Side effects of temodar chemotherapy

Temodar

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Newly Diagnosed Glioblastoma Multiforme

During the concomitant phase (TEMODAR+radiotherapy), adverse reactions including thrombocytopenia, nausea, vomiting, anorexia, and constipation were more frequent in the TEMODAR+RT arm. The incidence of other adverse reactions was comparable in the two arms. The most common adverse reactions across the cumulative TEMODAR experience were alopecia, nausea, vomiting, anorexia, headache, and constipation (see Table 7). Forty-nine percent (49%) of patients treated with TEMODAR reported one or more severe or life-threatening reactions, most commonly fatigue (13%), convulsions (6%), headache (5%), and thrombocytopenia (5%). Overall, the pattern of reactions during the maintenance phase was consistent with the known safety profile of TEMODAR.

TABLE 7: Number (%) of Patients with Adverse Reactions: All and Severe/Life Threatening (Incidence of 5% or Greater)

Myelosuppression (neutropenia and thrombocytopenia), which is a known dose-limiting toxicity for most cytotoxic agents, including TEMODAR, was observed. When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients, and Grade 3 or Grade 4 platelet abnormalities, including thrombocytopenic reactions, were observed in 14% of the patients treated with TEMODAR.

Refractory Anaplastic Astrocytoma

Tables 8 and 9 show the incidence of adverse reactions in the 158 patients in the anaplastic astrocytoma study for whom data are available. In the absence of a control group, it is not clear in many cases whether these reactions should be attributed to temozolomide or the patients’ underlying conditions, but nausea, vomiting, fatigue, and hematologic effects appear to be clearly drug-related. The most frequently occurring adverse reactions were nausea, vomiting, headache, and fatigue. The adverse reactions were usually NCI Common Toxicity Criteria (CTC) Grade 1 or 2 (mild to moderate in severity) and were self-limiting, with nausea and vomiting readily controlled with antiemetics. The incidence of severe nausea and vomiting (CTC Grade 3 or 4) was 10% and 6%, respectively. Myelosuppression (thrombocytopenia and neutropenia) was the dose-limiting adverse reaction. It usually occurred within the first few cycles of therapy and was not cumulative.

Myelosuppression occurred late in the treatment cycle and returned to normal, on average, within 14 days of nadir counts. The median nadirs occurred at 26 days for platelets (range: 21-40 days) and 28 days for neutrophils (range: 1-44 days). Only 14% (22/158) of patients had a neutrophil nadir and 20% (32/158) of patients had a platelet nadir, which may have delayed the start of the next cycle. Less than 10% of patients required hospitalization, blood transfusion, or discontinuation of therapy due to myelosuppression.

In clinical trial experience with 110 to 111 women and 169 to 174 men (depending on measurements), there were higher rates of Grade 4 neutropenia (ANC less than 500 cells/μL) and thrombocytopenia (less than 20,000 cells/μL) in women than men in the first cycle of therapy (12% vs. 5% and 9% vs. 3%, respectively).

In the entire safety database for which hematologic data exist (N=932), 7% (4/61) and 9.5% (6/63) of patients over age 70 experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients less than or equal to age 70, 7% (62/871) and 5.5% (48/879) experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. Pancytopenia, leukopenia, and anemia have also been reported.

TABLE 8: Adverse Reactions in the Anaplastic Astrocytoma Trial in Adults (≥ 5%)

TABLE 9: Adverse Hematologic Effects (Grade 3 to 4) in the Anaplastic Astrocytoma Trial in Adults

TEMODAR for injection delivers equivalent temozolomide dose and exposure to both temozolomide and 5-(3-methyltriazen-1yl)-imidazole-4-carboxamide (MTIC) as the corresponding TEMODAR capsules. Adverse reactions probably related to treatment that were reported from the 2 studies with the intravenous formulation (n=35) that were not reported in studies using the TEMODAR capsules were: pain, irritation, pruritus, warmth, swelling, and erythema at infusion site as well as the following adverse reactions: petechiae and hematoma.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of TEMODAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure.

Dermatologic disorders: Toxic epidermal necrolysis and Stevens-Johnson syndrome

Immune system disorders: Allergic reactions, including anaphylaxis. Erythema multiforme, which resolved after discontinuation of TEMODAR and, in some cases, recurred upon rechallenge.

