多癌种早期检测试验在随机对照的 NHS-Galleri 试验中的表现
Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial
NHS-Galleri 是一项随机对照试验，评估在常规医疗中加入多癌种早期检测（MCED，通过一次抽血同时筛查多种癌症）检测。此前已报告主要终点——干预组 III/IV 期癌症诊断发生率降低——未达到。本文报告预设的次要检测性能终点：142,250 名 50–77 岁参与者按 1:1 随机分组，干预组在三轮年度筛查中阳性率分别为 1.03%、0.80% 和 0.90%；阳性预测值为 58.0%、50.4% 和 45.8%；阴性预测值约 98.9%；特异性 99.50%–99.60%；全体癌症的每轮灵敏度为 26.7%–37.2%，12 种预设癌种为 47.6%–63.4%；癌症信号来源（预测肿瘤位置以指导后续检查）准确率为 91.1%–93.6%。这些数据为 MCED 在 NHS 人群筛查中的表现提供了参考。
为什么推荐给您：大型随机对照试验中 MCED 筛查的关键性能数据，但主要终点未达成，属重要但不改变实践的进展。
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摘要Abstract
The NHS-Galleri trial was a randomized controlled trial evaluating a multi-cancer early detection (MCED) test added to usual care. We reported elsewhere that the primary endpoint of a reduction in the incidence of stage III/IV cancer diagnoses in the intervention arm versus control arm was not met. Here we report prespecified secondary test performance endpoints among evaluable intervention arm participants across three annual screening rounds. These analyses were descriptive; there was no hypothesis testing. Participants aged 50-77 years (N = 142,250) were randomized 1:1 into intervention (MCED) or control arms. Intervention arm participants with positive MCED results were referred to National Health Service (NHS) standard-of-care pathways for diagnostic workup, with referrals informed by the predicted cancer signal origin (CSO). Positive test results were returned for 722 of 70,325 (1.03%), 518 of 64,498 (0.80%) and 561 of 62,323 (0.90%) participants in rounds 1-3, respectively. In aggregate, 937 participants had MCED-detected primary cancers. Respective by-round cancer detection rates were 0.60%, 0.40% and 0.41%; positive predictive values were 58.0% (419/722), 50.4% (261/518) and 45.8% (257/561); and negative predictive values were 98.98% (68,895/69,603), 98.90% (63,278/63,980) and 98.86% (61,058/61,762). Across rounds, specificity ranged from 99.50% to 99.60%; episode sensitivity ranged from 26.7% to 37.2% for all cancers and from 47.6% to 63.4% for 12 prespecified types; and CSO accuracy ranged from 91.1% to 93.6%. These data provide insights on the performance of the MCED test in population screening within the NHS setting. ClinicalTrials.gov: NCT05611632 ; ISRCTN: ISRCTN91431511 .