Flash Proton Therapy: The Future of Radiation Therapy By Ron DiGiaimo, MBA, FACHE, Matt Palmer, MBA, CMD, Jon Hopkins, BSRT(R)(T), Bri Driggers

FLASH proton therapy is a groundbreaking technological advancement in the world of cancer care that has the promise to save lives, ease the patient experience, and open the door for numerous advancements in the field of radiation oncology.

What is FLASH Proton Therapy?

Proton therapy has made significant advancements to the cancer care sector of healthcare since the 1950s. Today, patients who undergo proton therapy treatments may receive accumulating doses of radiation five days a week for two to eight weeks depending on the type of cancer and the total dose necessary for treatment. In comparison to current treatment delivery methods, FLASH delivers the same amount of radiation in a fraction of the time, thus reducing the damaging effects of radiation on healthy tissue.

FLASH radiotherapy is the delivery of ultra-high dose rate radiation several orders of magnitude higher than what is currently used in conventional clinical radiotherapy and has the potential to revolutionize the future of cancer treatment. FLASH radiotherapy induces a phenomenon known as the FLASH effect, whereby the ultra-high dose rate of radiation reduces the normal tissue toxicities commonly associated with conventional radiotherapy, while still maintaining local tumor control. 1

This targeted radiation therapy reduces the number of treatment sessions and the overall length of a patient’s course of treatment. Traditional radiation therapy can be highly effective in treating certain types of cancer, but it can also cause severe side effects as with many therapies. For example, high-dose radiation can cause side effects such as nausea, vomiting, skin burns, hair loss, and damage to internal organs. However, this revolutionary FLASH proton therapy can reduce patient recovery time and side effects with only one to three treatments in a fraction of a second.

What are the Benefits of FLASH Proton Therapy?

This innovative research is focused on patient benefits. The patient experience has become more impactful than the actual treatment itself.

It is optimal for all patients undergoing radiation therapy to remain relaxed and motionless throughout the duration of treatment. This becomes increasingly difficult for patients seeking treatment for head and neck cancer, who must remain still with a constrictive mask on during treatment. Remaining perfectly still within the confinement of an uncomfortable mask is challenging enough to do once, let alone multiple times a week over several weeks. Providing a seamless experience that helps them remain comfortable and still during their sessions is necessary for all cancer treatments, including FLASH. However, FLASH proton therapy delivers an entire dose in one treatment session, which significantly reduces the length of time that a patient needs to be perfectly still.

FLASH proton therapy will also be highly beneficial for the mental health of family members and patients undergoing cancer care treatments. Many, if not all, patients who receive cancer treatment experience a significant amount of stress, anxiety, and depression. The cost of care can be overwhelming. Then factor in the cost of lodging and transportation and overwhelming stress turns into a complete change in the patient’s ongoing quality of life. Additionally, often those who are caring for cancer patients must make sacrifices, such as quitting their jobs to take on providing care for their family members throughout treatment. The whole process can be detrimental to both the patient and caregivers’ physical and mental health. FLASH proton therapy will reduce treatment duration from months to a single day, allowing patients to return home sooner and return to their normal lives easily. This new technology has the potential to change the worldwide approach to Radiation Therapy. To put it simply: More focused targeting reduces the number of treatments and overall length of therapy, accommodating patients and improving the quality of life and total cost of care during treatment with the goal of also elevating the effectiveness of the treatment. John C. Breneman, MD, medical director of the Proton Therapy Center explains that … “preclinical FLASH research indicates there’s a potential for reducing toxicity associated with conventional radiation therapy techniques when treating at ultra-high dose rates.” Breneman continues that, “delivering higher cancer-killing doses without causing inordinate side effects … would be a real advance.” 3

What is the Risk?

With any research and development in healthcare, there are associated risks and a lengthy timeline for adoption.

But the bigger question is: “What happens if a mistake is made?” Accidents in cancer care occur, such as misalignment or incorrect dosage of radiation during a single treatment. In current proton therapy practices, the dosage can be adjusted during the full 15-20 sessions. FLASH proton therapy delivers an ultra-high dose of radiation in just one session, meaning there is no ability to adjust the dosage in future treatments and the margin for error is reduced to zero. However, researchers at Cincinnati Children’s Hospital who are developing FLASH proton therapy and completing Phase One trials believe the risk of misalignment is no greater with FLASH than with other procedures. Varian has also developed a FlashForward? Consortium from “institutions around the world to establish preclinical study designs, develop technical solutions, and share research protocols to help advance the science and clinical translation of FLASH therapy.” 4 The collective knowledge from these academic and industry experts around the world will further support the treatment technology and prevent missteps in the development of this advantageous form of cancer care. We will anxiously await the clinical outcomes of today’s research and a decade from now results.

How Will Current Treatment Centers Adopt FLASH Proton Therapy?

For FLASH to be clinically adopted, the following will need to be done:

• Clinical trial completion (by cancer type)
• Machine quality assurance
• Treatment delivery quality assurance
• Treatment planning software advancements
• Patient setup
• Imaging optimization

“New machines are already FLASH capable, and most existing systems are capable as well. Systems will be required to go into a different treatment mode” to allow delivery of ultra-high radiation doses, said Matt Palmer, MBA, CMD of Legion Healthcare Partners. However, there must be strict processes adopted and state-of-the-art targeting mechanisms developed to ensure 100% accurate dosage. We must also ensure immobilization in the practical use of FLASH. If FLASH becomes normalized as hoped, any errors in positioning will be much worse due to the higher dose rate and, subsequently, higher consequences.

The Future of Cancer Care

FLASH proton therapy is at the earliest stages of testing, having just completed one Phase I clinical trial for bone metastasis. This revolutionary technology must maintain high safety standards and ensure the proper procedures are in place. There are estimated 5-10 more years of testing and approvals before full completion and adoption in the US.

As with any new medical development, FLASH proton therapy attracts both excitement and skepticism. However, Intensity-modulated radiation therapy (IMRT) followed a similar path of skeptical adoption, and it still is used widely to treat patients today. FLASH proton therapy is the next new and exciting advancement in the future of cancer treatment innovation.

Our specialty must unite and support both technological advancements and continual research by appropriate reimbursing such technology. The current reimbursement methodology does not adequately allow for the new leaps that are both possible and necessary in cancer care as a whole; but specifically, Radiation Therapy. Chemotherapeutic drugs dwarf radiation therapy expenditures while approximately 60% of cancer patients receive radiation therapy at some time during their battle with cancer and only a small fraction of the cost of drugs across the nation. This radiotherapeutic technology was made possible due to extensive research and is a hopeful benefit to the patients that await treatment in the coming years.

1 Int J Mol Sci. 2020 Sep; 21(18): 6492.Published online 2020 Sep 5. doi: 10.3390/ijms21186492

2 https://www.cincinnatichildrens.org/service/p/proton-therapy/research/flash

3 https://www.varian.com/about-varian/research/flashforward-consortium

4 https://www.varian.com/about-varian/research/flashforward-consortium

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About Legion

Legion Healthcare Partners is a privately held healthcare company with a team of experienced executives, clinical advisors, and domain experts with a core focus on proton therapy (radiation oncology). Legion provides development, management, financing, and ownership opportunity in partnership with large health systems with comprehensive cancer service lines. In addition, leveraging over two decades of particle therapy knowledge and a group of expert faculty advisors, Legion offers certified and accredited proton therapy educational programs for radiation oncology professionals. For more information, visit legionhp.com or email [email protected]. Legion Healthcare Partners is based in Houston, Texas.