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Anastrozole Versus Tamoxifen as First-Line Therapy in Postmenopausal Patients With Hormone-Dependent Advanced Breast Cancer: A Prospective, Randomized, Phase III Study

Milla-Santos, Alfredo M.D.; Milla, Lidon M.D.; Portella, Jordi M.D.; Rallo, Lidon M.D.; Pons, Maria M.D.; Rodes, Esther M.D.; Casanovas, Jose M.D.; Puig-Gali, Margarita M.D.

American Journal of Clinical Oncology: June 2003 - Volume 26 - Issue 3 - p 317-322
doi: 10.1097/01.COC.0000047126.10522.F9

A prospective phase III trial comparing anastrozole with tamoxifen as first-line therapy in postmenopausal, hormone-dependent, advanced breast cancer (ABC). Patients were randomized to anastrozole 1 mg daily (n = 121) or tamoxifen 40 mg daily (n = 117). Efficacy and tolerability were evaluated after 3 months’ therapy, and survival was evaluated at median time of follow-up. At a median follow-up of 13.3 months, clinical benefit (CB) was achieved in 83% and 56% of anastrozole and tamoxifen patients, respectively (p < 0.001); median time to disease progression (TTP) in patients achieving CB was 18.0 months and 7.0 months, respectively, (hazard ratio [HR] = 0.13, 95% CI = 0.08–0.20, p < 0.01). At data cutoff, 89% of tamoxifen patients had died, compared with 60% of anastrozole patients; median time to death was 17.4 months and 16.0 months, respectively (HR = 0.64, 95% CI = 0.47–0.86, p = 0.003). Therapy was well tolerated in both groups. Anastrozole showed significant advantages over tamoxifen for CB, median TTP in patients gaining CB, and survival. These data further support routine use of anastrozole as first-line treatment for postmenopausal hormone-dependent ABC.

From the Medical Oncology Service (A.M-S., L.R., M.P-G.) and Gynecological Service (J.P., M.P., E.R.), Sanitas Hospitales, Barcelona. From the CRC Radiological Department, Sant Joan Universitary Hospital, Reus, Tarragona, Spain (L.M.). From the Medical Oncology Service, Clinica Carmelitana, Barcelona, Spain (J.C.).

Address correspondence and reprint requests to Dr. A. Milla-Santos, Medical Oncology Service, Sanitas Hospitales, 111 Balmes Street, 08008 Barcelona, Spain. E-mail:

© 2003 Lippincott Williams & Wilkins, Inc.