External beam radiation therapy (EBRT) for asymptomatic bone metastases in patients with solid tumors reduces the risk of skeletal-related events (SREs)

Shulman, Rebecca M.; Meyer, Joshua E.; Li, Tianyu; Howell, Krisha

doi:10.21037/apm.2018.10.04

Cited by 18 publications

(19 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…With the goal to develop a robust patient-centered outcome, we therefore selected skeletal related events (SREs), which incorporates pathologic fractures (either from disease or treatment), cord compression, and radiation or surgical intervention. Furthermore, SREs are supported by retrospective data in the setting of radiation for asymptomatic bone metastases [17] and commonly used in the prophylactic setting for prospective trials of medical therapy [29].…”

Section: Discussionmentioning

confidence: 97%

“…On prospective trials, patients undergoing conventional RT for symptomatic bone metastases have fracture rates around 5% [9]. Retrospective studies have shown that RT significantly reduces the risk of SREs in patients with asymptomatic bone metastases [17]. Until the current study, there have been no prospective trials to address the possible benefits of RT to asymptomatic or minimally symptomatic high-risk bone metastases in reducing the risk of the development of SREs.…”

Section: Skeletal-related Eventsmentioning

confidence: 95%

See 1 more Smart Citation

Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

et al. 2020

View full text Add to dashboard Cite

Background In patients with metastatic cancer, the bone is the third-most common site of involvement. Radiation to painful bone metastases results in high rates of pain control and is an integral part of bone metastases management. Up to one-third of inpatient consults are requested for painful bone metastases, and up to 60% of these patients had evidence of these lesions visible on prior imaging. Meanwhile recent advances have reduced potential side effects of radiation. Therefore, there is an opportunity to further improve outcomes for patients using prophylactic palliative radiation to manage asymptomatic bone metastases. Methods/study design In this trial, 74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases will be enrolled and randomized to early palliative radiation or standard of care. This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint. This endpoint was selected to encompass patient-centered outcomes that impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation. Secondary endpoints include hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy. Discussion In this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization. Observations from early patient enrollment have demonstrated robustness of the primary endpoint and need for minor modifications to Bone Pain Index and data collection for opioid use and hospitalizations. With increasing indications for radiation in the oligometastatic setting, this trial aims to improve patient-centered outcomes in the polymetastatic setting. Trial registration ISRCTN Number/Clinical trials.gov, ID:NCT03523351. Registered on 14 May 2018.

show abstract

Section: Discussionmentioning

confidence: 97%

Section: Skeletal-related Eventsmentioning

confidence: 95%

Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

et al. 2020

View full text Add to dashboard Cite

show abstract

“…We will conduct prespecified subgroup analyses for our primary outcomes based on symptomatic and asymptomatic bone metastases. Symptomatic bone metastases are loosely defined as the use of palliative radiotherapy or surgical intervention to relieve pain, incident of new symptomatic pathological bone fractures and spinal cord compression,40 whereas asymptomatic bone metastases are defined as no bone pain and no evidence of pathological fracture or spinal cord compression 41. Additional subgroup analyses will be conducted, if possible, based on the cancer type (breast and prostate cancer vs others), site of bone metastases (vertebral metastasis vs limb metastasis) and publication year (before 2002 vs after 2002) 42…”

Section: Methods and Designmentioning

confidence: 99%

Optimal dose-fractionation schedule of palliative radiotherapy for patients with bone metastases: a protocol for systematic review and network meta-analysis

Tang

Chen

et al. 2020

BMJ Open

View full text Add to dashboard Cite

IntroductionThe optimal dose-fractionation schedule of palliative radiotherapy has been debated in patients with bone metastases. Our objective is to comprehensively compare multiple fraction schedules with single fraction radiotherapy in terms of efficacy and toxicities by performing a systematic review and network meta-analysis.Methods and analysisElectronic searches of titles/abstracts of palliative radiotherapy for bone metastases will be performed, using PubMed, Cochrane Library, Embase,clinical trials, American Society for Therapeutic Radiology and Oncology and European Society of Radiotherapy and Oncology. The primary outcome of interest is the incidence of skeletal-related event following palliative radiotherapy for bone metastases in prospective studies. The risk of bias and quality of evidence will be evaluated based on Cochrane Collaboration’s tool and Grades of Recommendation, Assessment, Development and Evaluation in the network meta-analysis. We will conduct subgroup analysis and sensitivity analysis regardless of heterogeneity estimates.Ethics and disseminationThis study will synthesise the evidence regarding dose-fractionation schedule of palliative radiotherapy in patients with bone metastases. We hope the findings from this study will help clinicians and patients select optimum palliative radiotherapy by identifying the optimal dose-fractionation schedule of palliative radiotherapy with the most value in terms of patient-important outcomes. The evidence obtained from network meta-analysis will help to guide head-to-head research in the future. The results will be disseminated through international conference reports and peer-reviewed manuscripts. Ethics review board is not required for this network meta-analysis.PROSPERO registration numberCRD42019135195.

show abstract

“…Complications of bone metastasis, such as pain, pathologic fracture, and spinal cord compression, are typically managed with radiotherapy and/or surgery. Radiation therapy has been shown to reduce pain in patients with bone metastases [45] and external beam radiation therapy has been shown to delay the onset of skeletal complications in patients with solid tumors and asymptomatic bone metastases [83]. Surgery is used to manage pathologic fractures and spinal cord compression in patients with bone metastases and improves outcomes [84–87].…”

Section: Composite Endpoints Related To Complications Of Bone Metastamentioning

confidence: 99%

The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone

Hussain

Lee

Graff

et al. 2019

Critical Reviews in Oncology/Hematology

View full text Add to dashboard Cite

Bone metastases are a frequent complication of solid tumors, leading to significant skeletal sequelae that negatively impact quality of life and survival. Prevention and management of skeletal-related complications are critical treatment goals in oncology. Endpoints used in clinical trials to evaluate skeletal-related complications have evolved. In contrast to single measures of bone health, contemporary clinical trial endpoints reflect composite measures of skeletal-related complications, and increasingly also survival. In addition, key symptomatic components, which are more reflective of quality of life and the patient experience, are being incorporated. Given the evolution and resulting diversity of the endpoints being used in pivotal trials, it is becoming increasingly relevant to clarify the utility and the potential clinical impact of these measures not only within the context of trials but also in the real-world setting. Here, we describe the development and evolution of skeletal endpoints used in trials, and discuss their clinical relevance.

show abstract

External beam radiation therapy (EBRT) for asymptomatic bone metastases in patients with solid tumors reduces the risk of skeletal-related events (SREs)

Cited by 18 publications

References 0 publications

Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial

Optimal dose-fractionation schedule of palliative radiotherapy for patients with bone metastases: a protocol for systematic review and network meta-analysis

The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone

Contact Info

Product

Resources

About