© 1990 by Oxford University Press
Journal of the National Cancer Institute, Vol. 82, No. 7, 570-574,
April 4, 1990
© 1990 Oxford University Press
Sixteen-Week Dose-Intense Chemotherapy in the Adjuvant Treatment of Breast Cancer
supported in part by American Cancer Society Clinical Oncology Career Development Awards. N. E. Davidson was supported in part by the Susan Komen Foundation
Oncology Center, The Johns Hopkins University School of Medicine Baltimore, MD
*Correspondence to: Martin D. Abeloff, M.D., The Johns Hopkins Oncology Center, 1st Floor, Rm. 124, 600 N. Wolfe St., Baltimore, MD 21205.
Fifty-three women with breast cancer were treated with a new 16-week dose-intense, chemotherapy regimen. Patients with operable breast cancer with 10 or more histologically positive axillary nodes were treated with this five-drug regimen that incorporated the concepts of weekly chemotherapy, sequential administration of antimetabolites, and continuous infusion of fluorouracil (5-FU). The chemotherapy regimen consisted of eight cycles (each of 2 wk duration) of 100 mg of cyclophosphamide/m2 orally on days 1–7, 40 mg of doxorubicin/m2 intravenous (IV) on day 1, 100 mg of methotrexate/m2 IV on day 1 with 10 mg of leucovorin rescue/m2 every 6 hours for six oral doses on day 2, 1 mg of vincristine IV on day 1, and 600 mg of 5-FU/m2 IV at hour 20 over 2 hours. A continuous infusion of 300 mg of 5-FU/m2 per day was given IV on days 8–9 of each 2-week cycle. The doses and schedule of drug administration were designed to minimize dosage reduction and treatment delay. At a median follow-up of 17 months, there have been eight relapses in the 53 patients. The actuarial 3-year disease-free survival is 80% (95% confidence interval, 62% to 90%). The major side effects were attributable to myelosuppression. Absolute neutrophil counts less than 250/µL were noted in 12 (23%) patients; seven patients (13%) required hospitalization for management of neutropenic fever. No treatment-related deaths occurred. Ninetyfour percent of the planned doses were administered, and only 5% of the courses were delayed because of toxic reactions. The encouraging therapeutic data, manageable side effects, and our ability to deliver over 90% of the planned doses provide the rationale for a phase III comparison of this new dose-intense regimen and standard chemotherapy in patients with operable disease and positive axillary nodes. [J Natl Cancer Inst 82: 570–574, 1990]
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