nationale Contre le Cancer (UICC) criteria and verified by independent, blinded review. All responses were confirmed by a second eva luation 4 to 12 weeks after the documentation of the initial response.
Table 16 shows the results for the first trial, with a minimum follow-up of 15 months, that compared Femara 0.5 mg, Femara 2.5 mg, and megestrol acetate 160 mg daily. (All analyses are unadjusted.)
Table 16: Megestrol Acetate Study Results * two-sided P-value
Femara Femara megestrol
0.5 mg 2.5 mg acetate
N=188 N=174 N=190
Objective Response (CR + PR) 22 (11.7%) 41 (23.6%) 31 (16.3%)
Median Duration of Response 552 days (Not reached) 561 days
Median Time to Progression 154 days 170 days 168 days
Median Survival 633 days 730 days 659 days
Odds Ratio for Response Femara 2.5: Femara 0.5=2.33 Femara 2.5: megestrol=1.58
(95% CI: 1.32, 4.17); P=0.004* (95% CI: 0.94, 2.66); P=0.08*
Relative Risk of Progression Femara 2.5: Femara 0.5=0.81 Femara 2.5: megestrol=0.77
(95% CI: 0.63, 1.03); P=0.09* (95% CI: 0.60, 0.98); P=0.03*
The Kaplan-Meier curves for progression for the megestrol acetate study are shown in Figure 4.
Figure 4 Kaplan-Meier Estimates of Time to Progression (Megestrol Acetate Study)
The results for the study comparing Femara to aminoglutethimide, with a minimum follow-up of 9 months, are shown in Table 17. (Unadjusted analyses are used.)
Table 17: Aminoglutethimide Study Results *2-sided P-value
Femara Femara
0.5 mg 2.5 mg aminoglutethimide
N=193 N=185 N=179
Objective Response (CR + PR) 34 (17.6%) 34 (18.4%) 22 (12.3%)
Median Duration of Response 619 days 706 days 450 days
Median Time to Progression 103 days 123 days 112 days
Median Survival 636 days 792 days 592 days
Odds Ratio for Response Femara 2.5: Femara 2.5:
Femara 0.5=1.05 aminoglutethimide=1.61
(95% CI: 0.62, 1.79); P=0.85* (95% CI: 0.90, 2.87); P=0.11*
Relative Risk of Progression Femara 2.5: Femara 2.5:
Femara 0.5=0.86 aminoglutethimide=0.74
(95% CI: 0.68, 1.11); P=0.25* (95% CI: 0.57, 0.94); P=0.02*
The Kaplan-Meier curves for progression for the aminoglutethimide study is shown in Figure 5.
Figure 5 Kaplan-Meier Estimates of Time to Progression (Aminoglutethimide Study)
16 HOW SUPPLIED/STORAGE AND HANDLING
Packaged in HDPE bottles with a safety screw cap.
2.5 milligram tablets
Bottles of 30 tablets...................................................................................NDC 0078-0249-15
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Information for Patients
Pregnancy: Femara is contraindicated in women of premenopausal endocrine status. The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who recently became postmenopausal, until their postmenopausal status is fully established.
Fatigue and Dizziness: Since fatigue and dizziness have been observed with the use of Femara and somnolence was uncommonly reported, caution is advised when driving or using machinery.
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