Antiestrogen, cytotoxic chemotherapy, and bacillus Calmette-Guerin vaccination in stage II breast cancer: a preliminary report

Surgery. 1980 May;87(5):494-501.


A prospective, randomized clinical trial of three treatment regimens: (1) Cytoxan, methotrexate, and 5-fluorouracil (CMF), (2) CMF plus the antiestrogen drug, tamoxifen (CMFT), and (3) CMFT plus bacillus Calmette-Guerin (BCG) vaccinations in women with stage 22 breast cancer is reported. All patients underwent mastectomy and estrogen receptor (ER) analysis was performed. The results of this study show that patients with ER- tumors have recurrences more rapidly and have a higher mortality rate than patients with ER+ tumors (P less than 0.0001). In ER+ patients CMFT treatment is more effective in delaying recurrence than CMF alone at 33 months (P = 0.0176). This effect appears to be occurring in both premenopausal and postmenopausal women. In ER- patients the recurrence rate is high, and there is no significant difference among the three treatment groups. In premenopausal patients treated with CMF alone, however, ER- patients recur more rapidly than ER+ patients (P = 0.0313) and suggests that the effect of CMF may be related to the suppression of ovarian function. These findings have demonstrated a significant role for the use of antiestrogen therapy in patients with state II, ER+ breast cancer.

Publication types

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

MeSH terms

  • Actuarial Analysis
  • BCG Vaccine / therapeutic use*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Breast Neoplasms / therapy*
  • Cyclophosphamide / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / therapeutic use*
  • Humans
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Neoplasm Recurrence, Local / prevention & control
  • Neoplasm Staging
  • Prospective Studies
  • Receptors, Estrogen / analysis
  • Tamoxifen / therapeutic use*


  • BCG Vaccine
  • Receptors, Estrogen
  • Tamoxifen
  • Cyclophosphamide
  • Fluorouracil
  • Methotrexate