Mesothelioma FAQ

A new drug has to undergo thorough testing before it can be sold over the counter or with a prescription. Clinical trials are the best and way to test whether a drug or treatment is safe and effective in humans. Depending on various factors, the Food and Drug Administration (FDA) approval process may take up to nine years to complete. Typically, clinical trials are conducted in a number of phases. These phases help scientists answer various questions:

Phase I trials: Researchers test a new drug or treatment in a small group of people (15 to 50) for the first time to assess its safety, find out a safe dosage range, and identify side effects. Participants are given slowly increasing amounts of a drug up to a level of side effects that is considered acceptable. Phase I trials may include healthy participants and/or patients. When testing chemotherapy medications, cancer patients are usually participants.

Phase II trials: In this stage, the experimental drug or treatment is given to a small group, less than a hundred people, in order to determine whether it is effective and to review its safety.  If the drug seems to help some of the people, and the side effects are acceptable, the drug can go on to be tested in Phase III trials

Phase III trials: The experimental drug is given to a much larger group of people (1,000-3,000) in order to confirm its effectiveness and observe side effects. The new drug or treatment is compared to the current standard treatment. Phase III trials are randomized, meaning who gets the standard and who gets the experimental treatment are selected at random. If possible, the study is also blinded, so that the patients do not know who is getting the new treatment and who is getting the standard treatment, or even double-blinded, so that the doctors also do not know. The trials are used to determine if the drug is as safe and effective as the standard treatment. A drug will be approved for sales only if it is successful in at least two phase III trials. This may take several years. After successful Phase III trials, a drug can be approved for general use by the FDA.

Phase IV trials: This stage occurs once the drug is in general use. There are side effects and adverse reactions that may only take place rarely, and may not have been seen in the Phase III trials. These trials involve a large number of patients. As more people take the new drug, rare side effects may be found. Depending on the nature of these adverse effects, there may be new warnings place on the drug, or it may even be removed from the market.

Dr. Kaplan

Managing medications properly is a vital task. The following strategies will be helpful to manage your medications:

1. Keep a medication record. A complete list of medications that include their brand as well as generic names would be helpful. Include any changes or adjustments of medications (with dates of change), dosage amount of the medications, times they have to be taken, and any additional instructions. Patients who have precise information regarding their medication regimens are more likely to follow through than those without. Bring a copy of this list to doctor’s appointments, especially new doctors.
2. Learn about the medications you are taking. Try to understand the action and side effects of your medications. You should know why you are taking each medication and how long you are supposed to take each of them. Well-informed patients are better able to assess how a new prescription is affecting them.
3. Make sure that you keep your old medications separate when your medications change.
4. Contact your physician at once if you’re having trouble with any of your medications. If you have difficulty in swallowing the medication, ask about alternative ways to take your medications.
5. Don’t forget to double check your medications when you purchase them from the drugstore. A change in medication may be due to a pharmacy error.
6. Setting a remainder via your cell phone or computer is a good idea if you are not able to take your medication on schedule. There are also pillboxes that can help organize and store your medicine, as well as show what time of day to take them.
7. The medications should be stored in a safe place. They should be kept away from heat, light and humidity.
8. If possible, make sure a family member knows about your medication. Give that person an updated copy of your list. Ask for help if you need it.

Dr. Kaplan

Patients with cancer often lose weight. For some, it is one of the problems that that drives them to seek medical care. They may have no appetite and sometimes have lost a large amount of weight. This, along with abdominal pain, may be the main symptoms of a patient with abdominal (peritoneal) mesothelioma. In patients with pleural mesothelioma, the chest pain, coughing and shortness of breath will probably be the most troubling symptoms. But they, too, can already have lost a lot of weight before they get their diagnosis.

This means that even before treatment, patients with mesothelioma may be underweight and also low on important vitamins and nutrients. Every attempt must be made to try and correct this, as they go on to have treatment which may make their weight loss worse.

In order to heal, the body needs enough of many important nutrients. These include carbohydrates, protein, fats, water, vitamins and minerals.

Carbohydrates are a major source of fuel for your body. The best sources of carbohydrates come from whole grains, fruits and vegetables. These also have fiber, which helps regulate your bowel function, and also phytonutrients – vitamins and other chemicals that come specifically from plants. Whole wheat bread and pasta have more nutritional value than white bread and pasta, but both are better than getting carbohydrates from sugary sources like candy. The carbohydrate in
most soda and candy is simply sugar, which does not last very long as a source of energy.

The body needs protein to build many things. Protein is necessary for the body to do repairs, for the body to grow, and to strengthen immunity. Cancer patients need extra protein to fight the cancer, and also to heal after surgery or other treatment. Protein comes from animal sources, including beef, chicken and other meats, also fish and eggs. Milk products contain protein, as do soy products as well as nuts and beans.

The right kinds of fats are needed by the body. Fat is a source of energy. It is also the way the body stores extra energy, which also provides insulation from the cold. Most people prefer foods cooked with at least some fat. It is best to use unsaturated fats, including many vegetable oils. There are some polyunsaturated fats that the body cannot make, although they are necessary for cell building and hormone production. Linoleic acid and alpha-linolenic acid are essential fatty acids which must come from food. Some kinds of fats are not good for the body, including transfats and saturated fats, the amounts of which should be limited.

