저위험도 전립선암 환자의 치료 편집하기 (부분)

== 근거표 ==
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!KQ2 
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!Reference<sup>[4]</sup>
|1. Wilt TJ, Jones KM, Barry MJ, Andriole GL, Culkin D, Wheeler T, Aronson WJ, Brawer MK.Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med 2017;377(2):132-42.
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!Study type
|Case-control study
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!Patients
|731 men with localized Prostate cancer 
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!Purpose of Study
|To assess our primary outcome, all-cause mortality, and the main secondary outcome, prostate-cancer mortality between radical prostatectomy and active surveillance groups
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!Study Results
|During 19.5 years of follow-up (median, 12.7 years), death occurred in 223 of 364 men (61.3%) assigned to surgery and in 245 of 367 (66.8%) assigned to observation (absolute difference in risk, 5.5 percentage points; 95% confidence interval [CI], -1.5 to 12.4; hazard ratio, 0.84; 95% CI, 0.70 to 1.01; P=0.06). Death attributed to prostate cancer or treatment occurred in 27 men (7.4%) assigned to surgery and in 42 men (11.4%) assigned to observation (absolute difference in risk, 4.0 percentage points; 95% CI, -0.2 to 8.3; hazard ratio, 0.63; 95% CI, 0.39 to 1.02; P=0.06). Surgery may have been associated with lower all-cause mortality than observation among men with intermediate-risk disease (absolute difference, 14.5 percentage points; 95% CI, 2.8 to 25.6) but not among those with low-risk disease (absolute difference, 0.7 percentage points; 95% CI, -10.5 to 11.8) or high-risk disease (absolute difference, 2.3 percentage points; 95% CI, -11.5 to 16.1) (P=0.08 for interaction). Treatment for disease progression was less frequent with surgery than with observation (absolute difference, 26.2 percentage points; 95% CI, 19.0 to 32.9); treatment was primㅁarily for asymptomatic, local, or biochemical (prostate-specific antigen) progression. Urinary incontinence and erectile and sexual dysfunction were each greater with surgery than with observation through 10 years. Disease-related or treatment-related limitations in activities of daily living were greater with surgery than with observation through 2 years.
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!Level of Study
|1
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!Reference<sup>[5]</sup>
|2. Wilt TJ. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer. J Natl Cancer Inst Monogr 2012(45):184-90.
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!Study type
|A large multicenter randomized controlled trial : The Department of Veterans Affairs/ National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT)
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!Patients
|13,022
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!Purpose of Study
|The primary aim of PIVOT is to compare all-cause mortality between the RP and WW groups. Secondary aims include comparison of prostate cancer mortality, progression, and disease-specific quality of life.
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!Study Results
|As noted previously, approximately 15% of potentially eligible men agreed to randomization. We compared baseline demographic, tumor, and health status characteristics of PIVOT enrollees with that of other cohorts of men with prostate cancer and with that of men eligible but declining randomization to assess external validity. Compared with men who were PIVOT eligible but declined enrollment, PIVOT enrollees were slightly older, more likely to be African American, have well-differentiated prostate cancer, and report their health status as excellent or very good. The cohort of all screen registrants (including those not satisfying eligibility requirements) was slightly older, less likely to be African American, had higher mean PSA values, and a PSA value 20 or higher than PIVOT enrollees. The most frequent reasons for PIVOT exclusion among the cohort of all screened registrants were nonlocalized disease (15%), life expectancy less than 10 years (8.5%), debilitating illness (6.1%), age greater than 75 years (4.9%), and PSA level greater than 50ng/mL (4.3%). We compared results with that in men enrolled in a similar, but smaller, ongoing RCT of RP vs WW conducted in several Scandinavian countries (SPCG-4) (7). Compared with PIVOT enrollees, men in SPCG-4 were slightly younger, had higher mean PSA values, and had many fewer cancers detected by PSA testing, and there appeared to be less racial diversity
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!Level of Study
|1
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!Reference<sup>[7]</sup>
|3. Bul M, van den Bergh RC, Zhu X, Rannikko A, Vasarainen H, Bangma CH, Schröder FH, Roobol MJ. Outcomes of initially expectantly managed patients with low or intermediate risk screen-detected localized prostate cancer. BJU Int 2012;110(11):1672-7.
