Radiofrequency ablation for palliative treatment of osseous metastases results in rapid, significant, and durable improvements in pain relief and quality of life: Results from the OPuS One trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12086-12086
Author(s):  
Jason Levy ◽  
Elizabeth David ◽  
Thomas Hopkins ◽  
Jonathan Morris ◽  
Nam D. Tran ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiofrequency Ablation ◽  
Pain Relief ◽  
Bone Metastases ◽  
Pain Score ◽  
Palliative Treatment ◽  
Vertebral Augmentation ◽  
Painful Bone Metastases ◽  
Treated Site

12086 Background: Patients with bone metastases may experience pain and decreased quality of life. Standard of care therapies such as radiation therapy could take weeks for pain relief and carry a risk of radiation induced fracture. Minimally invasive percutaneous radiofrequency ablation (RFA) have been shown in small observational studies to be an alternative treatment for bone metastases. We report the results of the OPuS One trial evaluating RFA for the palliative treatment of patients with painful bone metastases. Methods: OPuS One (NCT03249584) was a multicenter prospective trial. 218 subjects with painful bone metastases (≥ 4/10 worst pain scores, Brief Pain Inventory [BPI], at target treated site) were enrolled from 15 sites. RFA was performed under image guidance at one or two locations. Vertebral augmentation was followed based on physician’s discretion. Subjects’ pain (BPI) and quality of life (EQ-5D) scores were calculated in subjects at three days, one week, and one, three, six, and 12 months post RFA. Rate of complete (0 pain score at treated site with no concomitant analgesic increase) and partial responders (≥ 2 pain score reduction without analgesic increase or analgesic reduction of ≥ 25% from baseline) were calculated. Device-, procedure-, and/or therapy-related adverse events (AEs) were collected. Results: 206 subjects, 113 (55%) female and 93 (45%) males (mean age was 63.7 years) were treated with RFA. Most common primary cancers were breast (23%), lung (23%), and kidney (10%). 184 (89%) subjects were treated for metastatic lesions involving the thoracolumbar spine and 22 (11%) subjects were treated for iliac crest, periacetabulum, sacrum or mixed vertebral and pelvic location. 99% (262/264) of RFA procedures were technically successful and 97% were followed by vertebral augmentation. Subjects reported significant improvement in worst pain from baseline at 7.8 to 5.5, 4.7, 3.6, 3.2, 2.4, and 2.6 at three days, one week and one, three, six, and 12 months post RFA, respectively (p < 0.0001 for all visits). Significant improvements were also seen in average pain (p < 0.0001 for all visits), pain interference (p < 0.0001 for all visits), and quality of life scores (p < 0.0001 for all visits). Overall response rates were 53%, 58%, 61%, 63%, 70%, and 75% at three days, one week, one month, three months, six months, and twelve months post RFA, respectively. Six AEs were reported with three as serious: intra-abdominal fluid collection, pneumonia and respiratory failure. 82 deaths were reported during the study, none were related to the device, therapy, and/or procedure. No skeletal related events were reported. Conclusions: In a large prospective multicenter trial, OPuS One, RFA provided rapid, significant, and durable improvements in pain relief and quality of life up to 12 months. Clinical trial information: NCT03249584.

Radiotherapy plus either transdermal fentanyl or paracetamol and codeine for painful bone metastases: a randomised study of pain relief and quality of life

2004 ◽  
Vol 20 (2) ◽  
pp. 159-163 ◽  
Author(s):  
Kyriaki Pistevou-Gompaki ◽  
Vassilis E. Kouloulias ◽  
Charalambos Varveris ◽  
Kyriaki Mystakidou ◽  
Grigoris Georgakopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Bone Metastases ◽  
Transdermal Fentanyl ◽  
Randomised Study ◽  
Painful Bone Metastases

scholarly journals Comparison of Various Radiotherapy Dose Fractionation Schedules in Palliation of Bone Metastasis

2021 ◽  
Author(s):  
Donald J. Fernandes ◽  
Mariappan Senthiappan Athiyamaan ◽  
Sandesh Rao ◽  
Sharaschandra Shankar ◽  
Abhishek Krishna
Keyword(s):  
Quality Of Life ◽  
Bone Metastasis ◽  
Pain Relief ◽  
Bone Metastases ◽  
Performance Status ◽  
Pain Reduction ◽  
The Mean ◽  
Painful Bone Metastases ◽  
Fractionation Schedules

