Treatment of primary breast cancer with chemotherapy and tamoxifen

N Engl J Med. 1981 Jul 2;305(1):1-6. doi: 10.1056/NEJM198107023050101.


We studied the possibility that the addition of tamoxifen to L-phenylalanine mustard combined with 5-fluorouracil enhances the benefit from the latter two drugs that has been observed in women with primary breast cancer and positive axillary nodes. Recurrence of disease was reduced at two years in patients given the three-drug regimen whose tumor estrogen-receptor levels were greater than or equal to 10 fmol. Among patients greater than or equal to 50 years old treatment failure was significantly reduced (P less than 0.001): by 51 per cent in those with one to three positive nodes and by 64 per cent in those with four or more. Higher receptor levels were associated with a greater probability of disease-free survival. Patients less than or equal to 49 years old were less responsive: those with one to three positive nodes received no benefit from tamoxifen at any receptor level, whereas those with four or more appeared to have reduced treatment failure associated with higher receptor levels. This adjuvant chemotherapy is not indicated in patients less than or equal to 49 years old whose tumor receptor levels are below 10 fmol; there is a suggestion of benefit in patients greater than or equal to 50 years old whose levels are low.

Publication types

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

MeSH terms

  • Age Factors
  • Breast Neoplasms / analysis
  • Breast Neoplasms / drug therapy*
  • Clinical Trials as Topic
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / administration & dosage*
  • Follow-Up Studies
  • Humans
  • Melphalan / administration & dosage*
  • Middle Aged
  • Random Allocation
  • Receptors, Estrogen / analysis
  • Tamoxifen / administration & dosage*
  • Tamoxifen / therapeutic use


  • Receptors, Estrogen
  • Tamoxifen
  • Melphalan
  • Fluorouracil