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Table 7: Updated Adjuvant Study Results – Monotherapy Arms Analysis (Median Follow-up 73 Months) Censored analysis censors follow-up at the date of selective crossover in 632 patients who crossed to Letrozole tablets or another aromatase inhibitor after the tamoxifen arms were unblinded in 2005. Figure 1 shows the Kaplan-Meier curves for Disease-Free Survival Monotherapy Analysis. Figure 1 Disease-Free Survival (Median follow-up 73 months, ITT Approach) 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 Letrozole tablets 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, steroids skin care products. Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 24 Months. A double-blind, randomized, placebo-controlled trial (MA-17, NCT00003140) of Letrozole tablets 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 Letrozole tablets 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 Letrozole tablets N=2582 Placebo 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. DFS 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. Letrozole tablets N = 2582 Placebo N = 2586 Hazard Ratio (95% CI) P -Value CI = confidence interval for hazard ratio. Hazard ratio of less than 1. P-value based on stratified log-rank test. Disease Free Survival (DFS) 1 Events 122 (4. Updated Analyses of Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months. Table 10 : Update of Extended Adjuvant Study Results. Letrozole tablets N=2582 (%) Placebo N=2586 (%) Hazard Ratio 1 (95%CI) P- Value 2 Disease Free Survival (DFS) events 3 344 (13.
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