Painful Bone Metastases Research Articles

Low molecular weight 35 kDa hyaluronan fragment HA35 in the treatment of bone metastasis pain: A case report.

Late-stage cancer patients often experience severe pain due to bone metastasis, caused by structural damage and cancer-induced inflammation. Hyaluronan, known to alleviate pain by blocking the TRVP1 calcium channel, faces limitations due to its high molecular weight. However, 35 kDa low molecular weight hyaluronan fragment (HA35) have shown promise in relieving various pains, including cancer-related pain. Nonetheless, evidence regarding their efficacy in bone metastasis pain remains scarce. A 52-year-old female with a rectal malignant tumor and multiple secondary tumors in the sacrum and lungs, accompanied by bone metastasis pain. Despite undergoing radiotherapy, her pain relief was unsatisfactory. Before treatment with HA35, her numerical rating scale score was 10, severely affecting her sleep, appetite, and daily activities. The patient was diagnosed with rectal malignant tumor with multiple metastases, presenting symptoms such as sacral metastasis pain, anal pain, lower limb pain, and anterior abdominal pain. Sacral metastasis pain and lower limb pain indicated a clear diagnosis of bone metastasis pain. Treatment involved subcutaneous injection into the deep fat tissue layer of the abdomen. A subcutaneous injection of 100 mg/5 mL of HA35 was administered once into the deep fat tissue of the abdomen, with subsequent injections repeated every 3 days. Following 1 injection, the patient's pain score decreased to 6 points within 20 minutes, providing 40% pain relief. After 40 minutes, the score further dropped to 4 points, with 60% pain relief. After 50 injections, pain was consistently controlled at around 3 points. Subcutaneous injection of HA35 into the abdominal fat tissue effectively alleviates pain in cancer and bone metastasis patients resistant to conventional treatments. Additionally, it helps alleviate anxiety and fatigue, and improves diet and sleep, thereby offering crucial palliative care for advanced cancer patients.

A Prospective Randomised Comparative Study to Evaluate the Effect of Single Dose (6.25Gy Vs 8Gy) Palliative Radiotherapy with Zoledronic Acid in Patients with Painful Bone Metastases

Background: To assess the effectiveness of a single fraction dose of radiotherapy (6.25Gy versus 8 Gy) with zoledronic acid in cancer patients with painful bone metastases in treating pain; quality of life; duration of pain response and incidence of skeletal related events (SREs). Material and methods: A total of 80 patients with bone metastases presented in the department of Radiation Oncology, S.M.S hospital were randomly assigned to: Group A, received single dose of 6.25Gy with Zoledronic acid 4mg and Group B, received single dose of 8Gy with Zoledronic acid 4mg. The main variable was pain which was assessed with 11 point Numeric pain Rating Score (NRS). Results: There were total 80 patients, 40 in each group, with mean age 54.6 years and 54.5 years in group A and B respectively. Most frequent primary malignant sites were lung (36.2%), breast (28.7%), and prostate (8.7%). At 4 weeks post radiotherapy, complete response was 25% in group A, 27.5% in group B and overall response was 82.5% in group A, 85% in group B. At 2 months post radiotherapy complete response was observed in 25% of patients in group A, while 30% in group B and overall response in 85 % in group A and 87.5% in group B. Quality of life improved in both groups. Mean duration of pain relief was 13.5 weeks vs. 14.5 weeks respectively in group A and group B. Conclusion: There was improvement in pain relief and quality of life post radiotherapy in both the groups. On comparison between 2 groups, the overall pain relief was insignificant between the two dose schedules. So a lower dose 6.25Gy is almost as effective as 8 Gy single fractions for treatment of painful bone metastases.

