Cabazitaxel (CBZ) is a taxane approved for mCRPC treatment post docetaxel based on Phase 3 clinical trial data. Observational studies are in progress to gather information on real-world treatment patterns, safety, efficacy and HRQL effect of CBZ outside of clinical trials.
The prospective, observational study CAPRISTANA evaluated the routine clinical use of CBZ (25 mg/m2 every 3 weeks plus prednisone 10 mg/day) in pts with mCRPC previously treated with docetaxel. HRQL was assessed using Functional Assessment of Cancer Therapy - Prostate (FACT-P) version 4 and EQ-5D-3L (including VAS - visual analogue scale) questionnaires at baseline and every two cycles until CBZ discontinuation.
A total of 192 pts were treated in 55 centers across 6 countries (Apr 2012–Jun 2016); 161 and 157 pts were evaluable for FACT-P and EQ-5D, respectively. Pts received 6 (median) cycles of CBZ (range 1–24); 53.6% achieved disease control with CBZ. The main reason for CBZ treatment discontinuation was disease progression (58.3%). No new safety signals were identified. In the overall FACT-P score analysis, HRQL improvement during CBZ treatment was recorded in 31.8%, no change in HRQL in 40.4%, and deterioration was recorded in 27.8% of pts. The highest rate of improvement was observed for the Prostate-Specific Concerns subscale (49.3%) and Pain Control subscale (54.2%). The highest rate of deterioration was recorded for the Functional Well-Being subscale (40.9%). Mean FACT-P score and EQ-5D health utility index and VAS scores did not show statistically significant changes during CBZ treatment.
In this real-world study investigating HRQL associated with the use of CBZ in pts with mCRPC, no significant changes were observed in mean on-treatment FACT-P score and EQ-5D scores. However, in contrast to observations in prospective clinical studies, pts had improvement in the Pain Control FACT-P subscale. These results suggest that, in addition to the previously demonstrated effectiveness, CBZ treatment may help pts to achieve better pain control.
Clinical trial identification
Legal entity responsible for the study
G. Barnes: Employee of Sanofi. M. Ghosn: Advisory boards for Sanofi, Astellas and Janssen. I. Koroleva: Research funding and speakers' bureau for AstraZeneca and Teva, travel reimbursement from MSD and Eisai. A. Ozatilgan: Employee of Sanofi. S. Hitier: Employee of Sanofi. J. Carles: Consulting/advisory role to Johnson&Johnson, Bayer, Astellas, BMS, Pfizer and Sanofi. All other authors have declared no conflicts of interest.
G. Barnes: Employee of Sanofi. M. Ghosn: Advisory boards for Sanofi, Astellas and Janssen. I. Koroleva: Research funding and speakers\' bureau for AstraZeneca and Teva, travel reimbursement from MSD and Eisai. A. Ozatilgan: Employee of Sanofi. S. Hitier: Employee of Sanofi. J. Carles: Consulting/advisory role to Johnson&Johnson, Bayer, Astellas, BMS, Pfizer and Sanofi. All other authors have declared no conflicts of interest.