SAN ANTONIOA multicenter phase II study conducted in France has shown that epirubicin(Drug information on epirubicin) (Ellence) and docetaxel (Taxotere) (ET) offer better results as first-line chemotherapy than fluorouracil(Drug information on fluorouracil) (5-FU), epirubicin, and cyclophosphamide(Drug information on cyclophosphamide) (FEC) among patients with metastatic breast cancer.
The study was reported by lead researcher Jacques Bonneterre, MD, at the 24th Annual San Antonio Breast Cancer Symposium (abstract 27).
Dr. Bonneterre, director of medical oncology, Centre Oscar Lambret, Lille, France, pointed out that several phase I studies have already demonstrated ET’s feasibility and safety. "These drugs appear to offer a rational therapeutic strategy and could be an alternative to standard treatment," he said.
The 142 patients enrolled in the study were equally divided into two arms. Patients in arm A were administered 75 mg/m² of epirubicin and 75 mg/m² of docetaxel(Drug information on docetaxel). They were also given prophylactic premedication with corticosteroids (6 × 40 mg of methylprednisolone(Drug information on methylprednisolone) or its equivalent) for 3 days. Patients in arm B received 500 mg/m² of 5-FU, 75 mg/m² of epirubicin, and 500 mg/m² of cyclophosphamide.
The treatment was administered once every 21 days for a maximum of eight cycles, with a maximum cumulative anthracycline dose equivalent to 550 mg/m² doxorubicin(Drug information on doxorubicin).
The median age of patients in both arms was 54. In the ET arm, 61% of the patients had three or more organs involved and in the FEC arm, 43%. Patients in both arms had metastases to the soft tissue, viscera, liver, and bone. About half the patients in each arm had no prior chemotherapy.
The response rate was significantly higher in the ET arm: 63% vs 34.3% in the FEC arm, Dr. Bonneterre reported. Median time to disease progression was 7.8 months for the ET arm and 5.9 months for the FEC arm.