Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials

Findings from the National Surgical Adjuvant Breast and Bowel Project B-14 and B-20 trials showed that tamoxifen benefited women with oestrogen-receptor-positive tumours and negative axillary nodes, and that chemotherapy plus tamoxifen was more effective than tamoxifen alone. We present long-term fi...

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Bibliographic Details
Published in:The Lancet (British edition) 2004-09, Vol.364 (9437), p.858-868
Main Authors: Fisher, Bernard, Jeong, Jong-Hyeon, Bryant, John, Anderson, Stewart, Dignam, James, Fisher, Edwin R, Wolmark, Norman
Format: Article
Language:English
Subjects:
Aged
Antineoplastic Agents, Hormonal - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - metabolism
Breast Neoplasms - mortality
Breast Neoplasms - pathology
Chemotherapy
Clinical trials
Disease-Free Survival
Double-Blind Method
Drugs
Estrogen Antagonists - therapeutic use
Female
Humans
Lymphatic Metastasis
Lymphatic system
Medical treatment
Middle Aged
Patients
Receptors, Estrogen - metabolism
Recurrence
Survival
Survival Rate
Tamoxifen - therapeutic use
Tumors
Women
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Summary:Findings from the National Surgical Adjuvant Breast and Bowel Project B-14 and B-20 trials showed that tamoxifen benefited women with oestrogen-receptor-positive tumours and negative axillary nodes, and that chemotherapy plus tamoxifen was more effective than tamoxifen alone. We present long-term findings from those trials and relate them to age, menopausal status, and tumour oestrogen-receptor concentrations. We also discuss the extent of progress made in the treatment of such patients. B-14 patients were randomly assigned to placebo (n=1453) or tamoxifen (n=1439); B-20 patients to tamoxifen (n=788) or cyclophosphamide, methotrexate, fluorouracil, and tamoxifen (CMFT, n=789). Primary endpoints were recurrence-free survival and overall survival estimated according to patients' age, menopausal status, and tumour oestrogen-receptor concentration. Smoothed recurrence rates were used to measure patterns of recurrence as a continuous function of age. Compared with placebo, tamoxifen benefited women in B-14 through 15 years, irrespective of age, menopausal status, or tumour oestrogen-receptor concentration (hazard ratio [HR] for recurrence-free survival 0·58, 95% CI 0·50–0·67, p
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(04)16981-X