Hematopoietic disorders: Prolonged pancytopenia, which may result in aplastic anemia and fatal outcomes .

Hepatobiliary disorders: Fatal and severe hepatotoxicity, elevation of liver enzymes, hyperbilirubinemia, cholestasis, and hepatitis .

Infections and infestations: Serious opportunistic infections, including some cases with fatal outcomes, can occur with bacterial, viral (primary and reactivated), fungal, and protozoan organisms.

Pulmonary disorders: Interstitial pneumonitis, pneumonitis, alveolitis, and pulmonary fibrosis.

Endocrine disorders: Diabetes insipidus

Read the entire FDA prescribing information for Temodar (Temozolomide)

Trials Produce Practice-Changing Results for Brain Cancer

June 9, 2016, by NCI Staff

Credit: National Cancer Institute

The standard treatment that some patients with brain cancer receive is likely to change, based on findings from two large clinical trials presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this week.

Both trials showed that administering the chemotherapy drug temozolomide (Temodar®) in addition to radiation therapy increased how long patients lived overall and without their disease progressing. The trial investigators and other leading brain cancer researchers agreed that the results of the two trials will change the standard of care.

In addition to improving survival, both trials resolved important questions about whether specific groups of patients benefit from receiving temozolomide, said Mark Gilbert, M.D., chief of NCI’s Neuro-Oncology Branch. “These are important studies in the brain cancer field,” he said.

Improved Survival in Older Patients with Glioblastoma

One of the trials tested the regimen in patients with glioblastoma, one of the most aggressive types of brain cancer. The trial, led by the Canadian Cancer Trials Group (CCTG), focused on patients over the age of 65.

This is an important group of patients, said the trial’s leader, James Perry, M.D., of Sunnybrook Research Institute in Toronto. The peak age for glioblastoma diagnoses is 64, Dr. Perry explained, and overall incidence of the disease has been creeping up in recent years. A pivotal 2005 trial showed that temozolomide can improve how long patients with glioblastoma live. The trial, however, was restricted to patients younger than 70, and very few patients over age 65 were included in the trial, he said.

Because of concerns about serious side effects of chemotherapy, radiation alone has been the standard of care for patients aged 70 and older, Dr. Gilbert explained.

“In fact, the radiation course is often truncated to 2, 3, or 4 weeks rather than the 6 weeks that is standardly used, along with chemotherapy, in the younger patient population,” he said.

In the CCTG trial, more than 560 patients aged 65 and older with advanced glioblastoma were randomly assigned to receive either short-course radiation alone or radiation plus temozolomide, given both at the same time (concurrent) and for an additional 12 rounds after radiation (adjuvant).

Median overall survival in patients treated with both radiation and temozolomide was 9.3 months, compared with 7.6 months in patients who received radiation therapy alone. The radiation and temozolomide combination also modestly improved progression-free survival.

The researchers also identified a group of patients for whom the addition of temozolomide was especially beneficial: Patients whose tumors have an alteration of the MGMT gene, known as promoter methylation, had an overall survival of 13.5 months compared with 7.7 months in patients with the alteration who received only radiation therapy.

This was not necessarily a surprise, Dr. Perry noted. Earlier studies have shown that methylation of the MGMT promoter in glioblastoma is associated with better prognosis and improved response to chemotherapy. Approximately 46% of patients with glioblastoma have MGMT promoter methylation, Dr. Perry explained, a proportion that is consistent regardless of age at diagnosis.

Although there was “substantially more benefit” in patients whose tumors had MGMT promoter methylation, he said, “to our surprise, unmethylated patients also derived clinical benefit.”

Adding temozolomide to radiation did not increase the toxicity of treatment, Dr. Perry said. In fact, he said, “most patients were able to easily complete the treatment plan.”

Survival Improved for Rare Brain Cancer

The other trial, dubbed CATNON, included patients with a rare type of low-grade glioma called anaplastic glioma, of which only 1,200 to 1,500 cases are diagnosed each year in the United States. The trial enrolled only patients whose tumors lack the 1p/19q co-deletion, a molecular alteration in chromosomes 1 and 19 that is commonly seen in patients with some low-grade gliomas, named anaplastic oligodendroglioma.

