Abstract 4658
Background
Long-term anticoagulant treatment is important for the prevention of recurrent VTE in patients with cancer-associated thrombosis (CAT). Associated burdens of treatment include daily injections of low molecular weight heparin (LMWH) and challenges in maintaining safe and effective anticoagulation with vitamin K antagonists (VKAs), which may limit patient satisfaction and negatively impact on patient adherence and outcomes. Rivaroxaban may provide a more convenient option for these patients.
Methods
COSIMO (a multinational, prospective, non-interventional study) evaluated patient-reported outcomes in patients with active cancer scheduled to be switched to rivaroxaban following LMWH or VKA therapy for ≥4 weeks for the treatment of CAT. Treatment satisfaction was evaluated through the Anti-Clot Treatment Scale (ACTS), a 17-item measure of the negative and positive aspects of anticoagulation treatment, on subscales for ACTS Burdens (maximum score 60) and ACTS Benefits (maximum score 15), respectively. A higher score represents higher patient satisfaction. The primary outcome was a change in the ACTS Burdens score at week 4 compared with baseline. Analyses generally included all patients who received ≥1 dose of rivaroxaban, and who completed the ACTS questionnaire at the time point being assessed. p-values were generated through the Wilcoxon signed-rank test.
Results
Of 509 patients enrolled, 381 (74.9%) patients were valid for the ACTS analysis at week 4, 341 (67.0%) at month 3, and 253 (49.7%) at month 6. There was a significant increase in mean ACTS Burdens scores from baseline at week 4 (51.8 vs 55.6; mean difference = 3.9; p < 0.0001), from baseline at month 3 (52.1 vs 56.2; mean difference = 4.2; p < 0.0001), and from baseline at month 6 (51.7 vs 56.5; mean difference = 4.8; p < 0.0001). There were also significant increases in ACTS Benefit scores from baseline at month 3 (p = 0.04) and month 6 (p = 0.01).
Conclusions
Patients with CAT reported a durable improvement in anticoagulation-associated treatment satisfaction, specifically a reduction in the perceived burdens of therapy, following the switch from a LMWH or VKA to rivaroxaban.
Clinical trial identification
NCT02742623, registered 19 April 2016.
Editorial acknowledgement
Hayley Dawson of Chameleon Communications Int. Ltd.
Legal entity responsible for the study
The authors.
Funding
Bayer AG and Janssen Scientific Affairs, LLC.
Disclosure
A.T. Cohen: Honoraria (self), Research grant / Funding (self): Bayer; Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): Daiichi Sankyo Europe ; Honoraria (self), Research grant / Funding (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Johnson & Johnson; Honoraria (self): Portola; Honoraria (self): Sanofi; Honoraria (self): XO1; Honoraria (self): Janssen ; Honoraria (self): Ono Pharmaceuticals. A. Maraveyas: Honoraria (self): Bayer; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Pfizer. J. Beyer-Westendorf: Honoraria (self), Research grant / Funding (self): Bayer; Honoraria (self), Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (self): Daiichi Sankyo; Honoraria (self), Research grant / Funding (self): Doasense; Honoraria (self), Research grant / Funding (self): Portola; Honoraria (self), Research grant / Funding (self): Pfizer. A.Y.Y. Lee: Honoraria (self): Bayer; Honoraria (self): LEO Pharma ; Honoraria (self): Pfizer; Research grant / Funding (self): Bristol-Myers Squibb. L.G. Mantovani: Honoraria (self): Bayer; Honoraria (self), Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self): Pfizer; Research grant / Funding (self): Daiichi Sankyo. K. Folkerts: Full / Part-time employment: Bayer. M. Bach: Full / Part-time employment: Bayer. Y. De Sanctis: Full / Part-time employment: Bayer. K. Abdelgawad: Full / Part-time employment: Bayer.
Resources from the same session
3158 - Tobacco Retail Access and Tobacco Cessation Among Head and Neck Cancer (HNC) Survivors
Presenter: Lawson Eng
Session: Poster Display session 1
Resources:
Abstract
5511 - ASSERT: A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Patients Treated for Moderate to Severe Hyponatremia Secondary to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in Italy (Lung Cancer Cohort)
Presenter: Rossana Berardi
Session: Poster Display session 1
Resources:
Abstract
3821 - Efficacy and safety of controlled ovarian stimulation with or without letrozole co-administration for fertility preservation: A systematic review and meta-analysis.
Presenter: Benedetta Bonardi
Session: Poster Display session 1
Resources:
Abstract
2168 - Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy
Presenter: Tineke Vandenbroucke
Session: Poster Display session 1
Resources:
Abstract
5855 - Update of the registry of young women with cancer by the International Network of Cancer, Infertility and Pregnancy
Presenter: Charlotte Maggen
Session: Poster Display session 1
Resources:
Abstract
5156 - Erectile dysfunction in patients with metastatic renal cell carcinoma
Presenter: Ilya Tsimafeyeu
Session: Poster Display session 1
Resources:
Abstract
4992 - Exercise level, interest and preferences in cancer patients.
Presenter: Alice Avancini
Session: Poster Display session 1
Resources:
Abstract
3427 - Filling the Gaps in Informed Consent for Advanced Cancer Patients considering Phase 1 Oncology Trials - an in-depth Qualitative Study of Key Stakeholders at a large United Kingdom Phase 1 unit
Presenter: Abhijit Pal
Session: Poster Display session 1
Resources:
Abstract
3537 - Breast Cancer Patients’ Quality of Life: Real World Data
Presenter: Thanos Kosmidis
Session: Poster Display session 1
Resources:
Abstract
4761 - High-sensitivity troponin as a cardiotoxicity biomarker in breast cancer treatment
Presenter: Joana Simões
Session: Poster Display session 1
Resources:
Abstract