A controlled trial of adjuvant tamoxifen, with or without prednisolone, in post-menopausal women with operable breast cancer

Br J Cancer. 1994 Oct;70(4):729-31. doi: 10.1038/bjc.1994.384.

Abstract

A randomised clinical trial has been conducted to compare adjuvant tamoxifen, 20 mg daily, with tamoxifen and prednisolone, 7.5 mg daily, in post-menopausal women with operable breast cancer. There were 254 evaluable patients, of whom 128 were given tamoxifen alone and 126 received tamoxifen and prednisolone. After a median follow-up of 48 months there was no significant difference in relapse-free or overall survival of the two groups. Furthermore, with survival slightly favouring tamoxifen, confidence intervals on the hazard ratio established that a difference in favour of tamoxifen plus prednisolone of even 5% at 5 years was very unlikely (P < 0.02). Thus, despite the relatively small number of patients in this trial, the data clearly establish that prednisolone is not of value as an additional adjuvant agent.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / surgery*
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Postmenopause*
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Tamoxifen / administration & dosage
  • Tamoxifen / adverse effects
  • Tamoxifen / therapeutic use*

Substances

  • Tamoxifen
  • Prednisolone