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
2728 - MicroRNA expression and DNA methylation profiles do not distinguish between primary and recurrent well-differentiated liposarcoma
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
3197 - Genomic Alterations, Tumor Mutation Burden and Prognosis of Chinese Cardiac Sarcoma Patients
Presenter: Na Zhu
Session: Poster Display session 1
Resources:
Abstract
4214 - Evaluation of a peptide-conjugated alkylator melflufen in osteosarcoma preclinical models
Presenter: Konstantin Byrgazov
Session: Poster Display session 1
Resources:
Abstract
2654 - Expression analysis of NHEJ and HR genes in Ewing sarcomas: indications of DSB repair dysfunction
Presenter: Anastasios Kyriazoglou
Session: Poster Display session 1
Resources:
Abstract
4383 - Epidemiology of Synovial Sarcoma in EU28 countries
Presenter: Nedra Joseph
Session: Poster Display session 1
Resources:
Abstract
1937 - Resection Of High-Grade Large Soft Tissue Sarcoma With Adequate Wide Margin Can Lead To Good Local Control Without Adjuvant Radiotherapy
Presenter: Toshiyuki Kunisada
Session: Poster Display session 1
Resources:
Abstract
3757 - Influence of eribulin on proliferation, migration and invasion properties of leiomyosarcoma cell line models
Presenter: Marta Mendiola
Session: Poster Display session 1
Resources:
Abstract
1040 - EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
1048 - A Phase 2 biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, a disease with a high unmet need
Presenter: Kan Yonemori
Session: Poster Display session 1
Resources:
Abstract
1511 - A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010)
Presenter: Herbert Loong
Session: Poster Display session 1
Resources:
Abstract