The impact of anticoagulant therapy on quality of life and treatment adherence in patients with cancer-induced venous thrombosis: a prospective, randomized, open-label study

Background: Venous thromboembolism (VTE) occurs in 10–15% of patients with malignancies and is associated with a clinically significant decrease in quality of life across all key domains. Traditional low-molecular-weight heparin (LMWH) therapy requires daily subcutaneous injections, which reduces adherence and worsens quality of life. Direct oral anticoagulants (DOAC) are comparable to LMWH in terms of efficacy and safety; however, their impact on quality of life as a primary endpoint in cancer patients has been poorly studied.

Objective: Evaluation of the impact of two anticoagulant regimens (rivaroxaban vs. enoxaparin) on quality of life, treatment adherence, and anxiety/depression in patients with newly diagnosed cancer-induced VTE after 3 and 6 months of follow-up.

Methods: A prospective, open-label, randomized, controlled trial included 70 patients (35 in each group) with histologically confirmed malignancy and newly diagnosed symptomatic VTE. Patients were randomized in a 1:1 ratio with stratification by tumor location and baseline EORTC QLQ-C30 global health status score. The DOAC group received rivaroxaban (15 mg twice daily for 21 days, then 20 mg once daily for up to 6 months). The LMWH group received enoxaparin (1.5 mg/kg subcutaneously once daily). The primary endpoint was the change in quality of life at 6 months according to the EORTC QLQ-C30 global health status questionnaire. Secondary endpoints included venous disease-specific quality of life (VEINES-QOL/Sym, PEmb-QoL), treatment adherence (Morisky-Green questionnaire + diary), psychoemotional status (HADS), incidence of post-thrombotic syndrome (Villalta scale), clinical outcomes, and treatment satisfaction (TSQM – Treatment Satisfaction Questionnaire for Medication).

Results: After 6 months of follow-up, global health status (EORTC QLQ-C30) improved by 12.4 points in the rivaroxaban group compared with baseline, while in the enoxaparin group the improvement was 4.2 points (between-group difference 8.2 points; p=0.004). Adherence to therapy (≥80% of doses taken) was 91.4% in the rivaroxaban group and 71.4% in the enoxaparin group (p=0.036). The level of anxiety and depression according to the HADS scale was significantly lower in the rivaroxaban group (HADS-A: 6.2±2.4 vs 8.9±3.1, p=0.008; HADS-D: 5.4±2.1 vs 7.6±2.8, p=0.011). The incidence of post-thrombotic syndrome at 6 months was 17.1% in the rivaroxaban group versus 31.4% in the enoxaparin group (p=0.042). Clinical outcomes (recurrent VTE, major bleeding) did not differ between the groups.

Conclusion: Rivaroxaban therapy was associated with clinically significant improvements in quality of life, higher treatment adherence, and a lower incidence of post-thrombotic syndrome compared with enoxaparin in patients with cancer-induced venous thromboembolism, with comparable efficacy and safety profiles. These data support the use of rivaroxaban in cancer patients with VTE, taking into account not only the risk of thrombosis and bleeding but also the predicted impact on quality of life.