The effectiveness and safety of cabazitaxel (CBZ) in patients with metastatic castration-resistant prostate cancer (mCRPC) in routine clinical practice: Results of a prospective observational study (CAPRISTANA)
INTRODUCTION
Cabazitaxel (CBZ) is approved for patients with mCRPC previously treated with docetaxel. This study reports on the observed effectiveness and safety of CBZ in routine clinical practice.
METHODS
The CAPRISTANA study evaluated clinical use of CBZ in 54 centers in 6 countries (Apr 2012-Jun 2016). Patients with mCRPC previously treated with docetaxel were planned to receive ≥ 1 dose of CBZ 25 mg/m2 once every 3 weeks + prednisone 10 mg/day. Primary endpoints included line of chemotherapy, number of cycles, cumulative dose, and reasons for CBZ discontinuation. Secondary endpoints included objective response, prostate-specific antigen response, progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS) and safety.
RESULTS
Of 189 patients treated (median age 69 years; range 47-87), 85% received CBZ as second line and 15% as third line or more. All patients had prior docetaxel (median 6 cycles; range 1-58); 60% progressed on their last docetaxel treatment. Patients received a median of 6 cycles of CBZ (range 1-24) and median cumulative dose of 141 mg/m2. The main reason for CBZ discontinuation was disease progression (59%); 12% of patients discontinued due to adverse events (AEs). Overall rate of disease control with CBZ was 53% (complete response 1%, partial response 22%, stable disease 30%). Median PFS was 5.6 months (95% confidence interval [CI]: 4.8-6.3), median OS 13.2 months (95% CI: 11.4-16.4) and median TTF 4.4 months (95% CI: 3.8-4.9). G-CSF use was mainly for secondary prophylaxis (> 50% of patients up to Cycle 6). AEs were seen in 63% of patients (Grades 3-5 in 33%). Most frequently occurring AEs were anemia (15%), neutropenia (10%), diarrhea (11%) and asthenia (10%). Grade ≥ 3 neutropenia occurred in 8% and Grade ≥ 3 febrile neutropenia in 1%. After CBZ discontinuation, 15% of patients received chemotherapy and 39% hormonal therapy.
CONCLUSION
This study recorded use of CBZ in routine clinical practice. The effectiveness and safety results were consistent with previous prospective clinical studies (e.g. TROPIC, PROSELICA), confirming that CBZ has a predictable effectiveness and safety profile.
Funding: Sanofi