostate Cancer Specialized Program of Research Excellence (Ms. Leonardson), and U01 CA199338 as part of the Cancer Intervention and Surveillance Modeling Network (CISNET) (Mr. Gulati and Dr. Etzioni); the Canary Foundation (Drs. Lin and Newcomb); Genomic Health and U.S. Department of Defense Translational Impact Award for Prostate Cancer award W81XWH-13-2-0074 (Drs. Carroll and Cooperberg and Ms. Cowan); and Prostate Cancer Canada (Dr. Klotz).
Disclosures: Dr. Trock reports grants from MDxHealth, personal fees from GenomeDx Biosciences, and grants and personal fees from Myriad Genetics outside the submitted work. Dr. Cooperberg reports personal fees from Dendreon, Astellas, GenomeDx, Myriad Genetics, and MDxHealth outside the submitted work. Ms. Cowan reports that she is a paid statistical peer reviewer for Journal of Urology and Urology. Dr. Penson reports grants from the National Cancer Institute at the National Institutes of Health during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0548.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Inoue (e-mail, email@example.com).
Requests for Single Reprints: Ruth Etzioni, PhD, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M2-B230, Seattle, WA 98109-1024; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Inoue: Department of Biostatistics, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195.
Dr. Lin: Department of Urology, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195.
Drs. Newcomb and Etzioni, Ms. Leonardson, and Mr. Gulati: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, WA 98109.
Dr. Ankerst: Technical University of Munich, Boltzmannstraße 3, 85748 Garching, Germany.
Drs. Carter and Trock: The James Buchanan Urological Institute, Johns Hopkins Medical Institutions, 600 North Wolfe Street, Baltimore, MD 21287.
Drs. Carroll and Cooperberg and Ms. Cowan: Department of Urology, University of California, San Francisco, 400 Parnassus Avenue, San Francisco, CA 94143.
Drs. Klotz and Mamedov: Division of Urology, University of Toronto, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.
Dr. Penson: Department of Urologic Surgery, Vanderbilt University, 1301 Medical Center Drive, Nashville, TN 37232.
Author Contributions: Conception and design: L.Y.T. Inoue, D.W. Lin, D. Ankerst, D.F. Penson.
Analysis and interpretation of the data: L.Y.T. Inoue, D.W. Lin, L.F. Newcomb, A.S. Leonardson, D. Ankerst, R. Gulati, H.B. Carter, B.J. Trock, P.R. Carroll, J.E. Cowan, L.H. Klotz, D.F. Penson, R. Etzioni.
Drafting of the article: L.Y.T. Inoue, D.W. Lin, D. Ankerst, J.E. Cowan, R. Etzioni.
Critical revision of the article for important intellectual content: L.Y.T. Inoue, D.W. Lin, L.F. Newcomb, R. Gulati, H.B. Carter, B.J. Trock, P.R. Carroll, M.R. Cooperberg, L.H. Klotz, D.F. Penson.
Final approval of the article: L.Y.T. Inoue, D.W. Lin, L.F. Newcomb, A.S. Leonardson, D. Ankerst, R. Gulati, H.B. Carter, B.J. Trock, P.R. Carroll, M.R. Cooperberg, J.E. Cowan, L.H. Klotz, A. Mamedov, D.F. Penson, R. Etzioni.
Provision of study materials or patients: L.F. Newcomb, H.B. Carter, B.J. Trock, P.R. Carroll, M.R. Cooperberg, L.H. Klotz.
Statistical expertise: L.Y.T. Inoue, D. Ankerst, R. Gulati, J.E. Cowan, R. Etzioni.
Obtaining of funding: L.Y.T. Inoue, D.W. Lin, P.R. Carroll, D.F. Penson.
Administrative, technical, or logistic support: L.Y.T. Inoue, R. Gulati, P.R. Carroll.
Collection and assembly of data: L.Y.T. Inoue, D.W. Lin, L.F. Newcomb, A.S. Leonardson, H.B. Carter, B.J. Trock, P.R. Carroll, J.E. Cowan, L.H. Klotz, A. Mamedov.
Active surveillance (AS) is increasingly accepted for managing low-risk prostate cancer, yet there is no consensus about implementation. This lack of consensus is due in part to uncertainty about risks for disease progression, which have not been systematically compared or integrated across AS studies with variable surveillance protocols and dropout to active treatment.
To compare risks for upgrading from a Gleason score (GS) of 6 or less to 7 or more across AS studies after accounting for differences in surveillance intervals and competing treatments and to evaluate tradeoffs of more versus less frequent biopsies.
Joint statistical model of longitudinal prostate-specific antigen (PSA) levels and risks for biopsy upgrading.
Johns Hopkins University (JHU); Canary Prostate Active Surveillance Study (PASS); University of California, San Francisco (UCSF); and University of Toronto (UT) AS studies.
2576 men aged 40 to 80 years with a GS between 2 and 6 and clinical stage T1 or T2 prostate cancer enrolled between 1995 and 2014.
PSA levels and biopsy GSs.
After variable surveillance intervals and competing treatments were accounted for, estimated risks for biopsy upgrading were similar in the PASS and UT studies but higher in UCSF and lower in JHU studies. All cohorts had a delay of 3 to 5 months in detecting upgrading with biennial biopsies starting after a first confirmatory biopsy versus annual biopsies.
The model does not account for possible misclassification of biopsy GS.
Men in different AS studies have different risks for biopsy upgrading after variable surveillance protocols and competing treatments are accounted for. Despite these differences, the consequences of more versus less frequent biopsies seem to be similar across cohorts. Biennial biopsies seem to be an acceptable alternative to annual biopsies.
National Cancer Institute.
Inoue LY, Lin DW, Newcomb LF, Leonardson AS, Ankerst D, Gulati R, et al. Comparative Analysis of Biopsy Upgrading in Four Prostate Cancer Active Surveillance Cohorts. Ann Intern Med. 2018;168:1–9. doi: 10.7326/M17-0548
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Published: Ann Intern Med. 2018;168(1):1-9.
Published at www.annals.org on 28 November 2017
Hematology/Oncology, High Value Care, Prostate Cancer.
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