Magnetic Resonance-Guided Focused Ultrasound for Patients With Painful Bone Metastases: Phase II Trial Results

作者：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

来源：JNCI-Journal of the National Cancer Institute, 2014, 106(5): dju082.

DOI：10.1093/jnci/dju082

Background 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. %26lt;br%26gt;Methods 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%26apos;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. %26lt;br%26gt;Results 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 %26lt; .001). MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score NRS (P %26lt; .001) and the BPI-QoL (P %26lt; .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. %26lt;br%26gt;Conclusions 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.

• 出版日期2014-5-14