Rivaroxaban thromboprohylaxis in ambulatory patients with pancreatic cancer: Results from a prespecified subgroup analysis of the CASSINI study

Saroj Vadhan-Raj, Mairead Mcnamara, M Venerito, H Riess, Eileen M O'Reilly, MJ Overman, Xiao Zhou, Ujjwala Vijapurkar, Simrati Kaul, P Wildgoose, Alok Khorana

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Pancreatic cancer patients are at risk for venous thromboembolism (VTE); 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 10mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. Primary efficacy endpoint was composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. Primary safety endpoint was International Society on Thrombosis and Haemostasis–defined major bleeding. Results: 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=0.328) 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=0.034). 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<0.01).
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.
Original languageEnglish
JournalCancer Medicine
DOIs
Publication statusPublished - 14 Jul 2020

Keywords

  • Pancreas cancer
  • Thromboprophylaxis
  • rivaroxaban

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