I. Nolvadex Fact File
Nolvadex was introduced by Astra-Zeneca pharmaceuticals.
Globally, Astra-Zeneca is one of the world's leading pharmaceutical companies with 60,000 people - 12,000 in the US alone - dedicated to the discovery, development, and marketing of new pharmaceutical solutions, to enrich the quality of people's lives all over the world.
The focused areas of research include:
- Cardiovascular
- Gastrointestinal
- Infection
- Neuroscience
- Oncology
- Respiratory
II. Nolvadex Medication
Nolvadex medication (tamoxifen) blocks the effects of estrogen hormone in the body. Tamoxifen is most commonly used to treat breast cancer in women or men. Nolvadex medication has been successfully helping save the lives of millions of women with breast cancer for over 20 years.
Nolvadex medication (tamoxifen) works by blocking estrogen. In breast tissue, Nolvadex medication is an antiestrogen. An antiestrogen or estrogen blocker works by blocking estrogen in breast tissue. While estrogen may not actually cause breast cancer, it may stimulate its growth, feeding the cancer. With estrogen blocked, the cancer cells that need it may not grow at all. In other words, antiestrogens may keep cancer from developing in your breast.
In clinical trials it has been shown that cancer of the uterus, stroke, and blood clots can occur approximately 2 to 4 times more frequently with Nolvadex medication than placebo, but each occurred in less than 1% of women. Some of these strokes, blood clots, and uterine cancers were fatal.
Breast Cancer: Information
Breast cancer is a malignant tumor, which starts in breast tissue. There are several types of breast cancer. They all begin in the milk ducts and/or the milk lobules.
Some breast cancers are found when they are 'in situ'. This means they have not spread outside the duct or lobule where they began. However, most breast cancers are found when they are 'invasive'. This means the cancers have grown beyond the duct or lobule into other breast tissue or out of the breast. Breast cancer which spreads out of the breast may also spread to lymph nodes in the armpit nearest the breast affected by cancer (axillary lymph nodes). Breast cancer which is found before it appears to have spread beyond the breast and axillary lymph nodes is known as 'early breast cancer'.
This information is mostly about early breast cancer. Breast cancer that has spread to other parts of the body, such as the bones and liver is known as advanced breast cancer.
Cancer begins in cells, the building blocks that make up tissues. Tissues make up the organs of the body. Normally, cells grow and divide to form new cells, as the body needs them. When cells grow old, they die, and new cells take their place.
Sometimes this orderly process goes wrong. New cells form when the body does not need them, and old cells do not die when they should. These extra cells can form a mass of tissue called a growth or tumor.
Not all tumors are cancer. Tumors can be benign or malignant:
Benign tumors are not cancer:
- Benign tumors are rarely life threatening.
- Usually, benign tumors can be removed, and they seldom grow back.
- Cells from benign tumors do not spread to tissues around them or to other parts of the body.
Malignant tumors are cancer:
- Malignant tumors generally are more serious than benign tumors. They may be life threatening.
- Malignant tumors often can be removed, but they can grow back.
- Cells from malignant tumors can invade and damage nearby tissues and organs. Also, cancer cells can break away from a malignant tumor and enter the bloodstream or lymphatic system. That is how cancer cells spread from the original cancer (primary tumor) to form new tumors in other organs. The spread of cancer is called metastasis.
Risk Factors (Causes) of Breast Cancer
A risk factor is anything that increases a person's chance of developing a disease. Studies have found the following risk factors for breast cancer:
- Age: The chance of getting breast cancer goes up, as a woman gets older. A woman over age 60 is at greatest risk. This disease is very uncommon before menopause.
- Personal history of breast cancer: A woman who has had breast cancer in one breast has an increased risk of getting this disease in her other breast.
- Family history: A woman's risk of breast cancer is higher if her mother, sister, or daughter had breast cancer, especially at a young age (before age 40). Having other relatives with breast cancer on either her mother's or her father's side of the family may also increase a woman's risk.