Patients whose tumors have the 1p/19q co-deletion have a better prognosis and respond better to chemotherapy than patients whose tumors lack the alteration, explained the trial’s lead investigator, Martin van den Bent, M.D., from the Erasmus MC Cancer Institute in the Netherlands.

So, given the need for new treatment options for patients whose tumors lack the 1p/19q co-deletion, Dr. van den Bent said, the CATNON trial was designed to determine whether these patients might benefit from adding temozolomide to standard radiation therapy.

The trial, which was led by the European Organization for Research and Treatment of Cancer (EORTC), involved nearly 120 institutions from around the world. Approximately 750 patients enrolled and were randomly assigned to one of four treatment arms: radiation therapy alone, concurrent radiation and temozolomide, radiation followed by adjuvant temozolomide, or radiation and concurrent temozolomide followed by adjuvant temozolomide.

At 5 years, 56% of patients who received adjuvant temozolomide (arms 3 and 4) were still alive compared with 44% of patients who did not (arms 1 and 2). Adjuvant temozolomide also more than doubled how long patients lived without their disease progressing: 42.8 months compared with 19 months.

Given the survival advantages seen when temozolomide is given to patients with glioblastoma, some oncologists already offer it to their patients with anaplastic glioma, explained Brian Alexander, M.D., of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute.

From the perspective of potential side effects, it’s not unexpected that temozolomide is given to such patients, Dr. Alexander continued. “Temozolomide has a degree of toxicity, but it is generally well tolerated,” he said.

Of the two trials presented at ASCO, CATNON “will have the largest impact, because it has answered some fundamental questions about the role of adjuvant chemotherapy in patients with anaplastic glioma that does not have the 1p/19q chromosome loss,” Dr. Gilbert said.

Dr. van den Bent and his colleagues are performing molecular analyses of tumor samples to determine whether patient treatment response correlates with the presence of other commonly seen genetic alterations in lower-grade gliomas, including mutations in the IDH1 gene.

They are also continuing to follow the survival outcomes in patients treated with radiation alone and concurrent temozolomide, he said.

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Temodar (temozolomide)

This chemotherapy medication is given for a variety of brain tumors types, primarily gliomas. It may be prescribed at a lower dose for daily use during radiation therapy or at a higher dose when used for only five days per month.

Temodar is usually the first line of chemotherapy drug used to treat gliomas. As long as you tolerate the chemotherapy well, and MRIs show no evidence of a growing tumor, then you may take Temodar for 12 cycles. It can be used safely for up to 24 cycles.

How is Temodar supplied

Temodar is supplied in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsules.

How should I take Temodar

  • Take nausea medicine (e.g., Kytril, Zofran or Anzemet) one hour before taking Temodar to combat anticipated side effect of nausea.
  • Take Temodar on an empty stomach.
    • Do not eat or drink anything for one hour before or after chemotherapy.
  • Take at bedtime with a glass of water.
    • It is better to take this particular chemotherapy drug at bedtime as there are fewer meals to plan around and IF you were to feel bad from the medication, you will be able to sleep through it.
  • Contact your neuro-oncology team if you miss a dose (do not double dose).

What are common side effects of Temodar and how can I manage them?

  1. Constipation
    Take a stool softener and/or a stimulant (i.e. MiraLAX) as needed to keep your bowels regular. All patients experience some degree of constipation while on Temodar.
  2. Nausea
    Take Kytril or Zofran at least once a day prior to chemotherapy, but more often if needed. There are also other drugs available to help with nausea if needed.
  3. Bone marrow suppression (a decrease in WBC, RBC, PLT)
    • White Blood Cells (WBC) – infection fighters
      Neutrophils (a type of white blood cell) may be lowest 21 days after treatment and should recover by day 28. If you are taking Temodar daily, you should have your blood tested weekly and take a medicine to protect you from pneumocystis pneumonia (PCP). Temodar affects your lymphocytes (types of white blood cell) and can put you at risk for this PCP.
    • Red Blood Cells (RBC) – oxygen carriers
      Anemia may worsen over a period of months. Rarely, a patient may need a blood transfusion.
    • Platelets (PLT) – blood-clotting cells
      In some cases, patients may need a platelet transfusion.
  4. Fatigue
    Fatigue associated with Temodar is usually manageable for most patients. Fatigue may worsen during the week of chemotherapy, but for some patients the fatigue may linger for one week or longer after treatment is completed. Talk to your healthcare provider if fatigue is interfering with your daily life.