Comparative evaluation of three palliative external beam radiotherapy schedules in painful bone metastases

Comparative evaluation of three palliative external beam radiotherapy schedules in painful bone metastases

Optimal production and purification of n.c.a.143Pr as a promising palliative agent for the treatment of metastatic bone pain

This study proposes the beta-emitting radioisotope 143Pr as a promising candidate for palliative treatment of metastatic bone pain due to its desirable physical decay characteristics. An optimized process was developed for the production and purification of non-carrier-added 143Pr using a medium flux research reactor. Calculations were performed to determine the optimal irradiation time and cooling period for irradiating 1 mg of natural cerium oxide to indirectly produce 143Pr through the decay of 143Ce. Following irradiation and cooling, extraction chromatography was employed to efficiently isolate 143Pr from the irradiated target material. A column containing Ln-resin was used along with nitric acid as the mobile phase and an optional oxidation step with NaBrO3/ascorbic acid to separate 143Pr from impurities such as 143Ce and 141Ce. Radionuclidic purity of over 99.995% was achieved as confirmed through gamma spectroscopy, demonstrating effective separation of 143Pr. Additional quality control analyses established the chemical and radiochemical purity of the purified 143Pr nitrate product. With a half-life of 13.6 days and maximum beta energy of 0.937 MeV, 143Pr exhibits favorable properties for palliative bone pain therapy. This study therefore provides a viable method for producing high-purity 143Pr through the optimized irradiation and purification processes described. Further investigation is warranted to explore potential clinical applications of 143Pr for palliation of metastatic bone cancer pain.

Single-fraction radiation retreatment for bone metastases: role of a rapid access clinic

ObjectivesThis study investigates retreatment rates in single-fraction radiation therapy (SFRT) for painful bone metastasis in patients with limited life expectancy. We compared retreatment-free survival (RFS) in patients from a rapid...

Current state of theranostics in metastatic castrate-resistant prostate cancer.

Prostate cancer remains one of the leading causes of cancer-related death in the world. There have been significant advances in chemotherapy, hormonal therapy and targeted therapy options for patients with castrate-resistant disease. However, these systemic treatments are often associated with unwanted toxicities. Targeted therapy with radiopharmaceuticals has become of key interest to limit systemic toxicity and provides a more precision oncology approach to treatment. Strontium-89, Samarium-153 EDTMP and Radium-223 have been trialled with mixed results. Strontium-89 and Samarium-153 EDTMP have shown benefits in palliating metastatic bone pain but with no impact on survival outcomes. Early therapeutic radiopharmaceuticals targeting PSMA that were developed were beta-emitting agents, but recently alpha-emitting agents are being investigated as potentially superior options. Radium-223 is the first alpha-particle emitter therapeutic agent approved by the FDA, with phase III trial evidence showing benefits in overall survival and delay in symptomatic skeletal events for patients. Recently, 177-Lutetium-PSMA-617 has demonstrated significant survival advantages in pre-treated metastatic castrate-resistant cancer patients in a number of phase II and III studies. Furthermore, 225-Actinium-PSMA-617 also showed promise even in patients pre-treated with 177-Lutetium-PSMA-617. Hence, there has been an explosion of radiopharmaceutical treatment options for patients with prostate cancer. This review explores past and current theranostic capacities in the radiopharmaceutical treatment of metastatic castrate-resistant prostate cancer.

FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach

BackgroundFLASH therapy is a treatment technique in which radiation is delivered at ultra-high dose rates (≥ 40 Gy/s). The first-in-human FAST-01 clinical trial demonstrated the clinical feasibility of proton FLASH in the treatment of extremity bone metastases. The objectives of this investigation are to assess the toxicities of treatment and pain relief in study participants with painful thoracic bone metastases treated with FLASH radiotherapy, as well as workflow metrics in a clinical setting.MethodsThis single-arm clinical trial is being conducted under an FDA investigational device exemption (IDE) approved for 10 patients with 1–3 painful bone metastases in the thorax, excluding bone metastases in the spine. Treatment will be 8 Gy in a single fraction administered at ≥ 40 Gy/s on a FLASH-enabled proton therapy system delivering a single transmission proton beam. Primary study endpoints are efficacy (pain relief) and safety. Patient questionnaires evaluating pain flare at the treatment site will be completed for 10 consecutive days post-RT. Pain response and adverse events (AEs) will be evaluated on the day of treatment and on day 7, day 15, months 1, 2, 3, 6, 9, and 12, and every 6 months thereafter. The outcomes for clinical workflow feasibility are the occurrence of any device issues as well as time on the treatment table.DiscussionThis prospective clinical trial will provide clinical data for evaluating the efficacy and safety of proton FLASH for palliation of bony metastases in the thorax. Positive findings will support the further exploration of FLASH radiation for other clinical indications including patient populations treated with curative intent.RegistrationClinicalTrials.gov NCT05524064.

