FDA’s approval follows the recommendation of the Oncologic Drugs Advisory Committee for accelerated approval of temozolomide to treat patients with anaplastic astrocytoma tumors.

FDA(food & drug administration) has approved temozolomide, a cancer treatment for adult patients diagnosed with a form of brain cancer — anaplastic astrocytoma — who have relapsed following chemotherapy including a nitrosourea drug (carmustine or lomustine) and procarbazine. The following may be used to respond to questions.

Approximately 18,000 new cases of primary intracranial (brain) cancer are diagnosed each year in the U.S. This represents about 2 percent of all adult cancers. More than 50 percent of these are high-grade gliomas (i.e. glioblastoma multiform and anaplastic astrocytoma tumors). Patients with these tumors often suffer from severe disabilities such as motor dysfunction, seizures, and vision abnormalities. The approval of temozolomide gives patients another option for treatment of their disease when they do not respond to initial treatment with radiation and chemotherapy.

Temozolomide has been granted accelerated approval - a regulatory mechanism that allows early approval for a product for the treatment of serious or life-threatening conditions for which no acceptable alternative treatments exist or which provide a meaningful therapeutic benefit over existing treatments. Accelerated approval is based on surrogate markers of effectiveness such as shrinkage of a tumor rather than a documented effect on clinical benefit such as survival or quality of life.

Temozolomide’s approval was supported by a single arm multi-center trial in l62 patients who had anaplastic astrocytoma at first relapse and who had received previous radiation therapy and may also have received chemotherapy. In the patients with tumors resistant to previous chemotherapy with a nitrosourea and procarbazine, seven (7) out of 54 patients (13 percent) had partial shrinkage of their tumors while nine percent or 5 out of 54 patients had a complete response.

Side effects reported include headaches, nausea, vomiting, fatigue and low blood counts. Patients with severe vomiting may require antiemetic therapy before or during temozolomide treatment.

The drug will be marketed under the name Temodar. As a condition of approval, the manufacturer, Schering-Plough Corp, Madison New Jersey will conduct a randomized trial to evaluate clinical benefit.

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In case of having any of the following symptoms, it is must to seek medical advisor: Unexplained, persistent vomiting Double vision or unexplained blurring of vision, especially on only one side Lethargy or increased sleepiness New seizures New pattern or type of headachesAlthough headaches are thought to be a common symptom of brain cancer, they may not occur until late in the progression of the disease. If any significant change in your headache pattern occurs, your health care provider may suggest that you go the hospital

It is often helpful to make a list of questions before an appointment.  This will help you to remember what the doctor says.  Patients and care givers can write notes or ask if they may use a tape recorder.  Sometimes it is helpful to have a family member or friend at the appointment to take notes, ask questions or just listen.  Below are a few suggested questions a patient may ask their doctor.

Will you please write down the type of cancer that I have?

What stage is my cancer and what does that mean?

What are my treatment options?

What treatment do you recommend and why?

What are the risks and benefits of each treatment?

What are possible side effects of treatment?

How will you help manage my side effects?

Are there other things I can be doing to help with my treatment, such as diet and exercise?

What are resources that I can turn to learn more about my cancer and help me deal with it?

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While taking medical treatments, this is also necessary to have skills to cope up with this disease. Patients may experience unpleasant side effects due to their treatment. Patients should discuss any side effects they experience with their doctors; occasionally an effect may be unexpected or dangerous and dosages may need to be adjusted. Doctors can help alleviate nausea with antinausea medications and may prescribe antidepressants to help the patient deal with the cancer on a psychological level. Joining support groups will also help patients deal with the psychological effects of treatment. Cancer survivors can help provide encouragement and offer advice for coping with cancer on a day-to-day basis.

Living with a serious disease such as a brain tumor is not easy. Some people find they need help coping with the emotional and practical aspects of their disease. Support groups can help. In these groups, patients or their family members get together to share what they have learned about coping with the disease and the effects of treatment. Patients may want to talk with a member of their health care team about finding a support group. Groups may offer support in person, over the telephone, or on the Internet.

People living with a brain tumor may worry about caring for their families, keeping their jobs, or continuing daily activities. Concerns about treatments and managing side effects, hospital stays, and medical bills are also common. Doctors, nurses, and other members of the health care team can answer questions about treatment, working, or other activities. Meeting with a social worker, counselor, or member of the clergy can be helpful to those who want to talk about their feelings or discuss their concerns. Often, a social worker can suggest resources for financial aid, transportation, home care, or emotional support.