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Generic Name: temozolomide (TEM oh ZOE loe mide)
Brand Names: Temodar

Medically reviewed by Drugs.com. Last updated on Oct 29, 2019.

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What is Temodar?

Temodar (temozolomide) is a cancer medicine that interferes with the growth and spread of cancer cells in the body in the body.

Temodar is used together with radiation therapy to treat certain types of brain tumor in adults.

Temodar is usually given after other cancer medicines have been tried without success.

Important information

You should not take Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome). Before taking Temodar, tell your doctor if you have liver or kidney disease.

Do not use Temodar if you are pregnant. It could harm the unborn baby.

Do not open a capsule, or use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if you accidentally inhale it, or if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Temodar is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends. There may be periods of time when you will take Temodar for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor’s instructions carefully.

Your doctor may occasionally change your dose to make sure you get the best results. The size, color, and number of Temodar capsules you take may be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact your doctor or pharmacist if you have any questions.

Taking temozolomide may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk.

Before taking this medicine

You should not take Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC).

To make sure Temodar is safe for you, tell your doctor if you have:

  • liver disease; or

  • kidney disease.

Using Temodar may increase your risk of developing certain types of bone marrow cancer. Ask your doctor about your specific risk.

FDA pregnancy category D. Do not use Temodar if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving Temodar, whether you are a man or a woman. Temozolomide use by either parent may cause birth defects.

It is not known whether temozolomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Temodar?

Take Temodar exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Temodar is given in a 28-day treatment cycle, and you may only need to take the medicine during the first few days of each cycle.

If you are also receiving radiation treatment, you may need to take temozolomide for 6 to 7 weeks in a row during your first treatment cycle. Then you may be switched to a 28-day maintenance treatment cycle.

Your doctor will determine how long to treat you with Temodar. Follow your doctor’s dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results. The size, color, and number of Temodar capsules you take may sometimes be different from earlier treatment cycles. Be sure you know the correct number of capsules to take and on which days to take them. Ask your doctor or pharmacist if you have any questions.

Take all of your capsules for the day (one entire daily dose) at the same time on each dosing day of a treatment cycle. Swallow the capsules whole with a full glass of water.

Take this medicine at the same time each day.

You may need to take Temodar at bedtime or on an empty stomach if the medicine upsets your stomach.

If you vomit shortly after taking the medicine, do not take another capsule until your next regularly scheduled dose.

Do not open a capsule. Do not use a broken pill. The medicine from an open or broken capsule can be dangerous if it gets in your mouth or nose, or on your skin. If this occurs, rinse thoroughly with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

You may be given medication to prevent nausea or other side effects while you are receiving Temodar.

Tell your doctor if you have any changes in height or weight. Temozolomide doses are based on body surface area (height and weight), and any changes may affect your dose.

Temozolomide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

You may also need blood tests to check your liver function during treatment and for 2 to 4 weeks after you stop using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Temodar.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Temodar?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Temodar side effects

Get emergency medical help if you have any signs of an allergic reaction to Temodar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a seizure (convulsions);

  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low white blood cell counts – fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Temodar side effects may include:

  • nausea, vomiting, loss of appetite;

  • bruising, skin rash;

  • loss of movement on one side of the body;

  • diarrhea, constipation;

  • headache, tired feeling, memory problems;

  • dizziness, weakness, loss of coordination;

  • sleep problems (insomnia);

  • low white blood cell counts (fever, flu symptoms); or

  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Temodar?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Temodar, especially:

  • steroid medicine (dexamethasone, prednisone, and others); or

  • valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with temozolomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Temodar only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Temozolomide (Temodar®), Oral Formulation

How to Take Temozolomide

Temozolomide is available in both oral and intravenous (IV) form. The dose, whether oral or intravenous, is dependent on your body size, the regimen your provider is following, and whether or not it is being used in conjunction with other chemotherapies or radiation therapy. You will have lab work regularly to monitor your blood counts.

