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      Survival in men older than 75 years with low- and intermediate-grade prostate cancer managed with watchful waiting with active surveillance

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          Abstract

          Objective: Recent studies have reported the underuse of active surveillance or watchful waiting for low-risk prostate cancer in the United States. This study examined prostate cancer–specific and all-cause death in elderly patients older than 75 years with low-risk tumors managed with active treatment versus watchful waiting with active surveillance (WWAS).

          Methods: We performed survival analysis in a cohort of 18,599 men with low-risk tumors (early and localized tumors) who were 75 years or older at the time of prostate cancer diagnosis in the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database (from 1992 to 1998) and who were followed up through December 2003. WWAS was defined as having annual screening for prostate-specific antigen and/or digital rectal examination during the follow-up period. The risks of prostate cancer–specific and all-cause death were compared by Cox regression models. The propensity score matching technique was used to address potential selection bias.

          Results: In patients with well-differentiated (Gleason score 2–4) and localized disease, those managed with WWAS without delayed treatment had higher risk of all-cause death (hazard ratio 1.20, 95% confidence interval 1.13–1.28) but a substantially lower risk of prostate cancer–specific death (hazard ratio 0.62, confidence interval 0.51–0.75) than patients undergoing active treatment. Patients managed with WWAS with delayed treatment had comparable mortality outcomes. Sensitivity analyses based on propensity score matching yielded similar results.

          Conclusion: In men older than 75 years with well-differentiated and localized prostate cancer, WWAS without delayed treatment had a lower risk of prostate cancer–specific death and comparable all-cause death as compared with active treatment. Those patients in whom treatment was delayed had comparable mortality outcomes. Our results support WWAS as an initial management option for older men with well-differentiated and localized prostate cancer.

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          Most cited references 37

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          Trends in Management for Patients With Localized Prostate Cancer, 1990-2013.

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            Radical prostatectomy versus watchful waiting in early prostate cancer.

            In 2008, we reported that radical prostatectomy, as compared with watchful waiting, reduces the rate of death from prostate cancer. After an additional 3 years of follow-up, we now report estimated 15-year results. From October 1989 through February 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy. Follow-up was complete through December 2009, with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death. Relative risks, with 95% confidence intervals, were estimated with the use of a Cox proportional-hazards model. During a median of 12.8 years, 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died (P=0.007). In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting, death was due to prostate cancer. This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6% and 20.7%, respectively (a difference of 6.1 percentage points; 95% confidence interval [CI], 0.2 to 12.0), and a relative risk with surgery of 0.62 (95% CI, 0.44 to 0.87; P=0.01). The survival benefit was similar before and after 9 years of follow-up, was observed also among men with low-risk prostate cancer, and was confined to men younger than 65 years of age. The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age. Among men who underwent radical prostatectomy, those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth (relative risk, 6.9; 95% CI, 2.6 to 18.4). Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer. Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment. (Funded by the Swedish Cancer Society and the National Institutes of Health.).
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              Radical prostatectomy versus watchful waiting in localized prostate cancer: the Scandinavian prostate cancer group-4 randomized trial.

              The benefit of radical prostatectomy in patients with early prostate cancer has been assessed in only one randomized trial. In 2005, we reported that radical prostatectomy improved prostate cancer survival compared with watchful waiting after a median of 8.2 years of follow-up. We now report results after 3 more years of follow-up. From October 1, 1989, through February 28, 1999, 695 men with clinically localized prostate cancer were randomly assigned to radical prostatectomy (n = 347) or watchful waiting (n = 348). Follow-up was complete through December 31, 2006, with histopathologic review and blinded evaluation of causes of death. Relative risks (RRs) were estimated using the Cox proportional hazards model. Statistical tests were two-sided. During a median of 10.8 years of follow-up (range = 3 weeks to 17.2 years), 137 men in the surgery group and 156 in the watchful waiting group died (P = .09). For 47 of the 347 men (13.5%) who were randomly assigned to surgery and 68 of the 348 men (19.5%) who were not, death was due to prostate cancer. The difference in cumulative incidence of death due to prostate cancer remained stable after about 10 years of follow-up. At 12 years, 12.5% of the surgery group and 17.9% of the watchful waiting group had died of prostate cancer (difference = 5.4%, 95% confidence interval [CI] = 0.2 to 11.1%), for a relative risk of 0.65 (95% CI = 0.45 to 0.94; P = .03). The difference in cumulative incidence of distant metastases did not increase beyond 10 years of follow-up. At 12 years, 19.3% of men in the surgery group and 26% of men in the watchful waiting group had been diagnosed with distant metastases (difference = 6.7%, 95% CI = 0.2 to 13.2%), for a relative risk of 0.65 (95% CI = 0.47 to 0.88; P = .006). Among men who underwent radical prostatectomy, those with extracapsular tumor growth had 14 times the risk of prostate cancer death as those without it (RR = 14.2, 95% CI = 3.3 to 61.8; P < .001). Radical prostatectomy reduces prostate cancer mortality and risk of metastases with little or no further increase in benefit 10 or more years after surgery.
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                Author and article information

                Journal
                FMCH
                Family Medicine and Community Health
                FMCH
                Compuscript (Ireland )
                2009-8774
                2305-6983
                September 2015
                October 2015
                : 3
                : 3
                : 25-36
                Affiliations
                1Department of Epidemiology and Biostatistics, Case Western Reserve University School of Medicine, Cleveland, OH, USA
                2Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA
                3Levine Cancer Institute, Carolinas Healthcare System, Charlotte, NC, USA
                4Department of Family Medicine-Research Division, Case Western Reserve University School of Medicine, Cleveland, OH, USA
                Author notes
                CORRESPONDING AUTHOR: Li Li, MD, PhD, Department of Family Medicine-Research Division, Case Western Reserve University School of Medicine, 11000 Cedar Ave, Suite 402, Cleveland, OH 44106, USA, Tel.: +1-216-3685437, Fax: +1-216-3684348, E-mail: ll134q@ 123456rocketmail.com
                Article
                fmch20150129
                10.15212/FMCH.2015.0129
                Copyright © 2015 Family Medicine and Community Health

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 Unported License (CC BY-NC 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc/4.0/.

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                Self URI (journal page): http://fmch-journal.org/
                Categories
                Original Research

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