CONKO-011: Rivaroxaban in the treatment of venous thrombembolism (VTE) in cancer patients – a randomized phase III study

M. Sinn1, A. Jühling1, J. Heinz2, M. Hellmann3, R. U. Trappe4, T. Südhoff5, B. Günther6, L. Wislocka1, J. Striefler1, U. Pelzer1, H. Riess1 (1Berlin, Germany, 2Freiburg, Germany, 3Köln , Germany, 4Bremen, Germany, 5Passau, Germany, 6Düsseldorf, Germany)

Antithrombotic treatment
Date: 17.02.2017,
Time: 17:15 - 18:15

Objective: Venous thrombembolism is a common and severe event in cancer patients, bleeding and recurrent VTE occur more frequently than in non-cancer patients and complicate treatment strategies. The actual standard is anticoagulation for 3 to 6 months with weight-adjusted low molecular weight heparine (LMWH). Direct oral anticoagulants as the Xa-inhibitor Rivaroxaban are considered to be an interesting alternative, but data for the direct comparison to LMWH from prospective studies are still missing.

Methods: The aim of the study is to investigate patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with LMWH measured by the anti-clot treatment scale (ACTS; Bamber Thromb Haemost 2013) as the primary endpoint of the study. Secondary endpoints are recurrence of VTE, clinically relevant bleeding and overall mortality after 3 and 6 months.

Results: CONKO-011 is a prospective, randomized, open-label, multicenter phase III study with two treatment arms. The trial is conducted in cooperation with the “Working group of medical oncology” (AIO) and the “Working group of Hemostaseology” of the German Society of Hematology and Oncology (DGHO). Main inclusion criteria are a newly diagnosed and objectively confirmed acute VTE, an active treatment-requiring malignancy, life expectancy of at least 6 months and a performance-status according to Karnofsky Performance Scale of ≥ 70%. Main exclusion criteria are therapeutic anticoagulation > 96 hours, relevant bleeding events, severe renal insufficiency with GFR < 30 ml/min, liver disease with coagulation impairment (including Child B and C cirrhosis) and treatment of underlying cancer with experimental therapies. In arm A patients are treated with Rivaroxaban orally 15 mg 2x daily for 21 days, followed by 20 mg 1x daily, in Arm B with LMWH in therapeutic dosage according to standards of the study centers. Anticoagulation treatment is done for at least 3 months or until symptomatic recurrence of VTE, major clinically relevant bleeding, severe side effects or withdrawal of informed consent. Begin of recruitment was March 2016 with an expected recruitment period of 24 months and a follow up of 6 months, end of study is planned for end of 2018. Currently, 37 patients are recruited by 19 study centers, 32 study centers have started active recruitment.