In its oral form, temozolomide comes in a capsule. It should be taken once a day, on an empty stomach (1 hour before a meal or 2 hours after). This helps to prevent nausea associated with this medication. You should take this medication around the same time each day. Swallow the capsules whole with a glass of water; do not open, crush or chew them.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

When taking temozolomide in conjunction with radiation, you will be given a medication to prevent a certain type of pneumonia called PCP.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Oral temodar is available through retail pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network pharmacy for distribution of this medication.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, are also available. Your care team can help you find these resources, if they are available.

The oral form of temozolomide is covered under Medicare part B for Medicare recipients. Make sure your pharmacist knows to process this prescription through your Medicare part B and NOT part D.

Possible Side Effects of Temozolomide

There are a number of things you can do to manage the side effects of temozolomide. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Nausea and/or Vomiting

Nausea may be helped by taking on an empty stomach and at bedtime. Talk to your doctor or nurse so they can prescribe medications to help you manage nausea and vomiting, which you can take about 30 minutes prior to the dose. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try antacids, (e.g. milk of magnesia, calcium tablets such as Tums), saltines, or ginger ale to lessen symptoms.

Call your doctor or nurse if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn’t heal.

Tips to preventing infection:

  • Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
  • Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
  • When working in your yard, wear protective clothing including long pants and gloves.
  • Do not handle pet waste.
  • Keep all cuts or scratches clean.
  • Shower or bath daily and perform frequent mouth care.
  • Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
  • Ask your doctor or nurse before scheduling dental appointments or procedures.
  • Ask your doctor or nurse before you, or someone you live with, has any vaccinations.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your doctor or nurse know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

  • Do not use a razor (an electric razor is fine).
  • Avoid contact sports and activities that can result in injury or bleeding.
  • Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin®, Aleve®, Advil®, etc. as these can all increase the risk of bleeding.
  • Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Decrease in Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your nurse about nutritional counseling services at your treatment center to help with food choices.

  • Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
  • If you are not eating enough, nutritional supplements may help.
  • You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment.
  • These symptoms can last for several months or longer after treatment ends.
  • Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
  • Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Loss or Thinning of Scalp and Body Hair (Alopecia)

Your hair may become thin, brittle, or may fall out. This typically begins two to three weeks after treatment starts. This hair loss can be all body hair, including pubic, underarm, legs/arms, eyelashes, and nose hairs. The use of scarves, wigs, hats and hairpieces may help. Hair generally starts to regrow soon after treatment is completed. Remember your hair helps keep you warm in cold weather, so a hat is particularly important in cold weather or to protect you from the sun.

Muscle or Joint Pain/Aches and Headache

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Rash

Some patients may develop a rash, scaly skin, or red itchy bumps. Use an alcohol free moisturizer on your skin and lips; avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Be sure to notify your oncology care team of any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Less common, but important side effects can include:

  • Liver Toxicity: This medication can cause liver toxicity, which your doctor may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown or pain in your abdomen, as these can be signs of liver toxicity.
  • Secondary Cancer: A secondary cancer is one that develops as a result of cancer treatment for another cancer. This is quite rare, but you should be aware of the risk. In most cases, a secondary cancer related to chemotherapy is a blood cancer (leukemia, lymphoma). This can occur years after treatment. This is most often associated with repeated treatments or high doses. Your provider will monitor your labs closely. Consider having a complete blood count with differential checked annually by your healthcare provider if you received high risk therapies.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication.

New Long-term Data for Tumor-Treating Fields in Glioblastoma

Transcript:
Daniela Bota, MD: At the Society for Neuro-Oncology Meeting this year, we have a new report on the long-term data for the EF-14 study. And the EF-14 study was the study that was instrumental to the Optune approval for newly diagnosed glioblastoma patients. The way the study was designed was as a randomized study, where 695 patients were allowed to complete the radiation on the Temodar (temozolomide) alone. Then they were randomized 2:1 to receive the combination of Optune and temozolomide, followed by, at recurrence, whatever was the best treatment their oncologist chose, in addition to the Optune, which was continued for up to 3 years. The other group of patients was treated with standard-of-care treatment, which was temozolomide followed by whatever treatment was considered to be the best by the oncologist.

