On August 18, 2004, the FDA approved docetaxel for injection (Taxotere®, a trademark of Aventis Pharmaceuticals, Inc.) for use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of women with operable node-positive breast cancer.

Investigators enrolled 1491 women with node positive operable breast cancer in an international, multicenter, randomized trial (TAX316). Patients were stratified according to the number of positive axillary lymph nodes (1-3, 4+) and were randomly allocated to receive adjuvant treatment with either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm). Both regimens were given every 3 weeks for 6 cycles. After the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.

The primary endpoint, disease free survival (DFS), included local and distant recurrences, contralateral breast cancer and deaths from any cause. At a median follow up of 55 months, results from a second interim analysis showed that the TAC regimen has significantly longer DFS than FAC, with an overall reduction in risk of relapse of 25.7% (hazard ratio= 0.74; 2-sided 95% CI= 0.60, 0.92, stratified log rank p = 0.0047). At the time of this interim analysis, based on 219 deaths, overall survival was longer for TAC than FAC (hazard ratio=0.69, 2-sided 95% CI=0.53, 0.90). There will be further analysis at the time survival data mature.

Women receiving TAC had an increase in anemia, grade > 3 neutropenia, stomatitis, amenorrhea, fever in absence of infection, hypersensitivity reactions, peripheral edema, neurosensory and skin events compared to those receiving FAC. The toxicity, while significant, did not cause a large number of patients to withdraw from treatment. As with other anthracycline/cyclophosphamide-containing regimens, long-term serious toxicity for the TAC regimen included leukemia (0.4%) and congestive heart failure (1.6%).

The approved dose of docetaxel for the adjuvant treatment of operable node-positive breast cancer is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

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