Background: Prospective investigation on cancer-associated venous thromboembolism (VTE) in non-small cell lung cancer (NSCLC) during treatment with immune checkpoint inhibitors (ICIs) is lacking. Patients and methods: A prospective real-world study using combined computed tomography venography and pulmonary angiography (CTVPA) to screen patients with NSCLC for VTE (cohort A). A retrospective multicenter cohort without additional screening with CTVPA was included as control (cohort B). A model with VTE as a time-dependent event using competing risk analysis model with death as a competing event was used to evaluate outcomes and differences in cumulative VTE incidences. Results: Cohort A (n = 146) and cohort B (n = 426) had median follow-up for VTE of 16.5 months (IQR 6.7–35.6). Cumulative VTE events at 1, 3, 6, and 12 months were 7.5 %, 9.6 %, 13.0 %, 14.4 % for cohort A and 1.9 %, 3.8 %, 4.9 %, 5.6 % for cohort B with SHR 2.42 (CI 95 % 1.37–4.27) p = 0.0024. Recurrent VTE comprised 52 % and 37 %, respectively. In multivariate overall survival analysis, VTE was significantly associated with impaired OS (HR 2.12 CI 95 % [1.49–3.03], p < 0.0001). Risk factors for VTE comprised prior VTE and ICI administered in first line. Conclusion: Cumulative VTE incidence in NSCLC patients following palliative ICI may be significantly higher than reported in randomised clinical trials and retrospective real-world reports. VTE development during ICI impair OS significantly. Thus, more focus on VTE during ICI is warranted to optimise both prevention and management of VTE. Whether there is a causal relationship between VTE and ICI remains to be explored.

TidsskriftThrombosis Research
Sider (fra-til)164-172
StatusUdgivet - jan. 2023

Bibliografisk note

Funding Information:
Department of Oncology, Odense University Hospital, The Region of Southern Denmark, Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital University of Southern Denmark (SDU), The Danish Cancer Foundation, Axel Muusfeldts fond, A.P. Møller and Hustru Chastine Mc-Kinney Møllers Fond for common purposes. Funding was made from non-profiting organisations only with no impact on study design, patient allocation, data analysis or manuscript preparation.

Publisher Copyright:
© 2022


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