FDA Approves NovoTTF-100L for Mesothelioma Therapy
The FDA Approves NovoTTF-100L for Mesothelioma Therapy
Researchers are working through new clinical studies on alternative treatments for cancer patients every day. Cancer patients, especially those that suffer from rare abnormalities, are counting on these alternative treatments to help them fight. For patients who are diagnosed with mesothelioma, the prognosis when they are diagnosed is often bleak, due to a long latency period. Patients with this cancer are looking for new treatments that can help improve their prognosis. Fortunately, The NovoTTF-100L therapy has become an FDA approved therapy that is helping improve the lives of mesothelioma patients.
What is mesothelioma
Mesothelioma is an aggressive form of cancer that can develop after exposure to asbestos, a known human carcinogen. Airborne contact with the toxin can cause the asbestos fibers to become embedded within the lungs and other organs inside the body. After a latency period of anywhere from 10-50 years, the fibers in the lungs can cause tumors to develop, thus resulting in mesothelioma. Unfortunately, due to its long latency period, patients with mesothelioma often have a poor prognosis because symptoms are not present until later stages.
Since the cancer is so rare and has minimal symptoms, it is common for physicians to misdiagnose mesothelioma for a less serious condition. With this, coupled with the long latency period in mind, mesothelioma is often diagnosed past the point of viable and successful treatment.
Typical Treatment for Mesothelioma
The stage of the disease can affect the treatment options available for patients. But a few therapy options are surgery, chemotherapy, and radiation. Surgery can be used to remove most of, or all of the tumor. Depending on how much the cancer has spread, radiation therapy and chemotherapy are used. While surgery and radiation therapy work directly on the mesothelioma tumors, chemotherapy is used to treat the cancer throughout the body. Some other types of treatment include immunotherapy, photodynamic therapy, and hormone therapy.
The most effective drugs that are approved by the U.S. Food and Drug Administration to treat mesothelioma are cisplatin and pemetrexed.
NovoTTF-100L
Recently, the FDA approved a new treatment for mesothelioma, a first in 15 years. The treatment, NovoTTF-100L, uses Tumor Treating Fields (TTF), which is a low-intensity alternating electrical field that disrupts cell division by destabilizing the protein responsible for division. This ultimately causes the cancer cells to stop dividing.
This type of treatment is effective and popular for late-stage cancer patients that are unable to undergo invasive surgery, which is why the treatment is a perfect fit for mesothelioma patients. The TTF is applied to the torso and chest and patients have the option to use an at-home portable TTF machine. In order for the treatment to be effective, patients need to be hooked up to the device for at least 18 hours each day, until there is disease regression, or the absence of toxicity.
STELLAR Study
Focusing on 80 mesothelioma patients, the study gave patients TTF treatment and chemotherapy. The patients who were receiving both TTF and chemotherapy were then compared to those only receiving chemotherapy.
The study showed that patients treated with the TTF therapy saw a median survival of 18.2 months, in comparison to chemotherapy patients who had a median survival of 12.2 months. Furthermore, 53 of the patients had epithelioid malignant pleural mesothelioma and showed a median of 21.2 months for survival rates and 21 patients who had non-epithelioid cell mesothelioma showed a 12.1 month median survival. Most impressively, 62% of the patients were alive after one year of treatment with the combination therapy. Due to its impressive results, the FDA deemed it worthy of treatment approval.
Precautions
In the clinical study, the therapy caused skin irritation, red rashes, small sores, and blisters where the machine was attached to the patient. Patients who had such irritations relocated the transducer arrays attached to the chest and were given a steroid cream. For all patients who had moderate to severe skin problems, the symptoms subsided once the treatment was done.
The NovoTTF-100L System should not be used on patients who have an implanted electronic medical device, such as a pacemaker or automatic defibrillator, or a sensitivity to conductive hydrogels.
