Background: Data on the performance of the Khorana, PROTECHT, and ONKOTEV risk assessment models (RAMs) to predict venous thromboembolism (VTE) in patients with pancreatic cancer (PC) receiving outpatient chemotherapy remain limited. We performed a head-to-head comparison of these RAMs in patients with newly diagnosed PC enrolled in the nationwide, multicenter, and prospective BACAP cohort. Methods: The Khorana, PROTECHT, and ONKOTEV scores were calculated at enrollment prior to chemotherapy. Patients were stratified into intermediate- and high-VTE-risk groups according to each RAM. The primary study outcome was VTE at a 6-month follow-up. The accuracy and discriminatory performance of the scores were assessed by calculating time-dependent Brier scores and c-indexes. Sub-distribution hazard ratios (SHRs) between high- and intermediate-risk patients were estimated. Results: Of 762 PC patients, 73 developed VTE within 6 months. In the competing risk analysis, the cumulative incidence of VTE at 6 months was 16.4% (95% CI, 13.8–19.1). The time-dependent Brier score was 0.14 (95% CI, 0.12–0.15) for all scores, indicating well-calibrated predictions. The respective time-dependent c-index of the Khorana, the PROTECHT, and the ONKOTEV scores was 0.50 (95% CI, 0.46–0.55), 0.50 (95% CI, 0.49–0.51), and 0.53 (95% CI, 0.48–0.58), indicating poor discrimination. The SHRs between high- and intermediate-risk patients ranged from 1.05 (95% CI, 0.76–1.44) for the ONKOTEV score to 1.06 (95% CI, 0.77–1.45) for the Khorana score. Conclusion: In newly diagnosed PC patients receiving outpatient chemotherapy, the Khorana, PROTECHT, and ONKOTEV scores demonstrated a poor performance in predicting VTE at 6 months, highlighting the need for new tools to guide thromboprophylaxis decisions.
背景：关于Khorana、PROTECHT和ONKOTEV风险评估模型（RAMs）在接受门诊化疗的胰腺癌（PC）患者中预测静脉血栓栓塞（VTE）性能的数据仍然有限。我们在全国性、多中心、前瞻性BACAP队列中纳入新诊断的PC患者，对这些RAMs进行了直接比较。方法：在化疗前入组时计算Khorana、PROTECHT和ONKOTEV评分。根据每个RAM将患者分为中危和高危VTE风险组。主要研究结局为6个月随访期间的VTE事件。通过计算时间依赖性Brier评分和c指数评估评分的准确性和区分性能。估计高危与中危患者之间的亚分布风险比（SHRs）。结果：在762例PC患者中，73例在6个月内发生VTE。竞争风险分析显示，6个月时VTE的累积发生率为16.4%（95% CI，13.8–19.1）。所有评分的时间依赖性Brier评分均为0.14（95% CI，0.12–0.15），表明预测校准良好。Khorana、PROTECHT和ONKOTEV评分的时间依赖性c指数分别为0.50（95% CI，0.46–0.55）、0.50（95% CI，0.49–0.51）和0.53（95% CI，0.48–0.58），表明区分能力较差。高危与中危患者之间的SHRs范围从ONKOTEV评分的1.05（95% CI，0.76–1.44）到Khorana评分的1.06（95% CI，0.77–1.45）。结论：在接受门诊化疗的新诊断PC患者中，Khorana、PROTECHT和ONKOTEV评分在预测6个月VTE方面表现不佳，凸显了需要新的工具来指导血栓预防决策。
Risk Assessment Models for Predicting Venous Thromboembolism in Patients with Pancreatic Cancer
肿瘤(癌症)患者之家