Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study Journal Article


Authors: Vadhan-Raj, S.; McNamara, M. G.; Venerito, M.; Riess, H.; O'Reilly, E. M.; Overman, M. J.; Zhou, X.; Vijapurkar, U.; Kaul, S.; Wildgoose, P.; Khorana, A. A.
Article Title: Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study
Abstract: Background: Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established. Methods: This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis–defined major bleeding. Results: In total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34-1.43; P =.328) in up-to-day-180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13-0.97; P =.034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D-dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P <.01). Conclusions: In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting. Trial registration: ClinicalTrials.gov identifier, NCT02555878. © 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Keywords: pancreatic cancer; venous thromboembolism; rivaroxaban; thromboprophylaxis; major bleeding
Journal Title: Cancer Medicine
Volume: 9
Issue: 17
ISSN: 2045-7634
Publisher: Wiley Blackwell  
Date Published: 2020-09-01
Start Page: 6196
End Page: 6204
Language: English
DOI: 10.1002/cam4.3269
PUBMED: 32663379
PROVIDER: scopus
PMCID: PMC7476843
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Eileen O'Reilly
    783 O'Reilly