Stereotactic Body and Conventional Radiotherapy for Painful Bone Metastases

Conventional external beam radiotherapy (cEBRT) and stereotactic body radiotherapy (SBRT) are commonly used treatment options for relieving metastatic bone pain. The effectiveness of SBRT compared with cEBRT in pain relief has been a subject of debate, and conflicting results have been reported. To compare the effectiveness associated with SBRT vs cEBRT for relieving metastatic bone pain. A structured search was performed in the PubMed, Embase, and Cochrane databases on June 5, 2023. Additionally, results were added from a new randomized clinical trial (RCT) and additional unpublished data from an already published RCT. Comparative studies reporting pain response after SBRT vs cEBRT in patients with painful bone metastases. Two independent reviewers extracted data from eligible studies. Data were extracted for the intention-to-treat (ITT) and per-protocol (PP) populations. The study is reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Overall and complete pain response at 1, 3, and 6 months after radiotherapy, according to the study's definition. Relative risk ratios (RRs) with 95% CIs were calculated for each study. A random-effects model using a restricted maximum likelihood estimator was applied for meta-analysis. There were 18 studies with 1685 patients included in the systematic review and 8 RCTs with 1090 patients were included in the meta-analysis. In 7 RCTs, overall pain response was defined according to the International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). The complete pain response was reported in 6 RCTs, all defined according to the ICPRE. The ITT meta-analyses showed that the overall pain response rates did not differ between cEBRT and SBRT at 1 (RR, 1.14; 95% CI, 0.99-1.30), 3 (RR, 1.19; 95% CI, 0.96-1.47), or 6 (RR, 1.22; 95% CI, 0.96-1.54) months. However, SBRT was associated with a higher complete pain response at 1 (RR, 1.43; 95% CI, 1.02-2.01), 3 (RR, 1.80; 95% CI, 1.16-2.78), and 6 (RR, 2.47; 95% CI, 1.24-4.91) months after radiotherapy. The PP meta-analyses showed comparable results. In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT. More patients had complete pain alleviation after SBRT, suggesting that selected subgroups will benefit from SBRT.

Altered gray matter volume and functional connectivity in lung cancer patients with bone metastasis pain.

Bone metastasis pain (BMP) is a severe chronic pain condition. Our previous studies on BMP revealed functional brain abnormalities. However, the potential effect of BMP on brain structure and function, especially gray matter volume (GMV) and related functional networks, have not yet been clearly illustrated. Voxel-based morphometry and functional connectivity (FC) analysis methods were used to investigate GMV and intrinsic FC differences in 45 right-handed lung cancer patients with BMP(+), 37 lung cancer patients without BMP(-), and 45 healthy controls (HCs). Correlation analysis was performed thereafter with all clinical variables by Pearson correlation. Compared to HCs, BMP(+) group exhibited decreased GMV in medial frontal gyrus (MFG)and right middle temporal gyrus (MTG). Compared with BMP(-) group, BMP(+) group exhibited reduced GMV in cerebelum_6_L and left lingual gyrus. However, no regions with significant GMV differences were found between BMP(-) and HCs groups. Receiver operating characteristic analysis indicated the potential classification power of these aberrant regions. Correlation analysis revealed that GMV in the right MTG was positively associated with anxiety in BMP(+) group. Further FC analysis demonstrated enhanced interactions between MFG/right MTG and cerebellum in BMP(+) patients compared with HCs. These results showed that BMP was closely associated with cerebral alterations, which may induce the impairment of pain moderation circuit, deficits in cognitive function, dysfunction of emotional control, and sensorimotor processing. These findings may provide a fresh perspective and further neuroimaging evidence for the possible mechanisms of BMP. Furthermore, the role of the cerebellum in pain processing needs to be further investigated.

