Radiofrequency Ablation Provides Rapid and Durable Pain Relief for the Palliative Treatment of Lytic Bone Metastases Independent of Radiation Therapy: Final Results from the OsteoCool Tumor Ablation Post-Market Study

• Authors: Jason Levy, Northside Hosp; Elizabeth David, Sunnybrook Health Sciences Centre; Thomas Hopkins, Duke University; Jonathan Morris, Mayo Clinic; Nam D Tran, Moffitt Cancer Center, Tampa, FL; Hamed Farid, St. Jude Medical Center; Francesco Massari, University Massachusetts Memorial Medical Center; William G O'Connell, Emory University; Alexander Vogel, Renown Regional Medical Center; Afshin Gangi, Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil; Peter Sunenshine, Banner - University Medical Center; Robert Dixon, University of Arkansas Medical Sciences; Nioclas Von der Höh, Universitaetsklinikum Leipzig; Sandeep Bagla, Prostate Centers USA, LLC, Falls Church
• Journal Title: CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY
• Volume: Volume 46, Number 5
• Publisher: SPRINGER | 2023-04-03, Pages 600-609
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1007/s00270-023-03417-x
• Subjects: Health Sciences, Radiology; Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Cardiac & Cardiovascular Systems; Radiology, Nuclear Medicine & Medical Imaging; Cardiovascular System & Cardiology; Ablation; RFA; Skeletal-related events; Osseous metastases; Radiation-induced fracture; EXTERNAL-BEAM RADIOTHERAPY; STEREOTACTIC BODY RADIOTHERAPY; VERTEBRAL COMPRESSION FRACTURE; MULTICENTER; OUTCOMES; CANCER; AUGMENTATION; RADIOSURGERY; RADIOLOGY; DISEASE

Abstract

Purpose: The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12 months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking. Materials and Methods: Prospective assessments were conducted at Baseline, 3 days, 1 week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life—5 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected. Results: 206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3 days post-RFA and sustained to 12 months (P < 0.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device/procedure-related adverse events. Conclusion: RFA for lytic metastases provides rapid (within 3 days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12 months and a high degree of safety, independent of radiation. Level of Evidence: 2b, Prospective, Non-Randomized, Post-Market study: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.