October 31, 2022 — Varian, a Siemens Healthineers company, and the Cincinnati Children's/University of Cincinnati Medical Center Proton Therapy Center, today announced clinical trial results from FAST-01 (FeAsibility Study of Flash Radiotherapy for the Treatment of Symptomatic Bone Metastases), the first clinical trial of ultra-high dose rate Flash therapy and the first-in-human experience of proton Flash. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForwardTM Consortium, including the Cincinnati Children's/University of Cincinnati Medical Center Proton Therapy Center, and the results have been published in the Journal of the American Medical Association Oncology (JAMA Oncology). The research findings were also presented at the American Society for Radiation Oncology's (ASTRO) 64th Annual Meeting in San Antonio, Texas.
Based on clinical workflow metrics, treatment efficacy, and safety data, researchers concluded that ultra-high dose rate proton Flash therapy is feasible in a clinical setting. Data surrounding the first experience in humans showed the desired therapeutic benefit in line with expectations and consistent with what conventional radiotherapy, the standard of care, would deliver and no significant toxicity.
The clinical trial involved the investigational use of Varian's ProBeam particle accelerator modified to enable and control the delivery of radiation therapy at ultra-high dose rates, allowing the entire dose to be delivered in less than one second. The trial was conducted at the Cincinnati Children's/University of Cincinnati Medical Center Proton Therapy Center and was led by John C. Breneman M.D., Medical Director, John P. Perentesis, M.D., Research Director, Anthony Mascia, Ph.D., Chief Physicist, and Emily Daugherty, M.D., Assistant Professor of Radiation Oncology. The related publication was authored by the foregoing individuals and other authors.
"The unique Flash research at our proton therapy center in Cincinnati has far-reaching implications for how we treat cancer in children and adults, now and in the future," said Dr. Perentesis.
"The FAST-01 trial has been an exciting step forward in exploring what is possible in Flash therapy delivery," said Dr. Mascia. "Working with Varian has been critical from a workflow efficiency standpoint and maximizing the potential of the ProBeam system from a performance standpoint. We look forward to continued collaboration as this research program advances."
"Varian is committed to streamlining the cancer care pathway, and empowering care teams to deliver more efficient precision therapy to patients. We're pleased that the FAST-01 clinical data further support the potential of Flash therapy to transform cancer care," said Ricky Sharma, M.D., Ph.D., Vice President of Clinical Affairs at Varian. "We look forward to further exploring this potentially groundbreaking form of therapy and demonstrating the benefits for cancer patients in future clinical trials."
The FAST-01 clinical trial enrolled 10 participants between the ages of 27 and 81 who underwent palliative Flash therapy to bone metastases in the extremities. Endpoints were evaluated by clinical workflow feasibility, treatment-related side effects, and efficacy of treatment as assessed by measuring pain relief of trial participants. Eight of 12 sites (67%) treated had pain relief, and six of 12 sites had a complete response (no pain). There were no Flash-related technical issues or delays, and all adverse events were mild and consistent with those expected from conventional radiotherapy.
"We are extremely encouraged by the results from the FAST-01 clinical trial, and we're eager to advance our Flash research pathway," said Dr. Daugherty, who presented the results at ASTRO. "We owe a debt of gratitude to our trial patients who have contributed to the Flash research program. They have without a doubt helped us advance this important program for the benefit of future cancer patients."
"Thanks to support and close collaboration with the FlashForward Consortium – including two of our key research collaborators Dr. Charles Simone from the New York Proton Center and Dr. Jeffrey Bradley from the Emory Winship Cancer Institute – we continue to advance Flash therapy as an integrated, end-to-end solution. As we look ahead, we see exciting opportunities to further develop and expand this important research," said Agam Sharda, Vice President of Flash Solutions at Varian. "Varian remains committed to building out the technology and organizational platforms that will empower our fellow Consortium members to conduct Flash therapy research at scale."
About Flash Therapy
Flash therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The concept of ultra-high dose rate radiation delivery has been studied for many years. Dedicated research and development by the team at Varian and the clinical collaborators in the FlashForward™ Consortium has led to the advancement of Flash therapy to clinical trials. The FlashForward Consortium, a group with over 30 member institutions from around the world, includes over 200 experts in radiation oncology, translational science and medical physics. Visit the FlashForward Consortium website for more information.
For more information: www.varian.com
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