Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IRCCS, Milan, Italy.
University Cancer Center Leipzig, University Hospital Leipzig, Leipzig, Germany.
JAMA Netw Open. 2023 Feb 1;6(2):e230010. doi: 10.1001/jamanetworkopen.2023.0010.
The assessment of the risk of venous thromboembolism (VTE) among outpatients with cancer represents an unsolved topic. Current international guidelines recommend primary prophylaxis for patients at intermediate to high risk of VTE, indicated by a Khorana score of 2 or more. A previous prospective study developed the ONKOTEV score, a 4-variable risk assessment model (RAM) consisting of a Khorana score of more than 2, metastatic disease, vascular or lymphatic compression, and previous VTE event.
To validate the ONKOTEV score as a novel RAM to assess the risk of VTE among outpatients with cancer.
DESIGN, SETTING, AND PARTICIPANTS: ONKOTEV-2 is a noninterventional prognostic study conducted in 3 European centers located in Italy, Germany, and the United Kingdom among a prospective cohort of 425 ambulatory patients with a histologically confirmed diagnosis of a solid tumor who were receiving active treatments. The total study duration was 52 months, with an accrual period of 28 months (from May 1, 2015, to September 30, 2017) and an overall follow up-period of 24 months (data were censored September 30, 2019). Statistical analysis was performed in October 2019.
The ONKOTEV score was calculated for each patient at baseline by collecting clinical, laboratory, and imaging data from tests performed for routine practice. Each patient was then observed to detect any thromboembolic event throughout the study period.
The primary outcome of the study was the incidence of VTE, including deep vein thrombosis and pulmonary embolism.
A total of 425 patients (242 women [56.9%]; median age, 61 years [range, 20-92 years]) were included in the validation cohort of the study. The cumulative incidences for the risk of developing VTE at 6 months were 2.6% (95% CI, 0.7%-6.9%), 9.1% (95% CI, 5.8%-13.2%), 32.3% (95% CI, 21.0%-44.1%), and 19.3% (95% CI, 2.5%-48.0%), respectively, among 425 patients with an ONKOTEV score of 0, 1, 2, and greater than 2 (P < .001). The time-dependent area under the curve at 3, 6, and 12 months was 70.1% (95% CI, 62.1%-78.7%), 72.9% (95% CI, 65.6%-79.1%), and 72.2% (95% CI, 65.2%-77.3%), respectively.
This study suggests that, because the ONKOTEV score has been validated in this independent study population as a novel predictive RAM for cancer-associated thrombosis, it can be adopted into practice and into clinical interventional trials as a decision-making tool for primary prophylaxis.
评估癌症门诊患者静脉血栓栓塞症（VTE）的风险仍是一个未解决的问题。目前的国际指南建议对 Khorana 评分 2 分及以上的中高危 VTE 患者进行初级预防，Khorana 评分是一种 4 变量风险评估模型（RAM），包括 Khorana 评分超过 2 分、转移性疾病、血管或淋巴压迫以及先前的 VTE 事件。
验证 ONKOTEV 评分作为一种新的 RAM，用于评估癌症门诊患者 VTE 的风险。
设计、地点和参与者：ONKOTEV-2 是一项在意大利、德国和英国的 3 个欧洲中心进行的非干预性预后研究，纳入了 425 名接受积极治疗的经组织学证实患有实体瘤的门诊患者，这些患者的 Khorana 评分超过 2 分，有转移性疾病、血管或淋巴压迫和先前的 VTE 事件。总研究时间为 52 个月，入组期为 28 个月（2015 年 5 月 1 日至 2017 年 9 月 30 日），总随访期为 24 个月（数据截止日期为 2019 年 9 月 30 日）。统计分析于 2019 年 10 月进行。
在基线时，通过收集常规实践中进行的临床、实验室和影像学检查数据，为每位患者计算 ONKOTEV 评分。然后观察每位患者在整个研究期间是否发生血栓栓塞事件。
研究的主要结局是 VTE 的发生率，包括深静脉血栓形成和肺栓塞。
共纳入 425 例患者（242 例女性[56.9%]；中位年龄 61 岁[范围 20-92 岁]）作为研究验证队列。425 例患者中，ONKOTEV 评分为 0、1、2 和大于 2 时，6 个月时 VTE 风险的累积发生率分别为 2.6%（95%CI，0.7%-6.9%）、9.1%（95%CI，5.8%-13.2%）、32.3%（95%CI，21.0%-44.1%）和 19.3%（95%CI，2.5%-48.0%）（P < .001）。3、6 和 12 个月时的时间依赖性曲线下面积分别为 70.1%（95%CI，62.1%-78.7%）、72.9%（95%CI，65.6%-79.1%）和 72.2%（95%CI，65.2%-77.3%）。
这项研究表明，由于 ONKOTEV 评分在这个独立的研究人群中已被验证为癌症相关血栓形成的新型预测 RAM，因此可以将其应用于实践和临床干预试验中，作为初级预防的决策工具。
