Doxetaxel: new indication. Prostate cancer: a few more weeks.

(1) The standard treatment for metastatic prostate cancer is hormone therapy, based on medical castration (with an LH-RH agonist) or surgical castration (pulpectomy), possibly combined with an androgen antagonist. For patients with hormone-resistant disease the only cytotoxic agents approved in France, estramustine and mitoxantrone, have no proven impact on survival. (2) Docetaxel is now approved in Europe for the treatment of hormone-resistant metastatic prostate cancer, in combination with a steroid. (3) In an open-label comparative trial involving 1006 patients, docetaxel infusion at a dose of 75 mg/m2 every 3 weeks, in combination with prednisone (or prednisolone), significantly extended the median survival time by about 2.5 months as compared with a mitoxantrone-prednisone combination (18.9 versus 16.5 months). In another open-label comparative trial involving 674 patients, a combination of docetaxel + estramustine was significantly more effective than a mitoxantrone + prednisone combination in extending median survival time (17.5 versus 15.6 months). (4) The adverse effects of docetaxel + prednisone were the same as those seen with other indications (hair loss, nausea and vomiting, diarrhea, neutropenia, nail disorders, neuropathies), and were severe in 25% of patients. (5) In France the cost of docetaxel therapy for hormone-resistant metastatic prostate cancer is more than 1000 euros every three weeks. (6) In practice, docetaxel is the first cytotoxic agent shown to prolong survival in men with hormone-resistant metastatic prostate cancer. The benefit is limited, however, especially given the potentially severe adverse effects of docetaxel, which must be disclosed to patients.