使用多癌种早期检测测试进行筛查对晚期癌症诊断的影响
完整摘要 · 中文译文
背景：在常规医疗之外使用基于血液的多癌种早期检测测试进行筛查是否具有临床效用尚不清楚。 方法：在一项于英格兰开展的随机对照试验中，我们在最多三次年度访视时采集了50至77岁人群的外周血。在采集基线血液后，参与者按1:1比例随机分组至干预组（血液接受检测的参与者）或对照组（血液被储存的参与者）。参与者与试验人员最初不知晓分组情况。主要终点为12种预设癌症类型中的Ⅲ期或Ⅳ期癌症；关键次要终点为12种预设癌症类型中的Ⅳ期癌症。在三次筛查轮次后以及最后一名参与者第三次访视后至少12个月的随访后，测量两组之间发病率（首次合格事件数除以风险人年数）的差异。 结果：总体而言，71,122名参与者被随机分配至干预组，71,128名被分配至对照组。两组间Ⅲ期或Ⅳ期癌症（主要终点）的发生率无显著差异（发生率比[干预组vs.对照组]，1.03；95%置信区间[CI]，0.92至1.14，P = 0.63）。三轮筛查后Ⅳ期癌症（关键次要终点）的发生率比为0.86（95% CI，0.74至1.00）。不到1%的参与者发生试验相关不良事件；无严重不良事件。 结论：在本试验中，我们未观察到在接受三种多癌种早期检测检测联合常规护理后，12种预设癌症中III期或IV期癌症的发生率低于单独接受常规护理。有必要进行进一步随访，以评估III期或IV期癌症的研究结果以及两组间IV期癌症差异随时间推移的变化方式。（资助方：Grail；NHS-Galleri ClinicalTrials.gov 编号，NCT05611632；ISRCTN 编号，ISRCTN91431511。）
完整摘要 · 英文原文
BACKGROUND: Whether screening with blood-based early-detection tests for multiple cancers in addition to usual care has clinical utility is unknown. METHODS: In a randomized, controlled trial conducted in England, we obtained peripheral blood from persons 50 to 77 years of age at up to three annual visits. After baseline blood collection, participants were randomly assigned in a 1:1 ratio to the intervention group (participants whose blood was tested) or the control group (participants whose blood was stored). Participants and trial personnel were initially unaware of the group assignments. The primary end point was stage III or IV cancer among 12 prespecified types of cancer, and a key secondary end point was stage IV cancer among the 12 prespecified types. The differences between the groups in the incidence rate (the number of first eligible events divided by person-years at risk) were measured after three screening rounds and at least 12 months of follow-up after the last participant's third visit. RESULTS: Overall, 71,122 participants were randomly assigned to the intervention group and 71,128 to the control group. The incidence rate of stage III or IV cancer (primary end point) did not differ significantly between the groups (incidence rate ratio [intervention vs. control], 1.03; 95% confidence interval [CI], 0.92 to 1.14, P = 0.63). The incidence rate ratio for stage IV cancer (a key secondary end point) after 3 screening rounds was 0.86 (95% CI, 0.74 to 1.00). Less than 1% of participants had trial-related adverse events; none were serious. CONCLUSIONS: In this trial, we did not observe a lower incidence rate of stage III or IV cancers across 12 prespecified cancers after three screening rounds with multicancer early-detection testing plus usual care than with usual care alone. Further follow-up is warranted to assess the way in which findings for stage III or IV cancers and the between-group difference in stage IV cancers evolve over time. (Funded by Grail; NHS-Galleri ClinicalTrials.gov number, NCT05611632; ISRCTN number, ISRCTN91431511.).