Risk assessment of thromboembolic events in hospitalized cancer patients

Federico Nichetti,Leonardo Provenzano,Luca Lalli,Giulia Montelatici,Marco Platania,Andrea Franza,Francesca Ligorio,Filippo De Braud,Luca Porcu,Emma Zattarin

doi:10.1038/s41598-021-97659-9

Abstract

Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). As untailored thromboprophylaxis is associated with hemorrhagic complications, the definition of a risk-assessment model (RAM) in this population is needed. INDICATE was a prospective observational study enrolling hospitalized cancer patients, with the primary objective of assessing the Negative Predictive Value (NPV) for TEs during hospitalization and within 45 days from discharge of low-grade Khorana Score (KS = 0). Secondary objectives were to assess KS Positive Predictive Value (PPV), the impact of TEs on survival and the development of a new RAM. Assuming 7% of TEs in KS = 0 patients as unsatisfactory percentage and 3% of as satisfactory, 149 patients were needed to detect the favorable NPV with one-sided α = 0.10 and power = 0.80. Stepwise logistic regression was adopted to identify variables included in a new RAM. Among 535 enrolled patients, 153 (28.6%) had a KS = 0. The primary study objective was met: 29 (5.4%) TEs were diagnosed, with 7 (4.6%) cases in the KS = 0 group (NPV = 95.4%, 95% CI 90.8–98.1%; one-sided p = 0.084). However, the PPV was low (5.7%, 95% CI 1.9–12.8%); a new RAM based on albumin (OR 0.34, p = 0.003), log(LDH) (OR 1.89, p = 0.023) and presence of vascular compression (OR 5.32, p < 0.001) was developed and internally validated. Also, TEs were associated with poorer OS (median, 5.7 vs 24.8 months, p < 0.001). INDICATE showed that the KS has a good NPV but poor PPV for TEs in hospitalized cancer patients. A new RAM was developed, and deserves further assessment in external cohorts.

Highlights

Illness or reduced mobility, in the absence of bleeding or other contraindications; without additional risk factors for Thromboembolic events (TEs), the decision whether to provide TP is left to clinicians’ judgement[9]
This led to the inclusion of patients whose main reason for hospitalization is expected to require less than 2 nights of in-hospital stay (i.e. central venous catheter (CVC) placement or biopsies), but who experienced procedurerelated complications or performed additional investigations resulting in prolonged in-hospital stay
Our study demonstrated that a low Khorana Score (KS) may serve as a negative predictor of thrombosis in hospitalized cancer patients, though the overall performance of the KS was poor

Summary

Introduction

Illness or reduced mobility, in the absence of bleeding or other contraindications; without additional risk factors for TEs, the decision whether to provide TP is left to clinicians’ judgement[9]. This uncertainty frequently leads to heterogeneous and sometimes inappropriate prescriptions, with potential drug interactions, preventable side effects and increased health care costs. The KS has demonstrated a high negative predictive value (NPV) in ambulatory cancer patients, representing a potential tool to identify hospitalized patients at negligible TEs risk[6]. The role of other clinical and biological variables on TEs risk, together with the impact of thrombotic events on patients’ survival, was evaluated

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Discussion

Conclusion