Tailorxtreatment options

A Clinical Trial Assigning IndividuaLized
Options for Treatment (Rx)

Treatment Options
The TAILORx trial is designed to find out if a new test (Oncotype DX) will be able to help doctorsand their patients with early breast cancer make better treatment decisions. Each patient whoenrolls in the study will receive a numerical Recurrence Score (RS), which will be determined by theOncotype DX assay (ODX) and that RS will determine to which study group a patient will beassigned. Patients with a RS of 10 or lower will have hormonal therapy; patients with a RS of 26 or higher will have hormonal and chemotherapy; and patients with a RS of 11 to 25 will be randomized to either hormonal therapy or hormonal and chemotherapy.
While a patient’s RS will determine the study group she will be in, the exact treatment or regimen(choice of drugs, timing of treatments, etc.) will be made by the doctor and the patient. There aremany different hormonal and chemotherapy treatments that are considered “standard of care.”As long as the regimen is considered a standard treatment, it will be accepted Hormonal therapy (aromatase inhibitor or tamoxifen as determined by physician and patient) Randomized to have hormonal OR hormonal AND standard chemotherapy Hormonal AND standard chemotherapy (specific hormonal and chemotherapy treatment to be determined by physician and patient) Chemotherapy
Normal cells in the body grow and divide in a controlled way. Cancer cells, however, grow and
divide very rapidly and in an uncontrolled manner. Chemotherapy is a general term used to
describe various drugs to treat cancer that work throughout the body. Many drugs used to treat
breast cancer interfere with and kill cells that grow and divide very fast. Because tumors are made
up of different kinds of cells, chemotherapy often consists of two or more drugs each having a
different way of killing cancer cells. This is called combination chemotherapy.
Patients in the TAILORx trial will have early stage-breast cancer that measures 1.1 to 5.0 cm, isER/PR positive, node negative and HER2 negative. The TAILORx trial allows those patients who arerandomized to receive chemotherapy to use any standard chemotherapy. The NationalComprehensive Cancer Network (NCCN) cancer treatment guidelines mention several drugs thatare used in various combinations and are given on different schedules for the treatment of thisstage of breast cancer. The list of the brand and generic names below can help you become familiar with the drugs doctors may mention. Only the patient and her physician can make thedecision about which chemotherapy regimen is best (brand name/generic names shown).
These therapies will be given in the medical oncologist’s office. Some regimens may be given over a period of time in a specific number of cycles.
Side Effects from Chemotherapy
As noted above, chemotherapy drugs are designed to interfere with or kill fast growing cancer cells
and that may affect other fast growing cells in the body. Side effects are the result of chemotherapy
drugs affecting non-cancer cells in the body. It is important to know that today many of the
problems from side effects can be managed and that many disappear after treatment is completed.
Having or not having a side effect is not related to whether the treatment is working or not. Because
each person is different, some patients won’t have a specific side effect while for others the side
effect will range from mild to severe.
Specific side effects are related to the type of cell the chemotherapy drug is affecting. Hair loss,fatigue, risk of infection, nausea and vomiting are some side effects that are commonly associatedwith chemotherapy treatments. These side effects may vary by individual patient and the chemotherapy drug regimen. The table below lists some of the common side effects duringchemotherapy treatment: treatment is completed and white blood cell production increases Abnormal blood clotting Low platelet count treatment is completed and platelet count returns to more normal levels.
Fertility issues, sexuality, Chemotherapy drugs concern, patients should child)talk to their doctor before any treatment begins. There are sometimes options for people who wishto maintain their fertility.
Hormonal Therapy
Estrogen contributes to the growth of breast cancer in women whose tumors are estrogen/
progesterone receptor positive (ER/PR+). Estrogen can sit on the receptor and signal the tumor to
grow. Hormonal therapies either reduce the amount of estrogen produced in postmenopausal
women or block estrogen from reaching the receptor in both pre- and postmenopausal women.
Hormonal therapies that are considered “standard of care” are:
• Aromatase inhibitors (AIs)* which reduce the amount of estrogen produced in postmenopausal women. Currently available aromatase inhibitors include (brand/generic names shown): - Arimidex/anastrozole - Aromasin/exemestane - Femara/letrozole • SERMs (Selective estrogen receptor modulators) block estrogen from reaching the cell by attaching to the receptor and preventing a signal to the cancer cell. - Tamoxifen (This drug is produced under different brand names.) Side Effects from Hormonal Therapy
Because all hormonal therapies lower the effects of estrogen in many areas of the body, often the
side effects are similar to menopause. Symptoms associated with SERMs and AIs are: hot flashes,
weight gain or bloating, vaginal dryness, mood swings, and depression. Menopausal-like symptoms
like these can be mild to severe.
Pre- and postmenopausal women may take tamoxifen. Some side effects reported with tamoxifen are fertility issues and hair and nail thinning. Potentially more serious side effects are: blood clots, endometrialcancer, abnormal growth of uterine tissue (endometriosis), and stroke. It is important to note that inwomen taking tamoxifen these serious side effects were reported in less than one percent of patients.
symptoms (hot flashes, weight gain or bloating, vaginal dryness, mood swings, and depression)Fertility issues More serious side effect (reported in less than More serious side effect (reported in less than More serious side effect (reported in less than More serious side effect (reported in less than * Note - By FDA indication, only anastrozole would be considered standard for treatment with aromatase inhibitors. In clinical practice, the three drugs (anastrozole,exemestane, and letrozole) are used somewhat interchangeably.
Only women who are postmenopausal can take aromatase inhibitors. Patients taking an AI mayexperience bone loss, joint pain, arthritis, increase in cholesterol levels and upset stomach or mildnausea. There are effective treatments for some of these side effects.
After reading a list of the possible side effects of chemotherapy and/or hormonal therapy, somepatients may ask if the treatment is worse than the disease. It is important to remember that mostside effect symptoms can be treated and many disappear when treatment is completed. We knowthat chemotherapy and hormonal therapy can be very effective in treating breast and some othertypes of cancer. Millions of people today are cancer survivors because of chemotherapy and hormonal therapy drugs. Patients should not be deterred from treatment because of possible sideeffects.

Source: http://www.ecog.org/general/gendocs/tailorx_treat_opt.pdf


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