STAMPEDE
Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
Phase 2/3N = 2,962NCT00268476
- Population
- Men with high-risk, locally advanced, metastatic or recurrent prostate cancer starting first-line long-term hormone therapy (61% with M+ disease)
- Design
- Multiarm, multistage platform trial (also registered as ISRCTN78818544); open-label, 2:1:1:1 randomization to standard of care (hormone therapy for at least 2 years; radiotherapy encouraged for N0M0 disease to November 2011, then mandated), plus zoledronic acid, plus docetaxel 75 mg/m2 with prednisolone 10 mg for six 3-weekly cycles, or plus both. Randomization October 2005 to March 2013.
- Primary endpoint
- OS
- Arms
- Standard of care only (control): Long-term hormone therapy (standard of care)
- Standard of care plus zoledronic acid (experimental): Standard of care plus zoledronic acid 4 mg for six 3-weekly cycles, then 4-weekly until 2 years
- Standard of care plus docetaxel (experimental): Standard of care plus docetaxel 75 mg/m2 for six 3-weekly cycles with prednisolone 10 mg daily
- Standard of care plus zoledronic acid and docetaxel (experimental): Standard of care plus zoledronic acid and docetaxel
- People
- James ND, STAMPEDE investigators
OSHR 0.78 (95% CI 0.66–0.93)Δ median OS+10 monthsOSHR 0.94 (95% CI 0.79–1.11)OSHR 0.82 (95% CI 0.69–0.97)Δ median OS+5 months
Show the numbers
| Endpoint | Analysis | Standard of care plus zoledronic acid / Standard of care plus docetaxel / Standard of care plus zoledronic acid and docetaxel | Standard of care only | Effect |
|---|---|---|---|---|
| OSRandomized men in the standard-of-care-only and docetaxel groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | median 81 months | median 71 months | HR 0.78 (95% CI 0.66–0.93)P=0.006Median follow-up applies to the whole trial. Interquartile ranges: 32 to not reached (standard of care only) and 41 to not reached (docetaxel). The hazard ratio is from adjusted Cox models. |
| OSRandomized men in the standard-of-care-only and zoledronic acid groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | — | median 71 months | HR 0.94 (95% CI 0.79–1.11)P=0.450Median overall survival was not reached in the zoledronic acid group. Hazard ratio from adjusted Cox models. |
| OSRandomized men in the standard-of-care-only and zoledronic acid plus docetaxel groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | median 76 months | median 71 months | HR 0.82 (95% CI 0.69–0.97)P=0.022Hazard ratio from adjusted Cox models. |
| Endpoint | Analysis | Standard of care plus zoledronic acid / Standard of care plus docetaxel / Standard of care plus zoledronic acid and docetaxel | Standard of care only | Effect |
|---|---|---|---|---|
| OSRandomized men in the standard-of-care-only and docetaxel groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | median 81 months | median 71 months | HR 0.78 (95% CI 0.66–0.93)P=0.006Median follow-up applies to the whole trial. Interquartile ranges: 32 to not reached (standard of care only) and 41 to not reached (docetaxel). The hazard ratio is from adjusted Cox models. |
| OSRandomized men in the standard-of-care-only and zoledronic acid groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | — | median 71 months | HR 0.94 (95% CI 0.79–1.11)P=0.450Median overall survival was not reached in the zoledronic acid group. Hazard ratio from adjusted Cox models. |
| OSRandomized men in the standard-of-care-only and zoledronic acid plus docetaxel groups (analysis population not stated in the abstract) | primarymedian follow-up 43 monthsJames 2016 | median 76 months | median 71 months | HR 0.82 (95% CI 0.69–0.97)P=0.022Hazard ratio from adjusted Cox models. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.78 | 0.66–0.93 |
| OS | 0.94 | 0.79–1.11 |
| OS | 0.82 | 0.69–0.97 |
- Standard of care only (control)
- Standard of care plus docetaxel (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Standard of care only | Standard of care plus docetaxel |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 51 | 60.8% | 64.6% |
| 101 | 37.3% | 42.1% |
| 152 | 22.7% | 27.2% |
| 203 | 13.8% | 17.6% |
- Standard of care only (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Standard of care only |
|---|---|
| 0 | 100.0% |
| 44 | 65.1% |
| 89 | 41.9% |
| 133 | 27.3% |
| 178 | 17.6% |
Appears in
Sources
James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016;387(10024):1163-77.