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Bending the Curve Trial by Trial
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SWOG 9916

Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer

Phase 3N = 770NCT00004001

Population
Men with metastatic, hormone-independent (androgen-independent) prostate cancer; 674 of the 770 randomized were eligible
Design
Randomized phase 3 trial, 21-day cycles: estramustine 280 mg three times daily on days 1-5 with docetaxel 60 mg/m2 on day 2 and dexamethasone 60 mg in three divided doses before docetaxel, or mitoxantrone 12 mg/m2 on day 1 with prednisone 5 mg twice daily.
Primary endpoint
OS
Arms
  • Mitoxantrone plus prednisone (control, n = 336): Mitoxantrone 12 mg/m2 day 1 plus prednisone 5 mg twice daily, every 21 days
  • Docetaxel plus estramustine (experimental, n = 338): Docetaxel 60 mg/m2 day 2, estramustine 280 mg three times daily days 1-5, dexamethasone premedication, every 21 days
People
Petrylak DP, senior author Crawford ED, SWOG
OSHR 0.80 (95% CI 0.67–0.97)Δ median OS+1.9 monthsΔ median TTP+3.1 months
Show the numbers
Results reported for SWOG 9916
EndpointAnalysisDocetaxel plus estramustineMitoxantrone plus prednisoneEffect
OSITT among 674 eligible patients (338 docetaxel and estramustine, 336 mitoxantrone and prednisone)primaryPetrylak 2004median 17.5 monthsmedian 15.6 monthsHR 0.80 (95% CI 0.67–0.97)P=0.02P by the log-rank test.
TTPITT among 674 eligible patientsprimaryPetrylak 2004median 6.3 monthsmedian 3.2 monthsP<0.001Median time to progression; progression-free survival was named as a secondary end point in the methods.
Results reported for SWOG 9916
EndpointAnalysisDocetaxel plus estramustineMitoxantrone plus prednisoneEffect
OSITT among 674 eligible patients (338 docetaxel and estramustine, 336 mitoxantrone and prednisone)primaryPetrylak 2004median 17.5 monthsmedian 15.6 monthsHR 0.80 (95% CI 0.67–0.97)P=0.02P by the log-rank test.
TTPITT among 674 eligible patientsprimaryPetrylak 2004median 6.3 monthsmedian 3.2 monthsP<0.001Median time to progression; progression-free survival was named as a secondary end point in the methods.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.80.67–0.97
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Mitoxantrone plus prednisone (control)
  • Docetaxel plus estramustine (experimental)

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

Data table (modelled values)
MonthsMitoxantrone plus prednisoneDocetaxel plus estramustine
0100.0%100.0%
1161.3%64.7%
2237.6%41.8%
3323.1%27.1%
4414.2%17.5%
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Mitoxantrone plus prednisone (control)
  • Docetaxel plus estramustine (experimental)

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

Data table (modelled values)
MonthsMitoxantrone plus prednisoneDocetaxel plus estramustine
0100.0%100.0%
442.0%64.4%
817.7%41.5%
127.4%26.7%
163.1%17.2%
Primary publication: Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513-20. PubMedDOI

Appears in

Sources

  1. Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513-20.

    PubMedDOI