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The second trial published the same day as TAX 327, showing the same thing by a different route: docetaxel beats mitoxantrone, though the partner drug it used has since been dropped for its side effects.
SWOG 9916 randomly assigned 770 men with metastatic androgen-independent prostate cancer to docetaxel with estramustine or to mitoxantrone with prednisone; 674 were eligible, 338 and 336 respectively.
Median overall survival was 17.5 months with docetaxel and estramustine against 15.6 months with mitoxantrone and prednisone (p=0.02 by log-rank), hazard ratio for death 0.80 (95 percent confidence interval 0.67 to 0.97). Median time to progression was 6.3 against 3.2 months (p<0.001). PSA declines of at least 50 percent occurred in 50 against 27 percent (p<0.001) and objective responses in 17 against 11 percent of men with bidimensionally measurable disease (p=0.30).
The reason estramustine is not used today is in the toxicity table: grade 3 or 4 neutropenic fever (p=0.01), nausea and vomiting (p<0.001) and cardiovascular events (p=0.001) were all more common with docetaxel and estramustine, and pain relief was no better than with mitoxantrone. TAX 327 achieved the same survival gain with prednisone rather than estramustine, so that is the regimen that survived.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
770 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Docetaxel with estramustine | 338 | 17.5 months | 0.8 (0.67 to 0.97) | 0.02 | link |
| Mitoxantrone with prednisone | 336 | 15.6 months | ||||
| Time to progression (median) | Docetaxel with estramustine | 338 | 6.3 months | - | <0.001 | link |
| Mitoxantrone with prednisone | 336 | 3.2 months |
Shares Estramustine, Mitoxantrone, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares PSA50 / PSA90 response, TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares TAX 327, Mitoxantrone, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares Estramustine, Prednisone, Docetaxel, Prostate cancer.
Shares Prednisone, Docetaxel, Metastatic castration-resistant prostate cancer, Cytotoxic chemotherapy.