Department of Interventional Radiology, Northside Hospital, Atlanta, GA, 30342, USA.
Department of Vascular/Interventional Radiology, Sunnybrook Health Sciences Centre, Toronto, ON, M4N 3M5, Canada.
Cardiovasc Intervent Radiol. 2023 May;46(5):600-609. doi: 10.1007/s00270-023-03417-x. Epub 2023 Apr 3.
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.
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.
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.
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.
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 .
OsteoCool 肿瘤消融市场后研究（OPuS One）是一项前瞻性、多中心、单臂研究，旨在调查射频消融（RFA）治疗溶骨性骨转移疼痛缓解的安全性和有效性，随访时间为 12 个月。RFA 在短期随访的小型临床研究中已证明对骨转移有有效的缓解作用；然而，缺乏具有大量受试者的长期评估。
前瞻性评估在基线、3 天、1 周以及 1、3、6 和 12 个月时进行。在 RFA 之前和术后使用简明疼痛量表、欧洲生活质量 5 维度和欧洲癌症研究与治疗组织姑息治疗生活质量问卷评估疼痛和生活质量。收集了放射治疗、化学治疗和阿片类药物的使用情况及相关不良事件。
OPuS One 中，15 个机构的 206 例患者接受了 RFA 治疗。在所有随访中，从 RFA 后 3 天开始，最差疼痛、平均疼痛、疼痛干扰和生活质量均显著改善，且持续到 12 个月（P<0.0001）。事后分析发现，RFA 指数部位的全身化疗或局部放疗均不影响最差疼痛、平均疼痛或疼痛干扰。6 例患者发生与器械/手术相关的不良事件。
RFA 治疗溶骨性转移可迅速（3 天内）改善疼痛和生活质量，并在 12 个月内持续获得显著的长期缓解，且安全性高，与放疗无关。
2B，前瞻性、非随机、市场后研究：本杂志要求作者为每篇文章指定一个证据水平。如需了解这些循证医学评级的完整描述，请参考目录或在线作者指南 www.springer.com/00266 。
