- Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative phase II clinical trial that enrolled 198 participants with painful bone metastases.
- When compared with external beam radiation therapy (EBRT), focused ultrasound produced a faster and better pain control response that lasted longer than EBRT.
- An accompanying editorial praised focused ultrasound as a promising new advance in interventional oncology and suggested that future comparative trials follow this study model as a practical approach to adopting innovative new treatments.
Focused Ultrasound and External Beam Radiation Therapy for Painful Bone Metastases: A Phase II Clinical Trial
Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative, nonrandomized, phase II clinical trial that enrolled 198 participants with painful bone metastases. The study compared the safety and effectiveness of treating the bone metastases with focused ultrasound or EBRT. Beyond numeric pain rating scales at 1- and 12-months following treatment, the open-label protocol also included assessment of quality-of-life measures and analysis of adverse events.
Focused ultrasound had statistically significant higher overall response rates than EBRT at both 1- and 12-months post procedure and statistically significant lower overall adverse event rates. The authors concluded that focused ultrasound was comparable to EBRT for improving pain palliation and quality of life.
In an accompanying editorial, “Radiation Therapy Castle Under Siege: Will It Hold or Fold?” Alexis Kelekis, MD, PhD, EBIR, FSIR, FCIRSE, said that focused ultrasound was among several new advances in interventional oncology for providing local energy deposition. He noted some of the current disadvantages of focused ultrasound (e.g., it is a long and tiring single-session treatment that requires anesthesia) but said that the technology’s absence of ionizing radiation and better overall results than EBRT for treating bone metastases make it “a promising alternative for the future.” After describing that the partial response rate in the study favored EBRT, Dr. Kelekis added, “Perhaps the future lies in combined therapies and hybrid techniques trying to bridge and exploit the advantages of each therapeutic approach.” He went on the praise the study design and suggested that the model should be adopted by more researchers to increase the use of innovative and novel therapies that provide real hope to patients.
Suzanne LeBlang, MD, the Foundation’s Director of Clinical Relationships, has known Dr. Napoli for nearly 16 years. She says, “Dr. Napoli was one of the early pioneers in the field, and this important paper adds to the mounting body of knowledge about the benefits of focused ultrasound. Moving forward, we are hopeful that others will perform seminal research projects and publish findings for other indications because focused ultrasound is a platform technology that has widespread applicability to other diseases.”