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Bending the Curve Trial by Trial
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CHAARTED

Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer

Phase 3N = 790NCT00309985

Population
Men with metastatic, hormone-sensitive prostate cancer (median age 63 years)
Design
Randomized trial of androgen-deprivation therapy (ADT) plus docetaxel 75 mg/m2 every 3 weeks for six cycles versus ADT alone, in men with metastatic hormone-sensitive prostate cancer. Primary objective: test whether median overall survival would be 33.3% longer with early docetaxel plus ADT than with ADT alone.
Primary endpoint
OS
Arms
  • ADT alone (control): Androgen-deprivation therapy alone
  • ADT plus docetaxel (experimental): ADT plus docetaxel 75 mg/m2 every 3 weeks for six cycles
People
Sweeney CJ, senior author DiPaola RS, ECOG-ACRIN
OSHR 0.61 (95% CI 0.47–0.80)Δ median OS+13.6 months
Show the numbers
Results reported for CHAARTED
EndpointAnalysisADT plus docetaxelADT aloneEffect
OSprimarymedian follow-up 28.9 monthsSweeney 2015median 57.6 monthsmedian 44 monthsHR 0.61 (95% CI 0.47–0.80)P<0.001Median overall survival was 13.6 months longer with ADT plus docetaxel.
Results reported for CHAARTED
EndpointAnalysisADT plus docetaxelADT aloneEffect
OSprimarymedian follow-up 28.9 monthsSweeney 2015median 57.6 monthsmedian 44 monthsHR 0.61 (95% CI 0.47–0.80)P<0.001Median overall survival was 13.6 months longer with ADT plus docetaxel.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.610.47–0.8
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100120140Months (modelled)
  • ADT alone (control)
  • ADT plus docetaxel (experimental)

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

Data table (modelled values)
MonthsADT aloneADT plus docetaxel
0100.0%100.0%
3656.7%64.8%
7232.2%42.0%
10818.2%27.3%
14410.3%17.7%
Primary publication: Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015;373(8):737-46. PubMedDOI

Appears in

Sources

  1. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015;373(8):737-46.

    PubMedDOI