An emerging method of Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) may be a good option for the palliative treatment of patients with metastatic bone disease, according to results presented during the “Best of Clinical Trials” session.
Napoli
Alessandro Napoli MD, PhD, professor of radiology in the Department of Radiological, Oncology and Pathological Science at the Sapienza University of Rome where he is also head of the MR-Guided Focused Ultrasound Treatment Unit, presented the research.
“The purpose of the study was to assess the efficiency and safety of the two different techniques for treatment of painful bone metastases,” Dr. Napoli said. “In our experience, this technique can provide rapid pain relief without radiation or invasive procedures, low rate of adverse events, and can be considered an alternative to external beam radiation therapy (EBRT).”
MRgFUS includes using high intensity focused ultrasound to pinpoint a small target and provide a therapeutic effect by raising the temperature high enough to destroy the target with no damage to surrounding tissue. MRI is used to guide and control the treatment.
This method has been used in the treatment of other conditions, but adoption has been slow for the palliation of bone metastases where EBRT is the standard of care. However, according to Giulia Alfieri, MD, Department of Radiology at Policlinico di Roma in Rome, many patients do not experience any pain relief after initial EBRT and up to 50% of initial responders experience pain relapse within one year of treatment.
Patients Experienced Complete or Partial Pain Response
The study included 198 participants with painful bone metastases between January and March 2019. Within that group, 100 underwent MRgFUS and 98 underwent EBRT. Patients who received MRgFUS treatment reported a significant difference in physical function, appetite, nausea and vomiting, dyspnea and quality of life.
At one month, 91% of patients treated with MRgFUS had complete or partial pain response compared to 67% of patients treated with EBRT. At final follow-up, 74% in MRgFUS and 34% in radiotherapy had a complete pain response.
Dr. Napoli said large, randomized trials are still necessary to validate the research, but that ultrasound guided treatment should be considered as an alternative to radiotherapy in patients with painful bone metastases.
One limitation of the study was the difference in treatment availability, Dr. Napoli noted. Radiotherapy was easier and faster to access, whereas ultrasound surgery required a longer set-up with more days between actual treatment from enrollment. Those challenges could be overcome with greater adoption of MRgFUS.
“MRgFUS in comparison to EBRT showed promising response when used as a palliative treatment in patients with painful bone metastases,” Dr. Alfieri said. “MRgFUS may represent a valid option for the palliative treatment of patients with metastatic bone disease, with promising results in terms of pain relief and quality of life when compared to EBRT.”
Following the presentation, Bruce G. Haffty, MD, chief of staff, Rutgers Cancer Institute of New Jersey, professor and chairman of radiation oncology, Rutgers-Robert Wood Johnson Medical School, and RSNA president-elect discussed the results.
“Bone metastasis is a common clinical issue and the most common cause of cancer related pain we see as radiation oncologists,” Dr. Haffty said.
Dr. Haffty noted that Dr. Napoli’s work is a “novel and cutting-edge approach to treat bone pain in metastatic disease.”
However, since the trial was not randomized, he said the topic would require further research to understand if one treatment option is better than the other.
Dr. Napoli said his team has received funding from the European Union to conduct a Phase 3 trial to continue studying the technique.
Access the presentation, “Magnetic Resonance-Guided Focused Ultrasound Versus External Beam Radiation Therapy for the Treatment of Pain in Bone Metastases: A Phase II Trial,” (M4-RCP48) on demand at Meeting.RSNA.org.
