Biological 18[F]-FDG-PET image-guided dose painting by numbers for painful uncomplicated bone metastases: A 3-arm randomized phase II trial

Berwouts, Dieter; Wolf, Katrien De; Lambert, Bieke; Bultijnck, Renée; Neve, Wilfried De; Lobel, Lizzy De; Jans, Lennart; Goetghebeur, Els; Speleers, Bruno; Olteanu, L; Madani, Indira; Goethals, Ingeborg; Ost, Piet

doi:10.1016/j.radonc.2015.04.022

Cited by 23 publications

(65 citation statements)

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“…Irradiation of healthy tissues also activates important transcription factors, activating a wide spectrum of genes implicated in inflammation, anti‐apoptosis, invasion and angiogenesis pathways, which confer tumour cell radioresistance . This hypothesis is supported by our clinical results with a pain response of 80% with DPBN‐8 Gy compared to 53% with ConvRT . Theoretically, the dose to the normal tissue might be further reduced by limiting the target to the 18 F‐FDG‐avid regions, excluding the non‐ 18 F‐FDG‐avid regions from the GTV‐concept.…”

Section: Discussionsupporting

confidence: 66%

“…Patients were randomly assigned (1:1:1) to receive either 8 Gy in a single fraction with conventionally planned radiotherapy (ConvRT‐8 Gy, arm A) or 8 Gy in a single fraction with dose‐painting‐by‐numbers (DPBN) (dose range between 6 and 10 Gy) (DPBN‐8 Gy, arm B) or 16 Gy in a single fraction with DPBN (dose range between 14 and 18 Gy) (DPBN‐16 Gy, arm C). The overall pain response reported in our phase II trial was 53% for ConvRT compared to 80% for DPBN‐8 Gy and 60% for DPBN‐16 Gy . Additionally, patients treated in DPBN‐8 Gy showed a significant improvement in several quality of life subcategories compared to ConvRT‐8 Gy .…”

Section: Introductionmentioning

confidence: 72%

“…The overall pain response reported in our phase II trial was 53% for ConvRT compared to 80% for DPBN-8 Gy and 60% for DPBN-16 Gy. 17 Additionally, patients treated in DPBN-8 Gy showed a significant improvement in several quality of life subcategories compared to ConvRT-8 Gy. 17 Consequently, DPBN-8 Gy was selected for further evaluation in phase III.…”

Section: Introductionmentioning

confidence: 92%

“…17 Additionally, patients treated in DPBN-8 Gy showed a significant improvement in several quality of life subcategories compared to ConvRT-8 Gy. 17 Consequently, DPBN-8 Gy was selected for further evaluation in phase III. Here, the delineation and dosimetric results of the phase II trial are reported (secondary endpoints).…”

Section: Introductionmentioning

confidence: 92%

“…15 This hypothesis is supported by our clinical results with a pain response of 80% with DPBN-8 Gy compared to 53% with ConvRT. 17 Theoretically, the dose to the normal tissue might be further reduced by limiting the target to the 18 F-FDG-avid regions, excluding the non-18 F-FDG-avid regions from the GTV-concept. With the DPBN-16 Gy experimental arm, we showed the possibility to double the prescribed dose to the GTV (16 Gy) without increase in normal tissue dose compared to conventional radiotherapy ( Table 2).…”

Section: Structurementioning

confidence: 99%

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Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

et al. 2016

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Section: Discussionsupporting

confidence: 66%

Section: Introductionmentioning

confidence: 72%

Section: Introductionmentioning

confidence: 92%

Section: Introductionmentioning

confidence: 92%

Section: Structurementioning

confidence: 99%

See 3 more Smart Citations

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

et al. 2016

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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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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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Biological 18[F]-FDG-PET image-guided dose painting by numbers for painful uncomplicated bone metastases: A 3-arm randomized phase II trial

Cited by 23 publications

References 35 publications

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

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

Stereotactic Body and Conventional Radiotherapy for Painful Bone Metastases

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Biological 18[F]-FDG-PET image-guided dose painting by numbers for painful uncomplicated bone metastases: A 3-arm randomized phase II trial

Cited by 23 publications

References 35 publications

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (18F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (18F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

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

Stereotactic Body and Conventional Radiotherapy for Painful Bone Metastases

Contact Info

Product

Resources

About

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial

Variations in target volume definition and dose to normal tissue using anatomic versus biological imaging (¹⁸F‐FDG‐PET) in the treatment of bone metastases: results from a 3‐arm randomized phase II trial