Stratified by National Comprehensive Cancer Network risk category (low risk: n=50 302; intermediate risk: n=81 836; high risk: n=32 622). Error bars indicate 95% confidence intervals.
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Mahal BA, Butler S, Franco I, et al. Use of Active Surveillance or Watchful Waiting for Low-Risk Prostate Cancer and Management Trends Across Risk Groups in the United States, 2010-2015. JAMA. Published online February 11, 2019321(7):704–706. doi:10.1001/jama.2018.19941
Historically, most patients with low-risk prostate cancer (clinical category T1c-T2a, prostate-specific antigen level <10 ng/mL, and Gleason 6 disease) were treated with radical prostatectomy, while radiotherapy-based treatment was the favored approach for high-risk localized prostate cancer.1 However, conservative management of low-risk prostate cancer with active surveillance or watchful waiting (AS/WW) offers an alternative to radical prostatectomy or radiotherapy,2 and national guidelines began advocating its use in 2010.3,4 Nevertheless, current AS/WW rates across the United States are not well established, and it is unclear if increasing acceptance of AS/WW for low-risk prostate cancer might be associated with changes in management patterns in higher-risk prostate cancer. Therefore, we examined US trends in management patterns for localized prostate cancer across risk groups.
The custom Surveillance, Epidemiology, and End Results (SEER) Prostate Active Surveillance/Watchful Waiting database, unlike other databases, includes a quality-assured AS/WW variable.5 The proposal for this study was approved by the SEER custom data group. All men with localized prostate cancer diagnosed between 2010 and 2015 and known management type were included.
Patients designated by treating facilities as receiving AS or WW as management without any receipt of definitive therapy were coded by SEER as AS/WW.5 If changes from AS/WW to definitive therapy occurred within 1 year of diagnosis for reasons other than disease progression, the cases were coded as the definitive therapy used. Definitive therapy types were defined by SEER as either definitive radical prostatectomy or radiotherapy (including external-beam radiotherapy, brachytherapy, or any combination thereof); the positive predictive value and specificity of both variables are high.
Baseline characteristics, stratified by year of diagnosis, were summarized by descriptive statistics. Use of initial management or therapy type (AS/WW, radical prostatectomy, or radiotherapy), stratified by National Comprehensive Cancer Network risk category (low, intermediate, or high),3 was determined from 2010 to 2015, with the Cochran-Armitage test used to test for trends.
Two-sided P values were applied with an α = .05. Analyses were performed with Stata/SE version 15.1 (StataCorp). The Dana-Farber/Harvard Cancer Center institutional review board granted a waiver of informed consent.
Among 164 760 men, 20 879 (12.7%) had AS/WW management, 68 350 (41.5%) had radiotherapy, and 75 531 (45.8%) had radical prostatectomy. Men with diagnoses in 2015 (n = 25 140) compared with 2010 (n = 31 355) had significantly lower rates of low-risk disease (24.5% vs 34.2%), a higher median age (65 vs 64 years), and a higher median prostate-specific antigen level (6.7 vs 6.0 ng/mL) (all P < .05) (Table).
In men with low-risk disease (n = 50 302), AS/WW use increased from 14.5% to 42.1% from 2010 to 2015 (P < .001 for trend), while radical prostatectomy decreased from 47.4% to 31.3% (P < .001 for trend) and radiotherapy from 38.0% to 26.6% (P < .001 for trend) (Figure, A). In men with intermediate-risk disease (n = 81 836), AS/WW use increased from 5.8% to 9.6% from 2010 to 2015 (P < .001 for trend), while radical prostatectomy decreased from 51.8% to 50.6% (P = .004 for trend) and radiotherapy from 42.4% to 39.8% (P < .001 for trend) (Figure, B). In men with high-risk disease (n = 32 622), AS/WW use remained stable (1.9% to 2.2%) from 2010 to 2015 (P = .08 for trend), while radical prostatectomy use increased from 38.0% to 42.8% (P < .001 for trend) and radiotherapy use decreased from 60.1% to 55.0% (P < .001 for trend) (Figure, C).
Use of AS/WW for men with low-risk localized prostate cancer increased from 2010 to 2015, becoming the most common management approach. Radical prostatectomy use declined among men with low-risk disease but increased among patients with higher-risk disease. Although increasing use of AS/WW for low-risk disease has been supported by high-level evidence and guidelines since 2010,2,3 shifting management patterns toward more radical prostatectomy in higher-risk disease and away from radiotherapy does not coincide with any new level 1 evidence or guideline changes.6 The potential downstream effects of efforts to increase AS/WW for men with low-risk disease on management of other risk groups requires further examination.
Strengths of this study include the large, diverse population representative of the US population and high-quality AS/WW data, providing an accurate and contemporary metric of AS/WW use and management trends in the United States. Limitations include lack of data on AS/WW compliance and lack of information regarding neoadjuvant androgen deprivation therapy use. Also, the study only investigated management patterns; how the trends will translate into clinical outcomes is unknown.
Accepted for Publication: November 19, 2018.
Corresponding Author: Brandon A. Mahal, MD, Dana-Farber Cancer Institute McGraw/Patterson Center for Population Sciences, 450 Brookline Ave, 1101 Dana, Boston, MA 02215 (email@example.com).
Published Online: February 11, 2019. doi:10.1001/jama.2018.19941
Author Contributions: Drs Mahal and Nguyen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Mahal and Mr Butler contributed equally as co–first authors.
Concept and design: Mahal, Butler, Rebbeck, Nguyen.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Mahal, Butler, D’Amico.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Mahal, Butler.
Obtained funding: Mahal.
Administrative, technical, or material support: Mahal, Franco, Rebbeck, D’Amico, Nguyen.
Supervision: Mahal, Spratt, Rebbeck, D’Amico, Nguyen.
Conflict of Interest Disclosures: Dr Spratt reported serving on an advisory board for Janssen and Blue Earth. Dr Rebbeck reported receipt of grants from the National Institutes of Health. Dr Nguyen reported receipt of consulting fees from Ferring, Augmenix, Bayer, Janssen, Astellas, Dendreon, Genome DX, Blue Earth Diagnostics, Cota, and Nanobiotix; grant funding from Janssen and Astellas; and equity in Augmenix. No other disclosures were reported.
Funding/Support: Dr Mahal is funded by the Prostate Cancer Foundation–American Society for Radiation Oncology Award to End Prostate Cancer. Dr Nguyen is funded by the Prostate Cancer Foundation. The work was also supported by the Wood Family Foundation, Baker family, Freedman family, Fitz’s Cancer Warriors, David and Cynthia Chapin, Frashure family, Hugh Simons in honor of Frank and Anne Simons, Campbell family in honor of Joan Campbell, Scott Forbes and Gina Ventre Fund, and a grant from an anonymous family foundation.
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Additional Contributions: We thank Vinayak Muralidhar, MD, MSc, David D. Yang, MD, Nina N. Sanford, MD, Janice Chavez, MSW, LICSW, Toni K. Choueiri, MD, Kent W. Mouw, MD, PhD, Quoc-Dien Trinh, MD (all from the Dana-Farber Cancer Institute), Amandeep Mahal, BS (Yale School of Medicine), Felix Y. Feng, MD (Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco), and Jim C. Hu, MD (Weill Cornell Medicine), for their contributions to the interpretation of the data and critical revision of portions of the manuscript. None of the persons named above were compensated for their contributions.
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