Abstract |
Women with breast carcinoma and four or more involved ipsilateral axillary lymph nodes were randomly assigned to receive an induction course and 2 yr of maintenance chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF, 150 patients), CMF plus vincristine and prednisone ( CMFVP, 166 patients), or chemoimmunotherapy with CMF plus the methanol extraction residue of BCG (CMF-MER, 85 patients). After 5 yr of accrual and a median follow-up of 34 mo, CMFVP is superior to CMF (p less than 0.01) with disease-free survival estimates at 4 yr of 60% for CMFVP compared to 45% for CMF. The disease-free survival advantage of CMFVP over CMF was greater in postmenopausal (p = 0.02) than in premenopausal patients (p = 0.09). CMF-MER was similar to CMF alone. CMF related side effects were similar in each regimen (see text), except for a greater incidence of leukopenia during induction with CMF than with CMFVP (p less than 0.01).
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Authors | D C Tormey, V E Weinberg, J F Holland, R B Weiss, O J Glidewell, M Perloff, G Falkson, H C Falkson, P H Henry, L A Leone |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 1
Issue 2
Pg. 138-45
(Feb 1983)
ISSN: 0732-183X [Print] United States |
PMID | 6366133
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- BCG Vaccine
- methanol extraction residue (MER) tubercle bacillus fraction
- Vincristine
- Cyclophosphamide
- Fluorouracil
- Prednisone
- Methotrexate
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Axilla
- BCG Vaccine
(administration & dosage, adverse effects)
- Breast Neoplasms
(drug therapy, mortality, therapy)
- Clinical Trials as Topic
- Combined Modality Therapy
- Cyclophosphamide
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Humans
- Lymphatic Metastasis
- Mastectomy
- Methotrexate
(administration & dosage, adverse effects)
- Middle Aged
- Nausea
(chemically induced)
- Paresthesia
(chemically induced)
- Prednisone
(administration & dosage, adverse effects)
- Random Allocation
- Time Factors
- Vincristine
(administration & dosage, adverse effects)
- Vomiting
(chemically induced)
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