- Certain breast changes: Some women have cells in the breast that look abnormal under a microscope. Having certain types of abnormal cells (atypical hyperplasia or lobular carcinoma in situ [LCIS]) increases the risk of breast cancer.
- Genetic alterations: Changes in certain genes (BRCA1, BRCA2, and others) increase the risk of breast cancer. In families in which many women have had the disease, genetic testing can sometimes show the presence of specific genetic changes. Health care providers may suggest ways to try to reduce the risk of breast cancer, or to improve the detection of this disease in women who have these changes in their genes. The Cancer Information Service can provide printed material about genetic testing.
- Reproductive and menstrual history:
- The older a woman is when she has her first child, the greater her chance of breast cancer.
- Women who began menstruation (had their first menstrual period) at an early age (before age 12), went through menopause late (after age 55), or never had children also are at an increased risk.
- Women who take menopausal hormone therapy (either estrogen alone or estrogen plus progestin) for 5 or more years after menopause also appear to have an increased chance of developing breast cancer.
- Much research has been done to learn whether having an abortion or a miscarriage affects a woman's chance of developing breast cancer later on. Large, well-designed studies have consistently shown no link between abortion or miscarriage and the development of breast cancer.
- Race: Breast cancer occurs more often in white women than Latina, Asian, or African American women.
- Radiation therapy to the chest: Women who had radiation therapy to the chest (including breasts) before age 30 are at an increased risk of breast cancer. This includes women treated with radiation for Hodgkin's lymphoma. Studies show that the younger a woman was when she received radiation treatment, the higher her risk of breast cancer later in life.
- Breast density: Older women who have mostly dense (not fatty) tissue on a mammogram (x-ray of the breast) are at increased risk of breast cancer.
- Taking DES (diethylstilbestrol): DES is a synthetic form of estrogen that was given to some pregnant women in the United States between about 1940 and 1971. (DES is no longer given to pregnant women.) Women who took DES during pregnancy have a slightly increased risk of breast cancer. This does not yet appear to be the case for their daughters who were exposed to DES before birth. However, as these daughters grow older, more studies of their breast cancer risk are needed.
- Being obese after menopause: After menopause, women who are obese have an increased risk of developing breast cancer. Being obese means that the woman has an abnormally high proportion of body fat. Because the body makes some of its estrogen (a hormone) in fatty tissue, obese women are more likely than thin women to have higher levels of estrogen in their bodies. High levels of estrogen may be the reason that obese women have an increased risk of breast cancer. Also, some studies show that gaining weight after menopause increases the risk of breast cancer.
- Physical inactivity: Women who are physically inactive throughout life appear to have an increased risk of breast cancer. Being physically active may help to reduce risk by preventing weight gain and obesity.
- Alcoholic beverages: Some studies suggest that the more alcoholic beverages a woman drinks, the greater her risk of breast cancer.
Treatment of Breast Cancer: Information
Many years of treating cancer patients and testing treatments in clinical trials has helped doctors know what is likely to work for a particular type and stage of cancer. Your doctor will advise you on the best treatment for your cancer. This will depend on the full pathology results, your age and general health, and what you want.
Treatments for breast cancer include surgery, radiotherapy, chemotherapy and hormone treatment. Usually more than one is used.
Treatment for breast cancer in men is similar to and as effective as the treatment for breast cancer in women.
A. Surgery
Surgery is usually the first treatment for breast cancer.
Surgery to the breast either removes part of the breast (breast-conserving surgery) or the whole breast (mastectomy). Most people have axillary surgery at the same time. This removes lymph nodes in the armpit near your affected breast. The number of lymph nodes removed depends on the type of axillary surgery you have.
Before your surgery, your doctor will explain the risks involved and ask you to read and sign a consent form. All surgery and anaesthesia have some risks, including infection, bleeding and deep vein thrombosis (blood clot in the leg). These are not common, but you need to understand the risks.
