Graph paper template R2 이지훈 / Prof. 맹치훈 Lancet Oncol 2012; 13:
INTRODUCTION Androgen-deprivation therapy –Median overall survival after CTx is less than 2 years –All patients ultimately progress to metastatic castration-resistant prostate cancer Docetaxel Sipuleucel-T Cabazitaxel
INTRODUCTION Abiraterone acetate –Selective inhibitor of androgen biosynthesis –Antitumour activity in both chemotherapy-naive and chemotherapy-treated patients Median survival of 14.8 vs 10.9 mo
METHODS Patients –Phase 3, multinational, double-blind, randomised placebo-controlled trial –Histologically or cytologically confirmed metastatic castration-resistant prostate cancer Previous treatment with docetaxel PSA progression or radiographic progression Ongoing androgen deprivation(lower than 50 ng/dL) ECOG performance status of 2 or less Haematology and chemistry laboratory values
Randomisation and masking –Stratification ECOG performance status (0-1 vs 2) BPI-SF (0-3 for absent vs 4-10 for present) Number of previous CTx regimen (1 vs 2) Type of progression (PSA only vs radiographic) Procedures –Abiraterone acetate 1000mg once daily, plus prednisone 5mg twice daily METHODS
RESULTS –Patients were enrolled between May 8, 2008, and July 28, 2009 (Aug 25, 2010 / 775 death) –Median follow-up : 12.8mo → 20.2mo –Median overall survival : 15.8mo vs 11.2mo
Table 1: Baseline and disease characteristics of patients RESULTS
Figure 2: Overall survival
RESULTS
Figure 3: Overall survival by subgroup analyses
RESULTS
CONCLUSION The survival benefit for patients assigned to the abiraterone group compared with the placebo group favoured abiraterone acetate across most of the subgroupsanalysed. The survival benefit of abiraterone acetate versus placebo was independent of previous docetaxel use when analysed on the basis of timing of docetaxel administration and reason for docetaxel discontinuation.