TAX 327
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
Phase 3N = 1,006
- Population
- Men with metastatic hormone-refractory prostate cancer
- Design
- Randomized phase 3 trial, three groups, all with prednisone 5 mg twice daily: mitoxantrone 12 mg/m2 every 3 weeks, docetaxel 75 mg/m2 every 3 weeks, or docetaxel 30 mg/m2 weekly for 5 of every 6 weeks. All statistical comparisons were against mitoxantrone. Enrolment March 2000 to June 2002.
- Primary endpoint
- OS
- Arms
- Mitoxantrone plus prednisone (control): Mitoxantrone 12 mg/m2 every 3 weeks plus prednisone 5 mg twice daily
- Docetaxel every 3 weeks plus prednisone (experimental): Docetaxel 75 mg/m2 every 3 weeks plus prednisone 5 mg twice daily
- Weekly docetaxel plus prednisone (experimental): Docetaxel 30 mg/m2 weekly for 5 of every 6 weeks plus prednisone 5 mg twice daily
- People
- Tannock IF, TAX 327 Investigators
OSHR 0.76 (95% CI 0.62–0.94)Δ median OS+2.4 monthsOSHR 0.91 (95% CI 0.75–1.11)Δ median OS+0.9 monthsΔ median OS+2.9 monthsΔ 36-month OS+5.1 points
Show the numbers
| Endpoint | Analysis | Docetaxel every 3 weeks plus prednisone / Weekly docetaxel plus prednisone | Mitoxantrone plus prednisone | Effect |
|---|---|---|---|---|
| OSMen randomized with metastatic hormone-refractory prostate cancer (analysis population not stated in the abstract) | primaryTannock 2004 | median 18.9 months | median 16.5 months | HR 0.76 (95% CI 0.62–0.94)P=0.009Hazard ratio for death with 3-weekly docetaxel versus mitoxantrone; P by the stratified log-rank test. Original analysis (data of August 2003, 557 deaths per the 2008 update). |
| OSMen randomized with metastatic hormone-refractory prostate cancer (analysis population not stated in the abstract) | primaryTannock 2004 | median 17.4 months | median 16.5 months | HR 0.91 (95% CI 0.75–1.11)P=0.36Hazard ratio for death with weekly docetaxel versus mitoxantrone. |
| OSMen randomized in TAX 327 (all three groups; 867 deaths by March 2007) | long term-updateBerthold 2008 | median 19.2 months (17.5–21.3); 18.6% at 3 y | median 16.3 months (14.3–17.9); 13.5% at 3 y | P=0.004P value is for the survival benefit of 3-weekly docetaxel plus prednisone compared with mitoxantrone plus prednisone. The landmark values are the proportions surviving at least 3 years. |
| Endpoint | Analysis | Docetaxel every 3 weeks plus prednisone / Weekly docetaxel plus prednisone | Mitoxantrone plus prednisone | Effect |
|---|---|---|---|---|
| OSMen randomized with metastatic hormone-refractory prostate cancer (analysis population not stated in the abstract) | primaryTannock 2004 | median 18.9 months | median 16.5 months | HR 0.76 (95% CI 0.62–0.94)P=0.009Hazard ratio for death with 3-weekly docetaxel versus mitoxantrone; P by the stratified log-rank test. Original analysis (data of August 2003, 557 deaths per the 2008 update). |
| OSMen randomized with metastatic hormone-refractory prostate cancer (analysis population not stated in the abstract) | primaryTannock 2004 | median 17.4 months | median 16.5 months | HR 0.91 (95% CI 0.75–1.11)P=0.36Hazard ratio for death with weekly docetaxel versus mitoxantrone. |
| OSMen randomized in TAX 327 (all three groups; 867 deaths by March 2007) | long term-updateBerthold 2008 | median 19.2 months (17.5–21.3); 18.6% at 3 y | median 16.3 months (14.3–17.9); 13.5% at 3 y | P=0.004P value is for the survival benefit of 3-weekly docetaxel plus prednisone compared with mitoxantrone plus prednisone. The landmark values are the proportions surviving at least 3 years. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.76 | 0.62–0.94 |
| OS | 0.91 | 0.75–1.11 |
- Mitoxantrone plus prednisone (control)
- Docetaxel every 3 weeks plus prednisone (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Mitoxantrone plus prednisone | Docetaxel every 3 weeks plus prednisone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 12 | 60.4% | 64.4% |
| 24 | 36.5% | 41.5% |
| 35 | 23.0% | 27.7% |
| 47 | 13.9% | 17.8% |
- Mitoxantrone plus prednisone (control)
- Weekly docetaxel plus prednisone (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Mitoxantrone plus prednisone | Weekly docetaxel plus prednisone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 11 | 63.0% | 64.5% |
| 22 | 39.7% | 41.6% |
| 33 | 25.0% | 26.9% |
| 44 | 15.7% | 17.3% |
Appears in
Sources
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502-12.
Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26(2):242-5.