nse (see Table 11).
Table 11 summarizes the results of the trial, with a total median follow-up of approximately 32 months. (All analyses are unadjusted and use 2-sided P-values.)
Table 11: Results of First-Line Treatment of Advanced Breast Cancer Femara tamoxifen Hazard or Odds
2.5 mg 20 mg Ratio (95% CI)
N=453 N=454 P-Value (2-Sided)
Median Time to Progression 9.4 months 6.0 months 0.72 (0.62, 0.83)1
P<0.0001
Objective Response Rate
(CR + PR) 145 (32%) 95 (21%) 1.77 (1.31, 2.39)2
P=0.0002
(CR) 42 (9%) 15 (3%) 2.99 (1.63, 5.47)2
P=0.0004
Duration of Objective Response
Median 18 months 16 months
(N=145) (N=95)
Overall Survival 35 months 32 months
(N=458) (N=458) P=0.51363
1 Hazard ratio
2 Odds ratio
3 Overall logrank test
Figure 2 shows the Kaplan-Meier curves for TTP.
Figure 2 Kaplan-Meier Estimates of Time to Progression (Tamoxifen Study)
Table 12 shows results in the subgroup of women who had received prior antiestrogen adjuvant therapy, Table 13, results by disease site and Table 14, the results by receptor status.
Table 12: Efficacy in Patients Who Received Prior Antiestrogen Therapy Variable Femara tamoxifen
2.5 mg 20 mg
N=84 N=83
Median Time to Progression (95% CI) 8.9 months (6.2, 12.5) 5.9 months (3.2, 6.2)
Hazard Ratio for TTP (95% CI) 0.60 (0.43, 0.84)
Objective Response Rate
(CR + PR) 22 (26%) 7 (8%)
Odds Ratio for Response (95% CI) 3.85 (1.50, 9.60)
Hazard ratio less than 1 or odds ratio greater than 1 favors Femara; hazard ratio greater than 1 or odds ratio less than 1 favors tamoxifen.
Table 13: Efficacy by Disease Site Femara tamoxifen
2.5 mg 20 mg
Dominant Disease Site
Soft Tissue: N=113 N=115
Median TTP 12.1 months 6.4 months
Objective Response Rate 50% 34%
Bone: N=145 N=131
Median TTP 9.5 months 6.3 months
Objective Response Rate 23% 15%
Viscera: N=195 N=208
Median TTP 8.3 months 4.6 months
Objective Response Rate 28% 17%
Table 14: Efficacy by Receptor Status Variable Femara tamoxifen
2.5 mg 20 mg
Receptor Positive N=294 N=305
Median Time to Progression (95% CI) 9.4 months (8.9, 11.8) 6.0 months (5.1, 8.5)
Hazard Ratio for TTP (95% CI) 0.69 (0.58, 0.83)
Objective Response Rate (CR+PR) 97 (33%) 66 (22%)
Odds Ratio for Response 95% CI) 1.78 (1.20, 2.60)
Receptor Unknown N=159 N=149
Median Time to Progression (95% CI) 9.2 months (6.1, 12.3) 6.0 months (4.1, 6.4)
Hazard Ratio for TTP (95% CI) 0.77 (0.60, 0.99)
Obje |
