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Active Surveillance in Men With Localized Prostate Cancer: A Systematic Review

Issa J. Dahabreh, MD, MS; Mei Chung, PhD, MPH; Ethan M. Balk, MD, MPH; Winifred W. Yu, PhD, MS; Paul Mathew, MD; Joseph Lau, MD; and Stanley Ip, MD
[+] Article, Author, and Disclosure Information

From Tufts Evidence-based Practice Center, Institute for Clinical Research and Health Policy Studies, and Tufts Medical Center, Boston, Massachusetts.

Disclaimer: The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Acknowledgment: The authors thank Iovin Ramon, PhD, who served as the medical editor of the original evidence report, and Jenny Lamont, MS, who served as the medical editor for this manuscript. Neither medical editor participated in the design of the study or the collection and synthesis of information and do not take responsibility for the contents of the article.

Grant Support: This project was funded under contract HHSA 290-2007-10055-I from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.

Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2849.

Requests for Single Reprints: Stanley Ip, MD, Tufts Evidence-based Practice Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Box 63, 800 Washington Street, Boston, MA 02111; e-mail, mailto:sip@tuftsmedicalcenter.org.

Current Author Addresses: Drs. Dahabreh, Chung, Yu, Balk, Lau, and Ip: Tufts Evidence-based Practice Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Box 63, 800 Washington Street, Boston, MA 02111.

Dr. Mathew: Division of Hematology/Oncology, Department of Medicine, Tufts Medical Center, 800 Washington Street, Boston, MA 02111.

Author Contributions: Conception and design: I.J. Dahabreh, M. Chung, E.M. Balk, W.W. Yu, S. Ip.

Analysis and interpretation of the data: I.J. Dahabreh, M. Chung, E.M. Balk, W.W. Yu, P. Mathew, S. Ip.

Drafting of the article: S. Ip.

Critical revision of the article for important intellectual content: I.J. Dahabreh, M. Chung, E.M. Balk, W.W. Yu, P. Mathew, J. Lau, S. Ip.

Final approval of the article: I.J. Dahabreh, M. Chung, E.M. Balk, W.W. Yu, P. Mathew, J. Lau, S. Ip.

Statistical expertise: I.J. Dahabreh.

Obtaining of funding: J. Lau.

Administrative, technical, or logistic support: J. Lau.

Collection and assembly of data: I.J. Dahabreh, M. Chung, E.M. Balk, W.W. Yu, S. Ip.

Ann Intern Med. 2012;156(8):582-590. doi:10.7326/0003-4819-156-8-201204170-00009
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Background: Active surveillance (AS) and watchful waiting (WW) have been proposed as management strategies for low-risk, localized prostate cancer.

Purpose: To systematically review strategies for observational management of prostate cancer (AS or WW), factors affecting their utilization, and comparative effectiveness of observational management versus immediate treatment with curative intent.

Data Sources: MEDLINE and Cochrane databases (from inception to August 2011).

Study Selection: Screened abstracts and reviewed full-text publications to identify eligible studies.

Data Extraction: One reviewer extracted data, and another verified quantitative data. Two independent reviewers rated study quality and strength of evidence for comparative effectiveness.

Data Synthesis: Sixteen independent cohorts defined AS, 42 studies evaluated factors that affect the use of observational strategies, and 2 evidence reports and 22 recent studies reported comparisons of WW versus treatment with curative intent. The most common eligibility criteria for AS were tumor stage (all cohorts), Gleason score (12 cohorts), prostate-specific antigen (PSA) concentration (10 cohorts), and number of biopsy cores positive for cancer (8 cohorts). For monitoring, studies used combinations of periodic PSA testing (all cohorts), digital rectal examination (14 cohorts), and rebiopsy (14 cohorts). Predictors of receiving no active treatment included older age, comorbid conditions, lower Gleason score, tumor stage, PSA concentration, and favorable risk group. No published studies compared AS with immediate treatment with curative intent. Watchful waiting was generally less effective than treatment with curative intent; however, applicability to contemporary patients may be limited.

Limitations: Active surveillance and WW often could not be differentiated in the reviewed studies. Published randomized trials have assessed only WW and did not enroll patients diagnosed by PSA screening.

Conclusion: Evidence is insufficient to assess whether AS is an appropriate option for men with localized prostate cancer. A standard definition of AS that clearly distinguishes it from WW is needed to clarify scientific discourse.

Primary Funding Source: Agency for Healthcare Research and Quality.


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Appendix Figure 1.

Summary of evidence search and selection.

AS = active surveillance; CCRCT = Cochrane Central Register of Controlled Trials; CDSR = Cochrane Database of Systematic Reviews; CEA = Cost-Effectiveness Analysis; EPC = Evidence-based Practice Center; HTA = Health Technology Assessment; ICER = Institute for Clinical and Economic Reviews; RCT = randomized, controlled trial; WW = watchful waiting.

* These studies were relevant to “Key Question 1” in the main report (5) but are not covered here. The numbers of studies for each question do not add up to the total number of included studies because some studies addressed many questions.

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Appendix Figure 2.

Evidence map for studies of factors affecting the offer of, acceptance of, or adherence to observational management strategies.

MV = multivariable; WW = watchful waiting. Two studies (43, 51) are not depicted in the graph because they assessed different outcomes (consent to randomization and decisional conflict, respectively).

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