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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. Updated analyses were conducted at a median follow-up of 62 months. In the Letrozole tablets arm, 71% of the patients were treated for a least 3 years and 58% of patients completed at least 4. 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 Letrozole tablets. In this updated analysis shown in Table 10 Letrozole tablets significantly reduced the risk of breast cancer recurrence or contralateral breast cancer compared with placebo (HR 0. However, in the updated DFS analysis (interval between randomization and earliest event of loco-regional recurrence, distant metastasis, contralateral breast cancer, or death from any cause) the treatment difference was heavily diluted by 60% of the patients in the placebo arm switching to Letrozole tablets and accounting for 64% of the total placebo patient-years of follow-up. Ignoring these switches, the risk of DFS event was reduced by a non-significant 11% (HR 0. There was no significant difference in distant disease-free survival or overall survival. First-Line Treatment of Advanced Breast Cancer. A randomized, double-blind, multinational trial (P025) compared Letrozole tablets 2. Time to progression (TTP) was the primary endpoint of the trial. Selected baseline characteristics for this study are shown in Table 11. Table 11: Selected Study Population Demographics. Baseline Status Letrozole tablets N=458 Tamoxifen N=458 Stage of Disease IIIB 6% 7% IV 93% 92% Receptor Status ER and PgR Positive 38% 41% ER or PgR Positive 26% 26% Both Unknown 34% 33% ER – or PgR – /Other Unknown Previous Antiestrogen Therapy Adjuvant 19% 18% None 81% 82% Dominant Site of Disease Soft Tissue 25% 25% Bone 32% 29% Viscera 43% 46% Letrozole tablets were superior to tamoxifen in TTP and rate of objective tumor response (see Table 12). Table 12 summarizes the results of the trial, with a total median follow-up of approximately 32 months, para que sirve el supradol f. Figure 2 shows the Kaplan-Meier curves for TTP. Figure 2 Kaplan-Meier Estimates of Time to Progression (Study P025) Table 13 shows results in the subgroup of women who had received prior antiestrogen adjuvant therapy, Table 14, results by disease site and Table 15, the results by receptor status. Table 13: Efficacy in Patients Who Received Prior Antiestrogen Therapy. Hazard ratio less than 1 or odds ratio greater than 1 favors Letrozole tablets; hazard ratio greater than 1 or odds ratio less than 1 favors tamoxifen. Variable Letrozole tablets 2. Hazard ratio less than 1 or odds ratio greater than 1 favors Letrozole tablets; hazard ratio greater than 1 or odds ratio less than 1 favors tamoxifen. Variable Letrozole tablets 2.
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