Magnetic Resonance–Guided Focused Ultrasound for Patients With Painful Bone Metastases: Phase III Trial Results

• Published in: JNCI : Journal of the National Cancer Institute Vol. 106; no. 5; p. 1
• Main Authors: Hurwitz, Mark D., Ghanouni, Pejman, Kanaev, Sergey V., Iozeffi, Dmitri, Gianfelice, David, Fennessy, Fiona Mary, Kuten, Abraham, Meyer, Joshua E., LeBlang, Suzanne D., Roberts, Ann, Choi, Junsung, Larner, James M., Napoli, Alessandro, Turkevich, Vladimir G., Inbar, Yael, Tempany, Clare Mary C., Pfeffer, Raphael M.
• Format: Journal Article
• Language: English
• Published: United States Oxford Publishing Limited (England) 23.04.2014; Oxford University Press
• Subjects: Adult; Aged; Aged, 80 and over; Bone cancer; Bone Neoplasms - diagnostic imaging; Bone Neoplasms - secondary; Bone Neoplasms - therapy; Clinical trials; Female; High-Intensity Focused Ultrasound Ablation - adverse effects; High-Intensity Focused Ultrasound Ablation - methods; Humans; Magnetic Resonance Imaging - adverse effects; Magnetic Resonance Imaging - methods; Male; Metastasis; Middle Aged; Neoplasms - diagnostic imaging; Neoplasms - pathology; Neoplasms - therapy; NMR; Nuclear magnetic resonance; Single-Blind Method; Ultrasonic imaging; Ultrasonography; Young Adult
• ISSN: 0027-8874; 1460-2105; 1460-2105
• DOI: 10.1093/jnci/dju082

Pain due to bone metastases is a common cause of cancer-related morbidity, with few options available for patients refractory to medical therapies and who do not respond to radiation therapy. This study assessed the safety and efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS), a noninvasive method of thermal tissue ablation for palliation of pain due to bone metastases. Patients with painful bone metastases were randomly assigned 3:1 to receive MRgFUS sonication or placebo. The primary endpoint was improvement in self-reported pain score without increase of pain medication 3 months after treatment and was analyzed by Fisher's exact test. Components of the response composite, Numerical Rating Scale for pain (NRS) and morphine equivalent daily dose intake, were analyzed by t test and Wilcoxon rank-sum test, respectively. Brief Pain Inventory (BPI-QoL), a measure of functional interference of pain on quality of life, was compared between MRgFUS and placebo by t test. Statistical tests were two-sided. One hundred forty-seven subjects were enrolled, with 112 and 35 randomly assigned to MRgFUS and placebo treatments, respectively. Response rate for the primary endpoint was 64.3% in the MRgFUS arm and 20.0% in the placebo arm (P < .001). MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score NRS (P < .001) and the BPI-QoL (P < .001). The most common treatment-related adverse event (AE) was sonication pain, which occurred in 32.1% of MRgFUS patients. Two patients had pathological fractures, one patient had third-degree skin burn, and one patient suffered from neuropathy. Overall 60.3% of all AEs resolved on the treatment day. This multicenter phase III trial demonstrated that MRgFUS is a safe and effective, noninvasive treatment for alleviating pain resulting from bone metastases in patients that have failed standard treatments.