Femara (Page 4 of 11)

6. 3 Updated Analy s is, Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months

The extended adjuvant treatment trial was unblinded early [see Adverse Reactions (6.2)]. At the updated (final analysis), overall the side effects seen were consistent to those seen at a median treatment duration of 24 months.

During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) a higher rate of fractures was observed for Femara (10.4%) compared to placebo (5.8%), as also a higher rate of osteoporosis (Femara 12.2% vs placebo 6.4%).

Based on 62 months median duration of follow-up in the randomized letrozole arm in the Safety population the incidence of new fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo. The incidence of new osteoporosis was 14.5% for letrozole and 7.8% for placebo.

During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) the incidence of cardiovascular events was 9.8% for Femara and 7.0% for placebo.

Based on 62 months median duration of follow-up in the randomized letrozole arm in the Safety population the incidence of cardiovascular disease at any time after randomization was 14.4% for letrozole and 9.8% for placebo.

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 over 5 years. Use of lipid lowering drugs or dietary management of elevated lipids was allowed. [see Warnings and Precautions(5.2 )]

6. 4 First-Line Treatment of Advanced Breast Cancer

A total of 455 patients were treated for a median time of exposure of 11 months. The incidence of adverse reactions was similar for Femara and tamoxifen. The most frequently reported adverse reactions were bone pain, hot flushes, back pain, nausea, arthralgia and dyspnea. Discontinuations for adverse reactions other than progression of tumor occurred in 10/455 (2%) of patients on Femara and in 15/455 (3%) of patients on tamoxifen.

Adverse reactions, regardless of relationship to study drug, that were reported in at least 5% of the patients treated with Femara 2.5 mg or tamoxifen 20 mg in the first-line treatment study are shown in Table 3.

Table 3: Percentage (%) of Patients with Adverse Reactions
Adverse Femara tamoxifen
Reaction 2.5 mg 20 mg
(N=455) (N=455)
% %
General Disorders
Fatigue 13 13
Chest Pain 8 9
Edema Peripheral 5 6
Pain NOS 5 7
Weakness 6 4
Investigations
Weight Decreased 7 5
Vascular Disorders
Hot Flushes 19 16
Hypertension 8 4
Gastrointestinal Disorders
Nausea 17 17
Constipation 10 11
Diarrhea 8 4
Vomiting 7 8
Infections/Infestations
Influenza 6 4
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.

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