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Originally published as JCO Early Release 10.1200/JCO.2007.12.6334 on March 10 2008 © 2008 American Society of Clinical Oncology. Efficacy, Toxicity, and Quality of Life in Older Women With Early-Stage Breast Cancer Treated With Letrozole or Placebo After 5 Years of Tamoxifen: NCIC CTG Intergroup Trial MA.17
From the University of Vermont Cancer Center, Burlington, VT; National Cancer Institute of Canada Clinical Trials Group, Queens University, Kingston; McMaster University, Hamilton; Toronto Sunnybrook Health Sciences Center and the University of Toronto, Toronto, Ontario, Canada; Mayo Clinic Cancer Center, Rochester, MN; Angeles Clinic and Research Institute, Santa Monica CA; Cancer Center, Inova Fairfax Hospital, Fairfax, VA; Oncology, Jules Bordet Cancer Institute, Brussels, Belgium; and Massachusetts General Hospital Cancer Center, Boston, MA Corresponding author: Hyman B. Muss, MD, University of Vermont College of Medicine, 1 South Prospect St, Saint Joseph 3400, Burlington, VT 05401; e-mail: hyman.muss{at}uvm.edu Purpose National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor–positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women.
Patients and Methods In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and
Results At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age Conclusion Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole. published online ahead of print at www.jco.org on March 10, 2008. Presented in part at a poster-discussion at the San Antonio Breast Cancer Symposium, December 14, 2006, San Antonio TX. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease–free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95% CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. 
