A Randomized Trial of Five and Three Drug Chemotherapy and Chemoimmunotherapy in Women With Operable Node Positive Breast Cancer

J Clin Oncol. 1983 Feb;1(2):138-45. doi: 10.1200/JCO.1983.1.2.138.

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).

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Axilla
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / adverse effects
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / therapy
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Dose-Response Relationship, Drug
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Humans
  • Lymphatic Metastasis
  • Mastectomy
  • Methotrexate / administration & dosage
  • Methotrexate / adverse effects
  • Middle Aged
  • Nausea / chemically induced
  • Paresthesia / chemically induced
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Random Allocation
  • Time Factors
  • Vincristine / administration & dosage
  • Vincristine / adverse effects
  • Vomiting / chemically induced

Substances

  • BCG Vaccine
  • methanol extraction residue (MER) tubercle bacillus fraction
  • Vincristine
  • Cyclophosphamide
  • Fluorouracil
  • Prednisone
  • Methotrexate

Supplementary concepts

  • CMF regimen
  • CMFVP protocol