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.

Department of Biostatistics Sanofi Chilly Mazarin France

Department of Clinical Outcomes Sanofi Cambridge MA USA

Department of Hematology and Oncology Hotel Dieu de France University Hospital Saint Joseph University Beirut Lebanon

Department of Hematology and Oncology Landeskrankenhaus Hochsteiermark Leoben Austria

Department of Medicine Medical University Reaviz Samara Russia

Department of Medicine St George Hospital Beirut Lebanon

Department of Oncology and Radiotherapy University Hospital Plzen Czech Republic

Department of Oncology Complex Oncology Center Plovdiv Bulgaria

Department of Oncology St Ann's University Hospital Brno Czech Republic

Global Medical Affairs Oncology Sanofi Cambridge MA USA

Vall d'Hebron Institute of Oncology Vall d'Hebron University Hospital Barcelona Spain

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