Category: Featured News
FDA Flags Some Mesothelioma Drugs On Quarterly Adverse Events Report
Mesothelioma patients have limited treatment options, and often times these come with some known side effects. While these side effects, such as pain, nausea and fatigue, can be treated by your medical team, there are some “adverse affects” that may require the U.S. Food and Drug Administration to take a second look at the drug. In the FDA’s latest quarterly watch list, it has identified seven cancer treatments, three of which are used in mesothelioma care, as having possible serious risks.
In “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April – June 2017” issued Oct. 6, the FDA listed 19 drugs from its FDA’s Adverse Event Reporting System (FAERS). FAERS, according to the FDA, is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA. It is used as a tool by the agency to look for new safety concerns that might be related to a marketed product.
Although the FDA issues these reports, the agency warns that the information does not give the complete story. The data, according to the FDA, is not an indicator of the safety profile of the drug or biologic, and the report does not establish “causation.” In fact, the FDA reports that “there is no certainty that a suspected drug caused the reaction.”
In the report, however, the FDA does indicate action it will take when looking into the data that caused a drug to end up on the report.
Identified Drugs and Related Mesothelioma Information
- Keytruda (pembrolizumab): Complications of allogeneic hematopoietic stem cell transplantation (FDA is evaluating the need for regulatory action), and Stevens-Johnson syndrome and toxic epidermal necrolysis (the “Warning and Precautions” section of the labeling for Keytruda was updated to include Stevens-Johnson syndrome and toxic epidermal necrolysis.)
- Opdivo (nivolumab): Complications of allogeneic hematopoietic stem cell transplantation (FDA is evaluating the need for regulatory action.)
- Taxotere (docetaxel): Docetaxel and neutropenic enterocolitis (FDA is evaluating the need for regulatory action.)
Both Keytruda and Opdivo work by blocking the PD-L1 protein and activating the immune system, leading it to attack and kill cancer cells. These drugs are immunotherapy treatments and involve allogeneic hematopoietic stem cell transplantation, which translates to donor blood stem cell transplants. Opdivo clinical trials are ongoing for mesothelioma patients and they have shown “significant benefits” for patients.
Keytruda is approved for use in lung cancer and melanoma, and in an unprecedented move, in May the FDA approved the use of Keytruda for any cancer having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), regardless of cancer type.
In the approval of Keytruda, the FDA noted potential complications or death related to allogeneic hematopoietic stem cell transplantation after using Keytruda. Stevens-Johnson syndrome is a rare, serious and potentially deadly disorder of the skin and mucous membranes that leads to a painful red or purplish rash that spreads and blisters.
Keytruda has brought hope to the mesothelioma community with mesothelioma warriors showing excellent results from use of the drug. Mavis Nye of England, an eight-year mesothelioma survivor, can now claim remission from her pleural mesothelioma after participating in a two-year clinical trial of Keytruda.
Docetaxel is a chemotherapy drug often combined with gemcitabine as a second-line treatment of lung cancer and mesothelioma. Neutropenic enterocolitisis, as triggered with docetaxel, is a rare yet severe complication of chemotherapy signaled by extreme abdominal pain. If not treated properly, it can lead to death.
This report can be considered as another source of information when determining to use a drug for treatment, and is not an indication that you should halt treatment or use of a drug. Any questions you may have should be directed to your doctor.
Mesothelioma, an asbestos-caused cancer, is both incurable and deadly. Close to 3,000 Americans are diagnosed with the disease each year.
Talk with your doctor to find out which treatment is best for you.
Determining the Appropriate Time For the Flu Shot in Mesothelioma Patients
For many, fall brings with it the vibrant color of the leaves, pumpkins, cinnamon and the anticipation of the holidays. It also brings with it flu and cold season. Thanks to the widespread availability of the flu shot, however, keeping the flu at bay is easier. Although for mesothelioma patients, that may not be the case.
According to an article from MD Anderson Cancer Center, home to the Mesothelioma Program that cares for more patients with mesothelioma than almost any other center in the U.S., when it comes time to get the flu shot, cancer patients should time it around their chemotherapy treatments. Specifically, the author suggests getting the flu shot two weeks prior to the first chemotherapy treatment or between chemo cycles, if treatment has already begun. Mesothelioma and cancer patients should not take the flu mist form of the flu since it contains an active virus.