The Inpatient Consultation Experience in Radiation Oncology: A Contemporary Evaluation of a Single Academic Institution

Participating in an inpatient consultation service is an essential aspect of radiation oncology residency training. However, there are no reports in the literature describing the inpatient on-call experience. To better describe the clinical burden and define the learning opportunities associated with inpatient consultation service participation, inpatient on-call data were tracked and assessed. From July 1, 2022, through Dec. 31, 2022, radiation oncology residents covering the on-call pager for the inpatient consultation service spanning two hospitals at a single academic institution prospectively self-reported the total number of pages, new consultations, inpatient treatment starts, and treatment indications. Patient billing records and paging logs were reviewed to confirm self-reported cases and track the number of business days between simulation and the first fraction of treatment. A new inpatient consultation was defined as a novel encounter requiring independent evaluation; as such, patients admitted during an ongoing course of radiotherapy who continued the planned course while inpatient were not included. During the initial six months of tracking, on-call residents received a total of 607 pages with an average of 23.1 pages per week (range: 14-38). Of these pages, 212 were for new inpatient consultations with an average of 8.1 consultations per week (range: 2-15). Out of these 212 new consultations, 75 patients (35%) were treated on an inpatient basis. Nine patients (12%) received their first fraction of treatment on the same day as simulation, 13 (17%) on the next day, 11 (15%) two days after, 22 (29%) three days after, and 20 (27%) four or more days after simulation. The most common indications for urgent treatment were malignant spinal cord compression (27%), brain metastases (24%), tumor-related bleeding (8%), malignant obstruction of the airway or vasculature (8%), painful bone metastases (7%), and heterotopic ossification prophylaxis (7%). The most common primary sites of disease were leukemia/lymphoma (16%), gastrointestinal (13%), breast (11%), lung (9%), gynecologic (9%), sarcoma (9%), and benign (9%). Each individual resident's caseload differed greatly in quantity, indication, treatment site, and primary site over this six-month time period. In this longitudinal analysis at a single academic institution, the radiation oncology inpatient consultation service experience was highly variable and diverse in clinical volume and treatment indication on a week-to-week and resident-to-resident basis. Exposure to radiation oncology emergencies is a vital component of residency training. However, the unpredictable nature of inpatient on-call scenarios can lead to variable educational experiences. Tracking inpatient on-call cases during residency may help identify areas needing improvement to enhance both patient care and residency training.

Efficacy of 153Sm-EDTMP on Bone Pain Palliation in Metastatic Patients: Breast and Prostate Cancers

Purpose: This study aimed to evaluate the effect of samarium-153-EDTMP (153Sm-EDTMP) on pain relief bone metastases of Breast Cancer (BC) and Prostate Cancer (PC) patients.
 Materials and Methods: Thirty patients aged 40-77 years (62.6±10.2 years) with intractable metastatic bone pain were included in the current study. A checklist of patient information and a standard questionnaire for the assessment of pain and quality of life were completed before and after four and eight week’s palliative treatment with 37 MBq/kg of 153Sm-EDTMP. To analyse the data, parametric and non-parametric tests were used in SPSS software.
 Results: Twelve females with BC (40%) and 18 males with PC (60%) were included. Four and eight weeks after palliative treatment of 153Sm-EDTMP, the mean pain score reduction and quality of life were statistically increased compared to before the intervention (P-value < 0.05). Notably, the amount of pain reduction in the fourth week was more than in the eighth week; however, the quality of life was better in the eighth week, without significant variation (P-value <0.05). In addition, there was no statistically significant relationship between pain reduction and the type of primary diseases, BC, and PC (P-value >0.05).
 Conclusion: The injection of 153Sm-EDTMP had therapeutic efficacy for bone pain palliation in patients with diffuse bone metastases at the end of the 4th and 8th week post-infusion.

Comparison of twice weekly palliative RT versus continuous hypofractionated palliative RT for painful bone metastases.