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While choosing a diagnostic test, following factors might be considered:

• Age and medical condition

• The type of cancer

• Severity of symptoms

• Previous test results

So that your doctors can plan your treatment, they need to find out as much as possible about the type, position and size of the tumour, by doing a number of tests and investigations.Neurological examination (nerve tests) .The first test you have will be a neurological examination to assess any effect of the tumour on your nervous system.

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Childhood cerebellar astrocytoma is a disease in which benign (noncancer) or malignant (cancer) cells form in the tissues of the brain.

Astrocytomas are tumors that develop from brain cells called astrocytes. Cerebellar astrocytomas start in the cerebellum, which is located at the lower back of the brain. The cerebellum is the part of the brain that controls movement, balance, and posture.

About 15-25% of all childhood brain tumors are cerebellar astrocytomas. Although cancer is rare in children, brain tumors are the most common type of childhood cancer other than leukemia and lymphoma.

This summary refers to the treatment of primary brain tumors (tumors that begin in the brain). Treatment for metastatic brain tumors, which are tumors formed by cancer cells that begin in other parts of the body and spread to the brain, is not discussed in this summary.

Brain tumors can occur in both children and adults; however, treatment for children may be different than treatment for adults. (Refer to the PDQ treatment summary on Adult Brain Tumors for more information.)

The cause of most childhood brain tumors is unknown.

The symptoms of childhood cerebellar astrocytoma vary and often depend on the child’s age and where the tumor is located.

These symptoms may be caused by an astrocytoma or other conditions. A doctor should be consulted if any of the following problems occur:

• Loss of balance, difficulty walking, worsening handwriting, or slow speech.

• Morning headache or headache that goes away after vomiting.

• Nausea and vomiting.

• Unusual sleepiness or change in energy level.

• Change in personality or behavior.

• Unexplained weight loss or weight gain.

Tests that examine the brain and spinal cord are used to detect (find) childhood cerebellar astrocytoma.

The following tests and procedures may be used:

• CT scan (CAT scan): A procedure that makes a series of detailed pictures of areas inside the body, taken from different angles. The pictures are made by a computer linked to an x-ray machine. A dye may be injected into a vein or swallowed to help the organs or tissues show up more clearly. This procedure is also called computed tomography, computerized tomography, or computerized axial tomography.

• MRI (magnetic resonance imaging): A procedure that uses a magnet, radio waves, and a computer to make a series of detailed pictures of areas inside the brain and spinal cord. A substance called gadolinium is injected into the patient through a vein. The gadolinium collects around the cancer cells so they show up brighter in the picture. This procedure is also called nuclear magnetic resonance imaging (NMRI).

Childhood cerebellar astrocytoma is diagnosed and removed in surgery.

If a brain tumor is suspected, a biopsy is done by removing part of the skull and using a needle to remove a sample of the brain tissue. A pathologist views the tissue under a microscope to look for cancer cells. If cancer cells are found, the doctor will remove as much tumor as safely possible during the same surgery.

Certain factors affect prognosis (chance of recovery) and treatment options.

The prognosis (chance of recovery) depends on:

• The type of astrocytoma.

• Whether cancer cells remain after surgery.

Treatment options depend on:

• Whether cancer cells remain after surgery or have spread to other parts of the brain.

• The location of the tumor.

• The child’s age.

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Major causes of Astrocytoma cancer are still unknown. Most people with brain cancer have no known risk factors.  The risk factors that do exist include:

• Radiation – Radiation to the head and jobs in the nuclear industry have been linked to an increase in brain cancer.

• Environmental – Exposure to vinyl chloride and acrylonitrile may increase the risk for brain cancer. 

• Family history – A small percent of people have a genetic mutation that increases their risk for brain cancer.

A risk factor is anything that increases a person’s chance of developing a disease, including cancer. There are risk factors that can be controlled, such as smoking, and risk factors that cannot be controlled, such as age and family history. Although risk factors can influence disease, for many risk factors it is not known whether they actually cause the disease directly. Some people with several risk factors never develop the disease, while others with no known risk factors do.

