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 with 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. 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) with a 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.
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.
Presented by: Joan Carles, Barcelona, Spain
Co-Author: Jana Katolicka, Brno, Czech Republic, Hana Korunkova, Plzen, Czech Republic, Antoaneta Tomova, Plovdiv, Bulgaria, Marwan Ghosn, Fadi El Karak, Joseph Makdessi, Beirut, Lebanon, Irina Koroleva, Samara, Russian Federation, Ayse Ozatilgan, Cambridge, MA, Simon Hitier, Chilly-Mazarin, France, Angelika Pichler, Leoben, Austria
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA
Read More on CAPRISTANA from the 2018 AUA: Health-Related Quality of Life in Patients with mCRPC Treated with Cabazitaxel, CAPRISTANA