Science is advanced through research, and the research process begins with clinical trials. Many us of have grown more familiar with the clinical trial process with the search for a vaccine for COVID-19. As the search continues for a cure for malignant mesothelioma, it is imperative that people involved in the mesothelioma community continue to be aware of what scientists are researching at this point for potential cures and quality life-extending treatments.
Chemotherapy has been the standard of care for patients with malignant pleural mesothelioma since it was approved by the FDA in 2004. Scientists continue to discover what the best methods to administer chemotherapy for malignant mesothelioma are. The usual route of administration is intravenously every three weeks for a 6 cycle treatment. In general, chemotherapy can be absorbed by mouth, intravenously, intramuscularly, subcutaneously, intraperitoneally directly into the abdomen, intravesicular directly into the bladder, intrapleurally into the pleural space, through implantable devices, topically, and intra-arterially. Intra-arterial chemotherapy is given directly into the artery that is supplying the blood to the tumor. It is done through angiography a special x-ray using dye to see the blood vessels.
NCT02611037 is a clinical trial that is currently being offered at the Lee Moffitt Center in Tampa, Florida. This is a unique trial that offers chemotherapy through a different approach by administering the chemotherapy intra-arterially, directly into the artery that is supplying the blood to the tumor. The chemotherapy is administered by angiography using a special x-ray dye to see the blood vessels.
One of the main challenges of treating malignant pleural mesothelioma is the location of the disease within the human body. The purpose of this study is to deliver transarterial chemoperfusion treatment with cisplatin, methotrexate, and gemcitabine in a safe and effective manner. This procedure is performed by an interventional radiologist, who injects one third of the drug into the internal mammary artery which supplies the blood supply to the pleura. The other two thirds of the drug are then injected into the descending aorta. This area of the body also has blood vessels that supply blood to the pleura. The procedure usually takes one hour and is followed by a one hour post-recovery period before patients are discharged.
In this study, patients undergo angiogram and transarterial chemo administration treatment every 4 weeks (3-6 weeks interval allowed) with cisplatin, methotrexate, and gemcitabine. The medications are administered into the thoracic aorta and/or the internal mammary artery.
Initial findings are promising. This treatment is safe and effective and may improve quality of life for patients who may not have many other options. For more information on the NCT02611037 trial, please go to www.clinicaltrials.gov or talk to your mesothelioma team.
The promising results yielded a four-month improvement in median overall survival for patients who received the new dual-immunotherapy regimen as compared with those who had received platinum-based chemotherapy, the current double-chemotherapy standard of care for mesothelioma.
“This is the first positive randomized trial of dual immunotherapy in first-line treatment of patients with unresectable MPM,” Dr. Bass noted. “And therefore nivolumab plus ipilimumab should be considered as a new standard of care.”
The patients featured in the phase III trial were randomly assigned treatment plans consisting of either a maximum of two years of nivolumab and ipilimumab, or six cycles of pemetrexed alongside cisplatin or carboplatin.
Results revealed that the treatment plan consisting of nivolumab and ipilimumab yielded comparable efficacy outcomes to chemotherapy for progression-free survival and objective response rate, but was significantly more successful than chemotherapy when it came to the duration of response (DOR). The DOR for the dual-immunotherapy treatment reached 11.0 months whereas the DOR for chemotherapy reached only 6.7 months.
“In the ipi/nivo survival curve, going out to 36 months, we see a plateau at about 30%,… suggesting, as we’ve seen with other trials of immunotherapy, there is a degree of durability that is way beyond what we’ve seen previously with chemotherapy. And this, indeed, may have been driven by maintenance nivolumab,” explained Dr. Dean Fennell of the Cancer Research UK Centre Leicester, University of Leicester and University Hospitals of Leicester NHS Trust.
The PrECOG cancer research group tested the effects of pairing Imfinzi, an AstraZeneca drug that blocks the activity of the PD-1 receptor in immune T-cells, with standard chemotherapy on a group of 55 individuals who had been recently diagnosed with inoperable malignant pleural mesothelioma. The PD-1/PD-L1 pathway affects inflammation, which causes pleural mesothelioma to develop at a faster rate.
