Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Huntington, New York, USA.
Department of Medicine, Hematology and Oncology, Northwell Health Systems at Lenox Hill Hospital, New York, New York, USA.
Oncologist. 2020 Jul;25(7):e1083-e1090. doi: 10.1634/theoncologist.2019-0482. Epub 2020 Feb 4.
Current risk assessment models (RAMs) for prediction of venous thromboembolism (VTE) risk in the outpatient cancer population have shown poor predictive value in many of the most common cancers. The Comparison of Methods for Thromboembolic Risk Assessment with Clinical Perceptions and AwareneSS in Real Life Patients-Cancer Associated Thrombosis (COMPASS-CAT) RAM was derived in this patient population and predicted patients at high risk for VTE even after initiation of chemotherapy. We sought to externally validate this RAM.
Patients aged ≥18 years who presented to a tertiary care center between January 1, 2014, and December 31, 2016, with invasive breast, ovarian, lung, or colorectal cancers were included. The COMPASS-CAT RAM was applied using our health system's tumor registry and variables that were identified by International Statistical Classification of Diseases and Related Health Problems-9 and -10 codes of the electronic health record and independent chart review. The primary endpoint at 6-month study follow-up was documented VTE.
A total of 3,814 patients were included. Documented VTE at 6-month follow-up occurred in 5.85% of patients. Patients stratified into low/intermediate- and high-risk groups had VTE rates of 2.27% and 6.31%, respectively. The sensitivity, specificity, and negative and positive predictive value of the RAM were 95%, 12%, 97.73%, and 6.31%, respectively. Diagnostic accuracy via receiver operating characteristic curve was calculated at 0.62 of the area under the curve.
In this large retrospective external validation study of the COMPASS-CAT RAM for VTE in patients with cancer undergoing active treatment, model discrimination was moderate and calibration was poor. The model had good negative predictive value. Further prospective validation studies-especially within 6 months of cancer diagnosis-are needed before the model can be implemented into routine clinical practice for primary thromboprophylaxis of high-VTE-risk patients with cancer with solid tumors.
This study provides further guidance for researchers and clinicians in determining clinical and laboratory risk factors associated with development of venous thromboembolism among the ambulatory population of patients being treated for lung, breast, colorectal, or ovarian cancer. It validates the COMPASS-CAT risk model that was developed in this cancer population and suggests that further prospective validation of the model, with more focus on patients within 6 months of their index cancer diagnosis, would likely enhance the accuracy and usefulness of this model as a clinical prediction tool.
目前用于预测门诊癌症患者静脉血栓栓塞（VTE）风险的风险评估模型（RAM）在许多最常见的癌症中显示出较差的预测价值。本研究在该患者人群中推导了比较方法用于血栓栓塞风险评估与临床认知和真实患者意识的血栓形成相关癌症（COMPASS-CAT）RAM，并预测了开始化疗后 VTE 风险较高的患者。我们试图对此 RAM 进行外部验证。
纳入 2014 年 1 月 1 日至 2016 年 12 月 31 日在三级护理中心就诊的年龄≥18 岁、患有浸润性乳腺癌、卵巢癌、肺癌或结直肠癌的患者。使用我们医疗系统的肿瘤登记处和电子病历的国际疾病分类和相关健康问题-9 和 -10 代码以及独立的图表审查来应用 COMPASS-CAT RAM。6 个月研究随访的主要终点是记录 VTE。
共纳入 3814 例患者。6 个月随访时发生 VTE 的患者占 5.85%。分层为低/中危和高危组的患者 VTE 发生率分别为 2.27%和 6.31%。RAM 的灵敏度、特异性、阴性和阳性预测值分别为 95%、12%、97.73%和 6.31%。通过接收者操作特征曲线计算的诊断准确性为曲线下面积的 0.62。
在这项针对正在接受积极治疗的癌症患者的 COMPASS-CAT RAM 用于 VTE 的大型回顾性外部验证研究中，模型的区分度中等，校准效果差。该模型具有良好的阴性预测值。需要进一步的前瞻性验证研究，尤其是在癌症诊断后 6 个月内，以便将该模型用于有实体瘤的高 VTE 风险癌症患者的初级血栓预防，从而将其应用于常规临床实践。
本研究为研究人员和临床医生提供了进一步的指导，以确定在接受肺癌、乳腺癌、结直肠癌或卵巢癌治疗的门诊患者人群中与静脉血栓栓塞发展相关的临床和实验室危险因素。它验证了在该癌症人群中开发的 COMPASS-CAT 风险模型，并表明对该模型进行进一步的前瞻性验证，更侧重于指数癌症诊断后 6 个月内的患者，可能会提高该模型作为临床预测工具的准确性和有用性。
