Femara (Page 5 of 11)

6. 5 Second- Line Treatment of Advanced Breast Cancer

Study 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
Adverse Pooled Pooled megestrol
Reaction Femara Femara acetate aminoglutethimide
2.5 mg 0.5 mg 160 mg 500 mg
(N=359) (N=380) (N=189) (N=178)
% % % %
Body as a Whole
Fatigue 8 6 11 3
Chest Pain 6 3 7 3
Peripheral Edema1 5 5 8 3
Asthenia 4 5 4 5
Weight Increase 2 2 9 3
Cardiovascular
Hypertension 5 7 5 6
Digestive System
Nausea 13 15 9 14
Vomiting 7 7 5 9
Constipation 6 7 9 7
Diarrhea 6 5 3 4
Pain-Abdominal 6 5 9 8
Anorexia 5 3 5 5
Dyspepsia 3 4 6 5
Infections/Infestations
Viral Infection 6 5 6 3
Lab Abnormality
Hypercholesterolemia 3 3 0 6
Musculoskeletal System
Musculoskeletal2 21 22 30 14
Arthralgia 8 8 8 3
Nervous System
Headache 9 12 9 7
Somnolence 3 2 2 9
Dizziness 3 5 7 3
Respiratory System
Dyspnea 7 9 16 5
Coughing 6 5 7 5
Skin and Appendages
Hot Flushes 6 5 4 3
Rash3 5 4 3 12
Pruritus 1 2 5 3

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 rash, vesicular rash

Other less frequent (<5%) adverse reactions considered consequential and reported in at least 3 patients treated with Femara, included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating and vertigo.

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