Multicenter, phase II trial of exemestane as third-line hormonal therapy of postmenopausal women with metastatic breast cancer

Stephen Jones, C. Vogel, A. Arkhipov, L. Fehrenbacher, P. Eisenberg, B. Cooper, S. Honig, A. Polli, F. Whaley, E. Di Salle, J. Tiffany, A. Consonni, L. Miller

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111 Scopus citations


Purpose: To assess the antitumor activity, safety, and hormone- suppressive effects of the irreversible aromatase inactivator, exemestane (Aromasin, Pharmacia and Upjohn, Kalamazoo, MI), administered as third-line hormone therapy to postmenopausal women with metastatic breast cancer that is refractory to tamoxifen and megestrol acetate. Patients and Methods: Exemestane was administered at a dose of 25 mg/d orally until patients experienced disease progression. The efficacy and safety of exemestane were clinically and radiographically evaluated. The impact of exemestane treatment on tumor-related signs and symptoms was assessed. The effect of exemestane on serum levels of estrogens and other steroidal hormones was determined. Results: Ninety-one patients were treated. There were four complete responses (CR) and eight partial responses (PR), for an objective response rate of 13% in the entire treated population. The overall success rate (CR, PR, or stable disease [SD] ≥ 24 weeks) was 30%. The median duration of response and overall success was 9 months and 8 months, respectively. Most patients with CR/PR (83%; 10 of 12 patients) and SD ≥ 24 weeks (80%; 12 of 15 patients) had improved or stable tumor-related signs and symptoms. Mean levels of circulating estrone (E1), estradiol (E2), and estrone sulfate decreased to 11%, 22%, and 13% of baseline levels, respectively (at week 8 or 16 of treatment). One half of the patients had undetectable E1 and E2 levels during treatment, including at the time of disease progression. Mild nausea (20% of patients) and hot flashes (20%) were the most common drug-related adverse events and were generally grade 1. Conclusion: Exemestane is an active and well-tolerated third-line hormonal therapy that represents a new treatment option for postmenopausal patients with advanced breast cancer that has become refractory to standard first- and second-line hormonal therapies.

Original languageEnglish (US)
Pages (from-to)3418-3425
Number of pages8
JournalJournal of Clinical Oncology
Issue number11
StatePublished - Nov 1999
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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