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

Kuznetsov M.R., Matveyev D.V., Lebedev S.S., Cheban S.V.

1) L.L. Levshin Institute of Cluster Oncology, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; 2) S.S. Yudin City Clinical Hospital, Moscow, Russia; 3) Russian Medical Academy of Continuous Professional Education, Moscow, Russia; 4) Reutov Clinical Hospital, Reutov, Moscow Region, Russia; 5) S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow, Russia

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. 

For citations: Kuznetsov M.R., Matveyev D.V., Lebedev S.S., Cheban S.V. 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. Pharmateca. 2026;33(4):8-18. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.4.8-18

Authors’ contribution: M.R. Kuznetsov – study concept and design, scientific supervision of the oncology component, and interpretation of results. D.V. Matveyev – scientific supervision of the surgical component, methodological support, data analysis, manuscript preparation and final revision, and correspondence with the editors. S.S. Lebedev – clinical assessment of patients, analysis of VTE and post-thrombotic syndrome data, and manuscript editing. S.V. Cheban – patient recruitment, primary data collection, research documentation, and participation in text preparation.
All authors have approved the final version of the article and are responsible for its content.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The study was conducted without any sponsorship.
Ethical Approval: The study protocol was approved by the local ethics committee of the I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (protocol No. 12-23 dated March 15, 2023).
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.

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About the Authors

Maxim R. Kuznetsov, Dr. Sci. (Med.), Professor, L.L. Levshin Institute of Cluster Oncology, I.M. Sechenov First Moscow State Medical University (Sechenov University); S.S. Yudin City Clinical Hospital, Moscow Healthcare Department, Moscow, Russia; mrkuznetsov@mail.ru, ORCID:
https://orcid.org/0000-0001-6926-6809, eLibrary SPIN: 7146-1348, AuthorID: 151399
Dmitry V. Matveev, Dr. Sci. (Med.), Professor, Department of Surgery, Transplantology, and Applied Oncology, Russian Medical Academy of Continuous Professional Education, Moscow; Reutov Clinical Hospital, Reutov, Moscow Region, Russia; dvmatveev@mail.ru, ORCID:
https://orcid.org/0000-0003-2990-2035, eLibrary SPIN: 2216-6090, AuthorID: 750104 (corresponding author)
Sergey S. Lebedev, Dr. Sci. (Med.), Professor, Department of Surgery, Transplantology, and Applied Oncology, Russian Medical Academy of Continuous Professional Education; Deputy Chief Physician for Oncology, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow, Russia; lebedevssd@yandex.ru, ORCID: https://orcid.org/0000-0001-5366-1281, eLibrary SPIN: 2736-0683, AuthorID: 936520
Sergey V. Cheban, Surgeon, Reutov Clinical Hospital, Reutov, Moscow Region, Russia; tchebansergiy@yandex.ru

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