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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 13^th 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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