Gastrointestinal malignancies and supportive care trials: a snapshot of the last two decades.
Gastrointestinal malignancies and supportive care trials: a snapshot of the last two decades.
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胃肠道恶性肿瘤和支持性护理试验：过去二十年的快照。
DOI：
10.1136/bmjspcare-2020-002538
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发表时间：
2022
影响因子：
2.7
通讯作者：
Taniguchi,CullenM
中科院分区：
文献类型：
--
作者：
Kouzy,Ramez;AbiJaoude,Joseph;Minsky,BruceD;Das,Prajnan;Koong,AlbertC;Subbiah,IshwariaM;Ludmir,EthanB;Taniguchi,CullenM
背景胃肠道（GI）癌症患者由于癌症和治疗的影响而经历了高症状负担。因此，评估症状负担和支持性干预措施的试验至关重要。在这里，我们回顾了III期GI癌症临床试验的概况，并探讨了以患者生活质量（QoL）为中心的研究结果。方法我们在www.example.com上搜索ClinicalTrials.gov了2000年至2017年注册的III期随机对照试验（RCT），这些试验评估了成年癌症患者的治疗干预措施，并按GI疾病部位进行了分组试验。我们确定了76项专门针对胃肠道癌症的III期临床试验，共纳入53725例患者。在分析测量的主要结局时，绝大多数研究（n=71，86%）测量了疾病相关终点，如无进展生存期或总生存期。所有试验都有测量不良事件的次要终点，但只有30项试验（39%）将QoL指标作为次要终点。在包括QoL次要终点的30项试验中，仅16项（53%）报告了这些结果。只有5项试验（7%）评估了旨在影响疾病相关或治疗相关毒性的支持性措施的干预措施。没有支持性试验包括生活质量作为一个主要终点，只有两个这些试验（40%）包括生活质量作为一个次要endpoint.ConclusionsMost GI癌症试验未能纳入以患者为中心的结果或生活质量的措施时，研究新的干预措施。这些研究结果要求更好地整合患者报告的指标，这可能会导致更好的护理和胃肠道恶性肿瘤患者的结果。
BackgroundPatients with gastrointestinal (GI) cancers experience a high symptom burden due to the effects of both cancer and treatment. As such, trials assessing symptom burden and supportive interventions are crucial. Here, we characterise the landscape of phase III GI cancer clinical trials and explore study outcomes centred on the patient’s quality of life (QoL).MethodsWe searched ClinicalTrials.gov for phase III randomised controlled trials (RCTs) registered between 2000 and 2017 that are assessing a therapeutic intervention in adult patients with cancer and grouped trials by GI disease sites.ResultsOverall, we identified 76 phase III trials specific to GI cancers that enrolled a total of 53 725 patients. When analysing the primary outcomes measured, the vast majority of studies (n=71, 86%) measured disease-related endpoints such as progression-free survival or overall survival. All trials had a secondary endpoint that measured adverse events, but only 30 trials (39%) included QoL measures as secondary endpoints. Of the 30 trials that included QoL secondary endpoints, only 16 (53%) reported these results. Only five trials (7%) assessed interventions aimed at supportive measures impacting disease-related or treatment-related toxicity. None of the supportive trials included QoL as a primary endpoint and only two of these trials (40%) included QoL as a secondary endpoint.ConclusionsMost GI cancer trials failed to incorporate patient-centred outcomes or QoL measures when studying new interventions. These findings call for greater integration of patient-reported metrics, which may lead to better care and outcomes for patients with GI malignancies.