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
3317 - Circulating tumor DNA (ctDNA) analysis in patients (pts) with non-small cell lung cancer (NSCLC) treated with telisotuzumab vedotin (teliso-v), an antibody-drug conjugate targeting c-Met
Presenter: Rebecca Heist
Session: Poster Display session 1
Resources:
Abstract
3887 - First Real Life Data on Durvalumab after definitive concomitant ChemoRadiotherapy (cCRT) in unresectable Stage (St) III Non-Small Cell Lung Cancer (NSCLC) in France: Analysis of 591 patients (pts) enrolled in the French cohort (c) Temporary Authorization of Use (ATU)
Presenter: Virginie Avrillon
Session: Poster Display session 1
Resources:
Abstract
682 - EGFR Inhibitor Versus Chemotherapy as Adjuvant Treatment for Locally-advanced EGFR-mutant Non-Small Cell Lung Cancer
Presenter: Peng Xie
Session: Poster Display session 1
Resources:
Abstract
2509 - Afatinib in EGFR TKI-naïve patients with EGFR mutation-positive (EGFRm+) NSCLC: interim analysis of a Phase IIIb, multi-national, open-label study
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3300 - First-line ceritinib versus chemotherapy in patients (pts) with advanced ALK rearranged (ALK+) non-small cell lung cancer (NSCLC): ASCEND-4 Asian subgroup analysis
Presenter: Daniel SW Tan
Session: Poster Display session 1
Resources:
Abstract
2653 - A combined analysis of two Phase IIIb studies of afatinib in EGFR TKI-naïve patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3663 - Impact of plasma EGFR mutation fractions on response to first generation tyrosine-kinase inhibitor in treatment of naïve non-small cell lung cancer patients
Presenter: Xiaohong Wang
Session: Poster Display session 1
Resources:
Abstract
5921 - Definition of an afatinib trough concentration threshold in the treatment of NSCLC
Presenter: Stephane Bouchet
Session: Poster Display session 1
Resources:
Abstract
2852 - A Phase Ib Trial of Neoadjuvant Chemoradiotherapy and Durvalumab(MEDI4736) for Potentially Resectable stage III Non-Small Cell Lung Cancer (NSCLC)
Presenter: Beung chul AHN
Session: Poster Display session 1
Resources:
Abstract
3273 - Low expression of Notch1 and combined Notch1/HES1 are associated with adverse survival factor for limited stage small cell lung cancer
Presenter: Jinsoo Lee
Session: Poster Display session 1
Resources:
Abstract