Doctors and researchers don’t know what causes most childhood cancers. Some evidence indicates that genetic factors may play a role in a small percentage of cerebral astrocytoma cases. For example, children who have neurofibromatosis may have an increased risk of developing astrocytoma. Neurofibromatosis is an inherited disorder that causes neurofibromas (benign tumors) to form on peripheral nerves in the body, brown spots on the skin, and deformities of tissues and bones. Neurofibromatosis is also called

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Different experiments are being performed to discover the ways to prevent the disease. Currently, scientists do not know what causes the majority of brain cancers. There may be a slight genetic predisposition, as family members of astrocytoma patients have a slightly increased incidence of the disease. Clinical studies show that a large number of genetic alterations take place in the higher grade astrocytomas; although this helps to explain what is going wrong in the cells, it does not explain what is causing these genetic mutations to take place.While it is known that ionizing radiation can cause brain tumors, most people are not exposed to this type of radiation unless they are being treated for cancer. Ongoing studies are examining the long-term risks of other types of radiation, but as of 2001, neither x rays, electromagnetic fields, or cellular phones appear to increase the likelihood of brain cancers.Although evidence is not yet conclusive, some studies suggest that some brain tumors may be caused by environmental exposure to certain organic chemicals. Exposure is most harmful to the developing fetus and infants, so pregnant women may wish to consider whether they have any occupational exposure to organic chemicals. Parents of infants should be aware of pesticides and any other potentially harmful chemical their child could come into contact with.Additionally there is some evidence that supplements containing vitamins A, C, E, and folate may have a protective effect when taken during pregnancy. The children of women who take these supplements during pregnancy are half as likely to develop brain tumors before age five.Early diagnosis and treatment of tumors may reduce the risk of metastatic brain tumors. There is no way to prevent brain cancer but there are some factors suggested as possible risk factors for primary brain tumors. Avoiding the factors that can be avoided may reduce your risk.

•  Radiation to the head

•  certain inherited conditions

•  HIV infection

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Survival rate may vary in different people depending upon nature and stage of disease. The major factors that influence survival seem to be the type of cancer, its location, whether it can be surgically removed or reduced, your age, and your other medical problems.

• The long-term survival rate (greater than 5 years) for people with primary brain cancer is less than 10% despite aggressive surgery, radiation, and chemotherapy.

• But these treatments do prolong survival in the short term and, perhaps more importantly, improve your quality of life while you are still alive.

• Most people with metastatic brain cancer die from their primary cancer rather than from the brain lesions.

• In this case as well, radiation and chemotherapy increase your life expectancy modestly.

• People who have seizures generally do poorly over the following 6 months.

• Despite seemingly dismal chances of long-term survival, these chances are clearly greater with treatment than without. Discuss treatment options and best-estimated prognosis with your cancer team.

While no specific alternative therapies have become popular for this particular type of brain cancer, patients interested in pursuing complementary therapies should discuss the idea with their doctor. A doctor may be able to provide information about the efficacy of certain techniques and whether they may interfere with conventional treatment.

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While treating with cancer, there can be variety of side effects. Some are easily controlled and others require specialized care. Below are some of the side effects that are more common to astrocytoma and its treatments. For more detailed information on managing these and other side effects of cancer and cancer treatment, visit the PLWC Managing Side Effects section.

Fatigue (tiredness): Fatigue is extreme exhaustion or tiredness, and is the most common problem that people with cancer experience. More than half of patients experience fatigue during chemotherapy or radiation therapy, and up to 70% of patients with advanced cancer experience fatigue. Patients who feel fatigue often say that even a small effort, such as walking across a room, can seem like too much. Fatigue can seriously impact family and other daily activities, can make patients avoid or skip cancer treatments, and may even impact the will to live.

Hair loss (alopecia): A potential side effect of radiation therapy and chemotherapy is hair loss. Radiation therapy and chemotherapy cause hair loss by damaging the hair follicles responsible for hair growth. Hair loss may occur throughout the body, including the head, face, arms, legs, underarms, and pubic area. The hair may fall out entirely, gradually, or in sections. In some cases, the hair will simply thin-sometimes unnoticeably-and may become duller and dryer. Losing one’s hair can be a psychologically and emotionally challenging experience and can affect a patient’s self-image and quality of life. However, the hair loss is usually temporary, and the hair often grows back.

Infection: An infection occurs when harmful bacteria, viruses, or fungi (such as yeast) invade the body and the immune system is not able to destroy them quickly enough. Patients with cancer are more likely to develop infections because both cancer and cancer treatments (particularly chemotherapy and radiation therapy to the bones or extensive areas of the body) can weaken the immune system. Symptoms of infection include fever (temperature of 100.5°F or higher); chills or sweating; sore throat or sores in the mouth; abdominal pain; pain or burning when urinating or frequent urination; diarrhea or sores around the anus; cough or breathlessness; redness, swelling, or pain, particularly around a cut or wound; and unusual vaginal discharge or itching.

