Tumor Treating Fields for Pleural Mesothelioma

FDA Approval of Optune Lua for Pleural Mesothelioma

In May 2019, the U.S. Food and Drug Administration (FDA) approved Optune Lua (previously known as NovoTTF-100L) under the Humanitarian Device Exemption (HDE) program for the treatment of unresectable pleural mesothelioma (meaning mesothelioma that cannot be treated with surgery). This marked the first FDA approval for pleural mesothelioma in more than 15 years.

Since mesothelioma affects only 2,500-3,000 U.S. residents each year, the cancer qualifies for HDE designation. This is reserved for rare conditions that impact fewer than 8,000 individuals annually.

The FDA limits the use of Optune Lua to adult patients with locally advanced or metastatic pleural mesothelioma who are not candidates for curative surgery. Treatment must be given in combination with standard chemotherapy – specifically pemetrexed plus a platinum agent (cisplatin or carboplatin).

Shortly after approval, the West Cancer Center in Germantown, TN, became the first U.S. institution to prescribe Optune Lua for a pleural mesothelioma patient. Since then, the device has continued to expand into clinical use, with ongoing studies exploring its role in real-world practice and in combination with other emerging therapies.

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What Are Tumor Treating Fields?

Tumor treating fields use low-intensity, electric waves that disrupt the process of cancer cells multiplying. Optune Lua uses adhesive patches that are placed on the patient’s chest and back. Patients must wear the device for at least 18 hours a day. The patches are attached to a small machine that generates the electrical fields. This portable device can be carried in a small backpack or shoulder bag.

Unlike radiation or chemotherapy, tumor treating fields do not damage DNA directly and are not associated with systemic toxicity. The main side effects are skin irritation beneath the device patches and mild fatigue.

The journal Clinical Cancer Research has referred to tumor treating fields as the “fourth modality” of cancer treatment, complementing the three traditional pillars of oncology:

• Surgery
• Chemotherapy
• Radiation therapy

In malignant pleural mesothelioma, tumor treating fields therapy (via Optune Lua) is used in combination with standard chemotherapy. Beyond mesothelioma, tumor treating fields therapy is already FDA-approved for the treatment of glioblastoma, an aggressive form of brain cancer. It is also being studied in clinical trials for the treatment of lung cancer, ovarian cancer, pancreatic cancer and liver cancer, among others.

How Do Tumor Treating Fields Stop Tumors?

Tumor treating fields target the most fundamental process of cancer growth: cell division. Pleural mesothelioma develops in the thin lining of the lungs, which consists of two mesothelial cell layers: the parietal (outer) and visceral (inner).

Healthy mesothelial cells become cancerous after chronic irritation and inflammation caused by asbestos fibers, which trigger mutations and allow damaged cells to bypass their natural life cycle. This results in uncontrolled replication that produces tumors that invade nearby tissues and organs.

Tumor treating fields send low-intensity, alternating electric fields to disrupt mitosis (the process of cell division). Delivered noninvasively through transducer arrays (patches) placed on the patient’s skin, these fields are tuned to an intermediate frequency (100–500 kHz).

These fields interfere with the ability of cancer cells to form key structures such as microtubules and mitotic spindles, which are essential for separating chromosomes during cell multiplication. Without these structures, tumor cells cannot properly multiply, leading to errors, cell cycle arrest, or programmed cell death.

Because cancer cells multiply more rapidly than normal healthy cells, they are selectively vulnerable to tumor treating fields. Normal tissues are largely spared, which is why tumor treating fields carry a favorable safety profile compared with chemotherapy or radiation.

“Basically, these fields disrupt the normal division process of cells and have the potential to inhibit the growth of tumors and even reverse their progression,” said Dr. Uri Weinberg, the Novocure vice president of clinical development. “Hopefully, this leads to extended survival of patients.”

What Is Optune Lua?

Optune Lua utilizes “tumor treating fields” to attack tumors in the chest cavity, which is where pleural mesothelioma forms. The device is manufactured by Novocure, which is an oncology company specializing in tumor treating fields.

“NovoCure has been working on tumor treating fields for close to the past 20 years now,” said Dr. Weinberg, who heads the company’s development and research.

How the Optune Lua Work for Mesothelioma

Optune Lua delivers tumor treating fields from four transducer arrays (patches) placed on the patient’s chest. These arrays are connected to “a small, lightweight” device, as Dr. Weinberg describes, that operates by battery or power outlet connection.

 

Patients can wear this device at any time of the day, or night, and it should not impede your ability to go about your usual routine. They can even sleep with it.

Front Placement for Optune Lua

Back Placement for Optune Lua

Benefits of Optune Lua for Pleural Mesothelioma

One of the main benefits of Optune Lua is the little-to-no downside of this therapy. Tumor treating fields will not damage healthy tissue like other mesothelioma treatment options. Tumor treating fields also do not carry the risk of surgical complications.

“Most patients do not feel anything unusual while receiving their therapy,” Dr. Weinberg told Mesothelioma Guide. “This is one of the major assets of the therapy: allowing patients to maintain their quality of life and allowing patients to function while receiving the therapy without disruption of their day-to-day activities.”

Other advantages of tumor treating fields, and Optune Lua in particular, include:

• Ability to wear the device during normal daily activities, such as working or spending time with family
• Noninvasive electrical currents and small compact design to the device
• Ability to wear the device and receive treatment while sleeping or during normal daily activities

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Which Hospitals Offer Tumor Treating Fields for Mesothelioma?

