Faslodex

Clinical Pharmacology

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Clinical Pharmacology

Faslodex

Antiestrogen for advanced disease ± adjuvant use

110 (53%)

97 (50%

126 (57%)

129 (56%)

Cytotoxic Chemotherapy

129 (63%)

122 (63%)

94 (42%)

98 (43%)

Site of Metastases

Visceral only*

39 (19%)

45 (23%)

30 (14%)

41 (18%)

Viscera

Liver involvement

47 (23%)

45 (23%)

48 (22%)

56 (24%)

Lung involvement

63 (31%)

60 (31%)

56 (25%)

60 (26%)

Bone only

47 (23%)

43 (22%

38 (17%)

40 (17%)

Soft Tissue only

12 (6%)

13 (7%)

11 (5%)

8 (3%)

Skin and soft tissue

43 (21%)

41 (21%)

40 (18%)

35 (15%)

* Defined as liver or lung metastatic, or recurrent, disease
ER/PgR Positive defined as ER positive or PgR positive
ER/PgR Unknown defined as ER unknown and PgR unknown

Results of the trials, after a minimum follow-up duration of 14.6 months, are summarized in Table 3. The effectiveness of FASLODEX 250 mg was determined by comparing RR and TTP results to anastrozole 1 mg, the active control. With respect to response rate, the two studies ruled out (by one-sided 97.7% confidence limit) inferiority of FASLODEX to anastrozole of 6.3% and 1.4%. There was no statistically significant difference in the survival time between the two treatment groups.

Table 3: Efficacy Results

Endpoint	North American Trial		European Trial
Endpoint	FASLODEX 250 mg (n=206)	Anastrozole 1 mg (n=194)	FASLODEX 250 mg (n=222)	Anastrozole 1 mg (n=229)
Objective tumor response Number (%) of subjects with CR + PR	35 (17.0)	33 (17.0)	45 (20.3)	34 (14.9)
% Difference in Tumor Response Rate (FAS-ANA) 2-sided 95.4% CI	0.0 (-6.3, 8.9)		5.4 (-1.4, 14.8)
Time to progression (TTP Median TTP (days)	165	103	166	156
Hazard ratio (FAS/ANA) 2-sided 95.4% CI	0.9 (0.7, 1.1)		1.0 (0.8, 1.2)
Stable Disease for ³24 weeks (%)	26.7	19.1	24.3	30.1
Survival Time Died n (%) Median Survival (days)	152 (73.8%) 844	149 (76.8%) 913	167 (75.2%) 803	173 (75.5%) 736
Median Survival (days) Hazard Ratio 2-sided 95% CI	0.98 (0.78, 1.24)		0.97 (0.78, 1.21)