LBA48 - Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism in patients with cancer
Date | 27 September 2014 |
Event | ESMO 2014 |
Session | Supportive and palliative care |
Topics | Supportive Measures |
Presenter | Martin Prins |
Citation | Annals of Oncology (2014) 25 (5): 1-41. 10.1093/annonc/mdu438 |
Authors |
M.H. Prins1, T. Lensing2, P. Prandoni3, A.T. Cohen4, B. Davidson5, F. Misselwitz2, Á. Pap2, M. Trajanovic6, S. Berkowitz6, P. Wells7
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Abstract
Aim
Objective: To compare the efficacy and safety of oral rivaroxaban with that of enoxaparin/vitamin K antagonist (VKA) in patients with cancer among 8282 patients with acute venous thromboembolism (VTE) enrolled in the EINSTEIN programme.
Rationale: Patients with cancer and VTE constitute a medical challenge for physicians because anticoagulant treatment is indicated to prevent recurrent VTE but is associated with a high risk of major bleeding.
Methods
EINSTEIN DVT and EINSTEIN PE were randomized, event-driven, non-inferiority, open-label phase III studies. Patients were treated for 3, 6 or 12 months with rivaroxaban (15 mg twice daily for 21 days followed by 20 mg once daily) or enoxaparin/VKA (international normalized ratio 2.0–3.0) and followed for suspected recurrent VTE, bleeding and mortality. Cancer patients were classified as: active cancer at baseline (diagnosis or treatment within 6 months before enrolment or recurrent/metastatic cancer) or diagnosed during the study (n = 655); or a history of cancer (n = 469).
Results
Recurrent VTE occurred with a similar incidence in the rivaroxaban and enoxaparin/VKA groups in patients with active cancer (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.35–1.30) and patients with a history of cancer (HR 0.98; 95% CI 0.28–3.43). In patients with active cancer, the risk of major bleeding was significantly reduced in the rivaroxaban group (HR 0.42; 95% CI 0.18–0.99), whereas it was similar between treatments in patients with a history of cancer (HR 0.23; 95% CI 0.03–2.06). Mortality occurred with a similar incidence between treatments in patients with active cancer (HR 0.93; 95% CI 0.64–1.35) and patients with a history of cancer (HR 1.12; 95% CI 0.30–4.22).
Rivaroxaban | Enoxaparin/VKA | HR (95% CI) | |
---|---|---|---|
Recurrent VTE, n (%) | |||
Active cancer | 16/354 (4.5) | 20/301 (6.6) | 0.67 (0.35–1.30) |
History of cancer | 5/233 (2.1) | 5/236 (2.1) | 0.98 (0.28–3.43) |
Major bleeding, n (%) | |||
Active cancer | 8/353 (2.3) | 15/298 (5.0) | 0.42 (0.18–0.99) |
History of cancer | 1/231 (0.4) | 4/236 (1.7) | 0.23 (0.03–2.06) |
Mortality, n (%) | |||
Active cancer | 58/354 (16.4) | 53/301 (17.6) | 0.93 (0.64–1.35) |
History of cancer | 5/233 (2.1) | 4/236 (1.7) | 1.12 (0.30–4.22) |
Conclusions
Rivaroxaban had similar efficacy to enoxaparin/VKA in patients with VTE and active cancer or a history of cancer, but was associated with a significant reduction in major bleeding in patients with active cancer.
Disclosure
M.H. Prins: is a consultant advisor for Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Pfizer, Sanofi, Boehringer Ingelheim, GlaxoSmithKline (GSK), LEO, and ThromboGenics; T. Lensing, F. Misselwitz, Á.F. Pap, M. Trajanovic and S.D. Berkowitz: is an employee of Bayer HealthCare Pharmaceuticals; P. Prandoni: has received consultant fees from Bayer Pharma, Daiichi Sankyo, Pfizer, Boehringer-Ingelheim and Sanofi-Aventis; A.T. Cohen: has received consultancy and clinical trial funding from Astellas, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, Daiichi, GSK, Johnson & Johnson, Mitsubishi Pharma, Pfizer, Portola, Sanofi-aventis, Schering-Plough & Takeda; B.L. Davidson: has received travel support from Bayer Healthcare, and is a steering committee member for Bayer HealthCare and Daiichi Sankyo;P. Wells: has received research support from Bristol-Myers Squibb, Pfizer; has participated on scientific advisory boards for Bayer Schering Pharma, Pfizer & Boehringer Ingelheim; and has received honoraria from Bayer Schering Pharma, Pfizer & Biomerieux.