Comparative Analysis of Hemostatic Biomarkers in Cancer Patients Receiving Immune Checkpoint Inhibitors Versus Chemotherapy: Results from a Prospective Cohort Study

Introduction: Venous thromboembolism (VTE) is a frequent complication in cancer patients. Although the role of hemostatic biomarkers to predict VTE has been studied in the context of chemotherapy, their utility in patients receiving immune checkpoint inhibitors (ICIs) remains uncertain. Recent studies suggest that patients on ICIs may also be at elevated risk for VTE. To investigate potential treatment-related effects on systemic hemostatic activity, we aimed to examine differences in hemostatic biomarker levels between cancer patients undergoing chemotherapy and those receiving ICIs.

Method: In the framework of the ongoing Vienna Cancer and Thrombosis and Bleeding (CAT-BLED) prospective cohort study, 30 patients were included, with 15 receiving ICI and 15 matched to chemotherapy. Of these, 20 (67%) had non-small cell lung cancer (NSCLC) and 10 (33%) had head and neck cancer. Baseline characteristics, stratified by therapy type, are provided in [Fig. 2]. Biomarkers, including extracellular vesicle tissue factor activity (EV-TF), D-dimer, and soluble P-selectin (sP-selectin), were measured at treatment initiation and after 3 weeks, and 3 months. Median biomarker levels were compared using Friedman's and Wilcoxon rank-sum tests. Spearman's correlation assessed biomarker relationships. Trends over time were visualized with scatter plots

Fig. 2  Baseline patient characteristics

Results: No significant differences in the three biomarkers were observed between the two treatment modalities or the 3 timepoints, though levels generally increased ([Fig. 1A-F]). As biomarker levels rose, they showed positive correlations, with a significant correlation between EV-TF and sP-selectin at 3 weeks (R=0.58, 95% CI: 0.18-0.61). sP-selectin levels were higher in metastatic and lung cancer patients at all 3 time points ([Fig. 1G-H]).

Fig. 1  Biomarker levels and trajectories by therapy type, stage and cancer type

Conclusion: No significant differences in the 3 hemostatic biomarkers were found between ICI and chemotherapy patients. Biomarkers tended to increase and correlated positively over time. Further research, incorporating additional biomarkers, is necessary to clarify potential differences between the two treatment modalities and to investigate associations with VTE in patients receiving ICIs.

Publication History

Article published online:
13 February 2025