隐匿性卒中后偶发性癌症的诊断：ARCADIA 随机试验的探索性分析。
Diagnosis of Incident Cancer After Cryptogenic Stroke: An Exploratory Analysis of the ARCADIA Randomized Trial.
机构信息
From the Clinical and Translational Neuroscience Unit (B.B.N., C.Z., A.P., M.B., H.K.), Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York; Department of Neurology (B.B.N.), Memorial Sloan Kettering Cancer Center, New York, NY; Department of Neurology (B.R.M., C.S.), University of Minnesota, Minneapolis; Division of Hematology and Oncology (M.C.), Department of Medicine, University of Vermont Larner College of Medicine, Burlington; Department of Neurology (S.E.K.), University of Pennsylvania School of Medicine, Philadelphia; Department of Neurology (D.T., W.L.), Department of Epidemiology (W.L.), and Department of Biostatistics (R.K.), University of Washington, Seattle; Department of Biostatistics (J.E.), Medical University of South Carolina, Charleston; Ochsner Neuroscience Institute (R.M.Z., J.T.), Ochsner Health, New Orleans, LA; Department of Neurology and Rehabilitation Medicine (J.P.B.), University of Cincinnati College of Medicine, OH; Sunnybrook Research Institute (D.J.G.), Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre, and Division of Neurology (D.J.G.), Department of Medicine, University of Toronto, Ontario, Canada; Department of Neurology (M.B.), Inselspital, Bern University Hospital and University of Bern, Switzerland; and Department of Neurology (M.S.V.E.), Vagelos College of Physicians and Surgeons, and Department of Epidemiology (M.S.V.E.), Mailman School of Public Health, Columbia University, New York, NY.
出版信息
Neurology. 2024 Nov 26;103(10):e210027. doi: 10.1212/WNL.0000000000210027. Epub 2024 Oct 31.
OBJECTIVES
The objective of this study was to estimate the incidence, timing, and type of new cancer diagnosis among patients with cryptogenic stroke.
METHODS
We used data from the ARCADIA trial, which enrolled patients with cryptogenic stroke and atrial cardiopathy. Participants were prospectively followed, and serious adverse events were assessed every 3 months or sooner if investigators were alerted between visits to an event. Kaplan-Meier statistics were used to estimate the cumulative incidence of a cancer diagnosis within the first year after randomization.
RESULTS
Among 878 participants without baseline history of cancer, 13 (1.5%) were diagnosed with incident cancer in the year after randomization, comprising 12 solid cancers (3 prostate, 2 breast, 2 gastrointestinal, and 5 other primary sites) and 1 hematologic cancer (non-Hodgkin lymphoma). The cumulative incidences of a cancer diagnosis were 0% at 3 months, 0.6% (95% CI 0.2%-1.5%) at 6 months, and 2.0% (95 CI 1.1%-3.4%) at 1 year. The median time from index stroke to cancer diagnosis was 261 days (interquartile range 183-358).
DISCUSSION
In a multicenter cryptogenic stroke cohort with prospective follow-up, the 1-year cumulative incidence of a cancer diagnosis was 2%. This rate may be an underestimation because of the clinical trial population and exclusion of cancers diagnosed immediately after stroke.
TRIAL REGISTRATION INFORMATION
ClinicalTrials.gov Identifier: NCT03192215. Registered June 20, 2017. First patient enrolled February 1, 2018.
目的
本研究旨在评估隐源性卒中患者新发癌症的发病率、时间和类型。
方法
我们使用了 ARCADIA 试验的数据，该试验纳入了隐源性卒中和心房心脏病患者。对参与者进行前瞻性随访，如果研究人员在随访期间发现任何事件，每 3 个月或更早进行一次严重不良事件评估。Kaplan-Meier 统计用于估计随机分组后 1 年内癌症诊断的累积发生率。
结果
在 878 名无基线癌症病史的参与者中，13 人（1.5%）在随机分组后 1 年内被诊断为新发癌症，包括 12 例实体瘤（3 例前列腺癌、2 例乳腺癌、2 例胃肠道癌和 5 例其他原发部位癌）和 1 例血液系统肿瘤（非霍奇金淋巴瘤）。癌症诊断的累积发生率分别为 3 个月时 0%、6 个月时 0.6%（95%CI 0.2%-1.5%）、1 年时 2.0%（95%CI 1.1%-3.4%）。从首发卒中到癌症诊断的中位时间为 261 天（四分位间距 183-358）。
讨论
在一项有前瞻性随访的多中心隐源性卒中队列中，1 年癌症诊断累积发生率为 2%。由于临床试验人群和排除了卒中后立即诊断的癌症，该率可能低估了实际情况。
临床试验注册信息
ClinicalTrials.gov 标识符：NCT03192215。注册时间：2017 年 6 月 20 日。首位患者入组时间：2018 年 2 月 1 日。
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