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!Study type
|Large, longitudinal observational study: the Rotterdam and Helsinki arms of the European Randomized Study of Screening for Prostate Cancer (ERSPC)
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!Patients
|509
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!Purpose of Study
|To assess the longer-term feasibility of active surveillance, we aimed to evaluate outcomes of patients with screen-detected localized prostate cancer (PCa) who initially elected to withhold radical treatment for either low or intermediate risk disease.
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!Study Results
|In all, 509 patients with PCa were eligible, of whom 381 were considered low risk and 128 intermediate risk. •During a median follow-up of 7.4 years, a total of 221 patients (43.4%) switched to deferred treatment after a median of 2.6 years. •The calculated 10-year disease-specific survival rates were 99.1% and 96.1% for low and intermediate risk patients, respectively (P=0.44), and for overall survival 79.0% and 64.5%, respectively (P=0.003). •Competing risks analysis showed similar results.
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!Level of Study
|2 
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!Reference<sup>[2]</sup> 
|4. Iversen P, Madsen PO, Corle DK. Radical prostatectomy versus expectant treatment for early carcinoma of the prostate: twenty-three year follow-up of a prospective randomized study. Scand J Urol Nephrol Suppl 1995;172:65-72.
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!Study type
|A large multicenter randomized controlled trial: the Veterans Administration Cooperative Urological Research Group (VACURG)
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!Patients
|142
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!Purpose of Study
|To assess the longer-term feasibility of active surveillance, we aimed to evaluate outcomes of patients with screen-detected localized prostate cancer (PCa) who initially elected to withhold radical treatment for either low or intermediate risk disease.
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!Study Results
|Median follow-up for survival is 23 years. The prognostic value of Gleason histologic grading was confirmed. A difference in overall survival in favor of radical prostatectomy was observed in stage I patients. However, after adjustment for imbalance in age distribution, no statistically significant differences in survival could be demonstrated in either stage or in both stages combined.
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!Level of Study
|2
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!Reference<sup>[6]</sup>
|5. Bill-Axelson A, Holmberg L, Garmo H, et al. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med 2014;370:932-42.
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!Study type
|Large, longitudinal observational study: the Rotterdam and Helsinki arms of the European Randomized Study of Screening for Prostate Cancer (ERSPC)
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!Patients
|695
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!Purpose of Study
|The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy.
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!Study Results
|During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P=0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgendeprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical prostatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P=0.04).
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!Level of Study
|2
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!Reference<sup>[3]</sup>
|6. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016;375:1415-24.
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!Study type
|Large, multicenter randomized controlled trial
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!Patients
|82,429
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!Purpose of Study
|The primary outcome was prostate-cancer mortality at a median of 10 years of followup. Secondary outcomes included the rates of disease progression, metastases, and allcause deaths.
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!Study Results
|There were 17 prostate-cancer-specific deaths overall: 8 in the active-monitoring group (1.5 deaths per 1000 person-years; 95% confidence interval [CI], 0.7 to 3.0), 5 in the surgery group (0.9 per 1000 person-years; 95% CI, 0.4 to 2.2), and 4 in the radiotherapy group (0.7 per 1000 person-years; 95% CI, 0.3 to 2.0); the difference among the groups was not significant (P=0.48 for the overall comparison). In addition, no significant difference was seen among the groups in the number of deaths from any cause (169 deaths overall; P=0.87 for the comparison among the three groups). Metastases developed in more men in the active-monitoring group (33 men; 6.3 events per 1000 person-years; 95% CI, 4.5 to 8.8) than in the surgery group (13 men; 2.4 per 1000 person-years; 95% CI, 1.4 to 4.2) or the radiotherapy group (16 men; 3.0 per 1000 person-years; 95% CI, 1.9 to 4.9) (P=0.004 for the overall comparison). Higher rates of disease progression were seen in the active-monitoring group (112 men; 22.9 events per 1000 person-years; 95% CI, 19.0 to 27.5) than in the surgery group (46 men; 8.9 events per 1000 person-years; 95% CI, 6.7 to 11.9) or the radiotherapy group (46 men; 9.0 events per 1000 person-years; 95% CI, 6.7 to 12.0) (P<0.001 for the overall comparison).
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!Level of Study
|2
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