Women who have a mastectomy may choose to have breast reconstruction surgery at the time of the mastectomy or later.
Breast-conserving surgery
Many women with early breast cancer can have operations that conserve most of their breast.
Lumpectomy removes the breast cancer and some tissue around it. Partial mastectomy removes more breast tissue than a lumpectomy. Axillary surgery is usually done at the same time, leaving a second scar under your armpit.
Women who have breast-conserving surgery usually have five to six weeks of radiotherapy afterwards. This is to substantially reduce the risk of breast cancer recurring in the same breast.
Mastectomy
Mastectomy removes your whole breast, usually including some skin and the nipple. The lymph nodes in the armpit closest to your affected breast will probably also be removed. The chest muscles are not removed.
Mastectomy is less disfiguring than the radical mastectomy of the past. The type of mastectomy used today also reduces the chance of your arm swelling (called lymphoedema) and allows for easier breast reconstruction. Sometimes radiotherapy is recommended after mastectomy.
Axillary surgery
Axillary surgery is usually done at the same time as breast-conserving surgery or mastectomy. It is done to see if there is any cancer in the axillary lymph nodes.
This part of your treatment helps your doctors decide on the best follow-up treatment for you. It also helps to stage the disease.
The lymph nodes are looked at under a microscope to see if they contain cancer cells. If they do, this means the cancer may have spread away from the breast. Your doctor will discuss chemotherapy or hormone treatment to follow your surgery.
Axillary dissection
This is the usual type of axillary surgery. The surgeon removes most of the lymph nodes from the armpit nearest the affected breast. They are checked by the pathologist. This is very effective at stopping cancer from coming back (recurring) in the underarm area.
This surgery can cause minor nerve damage. This can lead to a changed feeling or loss of sensation in the affected armpit. Some people won't sweat again in that area. It can also lead to lymphoedema.
Sentinel lymph node biopsy
Sentinel lymph node biopsy can show whether cancer has spread to the nodes, and whether axillary dissection is needed.
Before your breast surgery, some dye is injected around the cancer. This is carried by the lymphatic vessels in your breast to a 'sentinel' lymph node. This node is the first to receive lymph from the cancer area. It is the one most likely to contain cancer cells if your breast cancer has begun to spread. The surgeon can see the sentinel node highlighted by the dye, and can remove just this node at first. A scan may be used to help find the sentinel node.
If there is no cancer in the sentinel node, it is unlikely there will be cancer in other nodes, so axillary dissection may not be necessary.
This new technique is available in clinical trials and special circumstances: ask your doctor if you are interested.
After surgery
When you wake up from the general anaesthetic, you will have a wound on your breast where the cancer was removed. If you had surgery on your lymph nodes you will usually have a second wound under your arm. A mastectomy leaves only one scar. You will have dressings on the wounds and may have a drainage tube coming from the wound under your arm. This will stay in for two or more days. You will be in hospital for two to five days, depending on how well you feel and what your doctor suggests.
Most people feel pain, numbness or tingling around the wound areas and upper arm. These feelings usually go away in the months after surgery, although the numbness may last longer. Ask your doctor or nurse for pain relief if you have any pain.
You may have problems moving your arm. Your doctor or the physiotherapist at the hospital will show you exercises which will help you get back movement in your arm.
After breast-conserving surgery, you will have small scars on your breast and under your arm. Your breast may be a different shape. The change may be small if you didn't have much tissue removed. It may be more noticeable if you had a larger amount of tissue removed.
After mastectomy, most people have a scar across their chest. Some women will choose to have breast reconstruction surgery. Other women may choose to wear a prosthesis.
If you are to have radiotherapy, it will start within a few weeks of your operation, unless you have chemotherapy first.
Lymphoedema
Lymphoedema affects some people who have lymph nodes removed as part of their breast cancer surgery (about one in ten people).