As of March 2021, Novocure’s tumor treating fields device is available for pleural mesothelioma patients in most U.S. states. Some of the Mesothelioma Centers of Excellence, top-ranked medical institutions, offering Optune Lua are:

• Baylor St Luke’s Medical Center (Houston, Texas)
• Brigham and Women’s Hospital (Boston, Massachusetts)
• Moffitt Cancer Center (Tampa, Florida)
• Swedish Cancer Institute (Seattle, Washington)
• New York Proton Center (New York City)
• Roswell Park Cancer Center (Buffalo, New York)
• University of Miami Sylvester Comprehensive Cancer Center (Miami, Florida)

If you’d prefer to search for a hospital based on geography, the states with hospitals offering Optune Lua are:

Optune Lua for the treatment of pleural mesothelioma is not restricted by state but must be provided by a certified physician. If you are interested in learning more about Optune Lua, our staff can provide additional information and help you find a provider near you.

You can easily access tumor treating fields for pleural mesothelioma. Our staff can recommend one of the top cancer centers to you — and will prioritize finding one that offers the Optune Lua device.

Survival From Tumor Treating Fields

Tumor treating fields can significantly improve mesothelioma prognosis. The Optune Lua device received FDA approval due to its excellent survival results in the phase 2 STELLAR clinical trial.

Epithelioid mesothelioma patients averaged a survival time of close to 21 months. This is an improvement from the general survival time of 19 months.

Sarcomatoid and biphasic patients combined for an average survival length of around 12 months. This result also was an improvement of a couple months, compared to overall mesothelioma survival times.

We can provide you with more information on other life-extending mesothelioma treatments, such as surgery, chemotherapy, immunotherapy, radiation and new emerging therapies. Request our free Guide to Mesothelioma book for more medical tips, insight and survival times from our expert staff.

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Frequently Asked Questions About Tumor Treating Fields for Mesothelioma

How do tumor treating fields work?

Tumor treating fields send low-intensity electric frequencies into the tumor site. These waves, or tumor treating fields, disrupt cell division and can cause cancerous cells to die before replicating. This process slows the spread of mesothelioma and can extend patients’ lives by months or years.

When was the first tumor treating fields therapy approved for mesothelioma?

The U.S. Food and Drug Administration approved a tumor treating fields device in May 2019. It received approval after outperforming chemotherapy alone in mesothelioma clinical trials. The device was originally called NovoTTF-100L System, and it is now called Optune Lua. The device is only for cases where surgery is not an option, and it must be used in combination with mesothelioma chemotherapy.

What are the survival times for Optune Lua for mesothelioma?

The median mesothelioma survival time in the most recent clinical trial was 18.2 months, which is an improvement from chemotherapy alone. Epithelioid patients survived for an average of 21 months. Other stats include:

• 62% one-year survival rate
• 97% disease control rate
• 57% stable disease

Where can I get Optune Lua for my mesothelioma?

The Optune Lua device is available in more than 60 hospitals covering more than half the country. Major cancer centers, such as Brigham and Women’s Hospital in Boston and Moffitt Cancer Center in Tampa, offer the treatment. Our patient advocates can help you find a hospital with this device.

Sources & Author

1. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clinical Cancer Research. Retrieved from: https://clincancerres.aacrjournals.org/content/24/2/266. Accessed: 06/12/2020.
2. West is first center in the country to offer the 1st FDA-approved Mesothelioma treatment in more than 15 years. West Cancer Center and Research Institute. Retrieved from: https://westcancercenter.org/west-is-1st-center-in-the-country-to-offer-the-1st-fda-approved-mesothelioma-treatment-in-more-than-15-years/. Accessed: 06/12/2020.
3. Humanitarian Use Device (HUD) Designations. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-use-device-hud-designations. Accessed: 06/12/2020.
4. FDA Approves the NovoTTF-100L™ System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma. Novocure. Retrieved from: https://www.novocure.com/fda-approves-the-novottf-100ltm-system-in-combination-with-chemotherapy-for-the-treatment-of-malignant-pleural-mesothelioma/. Accessed: 06/12/2020.
5. Novocure Announces Optune Lua as the Brand Name for the NovoTTF-100L System. Novocure. Retrieved from: https://www.novocure.com/novocure-announces-optune-lua-as-the-brand-name-for-the-novottf-100l-system/. Accessed: 06/12/2020.
6. Presentation, initial evaluation, and prognosis of malignant pleural mesothelioma. UpToDate. Retrieved from: https://www.uptodate.com/contents/presentation-initial-evaluation-and-prognosis-of-malignant-pleural-mesothelioma. Accessed: 03/19/19.
7. Malignant peritoneal mesothelioma: a review. Annals of Translational Medicine. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5497105/. Accessed: 06/10/2020.
8. Life Expectancy in Pleural and Peritoneal Mesothelioma. U.S. National Library of Medicine via the Annals of Thoracic Oncology. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5292397/. Accessed: 03/19/19.
9. Certified treatment centers are available to get you started on Optune Lua. Optune Lua. Retrieved from: https://optunelua.com/find-a-treatment-center. Accessed: 07/08/2020.

About the Writer, Devin Golden

Devin Golden is the senior content writer for Mesothelioma Guide. He produces mesothelioma-related content on various mediums, including the Mesothelioma Guide website and social media channels. Devin's objective is to translate complex information regarding mesothelioma into informative, easily absorbable content to help patients and their loved ones.