Miami Cancer Institute Begins Using Novel Treatment for Mesothelioma
The Miami Cancer Institute on Thursday will begin using the innovative Tumor Treating Fields device for patients with malignant pleural mesothelioma.
It is the first new treatment approved for mesothelioma by the U.S. Food and Drug Administration in more than 15 years.
“This is actually pretty exciting for us,” Dr. Rupesh Kotecha, the radiation oncologist who will oversee the treatment protocol in Miami, told The Mesothelioma Center at Asbestos.com. “It’s another tool in our armamentarium. It’s something we can offer patients that has shown a real benefit.”
The noninvasive Tumor Treating Fields device works by disrupting cancer cell division through low-voltage electric fields.
It will be used in combination with chemotherapy and administered through the FDA’s Humanitarian Device Exemption Protocol for patients with unresectable, locally advanced or metastatic disease.
The Miami Cancer Institute has joined the West Cancer Center in Memphis, Tennessee, and the Oregon Health & Sciences University as the first three centers to receive approval for its use with pleural mesothelioma.
More than a dozen other cancer centers around the country — some mesothelioma specialty centers — are still awaiting approval.
Could Become a Game Changer
The FDA first approved the use of Tumor Treating Fields in 2011 for recurrent glioblastoma, an aggressive form of brain cancer. It is being studied today in several other diseases, including lung, pancreatic and ovarian cancers.
Kotecha already has experience using it at the Miami Cancer Institute with other cancers, clinically and in research studies.
“There is precedent that Tumor Treating Fields improves outcomes. It has been a game changer with glioblastoma,” he said. “I can’t say that [it is game changer] yet with mesothelioma because we don’t have that level of data, but we’re encouraged by the data we have.”
The approval by the FDA stems from the STELLAR study, a multi-center phase II mesothelioma clinical trial across Europe. The device, officially called the NovoTTF-100L System, was developed by Novocure, a global oncology company based in the United Kingdom.
Study results included one- and two-year survival rates of 62.2% and 41.9%, respectively. The median overall survival of the 80 patients in the trial was 18.2 months.
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European Results Have Been Impressive
Oncologist Dr. Giovanni Ceresoli at the Cliniche Humanitas Gavazzeni in Italy and the principal investigator of the STELLAR study, told The Mesothelioma Center at Asbestos.com in October that of his 13 patients, one remains progression free after four years, and three more are still thriving after three years.
“I know this is a promising treatment, very promising,” Ceresoli said.
Requires Commitment from Patients
The use of Tumor Treating Fields will involve a considerable commitment for mesothelioma patients and is designed as a take-home medical device that patients will wear for 18 hours daily with minimal breaks.
It includes pads attached to the front, sides or back of the patient’s chest and a sizable, rechargeable battery pack that must be worn.
The intravenous chemotherapy cycle of Alimta (pemetrexed) and cisplatin or Alimta and carboplatin will be given every 21 days for up to six cycles, which is standard for patients with this disease
After completion of chemotherapy, patients will continue with Tumor Treating Fields until disease progression or unacceptable toxicity. Side effects during the previous trial were minimal.
The offering of Tumor Treating Fields has added to the reputation of the Miami Cancer Institute as a leader in mesothelioma treatment.
The institute takes a multimodality approach that includes thoracic surgeons, medical oncologists and radiation oncologists, all with extensive experience in treating this rare disease.
Its comprehensive radiation oncology program also offers pencil-beam delivery of proton therapy, the finest, most exact radiation treatment available, making it more effective for cancers such as mesothelioma.
“[Tumor Treating Fields] takes it up another step,” Kotecha said. “If we can deliver therapy that helps control this disease, and not put the patients at risk, that is something exciting for us to offer.”