OC-0762 Single fraction SBRT vs 3D-CRT for painful bone metastases: a single-blind phase 3 RCT (NCT03831243)

Mercier, Carole; Billiet, Charlotte; Kerf, Geert De; Vandecasteele, Katrien; Ost, Piet; Joye, Ines; Vermeulen, Peter; Dirix, Luc; Lievens, Y.; Verellen, Dirk; Dirix, Piet

doi:10.1016/s0167-8140(23)08703-0

Cited by 3 publications

(26 citation statements)

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“…After title and abstract screening, 92 studies needed full-text screening, of which 17 studies 7 , 8 , 9 , 10 , 11 , 12 , 13 , 19 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 were included in the review. Additionally, we included 1 recently completed RCT 20 and the unpublished complete pain response data from an already published RCT 8 (eFigure 1 in Supplement 1 ). Finally, 18 comparative studies 7 , 8 , 9 , 10 , 11 , 12 , 13 , 19 , 20 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 were included in the review, with 1685 patients.…”

Section: Resultsmentioning

confidence: 99%

“…Overall survival was comparable among RCTs: Berwouts et al 29 reported a median overall survival of 8 (95% CI, 3.6-12.4) months, Nguyen et al 7 a median of 6.7 (95% CI, 4.6-10.9) months, and Sprave et al 33 a mean of 7.9 months (SD not reported). The overall 3-month survival was 84% in the trial by Pielkenrood et al 8 and in the trial by Mercier et al, 20 it was 88% after…”

Section: Overall Survivalmentioning

confidence: 92%

“…Study protocols were followed up and reference lists from included articles were cross-checked to identify other potential articles. We also included the full results from a recently completed RCT 20 and unpublished data from an already published RCT 8 through collaboration with the investigators.…”

Section: Methodsmentioning

confidence: 99%

“…50 An individual patient data meta-analysis offers numerous advantages compared with the use of summary data, including enhancement of data quality, enabling different forms of outcomes to be combined, and increased precision of statistical techniques. 51 We therefore aim to conduct an individual patient data meta-analysis of at least the trials conducted in Belgium 20,29 and the Netherlands 8,52 to identify subgroups who benefit from SBRT.…”

Section: Limitationsmentioning

confidence: 99%

“… 14 , 15 , 16 , 17 , 18 In our review, we included the largest RCT 19 to our knowledge and an eighth RCT on this subject. 20 Additionally, we assessed unpublished results from an RCT previously conducted by our team. 8 Using these data, we conducted a systematic review and meta-analysis with the updated trial data to evaluate the comparative effectiveness associated with SBRT vs cEBRT for relieving metastatic bone pain.…”

Section: Introductionmentioning

confidence: 99%

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Stereotactic Body and Conventional Radiotherapy for Painful Bone Metastases

Bindels,

Mercier,

Gal

et al. 2024

JAMA Netw Open

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ImportanceConventional 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.ObjectiveTo compare the effectiveness associated with SBRT vs cEBRT for relieving metastatic bone pain.Data SourcesA 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.Study SelectionComparative studies reporting pain response after SBRT vs cEBRT in patients with painful bone metastases.Data Extraction and SynthesisTwo 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.Main Outcomes and MeasuresOverall 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.ResultsThere 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.Conclusions and RelevanceIn 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.

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