Mouth sores (mucositis). Mucositis is an inflammation of the inside of the mouth and throat, leading to painful ulcers and mouth sores. It occurs in up to 40% of patients receiving chemotherapy treatments. Mucositis can be caused by a chemotherapeutic drug directly, the reduced immunity brought on by chemotherapy, or radiation treatment to the head and neck area.

Nausea and vomiting: Vomiting, also called emesis or throwing up, is the act of expelling the contents of the stomach through the mouth. It is a natural way for the body to rid itself of harmful substances. Nausea is the urge to vomit. Nausea and vomiting are common in patients receiving chemotherapy for cancer and in some patients receiving radiation therapy. Many patients with cancer say they fear nausea and vomiting more than any other side effects of treatment. When it is minor and treated quickly, nausea and vomiting can be quite uncomfortable but cause no serious problems. Persistent vomiting can cause dehydration, electrolyte imbalance, weight loss, depression, and avoidance of chemotherapy.

Nervous system disturbances: Nervous system disturbances can be caused by many different factors, including cancer, cancer treatments, medications, or other disorders. Symptoms that result from a disruption or damage to the nerves caused by cancer treatment (such as surgery, radiation treatment, or chemotherapy) can appear soon after treatment or many years later. See Managing Side Effects: Nervous System Disturbances for the most common symptoms.

Sleeping problems:  hypersomnia, somnolence syndrome, and nightmares. Hypersomnia, also called somnolence, excessive daytime sleepiness, or prolonged drowsiness, is a condition characterized by excessive sleeping or the inability to maintain wakefulness when desired. Somnolence syndrome is a type of hypersomnia associated with cranial radiation therapy (radiation treatment to the head) in children. Symptoms of somnolence syndrome include excessive drowsiness, prolonged periods of sleep (up to 20 hours a day), headaches, low-grade fever, nausea and/or vomiting, and irritability. Nightmares are vivid, frightening dreams that usually cause the dreamer to wake up able to remember part or most of the nightmare. Most people have nightmares from time to time, but the frequency or vividness of nightmares can increase after a cancer diagnosis and during cancer treatment. Possible causes of hypersomnia include some brain cancers in adults (for example, ependymoma or meningioma); some childhood central nervous system (CNS) cancers (for example, brain stem glioma, cerebellar astrocytoma, medulloblastoma); some secondary brain tumors (brain metastases); some chemotherapeutic drugs (for example, teniposide [VM-26], pegaspargase [Oncaspar], thalidomide [Thalomid]); and other prescription and over-the-counter medications (for example, some antidepressants, antinausea medications, opioid pain killers, sedatives, antihistamines, sleeping pills).

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Different treatment options are given to cope up with this deadly disease. There are treatments for all patients with an adult brain tumor. Three kinds of treatment are used:

• surgery

• radiation therapy

• chemotherapy

Surgery is the most common treatment of adult brain tumors. To take out the cancer from the brain, a doctor will cut a part of the bone from the skull to get to the brain. This operation is called a craniotomy. After the doctor removes the cancer, the bone will be put back or a piece of metal or fabric will be used to cover the opening in the skull.

Radiation therapy uses x-rays produced by a machine called a linear accelerator or a cobalt machine to kill cancer cells from the outside and shrink tumors (external-beam radiation therapy). Radiation therapy may also be used by putting materials that produce radiation (radioisotopes) through thin plastic tubes into the tumor to kill cancer cells from the inside (internal radiation therapy).

Chemotherapy uses drugs to kill cancer cells. Chemotherapy may be taken by pill, or it may be put into the body by a needle in the vein or muscle. Chemotherapy is called a systemic treatment because the drug enters the bloodstream, travels through the body, and can kill cancer cells throughout the body.

Biological therapy (using the body’s immune system to fight cancer) is also being studied in clinical trials. Biological therapy tries to get the body to fight cancer. It uses materials made by the body or made in a laboratory to boost, direct, or restore the body’s natural defenses against disease.

Treatment by type: Treatment of adult brain tumor depends on the type and stage of the disease, and the patient’s age and overall health.

Standard treatment may be considered because of its effectiveness in past studies, or participation in a clinical trial may be considered. Not all patients are cured with standard therapy, and some standard treatments may have more side effects than are desired. For these reasons, clinical trials are designed to find better ways to treat cancer patients and are based on the most up-to-date information. Clinical trials are ongoing in most parts of the country for most types of adult brain tumor.

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