# FIRSTANA

Source: https://onco.cc/trials/firstana/  
OnCo record `firstana` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Cabazitaxel is no better than docetaxel as the first chemotherapy for castration-resistant prostate cancer. It is a different set of side effects, not a better drug.

## Summary

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-25
- Also known as: FIRSTANA; cabazitaxel against docetaxel first line
- Registry id: NCT01308567
- Phase: 3
- Setting: Chemotherapy-naive metastatic castration-resistant prostate cancer with ECOG performance status 0 to 2: cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 or docetaxel 75 mg/m2 every 3 weeks with daily prednisone, with overall survival as the primary endpoint
- Sponsor: Sanofi
- Enrolled: 1168
- Result: Median overall survival 24.5, 25.2 and 24.3 months for cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 and docetaxel; neither cabazitaxel dose was superior. Grade 3 or 4 adverse events 41.2, 60.1 and 46.0 percent, with different profiles.
- Outcomes: Overall survival (median): Cabazitaxel 20 mg/m2 24.5 months vs Cabazitaxel 25 mg/m2 25.2 months vs Docetaxel 75 mg/m2 24.3 months, HR 1.01; Grade 3 or 4 treatment-emergent adverse events: Cabazitaxel 20 mg/m2 41.2% vs Cabazitaxel 25 mg/m2 60.1% vs Docetaxel 75 mg/m2 46%
- Replication: Consistent with PROSELICA, run in parallel, which showed the lower cabazitaxel dose is non-inferior after docetaxel; docetaxel remains the first taxane.

## Sources

- ClinicalTrials.gov NCT01308567: https://clinicaltrials.gov/study/NCT01308567
- FIRSTANA (Journal of Clinical Oncology 2017): https://doi.org/10.1200/JCO.2016.72.1068

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Cabazitaxel](https://onco.cc/drugs/cabazitaxel/), [Docetaxel](https://onco.cc/drugs/docetaxel/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Sanofi](https://onco.cc/companies/sanofi/)
- terms: [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/)
- trials: [PROSELICA](https://onco.cc/trials/proselica/), [TAX 327](https://onco.cc/trials/tax-327/), [TROPIC](https://onco.cc/trials/tropic/)

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