FIRSTANA

FIRSTANA randomised 1,168 men with chemotherapy-naive metastatic castration-resistant prostate cancer 1:1:1 to cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 or docetaxel 75 mg/m2 every 3 weeks with daily prednisone.

Median overall survival was 24.5 months with cabazitaxel 20, 25.2 months with cabazitaxel 25 and 24.3 months with docetaxel. The hazard ratio for cabazitaxel 20 against docetaxel was 1.01 (95 percent confidence interval 0.85 to 1.20, p=0.997) and for cabazitaxel 25 against docetaxel 0.97 (0.82 to 1.16, p=0.757). Median progression-free survival was 4.4, 5.1 and 5.3 months with no significant differences.

Radiographic tumour responses were numerically higher with cabazitaxel 25 (41.6 percent) than docetaxel (30.9 percent), nominal p=0.037 without adjustment for multiplicity, but pain progression-free survival was numerically better with docetaxel.

The useful result is the toxicity contrast, because it lets a man and his oncologist choose on side effects when efficacy is equal. Grade 3 or 4 treatment-emergent adverse events occurred in 41.2 percent, 60.1 percent and 46.0 percent respectively. Febrile neutropenia, diarrhoea and haematuria were more frequent with cabazitaxel 25; peripheral neuropathy, peripheral oedema, alopecia and nail disorders were more frequent with docetaxel.