Background Cabazitaxel has been approved as combination treatment with prednisone in patients with metastatic prostate cancer (MPC) refractory to hormone treatment previously treated with docetaxel.

Purpose To analyse the effectiveness and safety of cabazitaxel in patients diagnosed with MPC.

Materials and methods A retrospective descriptive study was done of patients treated with cabazitaxel from its introduction on the market until September 2013. Study variables: age, ECOG score, previous chemotherapy, cycles of cabazitaxel, response or progression of PSA levels, tumour response rate based on the Response Evaluation Criteria in Solid Tumours (RECIST), progression-free survival (PFS), overall survival (OS), and adverse reactions (ARs). Data source: clinical history and Farmis-Infowind pharmaceutical validation program.

Results We included 7 patients with a median age of 71 years and an ECOG score ≤2. The median number of previous lines of treatment was 3 (range 2–5), and treatment consisted of the following: 7 patients received docetaxel 75 mg/m² (4–11 cycles), 3 received mitoxantrone 12 mg/m² (2–5), 4 received abiraterone 1000 mg/day, 2 received cyclophosphamide 50 mg/day, and one received vinorelbine 30 mg/m² (3). The mean number of cabazitaxel cycles was 3 (range 2–6). One patient presented a decrease in PSA with radiological response according to the RECIST criteria after the third cycle, while the rest (n = 6) showed progression. Median PFS was 1.5 months (range 1–4), while OS (measurable in 3 patients) was 9 months in one patient and 6 months in two. The following ARs were recorded: G3 asthenia 2 cases, G2 neutropenia 1 case, G3 nausea 1 case, acute coronary syndrome without ST-segment elevation 1 case, G1 diarrhoea 1 case, and severe pancytopenia 1 case. In two cases dose reduction was required due to G3 asthenia and G2 neutropenia. Treatment was discontinued in 5 patients (71%) due to disease progression, and in two subjects (30%) due to toxicity (G3 asthenia and nausea and severe pancytopenia). All received prophylactic treatment with G-CSF to reduce the haematological toxicity.

Conclusions The efficacy results for cabazitaxel are far lower than those described in pivotal clinical trials, and the associated toxicity profile is notorious. Adequate selection will be required of those patients who may benefit from use of the drug.

No conflict of interest.