Vitamins and minerals are crucial for growth and repair. They are needed in order for the body to use ingested calories. Theoretically, a person can get all the vitamins and minerals needed by eating a balanced diet. Usually people with cancer cannot get enough of the nutrients through their diet. A person with mesothelioma may need a regular vitamin and mineral supplement daily. This should be discussed with the doctor and/or a dietitian. A dietitian can take a look at a person’s diet and figure out what is missing and the best way to get more of it.
There are alternative and complementary therapies based on megavitamin doses. It is best to discuss these with your doctor. Very high vitamin doses can be bad for the body and can even make chemotherapy and radiotherapy less effective.

Antioxidants are very popular supplements, and the foods which have antioxidants are touted as very healthy. It is true that antioxidants can protect the body from some kinds of damage. Fruits and vegetables are the best source of anti-oxidants, including blueberries and other berries, carrots, tomatoes, red grapes, and many others. A patient with mesothelioma may be best off not taking supplements of these chemicals (including vitamins E, C, A and selenium). Again, this can be discussed with the doctor or nutritionist.

All of the functions of the body depend on water. It is recommended that every person should drink 8 eight-ounce glasses of water or clear fluids a day.

Herbs are sometimes traditional remedies from other cultures, and also often part of complementary or alternative therapies. If a patient wants to undergo regular medical treatment and also use herbs, he or she should discuss this with the doctor, to make sure that the herbs will not endanger the patient or compromise the treatment.

Once you are diagnosed with cancer, you probably need to see a dietitian. It is important to try and correct any deficiencies before treatment begins, because most cancer treatment makes it even harder to eat and drink everything the body needs. In fact, the body needs more of everything to heal itself after surgery, chemotherapy or radiation therapy. So if you can, you should eat a healthy diet as much as possible before treatment.

You may want to anticipate your needs after treatment. If someone else is going to be doing the shopping and cooking, they need to be ready to feed you nutritious foods. If you usually cook, you can make foods you like best and freeze them for later use. Stock up on snacks, especially bland snacks that you usually have been able to eat in the past when you were sick.

You will need to eat foods high in protein and calories after your treatment. You can often add both by using milk products, nuts, and eating meats.

Milk shakes and other drinks that are high in calories and protein can be good if you are having trouble chewing and swallowing because of sores in your mouth.

Specifically after surgery and general anesthetic, it may take some time for your intestinal tract to start working. This will be even more of a problem if you have had abdominal surgery. There are medications that can help with pain and nausea, so be sure to tell your doctor your symptoms. After surgery there is usually a progression from sips of clear liquids, to more clear liquids, to easy to digest foods and eventually a normal diet. If you are not able to eat normally, you will need the help of a dietitian and your doctor to find ways to get you more calories.

With surgery of the chest, especially if it is a large procedure like an extrapleural pneumonectomy, in addition to pain, you may have feelings of fullness and shortness of breath when you try and eat.

Radiation therapy usually causes problems in the area being treated. If you have radiotherapy to the chest, you can have some discomfort related to the esophagus – the tube that brings food from your mouth to your stomach. It will get some of the irradiation and can have some damage, usually temporary. You can have pain on swallowing or heartburn. If this does not improve over time, your doctor will need to evaluate you further.

Just about everyone being treated with cancer will have fatigue as well as a reduced appetite. One problem just makes the other one worse.

Chemotherapy may be the treatment that makes eating the hardest. Essentially every medication causes nausea and vomiting. In addition, sores in the mouth or esophagus are common, causing pain with eating. Try to eat small snacks frequently. Ask your doctor or radiation therapist for advice. Meet with a dietitian to get other suggestions. Remember that there are medications to counteract nausea. There are food supplements to add calories and protein.

As you are getting treatment for your mesothelioma, and as you recover from surgery, chemotherapy and or radiotherapy, you need to give your body the nutrition it needs in order to help heal.

Dr. Kaplan

The term “tumor markers” refers to chemicals and substances made by tumor cells that can be measured. Often these chemicals will also be made by normal cells, but not in as much quantity.
While often makes them unsuitable for diagnosis, the amount of these substances can be monitored to get an idea about the tumor, as to whether or not it is growing or responding to treatment.Soluble Mesothelin-Related Peptides and osteopontin are tumor markers for mesothelioma. Tumor markers for other cancers are probably more recognized by most people, such as PSA (prostate specific antigen) which has been used to follow prostate cancer, or CA 125 which is elevated in patients with ovarian cancer.

Dr. Kaplan

There is active research trying to find blood tests to help diagnose mesothelioma. Researchers are looking for chemicals that may come from mesothelioma cells and not normal cells. If a chemical from mesothelioma cells can be measured, it could indicate the presence of mesothelioma.More than one group of these chemicals has been found. Soluble Mesothelin-Related Peptides, or SMRP, have been studied for some time. Levels of SMRP are high in patients with mesothelioma. There is a blood test available to measure levels of SMRP called a Mesomark Assay. It is an Enzyme-Linked Immunosorbent Assay, or ELISA test. SMRP levels can be high in patients long before they are diagnosed with mesothelioma. It is hoped that this can become a useful screening test for patients at risk of mesothelioma – anyone with known asbestos exposure but with no symptoms.

