An observational, multicentre study of cabazitaxel in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (CAPRISTANA)

Abstract

Objectives: To obtain routine clinical practice data on cabazitaxel usage patterns for patients with metastatic castration-resistant prostate cancer (mCRPC) and to describe physician-assessed cabazitaxel effectiveness, health-related quality of life (HRQoL) and safety.

Patients and methods: CAPRISTANA was an international, observational cohort study examining cabazitaxel use for the treatment of patients with mCRPC. Effectiveness was assessed by overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF) and disease control rate. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) and the three-level European Quality of Life questionnaire (EQ-5D-3L). Safety was assessed by adverse event (AE) reporting.

Results: A total of 189 patients were treated across 54 centres between April 2012 and June 2016. At baseline, 58.7% had ≥1 comorbidity, 93.7% had an Eastern Cooperative Oncology Group performance status ≤1, and 60.1% had a Gleason score at diagnosis of ≥8. Patients received a median of 6 cabazitaxel cycles; 84.7% received cabazitaxel as second-line therapy. The median OS, PFS and TTF were 13.2, 5.6 and 4.4 months, respectively. Cabazitaxel led to disease control in 52.9% of patients. HRQoL was maintained (40.3%) or improved (32.2%) in 72.5% of patients based on total FACT-P scores. Interestingly, 53.6% of patients reported pain improvement and a further 21.2% maintained pain control based on FACT-P prostate cancer-specific pain scores. The most common treatment-related grade ≥3 AEs were neutropenia (7.9%) and anaemia (2.1%).

Conclusion: Patients in CAPRISTANA treated with cabazitaxel had similar disease outcomes and safety profiles compared with large phase III clinical trials. Most patients had maintained or improved HRQoL scores; >70% of patients had maintained or improved pain control.

Keywords: mCRPC; #PCSM; #ProstateCancer; HRQoL; cabazitaxel; health-related quality of life; metastatic castration-resistant prostate cancer; real-world.

Figure 1

Cabazitaxel effect on patient survival and outcome. Response not evaluated in 13 patients and unknown/non‐evaluable in one patient. CR, complete response; NE, non‐evaluable; OS, overall survival; PD, progressive disease; PFS, progression‐free survival; PR, partial response; RNE, response not evaluated; SD, stable disease; TTF, time to treatment failure.

Figure 2

Change in mean Functional Assessment of Cancer Therapy‐Prostate questionnaire ( FACT‐P) total and subscale scores from baseline with cabazitaxel over time. Red lines at ±10 for total score, ±3 for physical, social, emotional and functional well‐being subscales and prostate‐cancer subscale (PCS) and ±2 for PCS‐pain subscale indicate limits of clinically important changes 14. Positive changes indicate improvement in health‐related quality of life, negative changes indicate deterioration.

Figure 3

Change in EQ‐5D‐visual analogue scale (VAS) score from baseline with cabazitaxel over time. Red lines at ±7 indicate limits of clinically important changes; clinically important changes were reported at cycles 6, 8 and 10 (mean changes of 8.5, 8.4 and 7.3, respectively) 19, 20. Positive changes indicate improvement in health‐related quality of life, negative changes indicate deterioration. *Decline in EQ‐5D‐VAS score from baseline for cycle 7 may be a result of a low number of patients providing feedback.