Dose and Dose Intensity as Determinants of Outcome in the Adjuvant Treatment of Breast Cancer

Background: Both total dose and dose intensity of adjuvant chemotherapy are postulated to be important variables in the outcome for patients with operable breast cancer. The Cancer and Leukemia Group B study 8541 examined the effects of adjuvant treatment using conventional-range dose and dose inten...

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Published in:JNCI : Journal of the National Cancer Institute 1998-08, Vol.90 (16), p.1205-1211
Main Authors: Budman, Daniel R., Berry, Donald A., Cirrincione, Constance T., Henderson, I. Craig, Wood, William C., Weiss, Raymond B., Ferree, Carolyn R., Muss, Hyman B., Green, Mark R., Norton, Larry, Frei, Emil
Format: Article
Language:English
Subjects:
Antineoplastic agents
Biological and medical sciences
Breast cancer
Chemotherapy
Medical research
Medical sciences
Pharmacology. Drug treatments
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Summary:Background: Both total dose and dose intensity of adjuvant chemotherapy are postulated to be important variables in the outcome for patients with operable breast cancer. The Cancer and Leukemia Group B study 8541 examined the effects of adjuvant treatment using conventional-range dose and dose intensity in female patients with stage II (axillary lymph node-positive) breast cancer. Methods: Within 6 weeks of surgery (radical mastectomy, modified radical mastectomy, or lumpectomy), 1550 patients with unilateral breast cancer were randomly assigned to one of three treatment arms: high-, moderate-, or low-dose intensity. The patients received cyclophosphamide, doxorubicin, and 5- fluorouracil on day 1 of each chemotherapy cycle, with 5- fluorouracil administration repeated on day 8. The highdose arm had twice the dose intensity and twice the drug dose as the low-dose arm. The moderate-dose arm had two thirds the dose intensity as the high-dose arm but the same total drug dose. Disease-free survival and overall survival were primary end points of the study. Results: At a median follow-up of 9 years, disease-free survival and overall survival for patients on the moderate- and high-dose arms are superior to the corresponding survival measures for patients on the low-dose arm (two-sided P
ISSN:0027-8874
1460-2105
DOI:10.1093/jnci/90.16.1205