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Bending the Curve Trial by Trial
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CARD

Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer

N = 255NCT02485691

Population
Men with metastatic castration-resistant prostate cancer previously treated with docetaxel and with progression within 12 months while receiving abiraterone or enzalutamide (a different population from TROPIC, COU-AA-301 and AFFIRM)
Design
Randomized 1:1 trial in men with metastatic castration-resistant prostate cancer previously treated with docetaxel and with progression within 12 months on the other androgen-signaling-targeted inhibitor: cabazitaxel 25 mg/m2 every 3 weeks plus prednisone and G-CSF, versus the alternative inhibitor (abiraterone 1000 mg plus prednisone daily, or enzalutamide 160 mg daily). Primary end point imaging-based progression-free survival.
Primary endpoint
Imaging-based PFS
Arms
  • Abiraterone or enzalutamide (control, n = 126): The alternative androgen-signaling-targeted inhibitor: abiraterone 1000 mg plus prednisone daily, or enzalutamide 160 mg daily
  • Cabazitaxel plus prednisone (experimental, n = 129): Cabazitaxel 25 mg/m2 every 3 weeks plus prednisone and G-CSF
People
de Wit R, CARD
Imaging-based PFSHR 0.54 (95% CI 0.40–0.73)Δ median Imaging-based PFS+4.3 monthsOSHR 0.64 (95% CI 0.46–0.89)Δ median OS+2.6 months
Show the numbers
Results reported for CARD
EndpointAnalysisCabazitaxel plus prednisoneAbiraterone or enzalutamideEffect
Imaging-based PFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 9.2 monthsde 2019median 8 monthsmedian 3.7 monthsHR 0.54 (95% CI 0.40–0.73)P<0.001
OSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 9.2 monthsde 2019median 13.6 monthsmedian 11 monthsHR 0.64 (95% CI 0.46–0.89)P=0.008Secondary end point.
Results reported for CARD
EndpointAnalysisCabazitaxel plus prednisoneAbiraterone or enzalutamideEffect
Imaging-based PFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 9.2 monthsde 2019median 8 monthsmedian 3.7 monthsHR 0.54 (95% CI 0.40–0.73)P<0.001
OSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 9.2 monthsde 2019median 13.6 monthsmedian 11 monthsHR 0.64 (95% CI 0.46–0.89)P=0.008Secondary end point.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Imaging-based PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Imaging-based PFS0.540.4–0.73
OS0.640.46–0.89
Illustrative — modelled from reported values, not trial data. Imaging-based PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Abiraterone or enzalutamide (control)
  • Cabazitaxel plus prednisone (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAbiraterone or enzalutamideCabazitaxel plus prednisone
0100.0%100.0%
539.2%64.8%
1015.4%42.0%
156.0%27.3%
202.4%17.7%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Abiraterone or enzalutamide (control)
  • Cabazitaxel plus prednisone (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAbiraterone or enzalutamideCabazitaxel plus prednisone
0100.0%100.0%
956.7%63.2%
1734.3%42.0%
2619.4%26.6%
3411.7%17.7%
Primary publication: de Wit R, de Bono J, Sternberg CN, Fizazi K, Tombal B, Wülfing C, et al. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019;381(26):2506-2518. PubMedDOI

Appears in

Sources

  1. de Wit R, de Bono J, Sternberg CN, Fizazi K, Tombal B, Wülfing C, et al. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019;381(26):2506-2518.

    PubMedDOI