고위험도 전립선암 환자의 치료 편집하기 (부분)

== 근거표 ==
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!KQ12
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!Reference
|1. Bolla M, Van Tienhoven G, Warde P, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol 2010;11(11):1066-73.
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!Study type
|Randomized study
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!Patients
|415 patients
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!Purpose of Study
|To present the 10-year results of European Organisation for Research and Treatment of Cancer (EORTC) 22863, with the aim of confi rming whether previously reported improvements in overall survival were sustained and assessing the effect of the treatment on long-term cardiovascular morbidity and bone fractures.
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!Study Results
|Between May 22, 1987, and Oct 31, 1995, 415 patients were randomly assigned to treatment groups and were included in the analysis (208 radiotherapy alone, 207 combined treatment). Median follow-up was 9.1 years (IQR 5.1-12.6). 10-year clinical disease-free survival was 22.7% (95% CI 16.3-29.7) in the radiotherapy-alone group and 47.7% (39.0-56.0) in the combined treatment group (hazard ratio [HR] 0.42, 95% CI 0.33-0.55, p<0.0001). 10-year overall survival was 39.8% (95% CI 31.9-47.5) in patients receiving radiotherapy alone and 58.1% (49.2-66.0) in those allocated combined treatment (HR 0.60, 95% CI 0.45-0.80, p=0.0004), and 10-year prostate-cancer mortality was 30.4% (95% CI 23.2-37.5) and 10.3% (5.1-15.4), respectively (HR 0.38, 95% CI 0.24-0.60, p<0.0001). No significant difference in cardiovascular mortality was noted between treatment groups both in patients who had cardiovascular problems at study entry (eight of 53 patients in the combined treatment group had a cardiovascular-related cause of death vs 11 of 63 in the radiotherapy group; p=0.60) and in those who did not (14 of 154 vs six of 145; p=0.25). Two fractures were reported in patients allocated combined treatment.
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!Level of Study
|1
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!Reference
|2. Bolla M, de Reijke TM, Van Tienhoven G, et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009;360(24):2516-27.
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!Study type
|Randomized study
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!Patients
|970 patients
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!Purpose of Study
|We compared the use of radiotherapy plus short-term androgen suppression with the use of radiotherapy plus long-term androgen suppression in the treatment of locally advanced prostate cancer.
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!Study Results
|A total of 1113 men were registered, of whom 970 were randomly assigned, 483 to short- term suppression and 487 to long-term suppression. After a median follow-up of 6.4 years, 132 patients in the short-term group and 98 in the long-term group had died; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; P=0.65 for noninferiority). Adverse events in both groups included fatigue, diminished sexual function, and hot flushes.
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!Level of Study
|1
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!Reference
|3. Mason MD, Parulekar WR, Sydes MR, et al. Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen- Deprivation Therapy Alone in Locally Advanced Prostate Cancer. J Clin Oncol. 2015 Jul 1;33(19):2143-50.
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!Study type
|Randomized controlled trial
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!Patients
|1,205 patients
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!Purpose of Study
|We have previously reported that radiotherapy (RT) added to androgen-deprivation therapy (ADT) improves survival in men with locally advanced prostate cancer. Here, we report the prespecified final analysis of this randomized trial.
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!Study Results
|One thousand two hundred five patients were randomly assigned between 1995 and 2005, 602 to ADT alone and 603 to ADT+RT. At a median follow-up time of 8 years, 465 patients had died, including 199 patients from prostate cancer. Overall survival was significantly improved in the patients allocated to ADT+RT (hazard ratio [HR], 0.70; 95% CI, 0.57 to 0.85; P < .001). Deaths from prostate cancer were significantly reduced by the addition of RT to ADT (HR, 0.46; 95% CI, 0.34 to 0.61; P < .001). Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity, but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT.
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!Level of Study
|1
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!Reference
|4. Warde P, Mason M, Ding K, et al. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11.
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!Study type
|Prospective single-arm cohort study
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!Patients
|Patients with: locally advanced (T3 or T4) prostate cancer (n=1,057); or organ-confined disease (T2)
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!Purpose of Study
|Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer.
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!Study Results
|Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6.0 years (IQR 4.4-8.0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0.77, 95% CI 0.61-0.98, p=0.033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0.5%) in the ADT only group, two (0.3%) in the ADT and RT group; diarrhoea grade >3, four patients (0.7%) vs eight (1.3%); urinary toxicity grade >3, 14 patients (2.3%) in both groups).
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!Level of Study
|1
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!Reference
|5. Widmark A, Klepp O, Solberg A, et al. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009 Jan 24;373(9660):301-8.
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!Study type
|Randomized controlled trial
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!Patients
|875 patients with locally advanced prostate cancer
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!Purpose of Study
|To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression.
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!Study Results
|After a median follow-up of 7.6 years, 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer. The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus radiotherapy group (difference 12.0%, 95% CI 4.9-19.1%), for a relative risk of 0.44 (0.30-0.66). At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus radiotherapy group (difference 9.8%, 0.8-18.8%), for a relative risk of 0.68 (0.52- 0.89). Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group (74.7%vs 25.9%, p<0.0001; HR 0.16; 0.12-0.20). After 5 years, urinary, rectal, and sexual problems were slightly more frequent in the endocrine plus radiotherapy group.
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!Level of Study
|1
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!Reference
|6. Lei JH, Liu LR, Wei Q, et al. Systematic review and meta-analysis of the survival outcomes of first-line treatment options in high-risk prostate cancer. Sci Rep. 2015 Jan 12;5:7713.
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!Study Results
|Systematic review and meta-analysis
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!Patients
|
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!Purpose of Study
|To compare the long-term survival outcomes of radical prostatectomy (RP), radiation therapy (RT), brachytherapy (BT), androgen- deprivation therapy (ADT), and watchful waiting (WW) in high-risk prostate cancer (PCa).
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!Study Results
|A RCT conducted by Bolla et al. reported that RT plus 3-yr aADT resulted in a significantly better 5-yr OS than RT alone (79% for the combination vs. 62% for RT, P=0.001). D’Amico et al. also performed a comparison between RT and RT plus 6-mo aADT. Significant difference was also found for 5-yr OS (88% vs. 78%, P=0.04). Pilepich et al. also reported a better CSS using RT plus aADT (63.5% vs. 48.2% P=0.01) than RT alone. Similarly, Miljenko, et al. revealed a better outcome using RT plus (n+c) ADT, although the difference was not significant (8-yr OS 38% vs. 31%, P=0.98; 8-yr CSM 44% vs. 54%, P=0.36).
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!Level of Study
|1
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