Prostate Cancer Health Center

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Chemotherapy for Hormone-Refractory Prostate Cancer

A randomized trial showed improved pain control in hormone-resistant patients treated with mitoxantrone plus prednisone compared with those treated with prednisone alone.[18] Differences in OS or measured global quality of life between the two treatments were not statistically significant.

In randomized trials of men with hormone-refractory prostate cancer, regimens of docetaxel given every 3 weeks have produced better OS (at 21-33 months) than mitoxantrone.[19,20][Level of evidence: 1iiA]

1. In a randomized trial of patients with hormone-refractory prostate cancer, docetaxel (75 mg/M² every 3 weeks) and docetaxel (30 mg weekly for 5 out of every 6 weeks) were compared with mitoxantrone (12 mg/M² every 3 weeks).[19] All patients received oral prednisone (5 mg twice per day). Patients in the docetaxel arms also received high-dose dexamethasone pretreatment for each docetaxel administration (8 mg were given at 12 hours, 3 hours, and 1 hour prior to the 3-week regimen; 8 mg were given at 1 hour prior to the 5 out-of-every-6 weeks' regimen). OS at 3 years was statistically significantly better in the 3-weekly docetaxel arm (18.6%) than in the mitoxantrone arm (13.5%, hazard ratio [HR] for death = 0.79; 95% confidence interval [CI], 0.67-0.93). However, the OS rate for the 5 out-of-every-6 weeks' docetaxel regimen was 16.8%, which was not statistically significantly better than mitoxantrone. Quality of life was also superior in the docetaxel arms compared with mitoxantrone (P = .009).[21][Levels of evidence: 1iiA; 1iiC]
2. In another randomized trial of patients with hormone-refractory prostate cancer, a 3-week regimen of estramustine (280 mg orally 3 times a day for days 1 to 5, plus daily warfarin and 325 mg of aspirin to prevent vascular thrombosis), and docetaxel (60 mg/M² intravenously on day 2, preceded by dexamethasone [20 mg times 3 starting the night before]) was compared with mitoxantrone (12 mg/M² intravenously every 3 weeks) plus prednisone (5 mg daily).[20] After a median follow-up of 32 months, median OS was 17.5 months in the estramustine/docetaxel arm versus 15.6 months in the mitoxantrone arm (P = .02; HR_death = 0.80; 95% CI, 0.67-0.97).[20][Level of evidence: 1iiA] Global quality of life and pain palliation measures were similar in the two treatment arms.[22][Level of evidence: 1iiC]

In hormone-resistant patients whose disease progresses during or after treatment with docetaxel, cabazitaxel has been shown to improve survival compared to mitoxantrone in a randomized trial (NCT00417079).[23] In the trial, 755 such men were treated with daily oral prednisone (10 mg) and randomly assigned to receive either cabazitaxel (25 mg/M² I.V.) or mitoxantrone (12 mg/M² I.V.) every 3 weeks. Median OS in the cabazitaxel and mitoxantrone study arms was 15.1 and 12.7 months, respectively (HR of death = 0.70; 95% CI, 0.59-0.83; P < .0001).[23][Level of evidence: 1iiA]