Translational cancer research · 2026
Venous thromboembolism risk in sarcoma patients receiving combined immune checkpoint inhibitors and VEGF pathway inhibitors: a real-world cohort study.
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Kumar Rahul, Phadke Rohan A, Bouras Andrew, Kaur Harlene, Salman Samer G, Sarnala Sai, Vaja Swapna, Riley Dylan, Rice Samuel W, Batus Marta, Blank Alan
Аннотация
BACKGROUND: Immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor (VEGF) pathway inhibitors are increasingly used in bone and soft tissue sarcomas. Risks associated with combination therapy, such as venous thromboembolism (VTE), carry significant consequences but remain poorly characterized. This study evaluated whether adding a VEGF pathway inhibitor to ICI therapy increases VTE risk in sarcoma patients.
METHODS: Using the TriNetX U.S. Collaborative Network, we identified patients with bone or soft tissue sarcoma [International Classification of Diseases (ICD)-10 C40, C41, C47, C49] who received either combination therapy (ICI plus VEGF pathway inhibitor within ±30 days of ICI initiation) or ICI monotherapy. Propensity score matching (1:1) balanced cohorts for age, sex, race, hypertension, diabetes, obesity, and smoking history. The primary outcome was 1-year VTE incidence (pulmonary embolism or venous thrombosis). Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox proportional hazards models.
RESULTS: After matching, 834 patients remained in each cohort (mean age 63 years; hypertension prevalence 60%). At 1 year, VTE occurred in 14.0% of the combination cohort and 12.4% of the monotherapy cohort (HR 1.23; 95% CI: 0.91-1.66; P=0.07), corresponding to an absolute risk difference of 1.6 percentage points (95% CI: -2.1 to 5.2). Musculoskeletal toxicity did not differ between groups (5.5% vs. 6.4%; HR 0.93; 95% CI: 0.61-1.41; P=0.82).
CONCLUSIONS: Sarcoma patients receiving ICI-based therapy experienced a high 1-year VTE burden. Although we did not detect a statistically significant increase in VTE with the addition of a VEGF pathway inhibitor, the point estimates were compatible with a modestly higher risk; however, the CIs were wide and included no difference between groups. These findings support clinical vigilance and risk assessment and motivate prospective studies of risk-adapted thromboprophylaxis in this population.
METHODS: Using the TriNetX U.S. Collaborative Network, we identified patients with bone or soft tissue sarcoma [International Classification of Diseases (ICD)-10 C40, C41, C47, C49] who received either combination therapy (ICI plus VEGF pathway inhibitor within ±30 days of ICI initiation) or ICI monotherapy. Propensity score matching (1:1) balanced cohorts for age, sex, race, hypertension, diabetes, obesity, and smoking history. The primary outcome was 1-year VTE incidence (pulmonary embolism or venous thrombosis). Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox proportional hazards models.
RESULTS: After matching, 834 patients remained in each cohort (mean age 63 years; hypertension prevalence 60%). At 1 year, VTE occurred in 14.0% of the combination cohort and 12.4% of the monotherapy cohort (HR 1.23; 95% CI: 0.91-1.66; P=0.07), corresponding to an absolute risk difference of 1.6 percentage points (95% CI: -2.1 to 5.2). Musculoskeletal toxicity did not differ between groups (5.5% vs. 6.4%; HR 0.93; 95% CI: 0.61-1.41; P=0.82).
CONCLUSIONS: Sarcoma patients receiving ICI-based therapy experienced a high 1-year VTE burden. Although we did not detect a statistically significant increase in VTE with the addition of a VEGF pathway inhibitor, the point estimates were compatible with a modestly higher risk; however, the CIs were wide and included no difference between groups. These findings support clinical vigilance and risk assessment and motivate prospective studies of risk-adapted thromboprophylaxis in this population.