Palliative hypofractionated radiotherapy (RT) is an effective mode of treating painful bone metastasis. While 8 Gy single fraction radiation is often effective for the same, for complicated bone metastases a protracted fractionated regimen is preferred, of which 30 Gy/10#/2weeks or 20 Gy/5#/1 week are the most common worldwide. However such schedules add to the burden of already overburdened radiation treatment facilities in a busy center, wherein alternative logistic favourable schedules with treatment on weekends are preferred. Here we compare the efficacy of a twice weekly schedule to that of standard continuous 20 Gy/5 #/1 week schedule in terms of pain relief, response and quality of life. A prospective non randomized study was undertaken from Jan 2018 to May 2019, wherein eligible patients of complicated bone metastases received palliative radiotherapy of 20 Gy/5#, either continuously for 5 fractions from Monday to Saturday or twice weekly, Saturday and Wednesday, starting on a Saturday over about 2 weeks. Pain relief was assessed by the Visual Analogue Scale (VAS) and FACES pain scale recorded prior to starting palliative RT and at 4 weeks, 3 months and 6 months. Thirteen patients received continuous Hypofractionated RT while 16 received it in a twice weekly schedule. Spine was the most common site receiving palliative Radiation (27/29), while breast cancer was the most common primary (16/29). The demographic and the baseline characteristics were comparable. The mean pain score decline at 4 weeks was 2.56 ± 1.1 and 2.71 ± 0.52 in the 5-day and the two-week schedule, respectively (p = 0.67). A twice weekly schedule over about two weeks was found to be equivalent in pain control and response to the standard fractionated palliative radiation and, thus, can be safely employed in resource constrained, busy radiotherapy centers.

What did COVID-19 pandemics teach us about single-fraction radiotherapy for painful bone metastases-State of the art or undertreatment?

Choosing the optimal treatment approach for patients with painful bone metastases during the COVID-19 pandemic became challenging. A simple technique, single fraction radiotherapy was recommended for these patients usually referring to bone metastases as a single entity, although it is a very heterogeneous group of patients. This study aimed to analyze the response to palliative single fraction radiotherapy in relation to age, performance status, primary tumor, histopathology, and bone localization in the group of patients with painful bone metastases. A clinical, prospective, non-randomized study was conducted at the Institute for Oncology and Radiology of Serbia, which included 64 patients with noncomplicated, painful bone metastases who underwent palliative, pain-relieving radiation therapy with a single tumor dose of 8Gy in a single hospital visit. Response to treatment was patient reported via telephone interview using visual analog scale. The response assessment was based on the international consensus panel of radiation oncologists. In the entire group of patients, 83% responded to radiotherapy. No statistically significant difference was observed in response to therapy, time to reach the maximum response, degree of pain reduction, nor in response duration depending on the patient's age, performance status, the primary origin of the tumor, histopathology, or location of the metastasis (bone) that was irradiated. Regardless of clinical parameters, palliative radiotherapy with a single dose of 8Gy can be considered very effective in quick pain relief in patients with noncomplicated painful bone metastases. Single fraction radiotherapy in a single hospital visit, as well as patient-reported outcome for these patients may be considered favorable beyond Covid pandemics.

The current role of nuclear medicine in breast cancer.

Breast cancer is the most common cancer in females worldwide. Nuclear medicine plays an important role in patient management, not only in initial staging, but also during follow-up. Radiopharmaceuticals to study breast cancer have been used for over 50 years, and several of these are still used in clinical practice, according to the most recent guideline recommendations.In this critical review, an overview of nuclear medicine procedures used during the last decades is presented. Current clinical indications of each of the conventional nuclear medicine and PET/CT examinations are the focus of this review, and are objectively provided. Radionuclide therapies are also referred, mainly summarising the methods to palliate metastatic bone pain. Finally, recent developments and future perspectives in the field of nuclear medicine are discussed. In this context, the promising potential of new radiopharmaceuticals not only for diagnosis, but also for therapy, and the use of quantitative imaging features as potential biomarkers, are addressed.Despite the long way nuclear medicine has gone through, it looks like it will continue to benefit clinical practice, paving the way to improve healthcare provided to patients with breast cancer.

Dosimetric Comparison of Different Radionuclides Used in Metastatic Bone Disease Treatment.

