LOS ANGELES--In a Canadian study of women with node-positive adenocarcinoma of the breast, a chemotherapy regimen (CEF) including epidoxorubicin (Epirubicin), an anthracycline available in Canada and Europe, produced better results than standard CMF (cyclophosphamide, methotrexate(Drug information on methotrexate), and fluorouracil(Drug information on fluorouracil)), Dr. Mark Levine reported at the ASCO annual meeting.
The beneficial effects of CEF (improved relapse-free survival and a lower risk of recurrence) came at a cost of more acute toxicity and worse quality of life during the first month of treatment.
Dr. Levine said that dose escalation of doxorubicin(Drug information on doxorubicin) (Adriamycin) is limited by the potential for cardiotoxicity. Since Epirubicin(Drug information on epirubicin) has comparable antitumor activity but is less cardiotoxic, it was included in the experimental regimen with an eye toward increasing the dose intensity of the anthracycline component.
Speaking on behalf of the National Cancer Institute of Canada Clinical Trials Group, Dr. Levine reported that the 716 pre- or perimenopausal women in the trial were randomized to receive CMF or CEF after mastectomy or lump-ectomy and axillary dissection. Both regimens were given monthly for 6 months.
CEF consisted of cyclophosphamide(Drug information on cyclophosphamide), 75 mg/m² orally on days 1 through 14; epidoxorubicin, 60 mg/m² IV on days 1 and 8; and fluorouracil, 500 mg/m² IV on days 1 and 8. These patients also received clotrimoxazole prophylaxis.
Better Relapse-Free Survival
Significantly more patients treated with CEF than CMF were alive and relapse free at 3 years (about 70% vs 60%), Dr. Levine said. At a median follow-up of 33 months, breast cancer had recurred in 35% of the CMF group, compared with 27% of the CEF group. Cox analysis showed that the risk of recurrence was 27% lower in CEF than in CMF patients.