• Mark D Hurwitz, Pejman Ghanouni, Sergey V Kanaev, Dmitri Iozeffi, David Gianfelice, Fiona Mary Fennessy, Abraham Kuten, Joshua E Meyer, Suzanne D LeBlang, Ann Roberts, Junsung Choi, James M Larner, Alessandro Napoli, Vladimir G Turkevich, Yael Inbar, Clare Mary C Tempany, and Raphael M Pfeffer.
• Affiliations of authors: Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA (MDH); Department of Radiology, Brigham and Women's Hospital, Boston, MA (FMF, CMCT); Department of Radiology, Stanford University Medical Center, Stanford, CA (PG); Department of Radiation Oncology and Radiology, N. N. Petrov Institute of Oncology, St. Petersburg, Russian Federation (SK, VT); Department of MRI and FUS, Rostov State Research Institute of Oncology, Rostov on Don, Russian Federation (DI); Department of Medical Imaging, University Health Network, University of Toronto, Toronto, Canada (DG); Department of Oncology, Rambam Medical Center, Haifa, Israel (AK); Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA (JM); University MRI & Diagnositc Imaging Centers, Boca Raton, FL (SDL); Department of Radiology, University of California at San Diego, San Diego, CA (AR); Department of Diagnostic Imaging and Interventional Radiology,H. Lee Moffitt Cancer Center, Tampa, FL (JC); Department of Radiation Oncology, University of Virginia, Charlottesville, VA (JML); Department of Radiological, Oncological, and Pathological Sciences, Sapienza University of Rome, Rome, Italy (AN); Department of Radiation Oncology, Sheba Medical Center, Tel Hashomer, Israel (YI,RMP). mark.hurwitz@jefferson.edu.
• J. Natl. Cancer Inst. 2014 Apr 23; 106 (5).

BackgroundPain 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.MethodsPatients 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.ResultsOne 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.ConclusionsThis 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.© The Author 2014. Published by Oxford University Press.

23 keywords...

hide…