Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
- PMID: 15470213
- DOI: 10.1056/NEJMoa040720
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
Abstract
Background: Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced, hormone-refractory prostate cancer, but it does not improve survival. We compared such treatment with docetaxel plus prednisone in men with this disease.
Methods: From March 2000 through June 2002, 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were randomly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks, 75 mg of docetaxel per square meter every three weeks, or 30 mg of docetaxel per square meter weekly for five of every six weeks. The primary end point was overall survival. Secondary end points were pain, prostate-specific antigen (PSA) levels, and the quality of life. All statistical comparisons were against mitoxantrone.
Results: As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P=0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel.
Conclusions: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone.
Copyright 2004 Massachusetts Medical Society.
Comment in
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Mechanisms of androgen-refractory prostate cancer.N Engl J Med. 2004 Oct 7;351(15):1488-90. doi: 10.1056/NEJMp048178. N Engl J Med. 2004. PMID: 15470210 No abstract available.
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Docetaxel-based chemotherapy trials in androgen-independent prostate cancer: first demonstration of a survival benefit.Curr Oncol Rep. 2005 May;7(3):205-6. doi: 10.1007/s11912-005-0074-1. Curr Oncol Rep. 2005. PMID: 15847711 No abstract available.
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Docetaxel plus prednisone improves survival in men with advanced prostate cancer.Cancer Treat Rev. 2005 Aug;31(5):403-7. doi: 10.1016/j.ctrv.2005.05.003. Cancer Treat Rev. 2005. PMID: 16169665 No abstract available.
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