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* * Most Breast Cancer Recurrences and Deaths Occur Beyond 5 Years of Tamoxifen The Oxford overview 2000 meta-analysis reviewed outcomes over 15 years of follow-up from diagnosis of early breast cancer, for patients treated with 5 years (years 0-5) of tamoxifen vs control.1,2 The meta-analysis found: About 15% of breast cancer recurrences occur within the first 5 years after starting tamoxifen; over the next 10 years, the incidence is about 18%. About 9% of breast cancer mortality occurs within the first 5 years after starting tamoxifen; for 10 years post-tamoxifen the incidence is 17%. 1. Adapted from Oxford overview 2000 meta-analysis. 2. Early Breast Cancer Trialists’ Collaborative Group. Lancet. 2005;365:1687. * * Long-Term Risk of Breast Cancer Recurrence Remains High in ER+ Patients— Higher After 5 Years Than in ER– Patients This slide demonstrates the development of the annual risk of breast cancer recurrence over time in 3562 patients categorized by estrogen receptor (ER) status. Results are combined for patients enrolled in 7 trials. Adjuvant treatment was with chemotherapy alone, endocrine therapy alone, or chemotherapy plus endocrine therapy. The mean follow-up times for ER-positive and ER-negative patients were 8.1 and 8.0 years, respectively. Not unexpectedly, for the complete 0- to 12-year interval, the cumulative hazard of recurrence between years 0 and 12 postsurgery was higher for the ER-negative patients than for the ER-positive patients (P0.00001). However, beyond 5 years the annual hazard of recurrence is higher for ER-positive patients (P=0.00002). Saphner et al. J Clin Oncol. 1996;14:2738. * * MA.17: Trial Design MA.17 is a phase 3 randomized, double-blind, placebo-controlled trial of letrozole in postmenopausal women with primary breast cancer completing approximately 5 years (4.5 to 6 years) of early adjuvant tamoxifen. Patients were randomized to receive either placebo or letrozole 2.5 mg orally, dailyfor 5 years. Stratification factors
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