At the current time it is not used for screening. It is only available as an FDA humanitarian-use device for the purpose of following patients treated for mesothelioma. Levels should drop after treatment, and can be watched to give an indication of whether or not the tumor is reoccurring or growing.

Because mesothelioma is a rare disease, sometimes devices that can only benefit a small group of people with the disease will be allowed in use without the same lengthy testing period normally required. When there are only a small number of affected patients, there will not be enough numbers to do the statistical analysis recommended. There may also not be the research money that would be provided for devices expected to help a lot of people. The FDA says:

“An Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.
To obtain approval for an HUD, an humanitarian device exemption (HDE) application is submitted to FDA. An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.”

 

The FDA has only approved the Mesomark Assay to follow patients with known mesothelioma.

Osteopontin is also elevated in the blood of patients with mesothelioma. It is both a tumor marker and a potential way to diagnose the cancer. Research continues on both osteopontin and SMRPs.

Dr. Kaplan

An MRI can also be useful in evaluating a patient who may have mesothelioma. MRI stands for Magnetic Resonance Imaging. It uses radio waves and magnets to generate images, but no radiation. Like a CT scan, this can be done with or without intravenous contrast material.MRI’s are the best imaging scans to look at the diaphragm, the muscle between the chest and abdomen, which is often involved in mesothelioma.

Dr. Kaplan

A CT scan (also called a CAT scan) is a specific type of computerized X-ray. CT stands for Computed Tomography. The machine taking the X-rays rotates around the patient, and by doing so is able to generate a three-dimensional picture of the body, in “slices.” One set of scans will be done, and then the patient may be given a “contrast agent” by vein – a substance that will help outline and delineate different parts of the body.When trying to evaluate a patient with an abnormal chest X-ray, doctors will usually order a CT scan because it provides much more information. What looks like an area that could be fluid or pneumonia on plain X-ray may be more clearly seen as separate tumor and/or fluid. Masses in the middle of the chest near the heart are almost impossible to see on plain X-ray, but CT scan can delineate masses in what that area, called the hilum.

CT scans can also be useful in diagnosing peritoneal mesothelioma, by getting the three-dimensional pictures of the abdomen, looking for abnormal masses or fluid.

Since a CT scan can often give a picture of the tumor, it can also give an indication of its size and if it appears to have spread. A CT scan may give doctors the information they need to decide where to attempt to take a biopsy.

Dr. Kaplan

Although most people with mesothelioma do not live even five years after treatment, there are people who do. If you are diagnosed with mesothelioma, remember these people and realize that everyone’s situation is different. You may be a person who is going to change statistics and live a very long time.Stephen J. Gould was a very influential evolutionary biologist. He was diagnosed with peritoneal mesothelioma in 1982. He did not despair, but decided that he would be in the group of patients who did better than average. He lived another 20 years, and died of a probably unrelated cancer in 2002.

Shirley Kaven was diagnosed with pleural mesothelioma in 1989. Despite a prognosis of 6 to18 months, she refused to give up. She and her husband travelled the country and she felt well for many years. She died 14 years after diagnosis.

Paul Kraus has been alive with peritoneal mesothelioma since 1997. Along with his doctors, he created his own treatment plan which included alternative treatments that he believes keep him alive.

An unnamed patient was reported in the Annals of Thoracic Surgery in 2007. This patient survived with only some local tumor resection for at least 12 years. The doctors evaluating this case believe that the patient’s own immune system stopped the cancer.

There are other patients with stories of survival. These stories are not only a reason to hope. They also point to the fact that there is much more to be learned about mesothelioma, and that doctors may find better ways to treat the disease if they study patients like this.

Dr. Kaplan

Mesothelioma is a very rare and very aggressive cancer. Because it is rare (only 2,000 to 3,000 new cases a year), and because there are new promising treatments emerging, it is hard to give hard-and-fast statistics.Mesothelioma is uniformly fatal. According to the American Cancer Society, the five-year survival rate is 10%, meaning that five years after diagnosis, approximately 10% of the patients will still be alive. The average survival time after diagnosis is 4 to 18 months.

Younger patients with whose disease is diagnosed earlier and whose cancer has not spread tend to do better.

New treatments are definitely improving the outcome for many patients. This can be seen in the results of clinical trials. There also patients who survive for many years despite the odds.

Dr. Kaplan

At the current time, there is no cure for mesothelioma. There is no treatment that will completely eradicate the cancer. In certain patients with early disease, surgical treatment with an extrapleural pneumonectomy can be considered potentially curative, if all of the tumor is removed. When radiation therapy and chemotherapy are added to the surgery, the possibility of a cure increases. As yet, however, this has not been achieved.There have been reports of patients living many years during which their mesothelioma seemed to have disappeared. One such case was reported in the Annals of Thoracic Surgery in 2007 (see mesothelioma survivors).

Dr. Kaplan