CONKO-011/AIO-SUP-0115/ass.: Rivaroxaban Compared to Low Molecular Weight Heparin in Cancer Patients with Acute Venous Thromboembolism

Sinn M, Lohneis A, Mohamed O, Roderburg C, Hellmann M, Südhoff T, Christoph DC, Krziwanie A, Heinz J, Semrau S, Schlenska-Lange A, Ettrich TJ, Trappe RU, Striefler JK, Pelzer U, Wernecke KD, Riess H (2025)

Publication Language: English

Publication Type: Journal article

Publication year: 2025

Journal

Oncology Research and Treatment Karger Publishers

DOI: 10.1159/000545976

Abstract

Introduction: Cancer-associated venous thromboembolism (CAT) is a frequent and medical relevant problem. Guidelines recommend treatment with low molecular weight heparins (LMWH) or direct oral factor-Xa inhibitors as rivaroxaban for ≥3 months. Patient’s preference and convenience is an important factor to guide treatment decision and to support treatment adherence. No data are available so far about patient-reported outcome in CAT. Methods: CONKO-011/ AIO-SUP-0115/ass. was an open-label, prospective, multicenter German phase III trial for cancer patients with newly diagnosed venous thromboembolism (VTE) randomized to rivaroxaban (Riva) or site-specific LMWH. Primary endpoint was patient-reported treatment satisfaction, measured by the Anti-Clot Treatment Scale (ACTS). The 12-item ACTS Burdens scale (primary endpoint after 4 weeks) and the 3-item ACTS Benefits scale were analyzed at 4, 8 and 12 weeks. Secondary endpoints included recurrent VTE, major/clinically relevant bleeding, safety, compliance, overall mortality at 3 and 6 months, quality of life measured by the Treatment Satisfaction Questionnaire for Medication II (TSQM II) and Spitzer Index. Results: Between 03/2016 and 06/2019, 247 (123 Riva/124 LMWH) patients were randomized. Mean ACTS Burdens scores after 4 weeks were 52.8 versus 51.2 in favor of rivaroxaban (p = 0.019) with mean score differences ranging from 3.3 (week 8; p = 0.001) to 2.4 (week 12; p = 0.006). The treatment effect of ACTS burden was consistent over treatment time (p < 0.001). More patients on LMWH requested to stop study treatment preterm (19.4% versus 11.1%). Conclusion: Oral treatment with rivaroxaban led to an improvement in patient-reported treatment satisfaction, particularly in reducing anticoagulation-related burden, resulting in less patient-requested treatment stops.

Authors with CRIS profile

Sabine Semrau Department of Radiation Oncology

Involved external institutions

DIAKO Evangelisches Diakonie-Krankenhaus gGmbH DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Krankenhaus Ludmillenstift Meppen DE Germany (DE) Centrum für Integrierte Onkologie Aachen Bonn Köln Düsseldorf (CIO ABCD) DE Germany (DE) Klinikum Passau DE Germany (DE) Kliniken Essen-Mitte DE Germany (DE) Universitätsklinikum Freiburg DE Germany (DE) Krankenhaus Barmherzige Brüder DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE)

How to cite

APA:

Sinn, M., Lohneis, A., Mohamed, O., Roderburg, C., Hellmann, M., Südhoff, T.,... Riess, H. (2025). CONKO-011/AIO-SUP-0115/ass.: Rivaroxaban Compared to Low Molecular Weight Heparin in Cancer Patients with Acute Venous Thromboembolism. Oncology Research and Treatment. https://doi.org/10.1159/000545976

MLA:

Sinn, Marianne, et al. "CONKO-011/AIO-SUP-0115/ass.: Rivaroxaban Compared to Low Molecular Weight Heparin in Cancer Patients with Acute Venous Thromboembolism." Oncology Research and Treatment (2025).

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