Petrylak DP et al. (2004) Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351: 1513–1520

Men with metastatic, androgen-independent prostate cancer have a median survival of 1 year or less. Current treatment with mitoxantrone plus prednisone or hydrocortisone palliates bone pain in some patients, but no available therapies prolong survival. Phase I and II studies have shown improved survival in patients receiving docetaxel plus estramustine; Petrylak and colleagues have investigated this in a randomized, phase III trial.

A total of 770 men with metastatic, hormone-independent prostate cancer were prospectively enrolled in the study. Of 674 eligible patients, half were assigned to receive docetaxel plus estramustine and half to receive mitoxantrone plus prednisone. Overall survival was compared in the two treatment groups during a median follow-up of 32 months.

The median overall survival was significantly longer in patients treated with docetaxel plus estramustine compared with those in the mitoxantrone plus prednisone group (17.5 months vs 15.6 months, P = 0.02). The median time to progression was also significantly longer in the docetaxel plus estramustine group, and post-treatment declines in serum PSA levels of ≥50% were more common in these patients. Pain relief was similar in both treatment groups. Adverse events (grade 3 or 4 neutropenic fevers, nausea and vomiting, and cardiovascular events) were significantly more frequent, however, in the docetaxel plus estramustine group than in the mitoxantrone plus prednisone group.

The authors conclude that docetaxel plus estramustine treatment moderately increased survival in these patients, but that this must be balanced against the increased rate of adverse events.