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Journal of Clinical Oncology, Vol 18, Issue 22 (November), 2000: 3748-3757
© 2000 American Society for Clinical Oncology

RAPID PUBLICATIONS

Anastrozole Versus Tamoxifen as First-Line Therapy for Advanced Breast Cancer in 668 Postmenopausal Women: Results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability Study

By J. Bonneterre, B. Thürlimann, J. F. R. Robertson, M. Krzakowski, L. Mauriac, P. Koralewski, I. Vergote, A. Webster, M. Steinberg, M. von Euler, for the Arimidex Study Group

From the Centre Oscar Lambret, Lille; Institut Bérgonié, Bordeaux, France; Medizinische Klinik C Kantonsspital, St Gallen, Switzerland; City Hospital, Nottingham; AstraZeneca, Alderley Park, Macclesfield, United Kingdom; Maria Sklodowska-Curie Memorial Centre of Oncology, Warsaw; Rydygier Memorial Hospital, Cracow, Poland; Department of Gynaecological Oncology, Leuven, Belgium; and AstraZeneca, Wilmington, DE.

Address reprint requests to Jacques Bonneterre, MD, PhD, Centre Oscar Lambret, 3 Rue Frédéric Combemale, BP 307 Lille, France; email j-bonneterre{at}o-lambret.fr

ABSTRACT

PURPOSE: To compare the efficacy and tolerability of anastrozole (Arimidex; AstraZeneca, Wilmington, DE, and Macclesfield, United Kingdom) with that of tamoxifen as first-line therapy for advanced breast cancer (ABC) in postmenopausal women.

PATIENTS AND METHODS: This randomized, double-blind, multicenter study evaluated the efficacy of anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with tumors that were hormone receptor–positive or of unknown receptor status who were eligible for endocrine therapy. The primary end points were time to progression (TTP), objective response (OR), and tolerability.

RESULTS: A total of 668 patients (340 in the anastrozole arm and 328 in the tamoxifen arm) were randomized to treatment and followed-up for a median of 19 months. Median TTP was similar for both treatments (8.2 months in patients who received anastrozole and 8.3 months in patients who received tamoxifen). The tamoxifen:anastrozole hazards ratio was 0.99 (lower one-sided 95% confidence limit, 0.86), demonstrating that anastrozole was at least equivalent to tamoxifen. Anastrozole was also as effective as tamoxifen in terms of OR (32.9% of anastrozole and 32.6% of tamoxifen patients achieved a complete response [CR] or partial response [PR]). Clinical benefit (CR + PR + stabilization of >= 24 weeks) rates were 56.2% and 55.5% for patients receiving anastrozole and tamoxifen, respectively. Both treatments were well tolerated. However, incidences of thromboembolic events and vaginal bleeding were reported in fewer patients treated with anastrozole than with tamoxifen (4.8% v 7.3% [thromboembolic events] and 1.2% v 2.4% [vaginal bleeding], respectively).

CONCLUSION: Anastrozole satisfied the predefined criteria for equivalence to tamoxifen. Together with the lower observed incidence of thromboembolic events and vaginal bleeding, these findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with ABC.




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