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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

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 p...

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Published in:Cardiovascular and interventional radiology 2023-05, Vol.46 (5), p.600-609
Main Authors: Levy, Jason, David, Elizabeth, Hopkins, Thomas, Morris, Jonathan, Tran, Nam D., Farid, Hamed, Massari, Francesco, O’Connell, William G., Vogel, Alexander, Gangi, Afshin, Sunenshine, Peter, Dixon, Robert, Von der Höh, Nicolas, Bagla, Sandeep
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container_title Cardiovascular and interventional radiology
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creator Levy, Jason
David, Elizabeth
Hopkins, Thomas
Morris, Jonathan
Tran, Nam D.
Farid, Hamed
Massari, Francesco
O’Connell, William G.
Vogel, Alexander
Gangi, Afshin
Sunenshine, Peter
Dixon, Robert
Von der Höh, Nicolas
Bagla, Sandeep
description 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  
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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  &lt; 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. 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The Author(s).</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). 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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  &lt; 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. 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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  &lt; 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 .</abstract><cop>New York</cop><pub>Springer US</pub><pmid>37012392</pmid><doi>10.1007/s00270-023-03417-x</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1272-5530</orcidid><oa>free_for_read</oa></addata></record>
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ispartof Cardiovascular and interventional radiology, 2023-05, Vol.46 (5), p.600-609
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source Springer Nature
subjects Ablation
Adverse events
Bone Neoplasms - radiotherapy
Bone Neoplasms - secondary
Cardiology
Catheter Ablation - methods
Chemotherapy
Clinical Investigation
Humans
Imaging
Interference
Medicine
Medicine & Public Health
Metastases
Metastasis
Non-Vascular Interventions
Nuclear Medicine
Pain
Pain - surgery
Palliation
Palliative Care - methods
Prospective Studies
Quality of Life
Radiation
Radiation therapy
Radio frequency
Radiofrequency ablation
Radiofrequency Ablation - methods
Radiology
Statistical analysis
Treatment Outcome
Tumors
Ultrasound
title 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
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