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Title: Women with Node-Positive, Hormone-Receptor Negative Breast Cancer Do Not Benefit From Doxorubicin: Presented at CFS

"Women with Node-Positive, Hormone-Receptor Negative Breast Cancer Do Not Benefit From Doxorubicin: Presented at CFS"

By Charlene Laino NEW YORK, NY -- November 19, 2003 -- Adding doxorubicin to the regimen of patients with node-positive, hormone-receptor negative breast cancer does not improve survival, according to results of the Southwest Oncology Group Trial 8313. Saul Rivkin, MD, a medical oncologist at the Swedish Cancer Institute in Seattle, Washington, United States, presented the findings here on November 13th at Chemotherapy Foundation Symposium XXI. Between May 1984 and June 1990, 531 patients were entered into the study, a randomized trial designed to compare a short-course of 5-fluorouracil, doxorubicin, cyclophosphamide and methotrexate versus a longer course of cyclophosphamide, methotrexate, 5-fluorouracil, vincristine and prednisone for node-positive, hormone-receptor negative breast cancer. The women were randomised to the CMFVP arm, which consisted of 1 year of therapy with daily oral cyclophosphamide 60 mg/m2/day, methotrexate 15 mg/m2 IV weekly, intravenous (IV) 5-fluorouracil (5-FU) 400 mg/m2 weekly, vincristine 0.625 mg/m2 IV weekly for 10 weeks, and oral prednisone at an initial dose of 30 mg/m2 tapering to zero over 10 weeks, or to the FAC-M arm, which consisted of 20 weeks of therapy with four 5-week cycles of 5FU 500 mg/m2 IV, doxorubicin 50 mg/m2 IV, cyclophosphamide 500 mg/m2 IV all on day 1, and methotrexate 50 mg/m2 IV on day 22. At 10 years, 53% of women in the CMFVP arm were alive, compared to 47% of those in the FAC-M arm, a non-significant difference, Dr. Rivkin reported. When looked at by subgroup, there was still no evidence of a survival advantage associated with the short-course CMFVP, he said. Among women with one to three positive nodes, 68% versus 65% were alive in the CMFVP and FAC-M groups, respectively. Among women with four or more positive nodes, 39% and 30% were alive, respectively. "The findings show [doxorubicin] in this cohort of patients did not add to survival," he said. [Study title: 20-Year Follow-up of the Early Southwest Oncology Group Adjuvant Breast Studies. Abstract 42]

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