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TROPIC

Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial

Phase 3N = 755NCT00417079

Population
Men with metastatic castration-resistant prostate cancer who had received previous hormone therapy and whose disease progressed during or after a docetaxel-containing regimen
Design
Open-label randomized phase 3 trial; all men received prednisone 10 mg orally daily and were randomly assigned to mitoxantrone 12 mg/m2 or cabazitaxel 25 mg/m2 intravenously every 3 weeks. Computer-generated random allocation; analysis by intention to treat.
Primary endpoint
OS
Arms
  • Mitoxantrone plus prednisone (control, n = 377): Mitoxantrone 12 mg/m2 every 3 weeks plus prednisone 10 mg daily
  • Cabazitaxel plus prednisone (experimental, n = 378): Cabazitaxel 25 mg/m2 every 3 weeks plus prednisone 10 mg daily
People
de Bono JS, TROPIC
OSHR 0.70 (95% CI 0.59–0.83)Δ median OS+2.4 monthsPFSHR 0.74 (95% CI 0.64–0.86)Δ median PFS+1.4 months
Show the numbers
Results reported for TROPIC
EndpointAnalysisCabazitaxel plus prednisoneMitoxantrone plus prednisoneEffect
OSfinalde 2010median 15.1 months (14.1–16.3)median 12.7 months (11.6–13.7)HR 0.70 (95% CI 0.59–0.83)P<0.0001Cutoff for the final analysis, 25 September 2009.
PFSfinalde 2010median 2.8 months (2.4–3.0)median 1.4 months (1.4–1.7)HR 0.74 (95% CI 0.64–0.86)P<0.0001
Results reported for TROPIC
EndpointAnalysisCabazitaxel plus prednisoneMitoxantrone plus prednisoneEffect
OSfinalde 2010median 15.1 months (14.1–16.3)median 12.7 months (11.6–13.7)HR 0.70 (95% CI 0.59–0.83)P<0.0001Cutoff for the final analysis, 25 September 2009.
PFSfinalde 2010median 2.8 months (2.4–3.0)median 1.4 months (1.4–1.7)HR 0.74 (95% CI 0.64–0.86)P<0.0001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.70.59–0.83
PFS0.740.64–0.86
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%0102030Months (modelled)
  • Mitoxantrone plus prednisone (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)
MonthsMitoxantrone plus prednisoneCabazitaxel plus prednisone
0100.0%100.0%
961.2%66.2%
1935.5%41.8%
2821.7%27.7%
3812.6%17.5%
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%01234567Months (modelled)
  • Mitoxantrone plus prednisone (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)
MonthsMitoxantrone plus prednisoneCabazitaxel plus prednisone
0100.0%100.0%
237.1%61.0%
413.8%37.1%
58.4%29.0%
73.1%17.7%
Primary publication: de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147-54. PubMedDOI

Appears in

Sources

  1. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147-54.

    PubMedDOI