Observational, multicenter study of cabazitaxel in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (CAPRISTANA).

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 (HRQL) 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. HRQL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L questionnaires. 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% an ECOG PS ≤1, and 60.1% a Gleason score at diagnosis of ≥8. Patients received a median of six cabazitaxel cycles; 84.7% received cabazitaxel second-line. 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. HRQL 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 HRQL; over 70% had maintained or improved pain control. This article is protected by copyright. All rights reserved.