“Your family members should also get the flu virus injection instead of the nasal mist,” says Shobha Pai, a physician assistant at MD Anderson in The Woodlands. “By protecting themselves from the flu, they’re also protecting you from getting it from them.”
Mesothelioma patients may still be susceptible to developing the flu due to their weakened immune system caused by the cancer and the chemotherapy treatments. The Centers for Disease Control and Prevention reports in “Frequently Asked Flu Questions 2017-2018 Influenza Season” that even after vaccination it is still possible to get sick with the flu. “Flu vaccination is not a perfect tool, but it is the best way to protect against flu infection,” the CDC notes.
The CDC recommends that people get a flu vaccine by the end of October, if possible. However, getting vaccinated later can still be beneficial.
Pleural mesothelioma is a rare, aggressive form of cancer primarily caused by exposure to airborne asbestos fibers, that affects the lining of the lungs. Mesothelioma symptoms include a persistent cough, and over half of the pleural mesothelioma patients suffer pain in the lower, back and sides of the chest. If a patient gets the flu, these symptoms will worsen and the patient may need hospitalization.
It is especially important for cancer patients to stay away from sick people and to wash their hands to reduce the spread of germs. Mesothelioma patients who develop the flu should contact their oncologist immediately to determine if they need medical care.
Close to 3,000 Americans are diagnosed with mesothelioma each year. There is no known cure for the disease.
Creative Scientists May Eventually Find a Simple Way To Monitor Mesothelioma Symptoms
MesotheliomaHelp has covered breakthrough technology that may seem more appropriate for science fiction articles, such as the Qualcomm Tricorder XPRIZE competition to design a handheld device to help diagnose health conditions, than for mesothelioma care. In another seemingly science fiction approach to medical care, scientists report a tattoo with “smart” ink could help monitor chronic health conditions.
Scientists from Harvard and MIT partnered in a “proof of concept” experiment to determine whether biosensitive inks could become a reliable standard as a biomedical monitoring device. The team wanted to find a way to check blood glucose levels, for example, without requiring a skin prick or wires, sensors and batteries, that are needed with today’s devices.
With mesothelioma, an asbestos-caused cancer primarily striking older patients, one issue with managing the disease is the co- conditions from which many of the patients also suffer. According to data, about three out of four people with mesothelioma are older than 65 years, and nearly half them may have medical problems, such as heart disease and diabetes, that also need to be monitored.
In seeking to find the “next generation after wearables,” the researchers determined they could use biosensors directly on the skin. Dubbing the project “Dermal Abyss,” the researchers turned to pig skin for their initial testing. Tattooing the inks onto segments of the skin, the researchers watched as the colors of the ink changed based on biomarkers. In one case, a green ink changed to brown indicating increased levels of glucose. In another, they shined a blue light on a green ink that intensified in color as sodium concentration increased indicating dehydration.
Mesothelioma patients undergoing chemotherapy and radiation are also vulnerable to infection, dehydration and exhaustion from the harsh drugs. Finding a way to more closely monitor these symptoms could help get the patients back on their feet more quickly. Nearly 3,000 Americans are diagnosed with mesothelioma each year.
The researchers point out that this tattoo is still in the very early stages and “The purpose of the work is to light the imagination of biotechnologists and stimulate public support for such efforts,” said Nan Jiang, a postdoctoral fellow at Harvard Medical School and Brigham and Women’s Hospital.
“These questions of how technology impacts our lives must be considered as carefully as the design of the molecular sensors patients may someday carry embedded in their skin,” said Jiang.
Photo Credit: Harvard Medical School
Is It Just A Cough Or Is It Mesothelioma?
Not everyone who has been exposed to asbestos will develop mesothelioma, but it is important to be aware of the symptoms and to know when to contact a doctor. A cough is one symptom that many pleural mesothelioma patients share, yet it can also simply be a cold or the flu. Knowing the difference can impact a patient’s long-term health.
According to a Sept. 18 article in Medical News Today, while coughing is a “protective action” that helps clear the lungs of germs or harmful objects, when the cough lingers, it may be time to take note. Specifically, the authors note, if a cough is associated with coughing up blood or rust-colored phlegm, shortness of breath, or chest pain you should call a doctor.
Mesothelioma is a terminal, asbestos-caused cancer that may not be diagnosed until decades after the patient was first exposed to the carcinogen. Many times the patient will not even realize he or she was exposed to the mineral, and chances are the deadly asbestos cancer is the last thing on a doctor’s mind when trying to understand why their patient cannot get rid of their cough, why their lungs are filling with fluid and why the antibiotics are not helping.
