Letrozole, a new oral aromatase inhibitor: Randomised trial comparing 2.5 mg daily, 0.5 mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer

M. Gershanovich, H. A. Chaudri, D. Campos, H. Lurie, A. Bonaventura, M. Jeffrey, F. Buzzi, I. Bodrogi, H. Ludwig, P. Reichardt, N. O'Higgins, G. Romieu, P. Friederich, M. Lassus

Research output: Article

268 Citations (Scopus)

Abstract

Background: The study compares letrozole and aminoglutethimide (AG), a standard therapy for postmenopausal women with advanced breast cancer, previously treated with antioestrogens. Patients and methods: 555 women were randomly assigned letrozole 2.5 mg once daily (n = 185), letrozole 0.5 mg once daily (n = 192) or aminoglutethimide 250 mg twice daily with corticosteroid support (n = 178) in an open-label, multicentre trial. The primary endpoint was objective response rate (ORR), with time events as secondary. ORR was analysed nine months after enrolment of the last patient, while survival was analysed 15 months after the last patient was enrolled. We report the results of these analyses plus an extended period of observation (covering a total duration of approximately 45 months) to determine the duration of response and clinical benefit. Results: Overall objective response rates (complete + partial) of 19.5%, 16.7%, and 12.4% were seen for letrozole 2.5 mg, 0.5 mg and AG respectively. Median duration of response and stable disease was longest for letrozole 2.5 mg (21 months) compared with letrozole 0.5 mg (18 months) and AG (14 months). Letrozole 2.5 mg was superior to AG in time to progression, time to treatment failure and overall survival. Treatment-related adverse events occurred in fewer patients on letrozole (33%) than on AG (46%). Transient nausea was the most frequent event with letrozole (7% on 0.5 mg, 10% on 2.5 mg, 10%, on AG), rash with AG (11%, 1% on 0.5 mg, 3% on 2.5 mg letrozole). Conclusions: Letrozole 2.5 mg offers longer disease control than aminoglutethimide and letrozole 0.5 mg in the treatment of postmenopausal women with advanced breast cancer, previously treated with anti-oestrogens.

Original languageEnglish
Pages (from-to)639-645
Number of pages7
JournalAnnals of Oncology
Volume9
Issue number6
DOIs
Publication statusPublished - jún. 1 1998

    Fingerprint

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Gershanovich, M., Chaudri, H. A., Campos, D., Lurie, H., Bonaventura, A., Jeffrey, M., Buzzi, F., Bodrogi, I., Ludwig, H., Reichardt, P., O'Higgins, N., Romieu, G., Friederich, P., & Lassus, M. (1998). Letrozole, a new oral aromatase inhibitor: Randomised trial comparing 2.5 mg daily, 0.5 mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer. Annals of Oncology, 9(6), 639-645. https://doi.org/10.1023/A:1008226721932