STAT RAD: Prospective Dose Escalation Clinical Trial of Single Fraction Scan-Plan-QA-Treat Stereotactic Body Radiation Therapy for Painful Osseous Metastases

Muller, Donald A.; Wages, Nolan A.; Wilson, Dan; Dutta, Sunil W.; Alonso, Clayton E.; Handsfield, Lydia L.; Chen, Quan; Smith, Amy; Romano, Kara D.; Janowski, Einsley-Marie; Showalter, Timothy N.; Larner, James M.; Read, Paul W.

doi:10.1016/j.prro.2020.03.008

Cited by 12 publications

(11 citation statements)

References 28 publications

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“…There is renewed interest in single-fraction dose escalation with the goal of improved pain response or, in some patients, more durable local control, with mixed results in recent trials. [13][14][15] The line between treatment for palliative versus definitive intent may seem blurred in patients who fit the evolving definition of oligometastasis. 16,17 Indeed, numerous factors must be considered when determining an appropriate palliative treatment course-tumor histology, size, and location, nearby critical structures, overall disease burden, patient performance status, patient preference, and others.…”

Section: Discussionmentioning

confidence: 99%

National Quality Measure Compliance for Palliative Bone Radiation Among Patients With Metastatic Non–Small Cell Lung Cancer

Grant

Smith

Colbert

et al. 2021

Journal of the National Comprehensive Cancer Network

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Background: There exists wide practice variability in palliative treatment schedules for bone metastases. In an effort to reduce variation and promote high-quality, cost-conscious care, the National Quality Forum (NQF) endorsed measure 1822 in 2012. This measure recommends the use of 30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, or 8 Gy in a single fraction for palliative radiation for bone metastases. We report on longitudinal compliance with this measure. Methods: Using the National Cancer Database, patients with metastatic thoracic non–small cell lung cancer diagnosed between 2004 and 2016 who received radiation therapy for bony sites of metastatic disease were identified. Treatment courses fitting 1 of the 4 recommended schedules under NQF 1822 were coded as compliant. Rates of compliance by patient, tumor, and treatment characteristics were analyzed. Results: A total of 42,685 patients met the criteria for inclusion. Among all patients, 60.2% of treatment courses were compliant according to NQF 1822. Compliance increased over time and was highest for treatments to the extremity (69.8%), lowest for treatments to the skull or head (48.8%), and higher for academic practice (67.1%) compared with community (56.0%) or integrated network facilities (61.2%). On multivariable analysis, predictors of NQF 1822 compliance included year of diagnosis after 2011, treatment to an extremity, or treatment at an academic facility. Of noncompliant treatment courses, extended fractionation (≥11 fractions) occurred in 62.6% and was more common before 2012, in community practice, and for treatments of the skull or head. Conclusions: Among patients treated for metastatic non–small cell lung cancer, compliance with NQF 1822 increased over time. Although extended fractionation constituted a majority of noncompliant treatment courses, a substantial proportion also involved shorter courses.

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Section: Discussionmentioning

confidence: 99%

National Quality Measure Compliance for Palliative Bone Radiation Among Patients With Metastatic Non–Small Cell Lung Cancer

Grant

Smith

Colbert

et al. 2021

Journal of the National Comprehensive Cancer Network

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“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement). Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO).…”

Section: Resultsmentioning

confidence: 99%

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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ImportanceApproximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications.ObjectiveTo investigate the use and reporting of PROs in clinical trials of palliative radiotherapy.Evidence ReviewThis preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines.FindingsAmong 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score.Conclusions and RelevanceIn this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

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“…In a recent prospective study, an expedited Scan-Plan-QA-Treat workflow for single-fraction SBRT, termed "STAT RAD", actually reduced expenditures compared with 10-fraction conventional RT for bone metastases. 13 Meanwhile, in 2014, the American Society for Clinical Oncology recommended moving toward bundled payments in an effort to standardize high-quality, value-based cancer care. 22 Then, in 2019, with radiation oncology identified as a specialty exceeding the sustainable growth rate, 23 the CMS proposed a new bundled payment model (RO-APM).…”

Section: Discussionmentioning

confidence: 99%

“…Meanwhile, potential costeffective solutions to delivering SBRT have been reported. 13 Therefore, an updated comparative analysis of trends in practice and associated expenditures is warranted.…”

Section: Introductionmentioning

confidence: 99%

Trends in Radiation Therapy for Bone Metastases, 2015 to 2017: Choosing Wisely in the Era of Complex Radiation

Santos

Lapen

Zhang

et al. 2021

International Journal of Radiation Oncology*Biology*Physics

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Purpose: Guidelines recommend short-course (10 fractions) external-beam radiation therapy (EBRT) for bone metastases. Stereotactic body radiation therapy (SBRT) may also improve outcomes; however, routine use is not recommended outside clinical trials. We assessed national radiation therapy trends in complex techniques for bone metastases and associated expenditures. Methods and Materials: Using a claims-based Medicare data set covering 84% of beneficiaries, we assessed the relative proportion of all radiation episodes represented by bone metastases. We then evaluated use of short-course and long-course (>10 fractions) EBRT, intensity modulated radiation therapy (IMRT), and SBRT for bone metastases in hospital-affiliated outpatient (OPD) or freestanding (FREE) facilities. We assessed differences using c 2 d or Wilcoxon rank sum tests for categorical and continuous variables, respectively. We identified associations with modality, fractionation, and expenditures using multivariable logistic/linear regression. Results: Among 467,781 radiation episodes for 17 cancer diagnoses, the overall proportion of episodes dedicated to bone metastases (9.4%) was stable from 2015 to 2017, although treatments were increasing in the hospital-affiliated outpatient CME NotedAn online CME test for this article can be taken at https:// academy.astro.org.

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STAT RAD: Prospective Dose Escalation Clinical Trial of Single Fraction Scan-Plan-QA-Treat Stereotactic Body Radiation Therapy for Painful Osseous Metastases

Cited by 12 publications

References 28 publications

National Quality Measure Compliance for Palliative Bone Radiation Among Patients With Metastatic Non–Small Cell Lung Cancer

National Quality Measure Compliance for Palliative Bone Radiation Among Patients With Metastatic Non–Small Cell Lung Cancer

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Trends in Radiation Therapy for Bone Metastases, 2015 to 2017: Choosing Wisely in the Era of Complex Radiation

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