ArticleClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026
Venous and arterial thromboembolic events associated with osimertinib in patients with lung cancer: a study by the thrombosis and cancer group of the spanish society of medical oncology (SEOM).
Article in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo determine the real-world clinical practice incidence and predictive factors of venous and arterial thromboembolic events (VTE/ATE) in lung cancer patients treated with osimertinib. METHODS/PATIENTS: A multicenter retrospective study including 546 lung cancer patients who initiated treatment with osimertinib before or during 2024, with a minimum follow-up of 6 months. The primary objective was to evaluate the incidence of VTE/ATE. Secondary objectives included identifying predictive factors for thrombosis and assessing its impact on overall survival (OS). Competing risk regression (Fine-Gray), multivariable Cox models, and Kaplan-Meier analyses (including landmark analysis at 6 months) adjusted for time-dependent covariates were performed to prevent immortal time bias. Missing data were handled using a complete-case strategy (n = 544) given <0.5% missingness in model covariates.
resultsOverall VTE/ATE incidence was 15.0% (82/546; 10.5 events per 100 person-years)[cite: 3, 4]. The cumulative incidence of first VTE/ATE (accounting for non-thrombotic death as a competing risk) was 8.34% (95% CI 6.08-10.74%) at 6 months and 10.54% (95% CI 7.96-13.21%) at 12 months. In the multivariable Fine-Gray model, higher body mass index (BMI) (sHR 1.07; 95% CI 1.02-1.12; p = 0.009) and central nervous system (CNS) metastases (sHR 2.30; 95% CI 1.30-4.07; p = 0.004) were independently associated with VTE/ATE. Metastatic recurrence versus de novo stage IV showed no association with thrombosis (sHR 0.85; 95% CI 0.48-1.50; p = 0.573). Median OS was significantly shorter in patients with VTE/ATE (22.0 vs. 31.0 months; log-rank p = 0.049). Modeled as a time-dependent covariate, thrombosis significantly increased mortality hazard (HR 2.43; 95% CI 1.78-3.33; p < 0.001). Sensitivity analysis excluding events at tumor progression confirmed these associations (Cox HR 1.78; p = 0.002). Neoplastic progression accounted for 77.5% of total deaths and 64.9% of deaths in patients with thrombosis.
conclusionsThe incidence of thromboembolic events during osimertinib treatment in routine practice was 15.0% and was associated with poorer overall survival. Elevated BMI and CNS metastases identify higher-risk patients, providing a rationale for evaluating individualized risk stratification in future prospective clinical trials.
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