Abstract
Treatment with tamoxifen (TM), alone or in combination with cyclophosphamide, methotrexate, and fluorouracil (CMF), was used as an adjuvant to surgery in 433 patients with stage I, II, or III(T3a) breast cancer. Oestrogen receptors (ER) and progesterone (PgR) receptors were assayed in most cases. 308 premenopausal node-negative and postmenopausal node-negative or node-positive patients were randomised to receive TM, 30 mg daily for 2 years, or no further therapy. 125 premenopausal node-positive patients were randomised to receive either CMF for nine courses plus TM or CMF alone. After a median follow-up of 63 months TM significantly reduced the incidence of relapses and deaths compared with no therapy. A significant interaction between treatment effect and ER/PgR status was seen. Disease-free and overall survival were similar after treatment with CMF+ TM or CMF.
Publication types
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Clinical Trial
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Breast Neoplasms / analysis
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Breast Neoplasms / drug therapy*
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Breast Neoplasms / mortality
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Breast Neoplasms / surgery
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Clinical Trials as Topic
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Combined Modality Therapy
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Cyclophosphamide / administration & dosage
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Cyclophosphamide / adverse effects
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Drug Evaluation
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Female
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Fluorouracil / administration & dosage
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Fluorouracil / adverse effects
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Follow-Up Studies
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Humans
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Italy
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Lymphatic Metastasis
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Menopause / blood
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Methotrexate / administration & dosage
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Methotrexate / adverse effects
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Middle Aged
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Neoplasm Recurrence, Local / prevention & control
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Patient Compliance
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Prognosis
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Random Allocation
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Receptors, Estrogen / analysis
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Receptors, Progesterone / analysis
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Tamoxifen / administration & dosage
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Tamoxifen / adverse effects
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Tamoxifen / therapeutic use*
Substances
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Receptors, Estrogen
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Receptors, Progesterone
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Tamoxifen
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Cyclophosphamide
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Fluorouracil
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Methotrexate