Docetaxel improves survival when hormones fail
Docetaxel (Taxotere) improves survival rates in men with advanced prostate cancer when hormone treatment fails, data from two studies show.
In the first study, more than 1,000 men were assigned to docetaxel (given
weekly or every three weeks) plus prednisone or standard chemotherapy — mitoxantrone
plus prednisone.
Men treated with docetaxel every three weeks survived longer and had
improved response rates compared with men given mitoxantrone (median
survival 18.9 months compared with 16.5 months, P=0.009).
Overall, compared with the mitoxantrone group, patients in the docetaxel
groups had better pain control and quality of life and more frequent
prostate-specific antigen responses, but also experienced more adverse
effects (New England Journal of Medicine 2004;351:1502).
The second study involved just under 800 men, also with advanced androgen-refractory
prostate cancer, who were assigned to standard chemotherapy or docetaxel
plus estramustine. Again, survival was prolonged in men treated with
the docetaxel-based regimen (17.5 months compared with 15.6 months, P=0.02).
Disease progression was also delayed among these men — median time
to progression was 6.3 months in the group given docetaxel and 3.2 months
for the group given mitoxantrone (P<0.001). The researchers warn that
these benefits must be balanced with an increased rate of adverse effects
seen with the docetaxel plus estramustine regimen (ibid, p1513).
Nick James, professor of clinical oncology at the University of Birmingham
and UK principal investigator of the first study, said: “Prior
to docetaxel, no drug has ever shown a survival benefit for men with
hormoneresistant prostate cancer. These results completely alter the
standard treatment paradigms for the disease.”
Sanofi-Aventis, manufacturer of Taxotere, hopes to receive regulatory
approval for the drug’s use in patients with hormone-refractory
prostate cancer in the next three months. |
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