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Patients were followed for a median of 20.7 months. Those who received docetaxel and prednisone at three-week intervals survived an average of 18.9 months. By contrast, median survival for patients treated with weekly docetaxel and prednisone was 17.4 months. Patients treated with prednisone and mitoxantrone lived for an average of 16.5 months.
More patients on the three-week docetaxel/prednisone regimen suffered low white blood cell counts; nevertheless, their levels of infection and fatigue were similar to the other groups.
As in Study 1, more patients in the groups treated with docetaxel experienced a drop in their PSA levels compared to the prednisone and mitoxantrone group.
On the basis of this study's findings, the U.S. Food and Drug Administration (FDA) recently approved docetaxel, in combination with prednisone, to treat advanced prostate cancer that is no longer responding to hormonal therapy.
The study results do not support the routine use of prostate cancer chemotherapy in less advanced prostate cancer.
Whether earlier use of chemotherapy can prolong survival in patients at a less advanced stage of their disease is something that is being investigated in several clinical studies.