The EF-14 study had 2 major endpoints. The primary endpoint was progression-free survival, and the secondary endpoint was overall survival. For the progression-free survival, the determinations were made by independent radiologists that were blinded to the assignment of the patients to each treatment group. The results showed that the patients that received Optune in combination with Temodar had the progression-free survival, from randomization, of 6.7 months, as compared to 4 months in the group that received temozolomide alone. For the overall survival and the combination group, a median overall survival was 21 months compared to only 16 months in the group that received the standard of care without the Optune. Those data are very, very similar with the previously published data on the interim analysis, which makes us even more confident that the treatment is working as it is supposed to be working.
I think the most important point that I also want to highlight is that the use of Optune in this study increased the number of people that have become long-term survivors. So, if we look at 2-year survival, the percentage of people that lived at 2 years for the combination group was 43% compared to 30% in the group that was treated with the standard of care. Even more important and rewarding for us is that at 4 years, the number of patients that survived in the combination group was 17% as compared to only 10% in the group that received the standard-of-care treatment.
So, when we talk about the safety profiles on the EF-14 study, we have to remember that every patient in the study got radiation, got temozolomide, and at progression, got more surgery or more radiation and other chemotherapy drugs based on the oncologist’s preference. It comes as no surprise for us that the side effects on the 2 groups are very similar, because we see side effects that we always have seen with chemotherapy agents such as temozolomide. We see some nausea, we see some decreased platelet counts and white blood cell count, and we see seizures and depression, which is very common for the patients, unfortunately, with brain tumors. And equally distributed between the 2 groups, we see headaches. What is different for the group that received Optune is that there is a small number of device-related side effects, which all of them are local. This device is composed of electrodes that get applied on the scalp. We can see some mild inflammation, some mild erosion at the level of the electrical device.
The other things that we have seen a little bit more are problems with falling, and this is related to the fact that the device has a cord. Some of the patients can also when they’re home, instead of using the battery, plug it to the wall. So, we want to be very careful to let the patients know that they have to pay attention where there is space and make sure that they don’t fall and institute safe fall precautions.
Suriya Jeyapalan, MD, MPH: The EF-14 trial, I do have a very special place in my heart for this because I think everybody who is an oncologist would like to participate in a trial that makes a difference in our patients. And I have to say, I have a tremendous gratitude to Dr. Stupp and the company and to Tufts Medical Center for having opened up the trial as well, for me being able to participate in it. Because it really has been the single biggest advance in the last decade in the treatment of these patients.
And I want to just talk about a little bit about the misconceptions that are out there, and I think these are coming from people that didn’t participate in the trial. It’s also, at an almost innate sense, like, how the heck is this going to work? I have to say, I was one of those doctors myself. I was like, “Oh, this sounds like a crazy idea. They’re going to send people around with this little cap on their head and hook them up to a battery and hope this cures GBMs, which is such a deadly disease.” I was wrong. And when I look at the data, it’s amazing to me how wrong I was, and I’m so glad to be wrong, because everybody wants all these trials to work. I’m glad this one works.
Other things that I’ve also heard about the trial was that people are confused about how the trial was designed. It was a very simple 2:1 randomization trial. It was basically two-thirds of the patient got the device with Temodar and radiation, and one-third just got the Temodar and radiation. The other thing I think people also are maybe misunderstanding, too, is that people were matched based on performance status, surgical resection, MGMT methylation—all the things that we know are prognostic indicators. So, I think it was a very fairly done trial. I think it was in a large population of patients, and they proved it. And we’re all scientists, and we should take a look at these data very carefully. It’s published in JAMA; it’s out there. They’ll publish the final analysis, I’m sure, in another journal here pretty soon. But realize that it really has very little side effects except for the skin reaction. It doesn’t cause your blood count to drop. It doesn’t cause you any nausea/vomiting, and it could be easily combined with other treatment modalities without any detriment to the patient. I think it should be offered to everybody.
Daniela Bota, MD: In my opinion, this is, without any doubt, the standard of care. It is included in the NCCN guidelines. It is an FDA-approved treatment, and it’s making a major impact on the patient’s survival. Let’s just look at the 4-year data: going from a 10% to 17% survival rate, it’s a significant step. It’s almost doubling in the number of patients that get to celebrate 4 years after their original diagnosis. Going back to what we talked before, the addition of Temodar gave us 2 months in the original study. So, I think that this should be incorporated in the practice. I think that we should all work with the patients. It’s, in the end, the patient’s decision. But I think the decision has to be made with the patient fully understanding that this is, right now, the most promising FDA-approved treatment that we have had for a while.
Transcript Edited for Clarity

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