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Journal of Clinical Oncology, Vol 18, Issue 22 (November), 2000: 3758-3767
© 2000 American Society for Clinical Oncology

RAPID PUBLICATIONS

Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial

By J. M. Nabholtz, A. Buzdar, M. Pollak, W. Harwin, G. Burton, A. Mangalik, M. Steinberg, A. Webster, M. von Euler, for the Arimidex Study Group

From the Cancer-Cross Institute, Edmonton, Alberta; Department of Oncology, Jewish General Hospital and McGill University, Montreal, Quebec, Canada; University of Texas M.D. Anderson Cancer Canter, Houston, TX; Florida Cancer Specialists, Fort Myers, FL; Louisiana State University Health Science Center, Shreveport, LA; University of New Mexico Cancer Center, Albuquerque, NM; AstraZeneca, Wilmington, DE; and AstraZeneca, Alderley Park, Macclesfield, United Kingdom.

Address reprint requests to J.M. Nabholtz, MD, MSc, University of California at Los Angeles, Peter Ueberroth Bldg, No 3360B, 10945 Leconte Ave, Los Angeles, CA 90095-7077; email jean-marc.nabholtz{at}bcirg.com

ABSTRACT

PURPOSE: The efficacy and tolerability of anastrozole (Arimidex; AstraZeneca, Wilmington, DE, and Macclesfield, United Kingdom) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women.

PATIENTS AND METHODS: The randomized, double-blind, multicenter study was designed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor–positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy. Primary end points were objective response (OR), defined as complete (CR) or partial (PR) response, time to progression (TTP), and tolerability.

RESULTS: Anastrozole was as effective as tamoxifen in terms of OR (21% v 17% of patients, respectively), with clinical benefit (CR + PR + stabilization >= 24 weeks) observed in 59% of patients on anastrozole and 46% on tamoxifen (two-sided P = .0098, retrospective analysis). Anastrozole had a significant advantage over tamoxifen in terms of TTP (median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen, respectively; two-sided P = .005). The tamoxifen:anastrozole hazards ratio was 1.44 (lower one-sided 95% confidence limit, 1.16). Both treatments were well tolerated. However, thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen (4.1% v 8.2% [thromboembolic events] and 1.2% v 3.8% [vaginal bleeding], respectively).

CONCLUSION: Anastrozole satisfied the predefined criteria for equivalence to tamoxifen. Furthermore, we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole. These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer.




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