Femara (Page 3 of 11)

6.2 Extended Adjuvant Treatment of Early Breast Cancer , Median Treatment Duration of 24 M onths

The median duration of extended adjuvant treatment was 24 months and the median duration of follow-up for safety was 28 months for patients receiving Femara and placebo.

Table 2 describes the adverse reactions occurring at a frequency of at least 5% in any treatment group during treatment. Most adverse reactions reported were Grade 1 and Grade 2 based on the Common Toxicity Criteria Version 2.0. In the extended adjuvant setting, the reported drug-related adverse reactions that were significantly different from placebo were hot flashes, arthralgia/arthritis, and myalgia.

Table 2: Percentage of Patients with Adverse Reactions
Number (%) of Patients with Grade 1-4 Adverse Reaction Number (%) of Patients with Grade 3-4 Adverse Reaction
Femara Placebo Femara Placebo
N=2563 N=2573 N=2563 N=2573
Any Adverse Reaction 2232 (87.1) 2174 (84.5) 419 (16.3) 389 (15.1)
Vascular Disorders 1375 (53.6) 1230 (47.8) 59 (2.3) 74 (2.9)
Flushing 1273 (49.7) 1114 (43.3) 3 (0.1) 0 -
General Disorders 1154 (45) 1090 (42.4) 30 (1.2) 28 (1.1)
Asthenia 862 (33.6) 826 (32.1) 16 (0.6) 7 (0.3)
Edema NOS 471 (18.4) 416 (16.2) 4 (0.2) 3 (0.1)
Musculoskeletal Disorders 978 (38.2) 836 (32.5) 71 (2.8) 50 (1.9)
Arthralgia 565 (22) 465 (18.1) 25 (1) 20 (0.8)
Arthritis NOS 173 (6.7) 124 (4.8) 10 (0.4) 5 (0.2)
Myalgia 171 (6.7) 122 (4.7) 8 (0.3) 6 (0.2)
Back Pain 129 (5) 112 (4.4) 8 (0.3) 7 (0.3)
Nervous System Disorders 863 (33.7) 819 (31.8) 65 (2.5) 58 (2.3)
Headache 516 (20.1) 508 (19.7) 18 (0.7) 17 (0.7)
Dizziness 363 (14.2) 342 (13.3) 9 (0.4) 6 (0.2)
Skin Disorders 830 (32.4) 787 (30.6) 17 (0.7) 16 (0.6)
Sweating Increased 619 (24.2) 577 (22.4) 1 (<0.1) 0 -
Gastrointestinal Disorders 725 (28.3) 731 (28.4) 43 (1.7) 42 (1.6)
Constipation 290 (11.3) 304 (11.8) 6 (0.2) 2 (<0.1)
Nausea 221 (8.6) 212 (8.2) 3 (0.1) 10 (0.4)
Diarrhea NOS 128 (5) 143 (5.6) 12 (0.5) 8 (0.3)
Metabolic Disorders 551 (21.5) 537 (20.9) 24 (0.9) 32 (1.2)
Hypercholesterolemia 401 (15.6) 398 (15.5) 2 (<0.1) 5 (0.2)
Reproductive Disorders 303 (11.8) 357 (13.9) 9 (0.4) 8 (0.3)
Vaginal Hemorrhage 123 (4.8) 171 (6.6) 2 (<0.1) 5 (0.2)
Vulvovaginal Dryness 137 (5.3) 127 (4.9) 0 - 0 -
Psychiatric Disorders 320 (12.5) 276 (10.7) 21 (0.8) 16 (0.6)
Insomnia 149 (5.8) 120 (4.7) 2 (<0.1) 2 (<0.1)
Respiratory Disorders 279 (10.9) 260 (10.1) 30 (1.2) 28 (1.1)
Dyspnea 140 (5.5) 137 (5.3) 21 (0.8) 18 (0.7)
Investigations 184 (7.2) 147 (5.7) 13 (0.5) 13 (0.5)
Infections and Infestations 166 (6.5) 163 (6.3) 40 (1.6) 33 (1.3)
Renal Disorders 130 (5.1) 100 (3.9) 12 (0.5) 6 (0.2)

Based on a median follow-up of patients for 28 months,the incidence of clinical fractures from the core randomized study in patients who received Femara was 5.9% (152) and placebo was 5.5% (142). The incidence of self-reported osteoporosis was higher in patients who received Femara 6.9% (176) than in patients who received placebo 5.5% (141). Bisphosphonates were administered to 21.1% of the patients who received Femara and 18.7% of the patients who received placebo.

The incidence of cardiovascular ischemic events from the core randomized study was comparable between patients who received Femara 6.8% (175) and placebo 6.5% (167).

A patient-reported measure that captures treatment impact on important symptoms associated with estrogen deficiency demonstrated a difference in favor of placebo for vasomotor and sexual symptom domains.

Bone Sub - study : [ s ee Warnings and Preca u tions (5. 1 ) ] .

Lipid Sub-study: In the extended adjuvant setting, based on a median duration of follow-up of 62 months, there was no significant difference between Femara and placebo in total cholesterol or in any lipid fraction at any time over 5 years. Use of lipid lowering drugs or dietary management of elevated lipids was allowed. [see Warnings and Precautions (5. 2 )] .

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