Abstract Introduction Bone metastasis is a common manifestation of malignancy. Bone metastases causes various morbidities and affect the quality of life. External beam radiotherapy is the mainstay of treatment of uncomplicated painful bone metastases. Different radiotherapy fractionation schedules are in practice for palliation of painful bone metastases. Objectives This study was aimed to compare and report the outcomes of various fractionation schedules of radiation therapy (RT) in terms of pain relief and quality of life in patients with painful bone metastases. Materials and Methods Eighty patients were randomized into four treatment arms with different RT fractionation schedules, namely, 8 Gy in 1 fraction, 20 Gy in 5 fractions, 24 Gy in 6 fractions, and 30 Gy in 10 fractions. Patients were assessed for pain by visual analog scale (VAS), performance status and quality of life before initiating the treatment, on the day of completion of treatment, and 1 week, 1 month, and 3 months of treatment completion. Results Majority of the metastases constituted from breast followed by lung cancer. Of these, 27.5% had metastases to the thoracic vertebra, 26.25% to the lumbar vertebra, 22.5% to the pelvis, 8.75% to the sternum, 6.25% each to cervical vertebra and femur, and 1.25% each to humerus and ribs. The mean VAS score prior to start of RT was 5.31, 5.21, 5.54, and 4.87 in arms A, B, C, and D, respectively. At the end of treatment, the scores were 3.0, 3.29, 2.77, and 2.47, respectively. At the end of 3 months, the scores were 1.54, 0.57, 0.54, and 0.60, respectively. The pain reduction was significant in all the four arms (p < 0.05). Also, 25% of the patients’ arm A had complete pain relief, whereas 45% of patients in arms B, C, and D had complete pain relief. In arm A, the performance status failed to improve at 3 months when compared with 1-week post-RT but the improvement was significant in the remaining three arms. There was improvement in the quality of life in all the arms, both in terms of function and symptoms. The mean score of symptomatic quality of life based on the EORTC BM22 module prior to start of RT was 38.14, 34.91, 28.85, and 29.17 in arms A, B, C, and D, respectively. There was a significant drop to 9.29, 6.55, 5.13, and 6.11 at 1-month posttreatment in the four arms, respectively. The outcomes in terms of functional quality of life showed a similar trend. Conclusion This study demonstrated that pain reduction by various RT fractionation schedules were similar, and no statistically significant difference was noted. Performance status and quality of life improved in all the four treatment arms post-RT.

scholarly journals PD-0533: Response and quality of life in elderly with painful bone metastases: results from a randomized radiotherapy study

2013 ◽  
Vol 106 ◽  
pp. S205
Author(s):  
P.G. Westhoff ◽  
A. de Graeff ◽  
A.K. Reyners ◽  
C.C. Rodenhuis ◽  
M. van Vulpen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Metastases ◽  
Painful Bone Metastases

Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre Venefit™ versus ClariVein® for varicose veins trial

2014 ◽  
Vol 31 (1) ◽  
pp. 61-65 ◽  
Author(s):  
R Bootun ◽  
TRA Lane ◽  
B Dharmarajah ◽  
CS Lim ◽  
M Najem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiofrequency Ablation ◽  
Randomised Controlled Trial ◽  
Pain Score ◽  
Varicose Veins ◽  
Controlled Trial ◽  
Early Results ◽  
Mechanochemical Ablation ◽  
Randomised Controlled

Objective Endovenous techniques are, at present, the recommended choice for truncal vein treatment. However, the thermal techniques require tumescent anaesthesia, which can be uncomfortable during administration. Non-tumescent, non-thermal techniques would, therefore, have potential benefits. This randomised controlled trial is being carried out to compare the degree of pain that patients experience while receiving mechanochemical ablation or radiofrequency ablation. The early results of this randomised controlled trial are reported here. Methods Patients attending for the treatment of primary varicose veins were randomised to receive mechanochemical ablation (ClariVein®) or radiofrequency ablation (Covidien® Venefit™). The most symptomatic limb was randomised. The primary outcome measure was intra-procedural pain using a validated visual analogue scale. The secondary outcome measures were change in quality of life and clinical scores, time to return to normal activities and work as well as the occlusion rate. Results One-hundred and nineteen patients have been randomised (60 in the mechanochemical ablation group). Baseline characteristics were similar. Maximum pain score was significantly lower in the mechanochemical ablation group (19.3 mm, standard deviation ±19 mm) compared to the radiofrequency ablation group (34.5 mm ± 23 mm; p < 0.001). Average pain score was also significantly lower in the mechanochemical ablation group (13.4 mm ± 16 mm) compared to the radiofrequency ablation group (24.4 mm ± 18 mm; p = 0.001). Sixty-six percent attended follow-up at one month, and the complete or proximal occlusion rates were 92% for both groups. At one month, the clinical and quality of life scores for both groups had similar improvements. Conclusion Early results show that the mechanochemical ablation is less painful than the radiofrequency ablation procedure. Clinical and quality of life scores were similarly improved at one month. The long-term data including occlusion rates at six months and quality of life scores are being collected.

