Urinary Tract Infection NOS 6 3
Injury, Poisoning and Procedural Complications
Post-Mastectomy Lymphedema 7 7
Metabolism and Nutrition Disorders
Anorexia 4 6
Musculoskeletal and Connective Tissue Disorders
Bone Pain 22 21
Back Pain 18 19
Arthralgia 16 15
Pain in Limb 10 8
Nervous System Disorders
Headache NOS 8 7
Psychiatric Disorders
Insomnia 7 4
Reproductive System and Breast Disorders
Breast Pain 7 7
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 18 17
Cough 13 13
Chest Wall Pain 6 6
Other less frequent (≤2%) adverse reactions considered consequential for both treatment groups, included peripheral thromboembolic events, cardiovascular events, and cerebrovascular events. Peripheral thromboembolic events included venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism. Cardiovascular events included angina, myocardial infarction, myocardial ischemia, and coronary heart disease. Cerebrovascular events included transient ischemic attacks, thrombotic or hemorrhagic strokes and development of hemiparesis.
6.5 Second- Line Treatment of Advanced Breast CancerStudy discontinuations in the megestrol acetate comparison study for adverse reactions other than progression of tumor were 5/188 (2.7%) on Femara 0.5 mg, in 4/174 (2.3%) on Femara 2.5 mg, and in 15/190 (7.9%) on megestrol acetate. There were fewer thromboembolic events at both Femara doses than on the megestrol acetate arm (0.6% vs 4.7%). There was also less vaginal bleeding (0.3% vs 3.2%) on Femara than on megestrol acetate. In the aminoglutethimide comparison study, discontinuations for reasons other than progression occurred in 6/193 (3.1%) on 0.5 mg Femara, 7/185 (3.8%) on 2.5 mg Femara, and 7/178 (3.9%) of patients on aminoglutethimide.
Comparisons of the incidence of adverse reactions revealed no significant differences between the high and low dose Femara groups in either study. Most of the adverse reactions observed in all treatment groups were mild to moderate in severity and it was generally not possible to distinguish adverse reactions due to treatment from the consequences of the patient’s metastatic breast cancer, the effects of estrogen deprivation, or intercurrent illness.
Adverse reactions, regardless of relationship to study drug, that were reported in at least 5% of the patients treated with Femara 0.5 mg, Femara 2.5 mg, megestrol acetate, or aminoglutethimide in the two controlled trials are shown in Table 4.
Table 4: Percentage (%) of Patients with Adverse Reactions 1 Includes peripheral edema, leg edema, dependent edema, edema
2 Includes musculoskeletal pain, skeletal pain, back pain, arm pain, leg pain
3 Includes rash, erythematous rash, maculopapular rash, psoriasiform |