Lymphoedema is lymph fluid building up in the arm, causing swelling. It happens when lymph vessels are removed or damaged and no longer drain away the fluid. It may be minor or more troublesome.
It is hard to predict who will get lymphoedema. Lymphoedema can start soon after the operation, or months or years later.
- Lymphoedema can be triggered or made worse by infection.
- Tell your doctor about any swelling, tightness or injury to your hand or arm.
- Take extra care with the arm from which lymph nodes have been removed: try not to have injections in that arm and use gloves when you wash dishes and do the gardening.
- If you cut your arm and/or hand, let your doctor know if any signs of infection develop.
- Clean and dress all cuts, burns and scratches.
- Protect your arm from sunburn and insect bites.
- Take care if shaving your armpit, so you do not cut the skin.
If you have lymphoedema, speak with a physiotherapist or breast care nurse about what you can do to manage the swelling. Massage exercises and clothes to restrict swelling are available.
Choosing between the surgical methods
The choice between mastectomy and breast-conserving surgery depends upon the size and type of the breast cancer and its position in your breast. It also depends on what you want.
Mastectomy with axillary dissection has been compared to breast-conserving surgery and radiotherapy with axillary dissection. Research shows they are equally effective treatments for early breast cancers. There is a slightly greater risk of local breast recurrence with breast-conserving surgery, but long-term survival is the same.
With breast-conserving surgery, you still have most of your breast. However, further treatment with radiotherapy is usually needed. This takes several weeks. Following radiotherapy, your breast may feel slightly different.
Small-breasted women with large lumps can find that the breast-conserving operation causes a big change in breast shape.
Mastectomy may be recommended when:
- the cancer is large
- cancer occurs in more than one part of the breast
- certain medical conditions (for example, scleroderma) mean the person can't have radiotherapy.
- The main disadvantage of mastectomy is the loss of your breast. Breast reconstruction can be done at the time of the mastectomy or at a later date.
B. Radiotherapy
If you have breast-conserving surgery, you will usually be advised to have a course of radiotherapy afterwards. Some women who have mastectomy also have radiotherapy. Radiotherapy aims to kill any cancer cells, which may still be in the breast or on the chest wall.
Radiotherapy is the use of radiation to destroy cancer cells. The radiation can be precisely targeted at the area requiring treatment.
So that exactly the same area is treated each time, the radiation oncologist makes some marks on your skin. Sometimes tiny tattoos mark particular spots. Tattoos are permanent marks. You could have them removed after treatment is finished-ask you doctor about this if you want to.
The usual course of treatment is:
- radiotherapy to the whole breast for five days a week over five weeks
- then radiotherapy to the cancer site for five days over one week.
- You have the treatment as an outpatient. It is painless and it takes about thirty minutes for each treatment. Most of this time is used to set you and the machine in the correct position for treatment. The machine is only on for a few minutes to give the treatment. Allow more time in case you have to wait for your treatment.
C. Additional or 'adjuvant' treatment
Some people will be advised to have extra treatment as well as their surgery and/or radiotherapy. These extra or adjuvant treatments aim to reduce the chances of the cancer coming back in other parts of the body, by killing cancer cells that may have spread outside the breast.
Chemotherapy
This is the treatment of cancer by anti-cancer drugs. The aim is to kill cancer cells and not harm normal cells. These drugs travel in the blood to all parts of the body.
Chemotherapy is taken in cycles. Each treatment is followed by a rest period. If you have chemotherapy after surgery, it will usually begin within six weeks of your surgery. You might have your chemotherapy as a tablet, injected into a vein or through a drip, or a mix of these. Chemotherapy is usually started before radiotherapy.
You will have your chemotherapy as an outpatient. Your visit may be a few minutes or it may be a few hours, depending on the drugs you have. The whole course of chemotherapy may last up to six months, sometimes longer.
