FEMARA (letrozole tablets) - Breast Cancer Symptom Glossary

Glossary

Many women feel like they have to learn a new language to understand breast cancer. The following is a list of terms which may help.

A

Absorption - The uptake of a drug into or across tissues.

Adjuvant Therapy - Therapy used to help reduce the risk of cancer coming back after surgery. Adjuvant Therapy may include chemotherapy, radiation and/or hormonal therapy. Femara is an approved adjuvant therapy.

Advanced Breast Cancer - Breast cancer that has progressed either in size or location beyond that of the early stages; generally includes stages III and IV.

Androgen - One of a group of hormones found in both men and women.

Anticancer - Having activity against cancer.

Anti-estrogen therapy - Drug that blocks the action of estrogen.

Arm Lymphedema - Swelling of the arm, caused by an abnormal collection of too much lymph fluid (clear fluid that contains white blood cells and antibodies, and is circulated throughout the body by the lymphatic system).

Aromatase - Enzyme that converts androgen into estrogen.

Aromatase inhibitor - Substance that blocks the action of aromatase.

Arthralgia - Pain of the tissues in and around the joints.

Axillary lymph nodes - Lymph nodes located under the arms.

B

Benign - Not cancerous; does not invade nearby tissue or spread to other parts of the body.

Breast Biopsy - The surgical removal of a small piece of breast tissue for microscopic examination to determine if cancer cells are present.

Bone Scan - Procedure by which an image of the bones is produced by injection of a radioisotope; used to determine if the cancer has spread to the bones.

C

Carcinoma in situ - Breast cancer that is contained and has not spread outside of the duct or lobule.

Cardiovascular events - Symptoms relating to the blood vessels affecting the heart.

CAT scan (Computerized Axial Tomography) - Special type of X-ray that produces detailed images of the human body.

Chemotherapy - The use of drugs to treat disease; when used to treat cancer, the goal is to kill cancer cells.

Clinical Trial - A scientific study conducted in people to determine the safety and effectiveness of a treatment.

D

Ductal carcinoma - Cancer located in one of the ducts of the breast.

Dyspnea - Difficulty in breathing.

E

Early stage breast cancer - Cancer that has not progressed beyond the breast tissue and local axillary lymph nodes.

Enzyme - Protein produced by a living cell that enables the body to carry out necessary chemical reactions.

Estrogen - Primarily female sex hormone; one of a group of hormones found in both men and women.

Estrogen receptor - Protein inside certain cells that binds to estrogen.

Estrogen receptor-negative - Cancer cells that do not contain estrogen receptors.

Extended adjuvant therapy - Therapy used to help reduce the risk of cancer coming back after adjuvant therapy—treatment with FEMARA for postmenopausal women who are within three months of completing five years of standard tamoxifen therapy.

G

Gastrointestinal tract - Organs of digestion, including the stomach and intestines.

Growth factor - Any substance that promotes the growth of cells within the body.

H

Hormonal therapy - Any therapy that blocks hormonal stimulation of the growth of cancer cells.

Hormone - Substance produced by living cells that circulates in the bloodstream and affects cells and tissues far from where it originates.

Hormone dependent - Cells that require the action of hormones for their growth.

Hormone replacement therapy (HRT) - Estrogen given in pill form to replace the estrogen lost after menopause; may or may not be given in conjunction with progesterone. Femara is not a hormone replacement therapy.

I

Infiltrating/Invasive Carcinoma - Cancer that has spread beyond the layer of tissue in which it started, growing into surrounding, normal tissues.

L

Lobular carcinoma - Breast cancer that begins in the lobules of the breast.

Lumpectomy - Removal of a cancerous lump and the breast tissue surrounding it.

Lymph - A liquid that contains cells that help the body fight infection.

Lymph node/nodes - Small, bean-shaped organs that make and store the cells that fight infection; they are found in many places in the body, including under the arms, behind the ears, and more.

M

Mammogram - An X-ray picture of the breast.

Mastectomy - Surgery that removes the entire breast.

Menopause - Cessation of menstruation (usually between the ages of 45 and 55).

Metastasis - The spread of cancer cells from the original site to other parts of the body.

N

Nodal status - Whether or not the cancer has spread from the original site to the lymph nodes. Cancer that has spread to the lymph nodes is referred to as lymph node-positive. Cancer that has not spread to the lymph nodes is referred to as lymph node-negative.

Non-invasive cancer - Cancer cells that remain within the borders of a duct or lobule and have not grown into the surrounding tissues. These tumors are also known as "in situ" tumors (tumors that remain "in the site" of origin).

