전이성 거세저항성 전립선암 환자의 치료 편집하기 (부분)

== 근거표 ==
{| class="wikitable"
!KQ22
!
|-
!Reference
|1. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367(13):118797.
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!Study type
| Randomized controlled trial
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!Patients
|1,199
|-
!Purpose of Study
| To evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy
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!Study Results
|1. Study stopped after a planned interim analysis at the time of 520 deaths. 
2. Median OS: enzalutamide group (18.4 months) vs. placebo group (13.6 months) 

3. Superiority of enzalutamide over placebo was shown with respect to all secondary end points:

- proportion of patients with a reduction in PSA level by 50% or more (54% vs. 2%, P<0.001)

- soft-tissue response rate (29% vs. 4%, P<0.001)

- quality-of-life response rate (43% vs. 18%, P<0.001)

- time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001)

- radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001)

- time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001).

4. Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. 

5. Seizures were reported in five patients (0.6%) receiving enzalutamide.
|-
!Level of Study
|1
|-
!Reference
| 2. Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012;13(10):983-92.
|-
!Study type
|Randomized controlled trial
|-
!Patients
|1,088
|-
!Purpose of Study
| To present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events).
|-
!Study Results
|1. abiraterone acetate plus prednisone (n=797) vs. placebo plus prednisone (n=398)
2. Median follow-up=20.2 months (IQR 18.4-22.1) 

3. Median OS: abiraterone group (15.8 months [95% CI 14.8-17.0]) vs. placebo group (11.2 months [10.4-13.1]); HR=0.74, 95% CI 0.64-0.86; p<0.0001. 

4. Median time to PSA progression: abiraterone group (8.5 months) vs. placebo group (6.6 months) 

5. Median radiologic progression-free survival: abiraterone group (5.6 months) vs. placebo (3.6 months); p<0.0001), 

6. Most common grade 3-4 adverse events: fatigue (72 [9%] of 791 patients in the abiraterone group vs 41 [10%] of 394 in the placebo group), anaemia (62 [8%] vs 32 [8%]), back pain (56 [7%] vs 40 [10%]), and bone pain (51 [6%] vs 31 [8%]).
|-
!Level of Study
|1
|-
!Reference
| 3. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010; 376: 1147-1154. 
|-
!Study type
|Randomized controlled trial
|-
!Patients
|755
|-
!Purpose of Study
| To compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment.
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!Study Results
|1. 755 men allocated to treatment groups: mitoxantrone (n=377), cabazitaxel (n=378) 
2. Median survival: cabazitaxel group=15.1 months, mitoxantrone group=12.7 months 

3. HR for death of men treated with cabazitaxel compared with those taking mitoxantrone=0.70 (95% CI 0.59-0.83, p<0.0001). 

4. Median progression-free survival: cabazitaxel group=2.8 months, mitoxantrone group=1.4 months (p<0.0001). 

5. Most common clinically significant grade 3 or higher adverse events: neutropenia (cabazitaxel, 303 [82%] patients vs mitoxantrone, 215 [58%]) and diarrhoea (23 [6%] vs one [<1%]). 28 (8%) patients in the cabazitaxel group.
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!Level of Study
|1
|}