This study aimed to determine the critical organ doses in 223Ra, 89Sr, 153Sm, and 32P treatments via dosimetry using the phantoms. The OpenDose was used to calculate S values (mGy MBq-1s-1) for bone surface, red bone marrow, urinary bladder wall, testes, ovaries, uterus, and kidneys using male (ICRP110AM) and female (ICRP110AF) phantoms. The cortical thoracic spine was modeled as metastasis. Moreover, the absorbed doses were computed via MIRD formalism according to the activities of 3.3, 148, 2220, and 370 MBq for ICRP110AM and 4.015, 148, 2701, and 370 MBq for ICRP110AF in 223Ra, 89Sr, 153Sm, and 32P treatments, respectively. Whilst the maximum bone surface doses were found as 1.22E+02 and 8.51E+01 mGy at 32P treatment, the minimum bone surface doses were calculated as 8.42E-02 and 8.26E-02 mGy at 223Ra. In terms of the comparison of red bone marrow, urinary bladder wall, and kidney doses, 153Sm and 89Sr treatments showed maximum doses of 2.45E-03, 1.50E-03, 3.23E-07, 5.45E-06, 1.20E-01, 1.49E-01 mGy and the minimum doses with 3.46E-05, 1.99E-05, 6.33E-09, 8.77E-09, 1.19E-04, 1.15E-04 mGy, respectively. The maximum testes and ovaries-uterus doses were found as 6.17E-08, 7.40E-06, 3.46E-07 mGy in 153Sm treatment, and minimum testes and ovaries doses as 1.70E-09, 1.34E-07 mGy in 223Ra. The minimum uterus dose with 7.03E-09 mGy was determined in 89Sr treatment. It is observed that 223Ra produces low critical organ doses in the treatment of painful bone metastasis. Among the beta-emitting radionuclides, 89Sr stands out by showing optimal dosimetric results.

PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.

Radiopharmaceuticals have been utilized for men with advanced prostate cancer for decades. Older agents, seldom used today, provided palliation for bone metastatic pain. In 2013, the alpha emitter radium-223 provided a catalyst for the field by prolonging survival in men with metastatic castrate-resistant prostate cancer (mCRPC). Recently radioisotopic therapies have gained further interest with the development and FDA approval of 177 lutetium (177Lu)-PSMA-617 (also known as lutetium Lu-177 vipivotide tetraxetan). This agent targets the prostate-specific membrane antigen (PSMA) expressed on the cell surface of prostate cancer cells with a beta-emitting isotope (177Lu). This clinical review summarizes key data reported from 177Lu-PSMA-617 clinical trials, including data from the phase III VISION trial which were pivotal for regulatory approval in heavily pretreated PSMA-PET-positive patients with mCRPC. The current field of radiopharmaceuticals is in a rapid state of flux. Additional phase III trials are now ongoing in patients with mCRPC and in patients with metastatic castrate-sensitive prostate cancer. The results from these potential practice-changing trials are highly anticipated. Earlier phase trials (I/II) are in progress examining combination therapies, radiolabeled monoclonal antibodies, and novel compounds. Studies of PSMA-targeted therapies using both beta emitters such as 177Lu and novel alpha emitters such 225 actinium are in progress. During the next decade, radiopharmaceuticals will likely play a central role in the management of patients with advanced prostate cancer.

Cryoablation for the Palliation of Painful Bone Metastasis: A Systematic Review.

Cryoablation is a minimally invasive procedure to treat painful bone metastases in patients with cancer. We designed a systematic review to understand the safety and effects of cryoablation on the pain and quality of life (QoL) of cancer patients. We searched PubMed, ISI, Cochrane library, and Scopus databases using the keywords "Cryoablation," "Pain," and "Bone metastasis." Inclusion criteria were: (1) Original studies published until September 8, 2022; (2) studies on patients over 18years and affected by bone metastasis; (3) bone metastasis treated with stand-alone cryoablation; (4) studies reporting patients' pain before and at least one time-point following cryoablation; and (5) English-language studies. We screened 696 articles. Fifteen studies on 376 patients were included. Time points for pain assessment ranged from 1day to 6months. Spine was the most frequent treated location. All studies reported a significant pain reduction between 1day and 6months after the cryoablation procedure. The highest mean difference between pre- and post-procedure scores was 5.8 (VAS scale) after 4 weeks. The overall rate of minor and major complications was 12.74%. Cryoablation improved the QoL of cancer patients and decreased the need for analgesics. Cryoablation is a safe and useful procedure for palliating painful bone metastasis and increasing the QoL of cancer patients. Future studies should adopt a standardized pain reporting scale to allow for meta-analysis.