scholarly journals Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Rupesh Kotecha ◽  
Brian J. Schiro ◽  
Justin Sporrer ◽  
Muni Rubens ◽  
Haley R. Appel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Radiation Therapy ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Pain Response ◽  
Vertebral Augmentation ◽  
Spine Metastasis ◽  
Randomized Controlled

Abstract Background Spine metastasis is a common occurrence in cancer patients and results in pain, neurologic deficits, decline in performance status, disability, inferior quality of life (QOL), and reduction in ability to receive cancer-directed therapies. Conventional external beam radiation therapy (EBRT) is associated with modest rates of pain relief, high rates of disease recurrence, low response rates for those with radioresistant histologies, and limited improvement in neurologic deficits. The addition of radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) to index sites together with EBRT may improve pain response rates and corresponding quality of life. Methods/design This is a single-center, prospective, randomized, controlled trial in patients with spine metastasis from T5-L5, stratified according to tumor type (radioresistant vs. radiosensitive) in which patients in each stratum will be randomized in a 2:1 ratio to either RFA/PVA and EBRT or EBRT alone. All patients will be treated with EBRT to a dose of 20–30 Gy in 5–10 fractions. The target parameters will be measured and recorded at the baseline clinic visit, and daily at home with collection of weekly measurements at 1, 2, and 3 weeks after treatment, and at 3, 6, 12, and 24 months following treatment with imaging and QOL assessments. Discussion The primary objective of this randomized trial is to determine whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone for patients with spine metastasis, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives include determining whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL. Trial registration ClinicalTrials.gov NCT04375891. Registered on 5 May 2020.

PP126 Radiofrequency Ablation For Metastatic Spinal Lesions

2021 ◽  
Vol 37 (S1) ◽  
pp. 20-21
Author(s):  
Alezandra Torres-castaño ◽  
Amado Rivero-Santana ◽  
Lilisbeth Perestelo-Pérez ◽  
Ana Toledo-chávarri ◽  
Andrea Duarte-Diaz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Radiofrequency Ablation ◽  
Systematic Reviews ◽  
Palliative Treatment ◽  
Case Series ◽  
Controlled Trials ◽  
Vertebral Metastases ◽  
Randomized Controlled

IntroductionAbout 70 percent of metastatic breast, lung, and prostate cancers affect the bones. When this phase of the disease affects the spine, the mobility and quality of life of patients are severely impaired. Radiofrequency ablation (RFA) has become a feasible option in the palliative treatment of vertebral metastases due to its minimal invasiveness and short procedure time. This health technology assessment report aimed to identify, evaluate, and synthesize evidence on the safety, effectiveness, and cost effectiveness of RFA for vertebral metastases.MethodsA systematic search was conducted to identify literature published from December 2016 to July 2019 in the following databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. Systematic reviews, randomized and non-randomized controlled trials, and case series studies evaluating the efficacy and safety of RFA in patients with vertebral metastases were included.ResultsSixteen studies were included: two systematic reviews, 13 case series studies, and one comparative study. None of the systematic reviews identified any randomized controlled trials. Of the 14 included primary studies, 10 evaluated RFA in combination with vertebroplasty, three evaluated RFA in combination with kyphoplasty, and one study evaluated a combination of RFA and radiation therapy. In all cases, the evaluated patients had different types of cancer (e.g., breast, lung, or liver). The follow-up periods varied between the studies from one day to 12 months. The most commonly used RFA devices were the STAR™ Tumour Ablation System (Merit Medical Systems) and the OsteoCool™ Radiofrequency Ablation System (Medtronic).ConclusionsRFA reduces pain, improves functional capacity, and provides greater local control of disease, potentially giving patients a higher quality of life, even in the context of metastatic disease. Although there is evidence on the safety and efficacy of this technology for the palliative treatment of vertebral metastases, more studies with higher methodological quality are needed. There were no studies available on the cost effectiveness of RFA for this indication.

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