Neoadjuvant chemotherapy
Sometimes, chemotherapy is given before surgery. This is known as neoadjuvant chemotherapy. It can reduce the size of cancers so that surgery becomes possible, or so that breast-conserving surgery can be done.
Hormone treatment
Many breast cancers are helped to grow by the sex hormones oestrogen and progesterone. Some breast cancers can be treated by changing the levels of these hormones in the body.
The most common hormone treatment for breast cancer is Nolvadex (tamoxifen). This blocks the effects of oestrogen in the cancer cells. It works in people whose cancers are oestrogen-receptor (ER) positive and/or progesterone-receptor (PR) positive. With a breast cancer like this, Nolvadex medication (tamoxifen) reduces the chance of the breast cancer coming back.
Nolvadex medication (Tamoxifen) is taken daily as a tablet. If your doctor prescribes tamoxifen, you will begin the tablets after your surgery. If you also have chemotherapy, you will begin Nolvadex medication (tamoxifen) when this has finished.
Other hormone treatments such as anastrozole (Arimidex) and letrozole (Femara) are being tested. Early results suggest these drugs are as effective as Nolvadex medication (tamoxifen) and may possibly be more effective. However they only work in women who have had menopause and had a hormone-receptor-positive breast cancer. They are also taken as a daily tablet. They have different side effects from tamoxifen. They are more expensive at this time because they are not subsidized for this sort of treatment. For some women, they may be a better choice than tamoxifen, but tamoxifen is the standard treatment for now.
Related treatments
Some women choose to have extra treatment, depending on their risk of cancer coming back and their own wishes. If you want to explore either of the following options, discuss it with your doctor. You may also wish to seek other medical opinions.
Ovarian ablation stops the ovaries from functioning. The ovaries are the main producers of oestrogen in premenopausal women. Ovarian ablation is for women who:
- have oestrogen-receptor positive cancers
- are at high risk of recurrent cancer (or have had recurrent cancer)
- are still menstruating.
Ovarian ablation can be done using surgery, radiotherapy or drug therapy.
In an operation called oophorectomy, a small cut is made above the pubic bone and the ovaries are removed. This is usually done under a general anaesthetic. Most women can go home the next day and return to normal activities in one to two weeks. The surgery can also be done using laparoscopy with smaller skin incisions.
With oophorectomy and radiotherapy, your ovaries stop working. This will bring on menopause. This means you will no longer be able to have children. If this concerns you, ask your doctor before surgery if you have any medical options (for example, storing eggs or embryos). You may have some menopausal symptoms. These can include hot flushes, and dry vagina. Your doctor or breast care nurse will be able to advise you on treatments for these symptoms. Your risk of osteoporosis may increase.
Temporary ovarian ablation can also be achieved by using injections of a drug known as goserelin (Zoladex). You have injections every month for two to five years. This type of ovarian ablation is reversible: when the injections are stopped, depending on your age, your periods (and fertility) will usually return.
- Bilateral mastectomy (preventive)
Some women choose to have both breasts removed (bilateral mastectomy) when cancer has been found in one breast. This is to prevent a new cancer occurring in the second breast.
Not all doctors agree that mastectomy should be done in these cases, since it does not always prevent breast cancer. However, some doctors believe that it is the most effective choice for women with a high genetic risk of breast cancer.
For most women treated for breast cancer in one breast, the risk of cancer in the other breast is low. Your doctor may suggest that all that is needed is regular check-ups. Discuss with your doctor any concerns you have about your risk of a cancer in the other breast.
Palliative treatment relieves or soothes symptoms of illness, including pain. It is for people who have symptoms from their cancer, whatever their stage of cancer treatment. It is an important type of treatment for people with advanced cancer, who cannot be cured but can expect to live without undue pain and distress.
Palliative care includes pain relief using painkilling drugs and other measures. Pain is usually well controlled with oral medication. General practitioners, spetadalafilts and palliative care teams in hospital play important roles in palliative treatment for people with cancer.