Prospective surveillance of patients after palliative radiation for painful bone metastases: a feasibility study.

Bone metastasis is the most common cause of cancer-related pain. Radiation therapy (RT) can provide successful palliation but there is currently no consensus for surveillance after palliative radiation. This study aimed to assess the feasibility of surveillance after RT for painful bone metastases. The study took place in an academic cancer center. Patient feasibility measures included % of calls answered, ease of recruitment and study retention. Clinician measures included % of calls made within 3 days, call time and qualitative feedback. Patients were identified with a painful bone metastasis treated with RT. The bone metastasis had a worst pain score of at least 4 (0-10 scale), with pain localized to a radiographically confirmed lesion. Patients were called at weeks 1, 4 and 8 following RT. Pain response and opioid use were assessed. Quality of life was assessed using a validated questionnaire. Descriptive statistics were used to assess if these metrics were met for patients and clinicians over 8 weeks post-RT. Twenty patients were consented: 14 participants completed treatment and were not hospitalized or deceased prior to week 1. The patients were 50% male and 50% female. Recruitment was completed quickly, with no patients withdrawing. Response rate was week 1: 85% week 4: 83% and week 8: 83%. Six patients were referred back to their provider for pain management. Calls were made to patients within 3 days a median of 63% of the time (range, 40-82%), with a median call time of 16 (range, 8-42) minutes. Call lengths were longer for patients who required interpretation. Nurse feedback highlighted length of call and nursing time available as limitations. All patient feasibility measures were met. Six patients required further pain management, highlighting a need for improved follow up post-RT for bone metastases. Staffing challenges for this intervention must be overcome.

Cervical Kyphoplasty and OsteoCoolTM Radiofrequency Ablation for Painful Cervical Metastasis: A Case Report and Novel Approach for Pain Relief

Background: Metastatic bone pain is very difficult to treat and challenging to manage for health care professionals. Kyphoplasty or vertebroplasty has been used to reinstate the height of a compressed fractured vertebral body. OsteoCoolTM radiofrequency ablation (RFA) is a relatively new ablation technique and at present, current literature only supports its role for thoracic and lumbar vertebral metastases. Case Report: In the present case report, we utilized OsteoCoolTM RFA using anterolateral cervical kyphoplasty for cervical spinal metastasis with intractable pain and limited range of motion. Discussion: A successful palliative treatment was provided with a combination of kyphoplasty and OsteoCoolTM RFA. The patient has had great relief of pain and an increased range of motion of the cervical spine post procedure. Conclusion: Anterolateral balloon kyphoplasty provides stability to fractured vertebrae and when combined with OsteoCoolTM RFA, it potentially can provide effective pain relief in patients who have failed radiation and for whom surgery is contraindicated. Key words: Cervical kyphoplasty, cervical vertebral metastasis, kyphoplasty, OsteoCoolTM

Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial

BackgroundCancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases.Methods/designThe FURTHER trial is an international multicenter, three-armed randomized controlled trial. A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or combined treatment with EBRT followed by MR-HIFU. During a follow-up period of 6 months, patients will be contacted at eight time points to retrieve information about their level of pain, QoL, and the occurrence of (serious) adverse events. The primary outcome of the trial is pain response at 14 days after start of treatment. Secondary outcomes include pain response at 14 days after trial enrolment, pain scores (daily until the 21st day and at 4, 6, 12 and 24 weeks), toxicity, adverse events, QoL, and survival. Cost-effectiveness and cost-utility analysis will be conducted.DiscussionThe FURTHER trial aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU—alone or in combination with EBRT—compared to EBRT to relieve CIBP. The trial will be performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium.Trial registrationThe FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13–01-2020.