Julia H. Hayes, MD; Daniel A. Ollendorf, MPH; Steven D. Pearson, MD, MSc; Michael J. Barry, MD; Philip W. Kantoff, MD; Pablo A. Lee, BS; Pamela M. McMahon, PhD
Acknowledgment: The authors thank Cancer Intervention and Surveillance Modeling Network investigators for helpful discussions.
Grant Support: By grant R25 CA92203-08 (National Cancer Institute at the National Institutes of Health), grant W81XWH-09-1-0512 (U.S. Department of Defense), a Young Investigators Award to Dr. Hayes (Prostate Cancer Foundation), and funding to the Institute for Clinical and Economic Review from the Blue Shield of California Foundation.
Potential Conflicts of Interest: Dr. Hayes: Grants (money to institution): U.S. Department of Defense, Prostate Cancer Foundation; Royalties: UpToDate. Dr. Ollendorf: Grants (money to institution): Blue Shield of California Foundation. Dr. Pearson: Consultancy: National Institutes of Health, Yale University; Employment: Massachusetts General Hospital; Grants/grants pending (money to institution): Agency for Healthcare Research and Quality. Dr. Barry: Board membership: Informed Medical Decisions Foundation; Employment: Informed Medical Decisions Foundation; Royalties (money to institution): Health Dialog. Dr. McMahon: Grants (money to institution): Blue Shield of California Foundation, Harvard Community Health Plan. All other authors have no disclosures. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0857.
Reproducible Research Statement: Study protocol: Not available. Statistical code: Available to approved individuals after discussion with Dr. Hayes (e-mail, Julia_Hayes@dfci.harvard.edu). Data set: Available from Dr. Hayes (e-mail, Julia_Hayes@dfci.harvard.edu).
Requests for Single Reprints: Julia H. Hayes, MD, Dana-Farber Cancer Institute, Dana 1230, 450 Brookline Avenue, Boston, MA 02115; e-mail, Julia_Hayes@dfci.harvard.edu.
Current Author Addresses: Drs. Hayes and Kantoff: Dana-Farber Cancer Institute, Dana 1230, 450 Brookline Avenue, Boston, MA 02115.
Drs. Ollendorf and Pearson: Institute for Clinical and Economic Review, 101 Merrimac Street, 10th Floor, Boston, MA 02114.
Dr. Barry: General Medicine Division, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114.
Mr. Lee and Dr. McMahon: Institute for Technology Assessment, 101 Merrimac Street, 10th Floor, Boston, MA 02114.
Author Contributions: Conception and design: J.H. Hayes, D.A. Ollendorf, M.J. Barry, P.W. Kantoff, P.M. McMahon.
Analysis and interpretation of the data: J.H. Hayes, D.A. Ollendorf, S.D. Pearson, M.J. Barry, P.W. Kantoff, P.M. McMahon.
Drafting of the article: J.H. Hayes, D.A. Ollendorf.
Critical revision of the article for important intellectual content: J.H. Hayes, D.A. Ollendorf, S.D. Pearson, M.J. Barry, P.M. McMahon.
Final approval of the article: J.H. Hayes, D.A. Ollendorf, S.D. Pearson, M.J. Barry, P.W. Kantoff, P.M. McMahon.
Provision of study materials or patients: D.A. Ollendorf.
Statistical expertise: J.H. Hayes, D.A. Ollendorf, P.M. McMahon.
Obtaining of funding: J.H. Hayes.
Collection and assembly of data: J.H. Hayes, D.A. Ollendorf, P.A. Lee, P.M. McMahon.
Hayes JH, Ollendorf DA, Pearson SD, Barry MJ, Kantoff PW, Lee PA, et al. Observation Versus Initial Treatment for Men With Localized, Low-Risk Prostate Cancer: A Cost-Effectiveness Analysis. Ann Intern Med. 2013;158:853-860. doi: 10.7326/0003-4819-158-12-201306180-00002
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Published: Ann Intern Med. 2013;158(12):853-860.
Observation is underutilized among men with localized, low-risk prostate cancer.
To assess the costs and benefits of observation versus initial treatment.
Decision analysis simulating treatment or observation.
Medicare schedules, published literature.
Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 µg/L, stage ≤T2a, Gleason score ≤3 + 3).
Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]).
Quality-adjusted life expectancy and costs.
Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15 374 ($24 520 vs. $39 894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11 746 ($18 302 vs. $30 048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment.
Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses.
Results depend on outcomes reported in the published literature, which is limited.
Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios.
National Cancer Institute, U.S. Department of Defense, Prostate Cancer Foundation, and Institute for Clinical and Economic Review.
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Hematology/Oncology, High Value Care, Prostate Cancer.
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