Department of Radiation Oncology, University Hospital Schleswig-Holstein, 24105 Kiel, Germany.
Department of Radiation Oncology, University Hospital Schleswig-Holstein, 24105 Kiel, Germany.
Radiother Oncol. 2022 Sep;174:123-131. doi: 10.1016/j.radonc.2022.07.013. Epub 2022 Jul 19.
Up to 50% of radiotherapy courses are delivered in palliative intent for various indications. Despite the large number of treated patients, we know little about the choice of endpoints in trials of palliative radiotherapy. Our primary aim was, therefore, to analyze primary endpoints in trials of palliative radiotherapy.
We conducted a pre-registered (https://doi.org/10.17605/OSF.IO/GMCAF) meta-research analysis searching Pubmed/MEDLINE, EMBASE, CENTRAL, and "ClinicalTrials.gov" for clinical trials of palliative radiotherapy published 1990-2020. Endpoints were categorized in "patient-centered endpoints", including overall survival and patient-reported outcomes, and "tumor-centered endpoints" such as local control. The remainder were "other endpoints" including toxicity or observer-rated symptoms. We applied descriptive statistics to summarize data and logistic regression to assess if year of publication predicted the choice of primary endpoints.
Of 7379 records screened, 292 were eligible. Trials were characterized by small sample sizes and use of external beam radiotherapy for metastases or thoracic primaries. Median patient age was 64 and median ECOG was 1. Only 64.4%(145/225) of published trials clearly stated their primary endpoint. Published trials employed a "patient-centered primary endpoint" in 45.5%(66/145) and a "tumor-centered primary endpoint" in 17.3%(25/145) of the cases. There was no statistically significant trend in time for the use of "patient-centered primary endpoints". Registered ongoing trials used a "patient-centered primary endpoint" in 32.8%(22/67) and a "tumor-centered primary endpoint" in 26.9%(18/67) of the cases.
Although "patient-centered primary endpoints" appear relatively prevalent in published trials of palliative radiotherapy, their use is still suboptimal and appears to be lower in currently ongoing trials.
多达 50%的放疗疗程是为各种适应证进行姑息治疗。尽管接受治疗的患者数量众多，但我们对姑息性放疗试验的终点选择知之甚少。因此，我们的主要目的是分析姑息性放疗试验的主要终点。
我们进行了一项预先注册的元研究分析（https://doi.org/10.17605/OSF.IO/GMCAF），在 1990 年至 2020 年间，我们在 Pubmed/MEDLINE、EMBASE、CENTRAL 和“ClinicalTrials.gov”上搜索了姑息性放疗的临床试验。终点分为“以患者为中心的终点”，包括总生存期和患者报告的结果，以及“以肿瘤为中心的终点”，如局部控制。其余的是“其他终点”，包括毒性或观察者报告的症状。我们应用描述性统计来总结数据，并应用逻辑回归来评估出版年份是否预测主要终点的选择。
在筛选出的 7379 条记录中，有 292 条符合条件。这些试验的特点是样本量小，且使用外部束放疗治疗转移或胸部原发肿瘤。中位患者年龄为 64 岁，中位 ECOG 为 1 分。只有 64.4%（145/225）的已发表试验明确了其主要终点。发表的试验中，有 45.5%（66/145）采用了“以患者为中心的主要终点”，17.3%（25/145）采用了“以肿瘤为中心的主要终点”。时间上并没有使用“以患者为中心的主要终点”的统计学显著趋势。正在进行的注册试验中，32.8%（22/67）采用了“以患者为中心的主要终点”，26.9%（18/67）采用了“以肿瘤为中心的主要终点”。
尽管“以患者为中心的主要终点”在姑息性放疗的已发表试验中似乎较为常见，但它们的使用仍不理想，而且在目前正在进行的试验中似乎更低。
