According to a recent article published in the

Journal of Clinical Oncology, 6 courses of the common chemotherapy combination fluorouracil (5-FU), epirubicin (Ellence®) and cyclophosphamide (FEC) appears superior to 3 courses of the same regimen as adjuvant therapy in premenopausal women with breast cancer.

Breast cancer claims the lives of approximately 40,000 women annually in the United States. Researchers have been evaluating and comparing optimal treatment regimens for patients with all stages of breast cancer in order to improve survival. Adjuvant therapy refers to treatment following the surgical removal of the cancer in order to kill any cancer cells that may have remained in the body following surgery. Different doses and duration of adjuvant treatment are still being investigated in patients with breast cancer that has not spread to distant sites in the body and debate still exists over the most appropriate treatment modalities for patients with differing disease characteristics.

Researchers from France recently conducted a clinical trial directly comparing 3 different adjuvant treatment schedules of the common chemotherapy combination FEC as adjuvant therapy for breast cancer. This trial involved over 600 premenopausal women with breast cancer that had spread to axillary (under the arm) lymph nodes, but not to distant sites in the body. Patients were initially treated with surgery to remove the cancer, radiation therapy and one of three FEC regimens: 6 cycles of FEC with a dose of epirubicin of 50 milligrams per size of the patient’s body (mg/m2) (6 FEC 50), 3 cycles of FEC 50 (3 FEC 50), or 3 cycles of FEC with an epirubicin dose of 75 mg/m2 (FEC 75). One cycle of treatment consisted of FEC given once every 21 days.

Ten years following therapy, cancer-free survival was 53.4% for the group of patients treated with 6 FEC 50, 43.6% for patients treated with the FEC 75 regimen and 42.5% for patients treated with 3 FEC 50. Overall survival at 10 years was 64.3% for patients treated with 6 FEC 50, 59.7% for patients treated with FEC 75 and 56.6% for patients treated with 3 FEC 50. There were no significant differences in side effects between the 3 treatment groups, except loss of hair occurring more frequently in patients treated with FEC 75. There were no treatment-related deaths.

These researchers concluded that 6 cycles of FEC 50 appeared more effective than 3 cycles of FEC 50 or FEC 75 in terms of long-term cancer-free survival and slightly more effective in overall long-term survival as adjuvant therapy in premenopausal women with breast cancer that has spread to axillary lymph nodes. Patients may wish to discuss the results of this trial with their physician or the risks and benefits of participating in a clinical trial further evaluating adjuvant therapy. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( and also provides personalized clinical trial searches on behalf of patients.

Reference: Fumoleau P, Kerbrat P, Romestaing P, et al. Randomized trial comparing six versus three cycles of epirubicin-based adjuvant chemotherapy in premenopausal, node-positive breast cancer patients: 10-year follow-up results of the French Adjuvant Study Group 01 Trial.

Journal of Clinical Oncology. 2003;21:208-305.

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