Neo-adjuvant therapy - The use of chemotherapy, radiation or hormonal therapy to reduce the tumor bulk or size prior to surgery.

O

Oncologist - A doctor who specializes in taking care of people with cancer. Some specialize in one type of cancer treatment. For example, a radiation oncologist treats cancer with radiation, and a medical oncologist treats cancer with medications. Some oncologists also specialize in one kind of cancer. For example, a breast cancer oncologist diagnoses and treats breast cancer.

Osteoporosis - The weakening of bone, wherein bone mass reaches the low end of a normal range.

Ovaries - The pair of female reproductive organs on either side of the uterus that produce eggs and hormones.

P

Postmenopausal - Refers to the time after menopause when menstruation has stopped.

Premenopausal - Refers to the years when menstruation is still ongoing.

Prognosis - The probable outcome or course of a disease; the chance of recovery.

Prostheses - A specially made replacement for a part of the body that has been removed, such as a breast or a limb.

R

Radiation - High-energy emissions from X rays, gamma rays, neutrons, and other sources.

Radiation therapy - The use of electromagnetic radiation for the local treatment of cancer.

Receptor - A "lock" inside the cell; in the case of a cancer cell, the hormone is the key, and when it binds to the receptor, it triggers the growth process.

Reconstruction - Surgery to rebuild a breast's shape after a mastectomy.

Recurrence - When cancer comes back after treatment, either in the same place, or in a new area of the body.

Remission - Complete or partial disappearance of the signs and symptoms of disease. A remission, however, is not necessarily a cure.

Response - Term used to indicate the result of therapy as it applies to shrinking tumors.

S

Stages/Staging - A way to describe the extent of the cancer, based on such factors as tumor size, whether lymph nodes have been affected, and whether it has spread to other parts of the body.

Surgery - When related to the treatment of cancer, any operative procedure in which the cancer is manually removed.

T

Tamoxifen - An oral anti-estrogen used in the treatment of breast cancer.

Thromboembolic events - Events caused by blood clots reducing or blocking the flow of blood to important tissues.

Toxicity - A specific harmful effect associated with therapy.

Tumor - A group of cancerous cells.

Tumor properties - Characteristics of the tumor, including size and whether or not it is hormone receptor-positive.

Indication

Femara� (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor�positive early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects.

In addition, Femara is approved for the treatment of postmenopausal women with estrogen receptor�positive or estrogen receptor�unknown breast cancer that has spread to another part of the body (metastatic cancer).

Ask your oncologist if Femara is right for you.

Important Safety Information

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated for postmenopausal women. Talk to your doctor if you're allergic to Femara or any of its ingredients. Femara should be used with caution by nursing mothers. You should not take Femara if you are pregnant as it may cause fetal harm. Some women reported fatigue and dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. Side effects that are comparable between Femara and tamoxifen include night sweats, weight gain, nausea and tiredness. Side effects seen more often with tamoxifen versus Femara were hot flashes and vaginal bleeding. Joint pain was experienced more often with Femara versus tamoxifen. The incidence of stroke was 1.1% for women on Femara and 1% for women on tamoxifen, and the incidence of other cardiovascular events was 6.6% for Femara versus 6.2% for tamoxifen. The percentage of women on Femara reporting bone fracture was 5.6% versus 4% for women on tamoxifen. The percentage of women reporting osteoporosis was 2% for Femara versus 1.1% for tamoxifen. Additional side effects for both Femara and tamoxifen are heart attack, thromboembolic events, endometrial cancer and second malignancies.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Those seen more often with Femara versus placebo were hot flashes (50% vs 43%), joint pain (22% vs 18%) and muscle pain (7% vs 5%). Other side effects, which were comparable to placebo, include fatigue (34% vs 32%), swelling due to fluid retention (18% vs 16%), headache (20% vs 20%), increase in sweating (24% vs 22%) and increase in cholesterol (16% vs 16%). The percentage of patients on Femara versus placebo reporting a fracture was 5.9% versus 5.5%. The percentage of patients reporting osteoporosis was 6.9% versus 5.5%. Bisphosphonates, drugs to increase bone strength, were given to 21.1% of Femara patients and 18.7% of placebo patients. Additional side effects seen in study are arthritis, dizziness, constipation, nausea and cardiovascular ischemic events.

In the metastatic cancer setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, tiredness, coughing, constipation, limb pain, chest pain and headache.

Femara is a once-daily, convenient prescription tablet.

For additional safety information, please see the prescribing information.

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