The Breasts: Information
Women's breasts are designed to produce milk after pregnancy. Each breast sits on chest muscles that cover the ribs.
Each breast is divided into 15 to 20 sections called lobes. Lobes contain many smaller lobules. Lobules contain groups of tiny glands that can produce milk. Milk flows from the lobules through thin tubes called ducts to the nipple. The nipple is in the center of a dark area of skin called the areola. Fat fills the spaces between the lobules and ducts.
Breast tissue is made up of milk glands, supportive fibrous tissue, fatty tissue, arteries, veins, lymph vessels and nerves. The milk glands consist of lobules, where milk is made, and ducts, which take the milk to the nipple. In women, breasts develop and change through their life under the influence of the hormones normally produced by the ovary.
The breasts also contain lymph vessels, which carry a clear fluid called lymph. The lymph vessels lead to small, round organs called lymph nodes. Groups of lymph nodes are found near the breast in the axilla (underarm), above the collarbone, in the chest behind the breastbone, and in many other parts of the body. The lymph nodes trap bacteria, cancer cells, or other harmful substances that may be in the lymphatic system.
Men also have breast tissue.
Side effects of Breast Cancer Treatments
- Radiotherapy
Side effects of radiotherapy may include tiredness, and some redness or 'sunburning' of the skin, which usually returns to normal in a few weeks. Rarely, the skin is more severely affected. Radiotherapy nurses can show you how to care for your skin.
After radiotherapy, your breast may feel slightly firmer and may change a little in size or shape. If you are having radiotherapy you should get extra rest. Try to wear loose cotton clothing to reduce any irritation to the area having the radiation. Cover the area when you are in the sun.
Talk with your doctor and the radiotherapy staff about these and other possible side effects and how to manage them.
- Chemotherapy
People can have side effects from chemotherapy depending on the drugs they take and their doses. People who have side effects from adjuvant chemotherapy usually cope well with them. Side effects may include nausea, vomiting for a short time, feeling 'off color' and tired, and some thinning or loss of hair from your body and head. These side effects are temporary (short term), and steps can be taken to prevent or reduce them.
For women, if you are still having periods, you may find that your periods stop while you are having treatment. Depending on your age, it is possible that your periods may not return once the treatment has stopped. You may want to discuss fertility issues and early onset of menopause with your doctor.
- Hormone treatment
Side effects of tamoxifen include hot flushes, blood clots, vaginal discharge or irritation and irregular periods (if you are still having periods). You may have none of these side effects, or one or more. Your doctor or breast care nurse will be able to advise you about how to manage them. A small number of postmenopausal women who take tamoxifen have a higher than average risk of developing cancer of the uterus. Tell your doctor if you have any unusual vaginal bleeding.
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III. Useful links
Government http://www.cdc.gov/
http://www.fda.gov/
http://www.fda.gov/cder/ogd/
http://www.nih.gov/
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
http://www.health.gov.on.ca/
National Library of Medicine
World Health Organization
Health Sites
MedicineNet.com
Drugdigest.org
Healthsquare.com
http://www.nolvadex.com/consumer/home.asp
http://www.astrazeneca-us.com/
http://www.nolvadex.com/consumer/nolvadex.asp
http://www.drugdigest.org/DD/DVH/Uses/0,3915,637%7CNolvadex,00.html
www.cancer-treatment.com
www.cancervic.org.au
Pharmacy sites
http://www.roche.com/home/company/com_hist.htm
http://www.healthdigest.org/Bactrim-DS(Oral)_2006_PRO.php
http://www.hsforum.com/stories/storyReader$1509
http://www.hsforum.com/stories/storyReader$1516
http://www.hsforum.com/stories/storyReader$1504
http://www.people.vcu.edu/~urdesai/atc.htm#Process%20of%20clotting
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