Prostate Cancer Chemotherapy and Survival

Prostate Cancer Chemotherapy and Survival: Study 1 Specifics

This first study involved 770 men with advanced prostate cancer that no longer responded to hormonal therapy. The men were randomly assigned to treatment with the drugs docetaxel and estramustine or with prednisone and mitoxantrone. The latter treatment is the only currently approved treatment for prostate cancer patients at this point in their disease.
Study Results
After a median follow-up period of 32 months, men who received docetaxel and estramustine lived for an average of 18 months. By contrast, men treated with prednisone and mitoxantrone lived for an average of 16 months. Progression of disease was delayed for twice as long (six months compared with three months) in patients treated with docetaxel and estramustine.
Severe side effects -- particularly stomach and heart problems -- occurred more frequently in the docetaxel/estramustine group. However, the number of patient deaths due to adverse reactions to chemotherapy was about the same in both groups.
Levels of prostate-specific antigen (PSA) -- an enzyme that can be elevated in men with prostate cancer -- declined more in patients treated with docetaxel/estramustine than in those on standard therapy.

Prostate Cancer Chemotherapy and Survival: Study 2 Specifics

This second study involved 1,006 men in the United States, Canada, Europe, and Latin America. All participants had advanced prostate cancer that had stopped responding to hormonal therapy. The men were randomly assigned to one of three treatment groups:
  • One group got weekly doses of the drugs prednisone and docetaxel
  • A second group got a higher dose of docetaxel, plus prednisone, every three weeks
  • A third group got the standard treatment of prednisone and mitoxantrone every three weeks.
This study was supported by Aventis Pharmaceuticals, Inc., which manufactures docetaxel.
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