Recurrent Prostate Cancer
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. 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]
- 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). 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).[Levels of evidence: 1iiA; 1iiC]
- 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). 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; HRdeath = 0.80; 95% CI, 0.67-0.97).[Level of evidence: 1iiA] Global quality of life and pain palliation measures were similar in the two treatment arms.[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). 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).[Level of evidence: 1iiA]