Safety considerations of adjuvant therapy in early breast cancer in postmenopausal women

William J. Gradishar*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

27 Scopus citations


Because of its proven efficacy profile based on long-term data, tamoxifen has been the standard adjuvant endocrine therapy for hormone-sensitive early breast cancer for the past 30 years. However, there is well-established evidence that long-term use of tamoxifen is associated with serious side effects. As adjuvant endocrine therapy is generally administered for long periods of time, the safety and tolerability of agents used in this setting are of particular importance. Due to their superior efficacy over tamoxifen, newer agents, such as the third-generation aromatase inhibitors (Als), are already established therapies for the treatment of advanced breast cancer. In addition, recent trials indicate that the Al anastrozole ('Arimidex') has improved efficacy compared with tamoxifen in the adjuvant setting in postmenopausal women. The other third-generation Als have reported disease-free survival benefits but not in the absence of prior treatment with tamoxifen; letrozole ('Femara') has been compared with placebo following 5 years of tamoxifen therapy and exemestane ('Aromasin') has been compared with tamoxifen following 2-3 years of prior treatment with tamoxifen. Long-term safety data show that anastrozole also has a more favorable overall safety profile compared with tamoxifen, particularly in terms of life-threatening events such as endometrial cancer and thromboembolism. Anastrozole alone, therefore, provides a new option for adjuvant therapy in postmenopausal women with hormone-receptor-positive early breast cancer. The Als have differing pharmacological profiles, which may translate into dissimilar adverse event profiles in the adjuvant treatment setting, but patient follow-up in most trials is relatively short to make a valid comparison. It cannot, therefore, be assumed that all Als will be equally well tolerated in the adjuvant setting. Further data on the long-term safety of Als other than anastrozole are therefore required to allow overall risk:benefit assessments on these agents to be made.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
Issue number1
StatePublished - Aug 2005


  • Adjuvant therapy
  • Anastrozole
  • Aromatase inhibitors
  • Early breast cancer
  • Efficacy
  • Safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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