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Poster Display session 1

4658 - Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism (VTE) in patients with active cancer


28 Sep 2019


Poster Display session 1


Supportive Care and Symptom Management

Tumour Site


Alexander Cohen


Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265


A.T. Cohen1, A. Maraveyas2, J. Beyer-Westendorf3, A.Y.Y. Lee4, L.G. Mantovani5, K. Folkerts6, M. Bach7, Y. De Sanctis8, K. Abdelgawad6

Author affiliations

  • 1 Haematological Medicine, Guys and St Thomas NHS Trust, SE11 4TX - London/GB
  • 2 Hull York Medical School, Hull York Medical School and Hull University Teaching Hospitals NHS Trust, HU16 5JQ - Cottingham/GB
  • 3 Thrombosis Research Unit, University Hospital “Carl Gustav Carus” Dresden, 01307 - Dresden/DE
  • 4 Vancouver Coastal Health And British Columbia Cancer Agency, University of British Columbia, BC V6T 1Z4 - Vancouver/CA
  • 5 Research Centre On Public Health (cesp), University of Milan-Bicocca, 20126 - Milano MI/IT
  • 6 Global Medical Affairs, Bayer AG, 13353 - Berlin/DE
  • 7 Global Medical Affairs, Bayer Pharma AG, 13353 - Berlin/DE
  • 8 Global Clinical Statistics, Bayer AG, NJ 07981 - Whippany/US


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Abstract 4658


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.


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.


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).


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.


Bayer AG and Janssen Scientific Affairs, LLC.


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.

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