Tumor Treating Fields Showing Early Success for Mesothelioma

Dr. Giovanni Ceresoli doesn’t think Tumor Treating Fields will work for every patient with mesothelioma cancer, but he knows it will work for some.

They are in his clinic.

As the principal investigator of the multicenter clinical trial that led to approval by the U.S. Food and Drug Administration in May, Ceresoli has played a major role in the development of this latest mesothelioma treatment.

“It might be too early to say this is a major breakthrough — we need more data — but I hope it is. I know it’s something promising, very promising,” Cerosoli told The Mesothelioma Center at Asbestos.com. “I can say that based on what we’ve seen.”

Tumor Treating Fields, which works in synergy with chemotherapy, is designed to disrupt cancer cell division through electric fields tuned to specific frequencies.

Cerosoli is section manager in the Department of Oncology at Cliniche Humanitas Gavazzeni in Bergamo, Italy, one of 12 sites across Europe that conducted the study called STELLAR.

The phase II trial involved using the combination of chemotherapy and the NovoTTF-100L System. The device is manufactured by Novocure, a global oncology company based in the United Kingdom with operations in Australia, the United States, Japan and Switzerland.

Study results were released in 2018 and included one- and two-year survival rates of 62.2% and 41.9%, respectively. The FDA approved it for first-line treatment under its Humanitarian Device Exemption earlier this year.

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Patient Progression Free at Four Years

Although the median overall survival of the 80 participants in the trial was an impressive 18.2 months — almost double the standard survival using only chemotherapy — the 13 patients under Ceresoli’s care fared even better.

One of his patients remains progression free after four years with no sign of recurrence. Three more of those patients are thriving after three years.

“We’ve had some long survivors, some patients doing really well,” he said. “This is not a treatment for everyone, but some are going to do quite well.”

Although there were five clinical trial sites throughout Italy during the trial period, Tumor Treating Fields has not been approved yet by its government regulatory agency. The use in Italy has continued only on a limited basis for those involved in trials that have ended.

Ceresoli believes a randomized phase III trial will soon follow. He also believes more work must be done to predict molecular biomarkers that can help identify which patients are likely to benefit from the treatment.

He also suggested further studies that include other combining Tumor Treating Fields with immunotherapy and possibly surgery.

Use in United States Underway

Because of the FDA approval, several cancer centers within the United States already have been conducting training of NovoTTF-100L.

The first mesothelioma patient, according to Novocure, began using the device in September.

“As you know, the treatment of pleural mesothelioma is quite challenging. We need new treatment options,” Ceresoli said. “This is a novel approach with great potential.”

The FDA previously approved its use for the treatment of glioblastoma, an aggressive form of brain cancer. It is being studied today for use with several other cancers.

For pleural mesothelioma, the electrical currents are delivered noninvasively throughout the upper torso. The treatment is designed for continuous home use that includes up to 16 to 18 hours each day.

The recent trial included the intravenous combination of either cisplatin or carboplatin with pemetrexed (Alimta), given every three weeks for six cycles.

During the first three months of treatment, patients used the Tumor Treating Fields device an average of 16.3 hours per day.

“This is not a treatment for everyone,” Ceresoli said. “Treatment is a major commitment, and compliance is important, but we’ve seen what it can do. We have a patient now with no sign of disease progression.”

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