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Figure 1: Disease-Free Survival (Median follow-up 73 months, ITT Approach) DFS events defined as loco-regional recurrence, distant metastasis, invasive contralateral breast cancer, or death from any cause (i. The medians of overall survival for both arms were not reached for the MAA. There was no statistically significant difference in overall survival. The hazard ratio for survival in the Femara arm compared to the tamoxifen arm was 0. There were no significant differences in DFS, OS, SDFS, and Distant DFS from switch in the Sequential Treatments Analysis with respect to either monotherapy (e. There were no significant differences in DFS, OS, SDFS, and Distant DFS from randomization in the Sequential Treatments Analyses. Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 24 Months. A double-blind, randomized, placebo-controlled trial (MA-17, NCT00003140) of Femara was performed in over 5,100 postmenopausal women with receptor-positive or unknown primary breast cancer who were disease free after 5 years of adjuvant treatment with tamoxifen. The planned duration of treatment for patients in the study was 5 years, but the trial was terminated early because of an interim analysis showing a favorable Femara effect on time without recurrence or contralateral breast cancer. At the time of unblinding, women had been followed for a median of 28 months, 30% of patients had completed 3 or more years of follow-up and less than 1% of patients had completed 5 years of follow-up. Selected baseline characteristics for the study population are shown in Table 8. Table 8: Selected Study Population Demographics (Modified ITT Population) Baseline Status Femara Placebo N = 2582 N = 2586 Hormone Receptor Status (%) ER+ and/or PgR+ 98 98 Both Unknown 2 2 Nodal Status (%) Node Negative 50 50 Node Positive 46 46 Nodal Status Unknown 4 4 Chemotherapy 46 46. Table 9 shows the study results. Disease-free survival was measured as the time from randomization to the earliest event of loco-regional or distant recurrence of the primary disease or development of contralateral breast cancer or death. Disease-free survival by hormone receptor status, nodal status and adjuvant chemotherapy were similar to the overall results. Data were premature for an analysis of survival. Table 9: Extended Adjuvant Study Results Femara N = 2582 Placebo N = 2586 Hazard Ratio (95% CI) P -Value Disease Free Survival (DFS) 1 Events 122 (4. Hazard ratio of less than 1. P -value based on stratified log-rank test. Updated Analyses of Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months. Table 10: Update of Extended Adjuvant Study Results Femara N = 2582 (%) Placebo N = 2586 (%) Hazard Ratio 1 (95% CI) P -Value 2 Disease Free Survival (DFS) events 3 344 (13. Updated analyses were conducted at a median follow-up of 62 months. In the Femara arm, 71% of the patients were treated for a least 3 years and 58% of patients completed at least 4, where to buy natural steroids. After the unblinding of the study at a median follow-up of 28 months, approximately 60% of the selected patients in the placebo arm opted to switch to Femara. In this updated analysis shown in Table 10 Femara significantly reduced the risk of breast cancer recurrence or contralateral breast cancer compared with placebo (HR 0.
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