CABAZITAXEL PLUS CORTICOSTEROIDS IN COMPARISON TO CORTICOSTEROIDS ALONE FOR THE TREATMENT OF METASTATIC HORMONE REFRACTORY / CASTRATION-RESISTANT PROSTATE CANCER (MHRPC)
Author(s)
Schinzel S1, Herbold M1, Bramlage P21Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany, 2Institut für Pharmakologie und präventive Medizin, Mahlow, Germany
Presentation Documents
OBJECTIVES: A combination Cabazitaxel plus Corticosteroids (CC) has been shown to prolong survival in patients with mHRPC versus Mitoxantrone plus Corticosteroids (MC) in the TROPIC study of patients with mHRPC. As there is no direct comparison CC vs. Corticosteroids (C) as requested by the German regulatory bodies we aimed to provide an indirect comparison. METHODS: A systematic search of the DIMDI database was conducted in 12/2011. Data were combined using meta-analyses and indirect comparisons (“Bucher et al. J Clin Oncol 2008”). The endpoints analysed were all cause mortality overall and in patients with or without pain and pain response (Hazard/Response Ratios with 95%-confidence intervals). RESULTS: A total of 168 potential publications resulted in three relevant studies (Berry, 2002; Kantoff, 1999; Tannock, 1996) for MC vs. C. A meta-analysis of mortality in the three studies resulted in HR=0.92 (95%-CI 0.74-1.13) for MC vs. C. Combined with TROPIC (CC vs. MC 0.70; 0.59-0.83) the indirect comparison (CC vs. C) resulted in HR=0.64 (0.49-0.84). For mortality in patients without pain at baseline, the HR for MC vs. C was 0.89 (0.59-1.34) (Berry). The indirect comparison CC vs. C resulted in HR=0.51 (0.30-0.84) using TROPIC patients without pain (HR=0.57; 0.42-0.77). For mortality in patients with pain at baseline, the HR for MC vs. C was 0.83 (0.60-1.16) (Tannock). The indirect comparison CC vs. C resulted in HR=0.65 (0.43-0.98) using TROPIC patients with pain (HR=0.78; 0.60-1.00). In patients with pain at baseline, pain response was higher with MC vs. C (RR=2.33; 1.19-4.57) (Tannock). The indirect comparison CC vs. C resulted in RR=2.77 (1.05-7.32) using TROPIC patients with pain (RR=1.19; 0.59-2.39). CONCLUSIONS: The analyses indicate a statistically significant reduction of mortality in patients with mHRPC receiving CC vs. C with or without pain and an increased pain response.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PCN5
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology