ATLANTAResults of the multicenter Italian phase III Taxit 216 trial show marginally better disease-free survival (DFS) with the addition of sequential docetaxel(Drug information on docetaxel) (Taxotere) to standard epirubicin(Drug information on epirubicin)→CMF (cyclophosphamide/methotrexate/fluorouracil) as adjuvant treatment for high-risk early breast cancer, with acceptable toxicity.
Angelo R. Bianco, MD, reported the results at the American Society of Clinical Oncology 42nd Annual Meeting (abstract LBA520). Dr. Bianco, of University Federico II, Naples, Italy, presented the data on behalf of the Taxit 216 Study Group.
"Docetaxel is among the most active drugs for the treatment of advanced breast cancer and has recently shown efficacy in the adjuvant setting," Dr. Bianco commented. "This trial was aimed at comparing the efficacy and tolerability of a sequential regimen containing docetaxel to a standard anthracycline-based regimen as adjuvant therapy in node-positive early breast cancer."
The investigators randomized 972 node-positive patients to one of two arms:
• Arm A: E→CMF (epirubicin 120 mg/m2 IV on day 1 every 21 days for four cycles, followed by cyclophosphamide(Drug information on cyclophosphamide) 600 mg/m2 IV, methotrexate(Drug information on methotrexate) 40 mg/m2 IV, and fluorouracil(Drug information on fluorouracil) 600 mg/m2 IV on days 1 and 8 every 28 days for four cycles)
• Arm B: E→T→CMF (with docetaxel 100 mg/m2 IV on day 1 every 21 days for four cycles after the fourth cycle of E and before the first cycle of CMF)
Colony-stimulating factors were used "according to the doctor's judgment," Dr. Bianco said.