The NovoTTF-100L System, combined with pemetrexed and platinum-based chemotherapy had recently been approved by the FDA for a front-line treatment option for patients who have unresectable, metastatic or locally advance malignant pleural mesothelioma. This marks the first treatment in 15 years for those who suffer from this condition. The FDA made its decision based on the findings from the single-arm STELLAR trial, which increased the median survival rate to just over 18 months when the treatment was combined with physical therapy.
What is malignant pleural mesothelioma?
Malignant pleural mesothelioma is a rare malignancy which has been linked to long-term or repeated exposure to asbestos. Specifically when the airborne asbestos fibers are inhaled. Over time, the fibers will become lodged in the pleura, and eventually lead to inflammation, scarring, and possibly mnesothelioma. More than 3,000 people a year are diagnosed in the United States alone. Exposure to asbestos was significantly common for first responders, construction workers, and shipyard workers, who would be exposed to the substance during demolition, construction, and renovations.
Only 10 to 20 percent of patients with the condition were good candidates for surgical removal of the tumor. The only other medical treatment was pemetrexed plus cisplatin, and many patients could only receive palliative care measures to minimize their symptoms and pain while the condition runs its course. But with NovoTTf-100L many patients have hope to improve their chance of survival in the battle to stop the aggressive disease.
What is NovoTTF-100L?
NovoTTF-100L is considered a noninvasive cancer treatment. It works by delivering TTF to the region where the tumors reside. This is done through the use of electric fields that have been tuned to specific frequencies. These levels of frequencies will disrupt the normal cell division of the solid tumor. The idea was considered as preclinical data had should that human mesothelioma cells are extremely sensitive to TTF.
The STELLAR study
It was the STELLAR study that provided the Federal Drug Administration with results it needed to push for approval. The study used 80 patients who had been diagnosed with unresectable, locally advanced or metastatic pleural mesothelioma who had not been receiving treatment. They were cleared as a candidate for pemetrexed and cisplatin or carboplatin. The first goal of the study was to determine if it could improve the overall odds or length of survival. Their secondary goal was to see what the overall response rate was.
Results for the 53 patients with epithelioid malignant pleural mesothelioma showed that the median overall survival moved to 21.2 months. For the 21 patients with non-epithelioid malignant pleural mesothelioma, the median survival was 12.1 months. 62% percent of the patients that were receiving chemotherapy along with NovoTTF-100L were still living after one year. In addition to the survival rate, the disease control rate in patients, who had a CT scan was 97%. Other findings included a partial response rate of 40%, a progressive disease rate of 3%, and a stable disease rate of 57%.
Side effects were minimal when the NovoTTF-100L was added to chemotherapy. There were no serious systemic wide effects, and the only side effects related to the device used was mild skin irritation.
Who is at an increased risk for developing mesothelioma?
Almost any job where you will be exposed to asbestos fibers released into the air can put you at a higher risk for developing mesothelioma. Some of the primary risk factors that have led to higher instances of the disease include:
- Having worked in a plant that processed asbestos, or a place where it was mined.
- Having worked in heavy industrial plants or construction zones.
- Having worked or served on military ships that were constructed using asbestos.
- Living in an area that is close to the location of an asbestos mine, or a site that was possibly contaminated.
If you have been diagnosed with mesothelioma, time is of the essence. The first thing to do is find the right doctor for treatment and inquire if you are right for possible new treatments such as Novo-TTF-100L. Unfortunately, treatments can be expensive and difficult on your body, inhibiting your ability to work. If you feel that your employer was responsible for your asbestos diagnosis, you should contact an attorney soon after to take on your case.