Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients

Abstract

Purpose: To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases.Materials and Methods: One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects' pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected.Results: Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n ¼ 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P <.0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure.Conclusions: Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

The American Society of Pain and Neuroscience (ASPN) Best Practices and Guidelines for the Interventional Management of Cancer-Associated Pain

“…There was significant improvement in pain (8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 months), pain interference and QOL. 162 The increasing number of prospective studies utilizing RFA with or without cement augmentation continue to demonstrate the safety and efficacy of this treatment with a more rapid rate of pain relief (0–2 weeks) compared to conventional fractionated radiotherapy (4–6) weeks. 163 Current therapies and treatments involve a combination of analgesics, bisphosphonates, and radiotherapy with variable results and many patients experiencing inadequate pain relief.…”

Bipolar Radiofrequency Ablation of Painful Spinal Bone Metastases Performed under Local Anesthesia: Feasibility Regarding Patient’s Experience and Pain Outcome

“…These findings are possible because careful attention was made to follow a well-codified anesthetic/pain management protocol which was strictly applied for each patient. Previous studies on RFA in the bone metastases report either the use of general anesthesia or conscious sedation [ 18 , 28 ]. However, a previous study assessing radiofrequency of extra axial metastasis has shown the feasibility of RF procedure under local anesthesia alone [ 13 ].…”

State-of-the-art of minimally invasive treatments of bone metastases

“…Another study concluded that POP has a weak antitumor effect and that PMMA infusion increases the risk of cancer cells entering the circulation within minutes after injection. So, ablation can be performed before cement infusion to obtain better local tumor control [27] , [30] , [31] . Levy [31] conducted a multicenter study that included 100 cases, 97 of which were treated with cementoplasty combined with radiofrequency ablation therapy.…”