Expert Insight
“A cough that is associated with lung cancer can be either dry or wet. It can occur at any time, and even be so severe that it interferes with sleep at night.”
However, early detection of mesothelioma is critical and can positively influence a patient’s survival by increasing treatment options and improving their quality of life while battling the cancer. An accurate diagnosis that distinguishes between a temporary illness, such as pneumonia, and mesothelioma is critical for ensuring an appropriate treatment plan is established from the onset.
There may be other symptoms that go along with your cough, that should also sound an alarm, such as wheezing or hoarseness of the voice, problems swallowing, loss of appetite, and returning bronchitis or pneumonia.
Mesothelioma can be challenging to diagnose, and often before an accurate diagnosis there are multiple misdiagnoses. It is not uncommon for a diagnosis to take months and many trips to the doctor’s office and even the emergency room. Pleural mesothelioma symptoms can mimic other diseases such as the flu, pneumonia, and other cancers, making it very difficult to diagnose.
If you have been exposed to asbestos in the past and are suffering from a lingering cough, do not hesitate to contact a doctor. Nearly 3,000 Americans are diagnosed with a form of mesothelioma each year.
Mesothelioma Treatment May Come From Discovery of Treatment for “Undruggable” Form Of Aggressive Lung Cancer
MesotheliomaHelp has reported many times on the challenges in treating KRAS-positive lung cancer, one of the most aggressive subtypes of lung cancer. Now, in a new study, researchers report they may have found a way to tackle lung cancer when the KRAS gene is present. This finding could also prove encouraging in the future for mesothelioma treatment.
According to an Oct. 2 press release in MIT News, a team of MIT researchers took a closer look at the Kirsten rat sarcoma virus (KRAS) and homed in on the KEAP1 mutation of KRAS, which, according to the researchers, is the third most frequently mutated gene in lung cancer. They found that in cancer where the KEAP1 gene is “nonfunctioning” cancer cells hunger for glutamine. They determined that if they could cut off the supply of glutamine to the tumors, they could treat both KRAS and KEAP1 mutations.
KRAS-mutated cancers are referred to as “undruggable” due to the inability to successfully target the protein with medicine. However, the MIT researchers began to experiment with suppressing KEAP1 which resulted in over-expression of yet another protein, NRF2, becoming hyperactive. This led them to then assess NRF2, and they determined that patients with “‘up-regulated’ NRF2 tumors had significantly worse survival rates” than other lung cancer patients.
Expert Insight
Tyler Jacks, MIT
“The complexity of human cancer can be quite daunting.”
The team then turned back to KEAP1 and focused on its need for glutamine, finding that in lung cancer cells with loss-of function mutations for both KRAS and KEAP1 the cells were more dependent than others on increased amounts of glutamine. Using inhibitors of glutaminase, an enzyme crucial to glutamine metabolism, in these cells slowed cancer cell growth and shrunk lung cancer tumors.
The KRAS/KEAP1 mutations can occur in 17 percent of lung cancer patients, according to the researchers. Various studies have found KEAP1 mutations in malignant mesothelioma cells, with one study finding it active in seven percent of the pleural mesothelioma tissue samples.
“The genetic tools that we have assembled allow us to create models of many individual subtypes of the disease [cancer] and in this way begin to define the exploitable vulnerabilities of each,” said Tyler Jacks, director of MIT’s Koch Institute for Integrative Cancer Research and co-senior author of the study. “The observed sensitivity of KEAP1 mutant tumors to glutaminase inhibitors is an important example of this approach. There will be more.”
The KRAS gene is also found in some pleural mesothelioma patients. Mesothelioma, a rare form of cancer caused by exposure to airborne asbestos fibers, is highly aggressive and is resistant to many current treatments. Care often follows the same protocol as lung cancer. As a result, mesothelioma patients struggling to find effective treatments for the incurable cancer stand to benefit greatly from this research.
The good news in this research is that one of the inhibitors used, CB-839, is already in phase I clinical trials for both KEAP1-mutant and KRAS-mutant lung cancer patients. This study might help identify appropriate patients for these trials.
The American Cancer Society estimates about 222,500 new cases of lung cancer and nearly 155,870 deaths from lung cancer in the U.S. in 2017. Close to 3,000 Americans will be diagnosed with mesothelioma this year with nearly the same number dying from the terminal cancer.
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