Clinical endpoints in trials of palliative radiotherapy: A systematic meta-research analysis

Fabian, Alexander; Domschikowski, Justus; Letsch, Anne; Schmalz, Claudia; Freitag‐Wolf, Sandra; Dunst, Jürgen; Krug, David

doi:10.1016/j.radonc.2022.07.013

Cited by 5 publications

(5 citation statements)

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“…Moreover, we did not collect data on local control or radiographic response rates precluding analyses of progression-free survival. However, this approach was predefined as PRO data and overall survival are widely considered as patient-centered endpoints in prospective studies [33] , [34] . Furthermore, a distribution-based MID across symptom domains has been used commonly in previous studies and offers an intuitive starting point [17] .…”

Section: Discussionmentioning

confidence: 99%

The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer – Results of a multicenter prospective cohort study

Weiß¹,

Domschikowski²,

Krug³

et al. 2023

Clinical and Translational Radiation Oncology

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Section: Discussionmentioning

confidence: 99%

The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer – Results of a multicenter prospective cohort study

Weiß¹,

Domschikowski²,

Krug³

et al. 2023

Clinical and Translational Radiation Oncology

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“…Prospective (randomized) trials comprising of these very old cancer with bone metastases are necessary to increase the scientific evidence on the ideal management for these special patient population [ 71 ]. Ideally, these studies should include QoL and other patient-reported outcomes as endpoints [ 72 ].…”

Section: Discussionmentioning

confidence: 99%

Palliative radiotherapy of bone metastases in octogenarians: How do the oldest olds respond? Results from a tertiary cancer center with 288 treated patients

et al. 2022

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Background Accompanied by the demographic change, the number of octogenarian cancer patients with bone metastases will increase in the future. Palliative radiotherapy constitutes an effective analgesic treatment; however, as pain perception and bone metabolism change with increasing age, the analgesic efficacy of radiotherapy may be altered in elderly patients. We therefore investigated the treatment outcomes of palliative radiotherapy for bone metastases in octogenarians. Methods Patients between 80 and 89 years undergoing radiotherapy for bone metastases between 2009 and 2019 at a tertiary cancer center were analyzed for patterns-of-care, pain response and overall survival (OS). Logistic regression analyses were carried out to examine parameters associated with pain response, and Cox analyses were conducted to reveal prognostic parameters for OS. Results A total of 288 patients with 516 irradiated lesions were included in the analysis. The majority (n = 249, 86%) completed all courses of radiotherapy. Radiotherapy led to pain reduction in 176 patients (61%) at the end of treatment. Complete pain relief at the first follow-up was achieved in 84 patients (29%). Bisphosphonate administration was significantly associated with higher rates of pain response at the first follow-up (p < 0.05). Median OS amounted to 9 months, and 1-year, 2-year and 3-year OS were 43%, 28% and 17%. In the multivariate analysis, ECOG (p < 0.001), Mizumoto score (p < 0.01) and Spinal Instability Neoplastic Score (SINS) (p < 0.001) were independent prognosticators for OS. Conclusion Palliative radiotherapy for bone metastases constitutes a feasible and effective analgesic treatment in octogenarian patients. ECOG, Mizumoto score and SINS are prognosic variables for survival and may aid treatment decisions regarding radiotherapy fractionation in this patient group. Single-fraction radiotherapy with 8 Gy should be applied for patients with uncomplicated bone metastases and poor prognosis. Prospective trials focusing on quality of life of these very old cancer patients with bone metastases are warranted to reveal the optimal radiotherapeutic management for this vulnerable population.

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“… 15 We followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses ( PRISMA ) reporting guideline wherever appropriate in the literature search and data extraction. A study protocol was preregistered online 16 and is available in the eAppendix 1 in the Supplement . In addition to the aforementioned objectives, a detailed analysis of end points in trials of palliative radiotherapy in general was another objective per protocol, which are reported elsewhere.…”

Section: Methodsmentioning

confidence: 99%

“…In addition to the aforementioned objectives, a detailed analysis of end points in trials of palliative radiotherapy in general was another objective per protocol, which are reported elsewhere. 17 …”

Section: Methodsmentioning

confidence: 99%

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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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Clinical endpoints in trials of palliative radiotherapy: A systematic meta-research analysis

Cited by 5 publications

References 35 publications

The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer – Results of a multicenter prospective cohort study

The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer – Results of a multicenter prospective cohort study

Palliative radiotherapy of bone metastases in octogenarians: How do the oldest olds respond? Results from a tertiary cancer center with 288 treated patients

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

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