The trial revealed that patients who took Imfinzi in addition to running out courses of standard chemotherapy (pemetrexed with cisplatin or carboplatin) survived for an average of 20.4 months, whereas patients who were given only standard chemotherapy lived for an average of 12.1 months. 81.8 percent of participants were male, their median age was 68, and three-quarters of them had been diagnosed with the epithelioid cancer subtype of malignant pleural mesothelioma.
“[Imfinzi] plus standard chemotherapy delivered a promising median overall survival rate for patients with previously untreated, inoperable malignant pleural mesothelioma,” affirmed Dr. Patrick Forde, director of the Kimmel Center’s thoracic cancer clinical research program, in a news release from the American Society of Clinical Oncology.
AstraZeneca, PrECOG, and the University of Sydney have plans to enroll participants who have been diagnosed with previously untreated, inoperable malignant pleural mesothelioma in a Phase 3 trial in Australia and the United States in September. More details about the upcoming clinical trial can be found here.
Malignant pleural mesothelioma is a form of cancer caused by exposure to asbestos and makes up 60 to 70 percent of all cases. MPM occurs when tumors develop in the lining of the lungs and chest cavity (called the pleura).
To obtain imaging that willhelp them diagnose mesotheliomaand prescribe treatment for patients, doctors use both CT scans, which combine several x-ray scans from different angles, and PET scans, which use a radioactive tracing fluid to demonstrate tissue and organ functions.
While they did not have the same results with CT scans, the Swiss research team was able to develop a quantitative model using machine learning to more effectively analyze PET scans and predict the movement of tumors.
Becausetreating mesotheliomaoften involves varying approaches and exposes patients to many chemicals, it is critical that doctors are able to determine a course of action for each patient that is most responsive to their individual cancer. Malignant pleural mesothelioma is an aggressive cancer that spreads rapidly, so it is imperative that patients begin receiving treatment as quickly as possible.
The COVID-19 virus has disrupted all of our lives and routines. Things that we always did and places we always went are no longer available. The pandemic has forced us to all look at things we routinely do and challenged us to do them differently.
Like in business, in medicine sometimes small disruptions can lead to larger innovative changes. In the treatment of malignant mesothelioma, disruptors have led the way. Over the years we have seen doctors challenging the previously held belief that there was no treatment for malignant mesothelioma time and time again. The treatment options and longer quality of life that many mesothelioma patients are now able to be part of was not an option 20 years ago.
Before the pandemic, having a doctor’s visit for the vast majority of people involved going to the office or clinic at an appointed time, waiting, and meeting with the doctor. Patients diagnosed with malignant mesothelioma had the option of travelling to a Mesothelioma Center of Excellence to consult with experts in the field. Since the pandemic, with social isolation and doctors offices and clinics closed to prevent the spread of the virus, there has been a surge of tele-health visits.
The U.S. Department of Health and Human Services’ Office for the Advancement of Telehealth promotes the use of telehealth technology for health care. Their definition of tele-health is “the use of electronic information and telecommunications technologies to support and promote long-distance clinical health care, patient and professional health-related education, public health and health administration. Technologies include videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.”
In 2018, tele-health was 0.1 percent of all medical claims filed. Since the pandemic those numbers are exploding.
Tele-health has made possible consults and reviewing of scans and meetings with mesothelioma experts. As things are starting to open back up, so are the patients coming back to the mesothelioma centers for in-person consultations.
Like any new technology telehealth has pros and cons. Some people have commented that you have the MD’s full attention without the distractions of an office and other responsibilities. Other people have missed the personal interaction and meeting in person with their doctor.
The coronavirus has brought to the forefront a technology that can benefit a lot of people as they search for the best advanced personalized care for themselves or loved ones with mesothelioma. Tele-health can help malignant mesothelioma patients connect with a mesothelioma center without having to travel. It will take awhile to assess how tele-health will be accessed and have the best results for patients. For patients, their satisfaction with tele-health will need to be studied and evaluated to continue to efficiently access tele-health with the best results.
If you or a family member is diagnosed with malignant mesothelioma reach out, either electronically or in person for the best possible care. Our experts can help connect you with both the medical and legal resources you need to move forward.
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