Abstract Number: PB2162
Meeting: ISTH 2020 Congress
Background: Neither venous nor arterial thromboembolic events (VTE/ATE) have been reported in phase III trials evaluating immune-checkpoint-inhibitors (ICI) in patients with cancer. Little is known about the risk of VTE and ATE in patients with cancer treated with ICI.
Aims: To quantify risk of VTE and ATE in a cohort of patients treated with ICI, explore its impact on mortality and identify potential risk factors.
Methods: Patients treated with an ICI approved by the European-Medical-Association at the Medical University of Vienna between 2015 and 2018 have been identified using the in-house pharmacy records (n=582; most frequent entities: melanoma: 35.6%, lung-cancer: 29.3%; stage-IV-disease: 89%). A retrospective chart-review was performed to screen for occurrence of VTE and/or ATE. Competing-risk analysis was performed to estimate cumulative incidences of VTE and ATE. Differences between subgroups were investigated by proportional sub-hazards regression model. The impact of VTE and ATE on mortality was studied within a multi-state model.
Results: Over a median follow-up of 13.1 months, 43 VTE 17 ATE and 259 deaths (median-survival: 23.4 months) occurred. The cumulative incidences of VTE and ATE were 10.8% [95%CI: 7.1-15.4)] and 3.5% [2.1-5.4], respectively. Occurrence of VTE was associated with increased mortality (transition hazard-ratio (THR): 3.05 [95%CI: 2.00-4.66]. ATE occurrence was not associated with mortality (1.38 [0.68-2.81]). Disease-stage (all VTE occurred in stage 4) and history of VTE (SHR: 3.23 [1.68-6.20]) were strong clinical predictors of VTE. No association with VTE risk was observed for ECOG performance-status, Charlson-Comorbidity-Index or tumour type. In 93 patients with available data on PD-L1 expression, higher levels were associated with VTE risk (HR per 10% increase: 1.20 [1.01-1.32]).
Conclusions: Patients with cancer undergoing ICI-therapy frequently developed VTE or ATE. Occurrence of VTE was associated with a prior history of VTE and PD-L1 expression and was associated with higher risk of early mortality.
To cite this abstract in AMA style:Moik F, Chan W-E, Wiedemann S, Höller C, Tuchmann F, Aretin M-, Fuereder T, Zöchbauer-Müller S, Preusser M, Pabinger I, Ay C. Incidence, Risk Factors and Clinical Outcome of Venous and Arterial Thromboembolic Events in Patients Treated with Immune-checkpoint Inhibitors: A Single-center Cohort Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/incidence-risk-factors-and-clinical-outcome-of-venous-and-arterial-thromboembolic-events-in-patients-treated-with-immune-checkpoint-inhibitors-a-single-center-cohort-study/. Accessed November 30, 2023.
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