On May 19, 2004, the FDA approved docetaxel for injection (Taxotere®, made by Aventis Pharmaceuticals, Inc) for use in combination with prednisone for the treatment of metastatic, androgen-independent (hormone-refractory) prostate cancer.

Safety and efficacy were demonstrated in TAX327, a randomized, multicenter global clinical trial designed to evaluate chemotherapy with Taxotere and prednisone in the treatment of men with metastatic, hormone-refractory prostate cancer. One thousand and six patients were randomized to one of three treatment arms:

• mitoxantrone + prednisone (MTX + P),
• weekly Taxotere (TXT qw) + prednisone, or
• Taxotere once every three weeks (TXT q3w) + prednisone

The primary efficacy endpoint was survival. The treatment arm of TXT q3w + prednisone demonstrated a statistically significant survival advantage over MTX+P control (median survival 18.9 vs. 16.5 months, respectively, p = 0.0094). The TXT qw + prednisone arm did not demonstrate an advantage in overall survival over the control arm.

Adverse events included anemia, neutropenia, infection, nausea, vomiting, anorexia, and fatigue. Adverse events occurring more frequently with TXT q3w compared to MTX+P included allergic reactions, fluid retention, sensory neuropathy, alopecia, nail changes, diarrhea, and stomatitis.

The approved dose for this indication is 75 mg/m2 docetaxel given intravenously as a 1-hour infusion every 21 days on day 1 plus 5 mg oral prednisone twice daily for 10 cycles.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications. There is also an FDA press release.

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