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.
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 )] .
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.