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© 2005 Oxford University Press
ARTICLE |
Randomized Trial of Letrozole Following Tamoxifen as Extended Adjuvant Therapy in Receptor-Positive Breast Cancer: Updated Findings from NCIC CTG MA.17
Affiliations of authors: The Division of Hematology-Oncology, Massachusetts General Hospital, Boston, MA (PEG); Mayo Clinic, Rochester, MN (JNI); John Wayne Cancer Institute, Santa Monica, CA (SM); Inova Fairfax Hospital, Falls Church, VA (NJR); University of Vermont, Burlington, VT (HBM); Institut Jules Bordet, Brussels, Belgium (MJ Piccart); SAAK/IBCSG Operations Office, Bern, Switzerland (MC); National Cancer Institute of Canada, Clinical Trials Group, Kingston, Ontario, Canada (DT, LES, MJ Palmer, JLP); Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada (KIP); University of Washington, Seattle, WA (RBL); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD (NED); Memorial Sloan-Kettering Cancer Center, New York, NY (LN); Mayo Clinic, Jacksonville, FL (EAP); Clinical Investigations Branch, National Cancer Institute, Rockville, MD (JSA); Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland (DAC)
Correspondence to: Paul E. Goss, MD, PhD, FRCPC, FRCP (UK), Massachusetts General Hospital Cancer Center, 55 Fruit St., Cox Bldg., Suite 640, Boston, MA 02114 (e-mail: pgoss{at}partners.org).
Background: Most recurrences in women with breast cancer receiving 5 years of adjuvant tamoxifen occur after 5 years. The MA.17 trial, which was designed to determine whether extended adjuvant therapy with the aromatase inhibitor letrozole after tamoxifen reduces the risk of such late recurrences, was stopped early after an interim analysis showed that letrozole improved disease-free survival. This report presents updated findings from the trial. Methods: Postmenopausal women completing 5 years of tamoxifen treatment were randomly assigned to a planned 5 years of letrozole (n = 2593) or placebo (n = 2594). The primary endpoint was disease-free survival (DFS); secondary endpoints included distant disease-free survival, overall survival, incidence of contralateral tumors, and toxic effects. Survival was examined using Kaplan–Meier analysis and log-rank tests. Planned subgroup analyses included those by axillary lymph node status. All statistical tests were two-sided. Results: After a median follow-up of 30 months (range = 1.5–61.4 months), women in the letrozole arm had statistically significantly better DFS and distant DFS than women in the placebo arm (DFS: hazard ratio [HR] for recurrence or contralateral breast cancer = 0.58, 95% confidence interval [CI] = 0.45 to 0.76; P<.001; distant DFS: HR = 0.60, 95% CI = 0.43 to 0.84; P = .002). Overall survival was the same in both arms (HR for death from any cause = 0.82, 95% CI = 0.57 to 1.19; P = .3). However, among lymph node–positive patients, overall survival was statistically significantly improved with letrozole (HR = 0.61, 95% CI = 0.38 to 0.98; P = .04). The incidence of contralateral breast cancer was lower in women receiving letrozole, but the difference was not statistically significant. Women receiving letrozole experienced more hormonally related side effects than those receiving placebo, but the incidences of bone fractures and cardiovascular events were the same. Conclusion: Letrozole after tamoxifen is well-tolerated and improves both disease-free and distant disease–free survival but not overall survival, except in node-positive patients.
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J. D. Yager and N. E. Davidson Estrogen Carcinogenesis in Breast Cancer N. Engl. J. Med., January 19, 2006; 354(3): 270 - 282. [Full Text] [PDF]
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S. M. Swain Aromatase Inhibitors -- A Triumph of Translational Oncology N. Engl. J. Med., December 29, 2005; 353(26): 2807 - 2809. [Full Text] [PDF]
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