전이성 거세저항성 전립선암 환자의 치료 편집하기 (부분)

== 근거표 ==
{| class="wikitable"
!KQ21
!
|-
!Reference
| 1. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. The New England Journal of Medicine 2014;371:424-33.
|-
!Study type
| Randomized controlled trial
|-
!Patients
|1,717
|-
!Purpose of Study
| To evaluate enzalutamide in men in whom hormonal agents are frequently administered (i.e., those who have asymptomatic or mildly symptomatic metastatic disease that has progressed despite the use of androgen-deprivation therapy) and who have not undergone chemotherapy.
|-
!Study Results
| 1. Radiographic progression-free survival rate at 12 months: 
- Enzalutamide: 65% (81% risk reduction; HR=0.19; 95% CI 0.15-0.23; P<0.001). 

- Placebo: 14% 
2. 626 patients (72%) in the enzalutamide group, as compared with 532 patients (63%) in the placebo group, were alive at the data-cutoff date (29% reduction in the risk of death; HR=0.71; 95% CI, 0.60 to 0.84; P<0.001).

 3. Benefit of enzalutamide was shown with respect to time until the initiation of cytotoxic chemotherapy, the time until the first skeletal-related event, complete or partial soft-tissue response, time until PSA progression, rate of decline of at least 50% in PSA (P<0.001 for all comparisons). 

4. Fatigue and hypertension were the most common clinically relevant adverse events associated with enzalutamide treatment.
|-
!Level of Study
|1
|-
!Reference
| 2. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Oncology 2015;16:152-60.
|-
!Study type
|Randomized controlled trial
|-
!Patients
|1,088
|-
!Purpose of Study
| To evaluate abiraterone acetate in men in whom hormonal agents are frequently administered (i.e., those who have asymptomatic or mildly symptomatic metastatic disease that has progressed despite the use of androgen-deprivation therapy) and who have not undergone chemotherapy.
|-
!Study Results
|1. Median follow-up of 49.2 months (IQR 47.0-51.8) 
2. 741 (96%) of the prespecified 773 death events for the final analysis had been observed  

- 354 (65%) of 546 patients in the abiraterone acetate group  

- 387 (71%) of 542 in the placebo group. 

3. Median OS: abiraterone acetate group (34.7 months) vs. placebo group (30.3 months) 

4. Most common grade 3-4 adverse events of special interest: cardiac disorders, increased alanine aminotransferase, hypertension.
|-
!Level of Study
|1
|-
!Reference
|  3. Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung, van Os S, Hasabou N, Wang F, Bhattacharya S, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. The Lancet Oncology 2016;17(2):153-63.
|-
!Study type
|Randomized controlled trial
|-
!Patients
|375
|-
!Purpose of Study
| To compare the efficacy and safety of enzalutamide with bicalutamide in patients with metastatic castration-resistant prostate cancer (TERRAIN).
|-
!Study Results
|1. 375 patients randomly assigned, 184 to enzalutamide and 191 to bicalutamide. 
2. Median follow-up: enzalutamide group=20.0 months, bicalutamide group=16.7 months 

3. Enzalutamide improved median progression-free survival (15.7 months) compared with bicalutamide (5.8 months) (p<0.0001). 3. Serious adverse events were reported by 57 (31%) of 183 patients and 44 (23%) of 189 patients in the enzalutamide and bicalutamide groups, respectively. 

4. One of the nine deaths in the enzalutamide group was thought to be possibly related to treatment (due to systemic infl ammatory response syndrome) compared with none of the three deaths in the bicalutamide group.
|-
!Level of Study
|1
|-
!Reference
| 4. Kim CS, Theeuwes A, Kwon DD, et al. The PREVAIL trial of enzalutamide in men with chemotherapy-naive, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investigative and clinical urology 2016;57:174-83.
|-
!Study type
| Randomized controlled trial
|-
! colspan="2" |
|-
!Purpose of Study
| To evaluate treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial.
|-
!Study Results
|1. Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). 
2. HRs for enzalutamide versus placebo were 0.23 for centrally assessed rPFS, 0.77 for OS, 0.21 for time to chemotherapy, 0.31 (0.17-0.56) for time to PSA progression. 

3. PSA response: enzalutamide-treated (70%), and placebo (10.5%). 

4. Adverse events of grade ≥3 occurred: enzalutamide-treated (33%) and placebo (11%). 5.Plasme concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97-1.10).
|-
!Level of Study
|1
|}