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

Cancer Medicine

卷:9

Hanno Riess¹  Alok A. Khorana²  Mairéad G. McNamara³  Ujjwala Vijapurkar⁴  Peter Wildgoose⁵  Simrati Kaul⁵  Marino Venerito⁶  Eileen M. O'Reilly⁷  Saroj Vadhan‐Raj⁸  Xiao Zhou⁸  Michael J. Overman⁹ 

[1] Charité Universitätsmedizin Berlin Berlin Germany;

[2] Department of Hematology and Medical Oncology Cleveland Clinic Cleveland OH USA;

[3] Department of Medical Oncology The Christie NHS Foundation Trust & Division of Cancer Sciences University of Manchester Manchester United Kingdom;

[4] Janssen Research & Development, LLC Raritan NJ USA;

[5] Janssen Scientific Affairs, LLC Titusville NJ USA;

[6] Klinik für Gastroenterologie Hepatologie und Infektiologie Universitätsklinikum Magdeburg Germany;

[7] Memorial Sloan Kettering Cancer Center Weill Cornell Medical College New York NY USA;

[8] The UT MD Anderson Cancer Center Department of Sarcoma Medical Oncology Section of Cytokines and Supportive Oncology Houston TX USA;

[9] The UT MD Anderson Cancer Center Houston TX USA;

关键词: major bleeding;    pancreatic cancer;    rivaroxaban;    thromboprophylaxis;    venous thromboembolism;   

DOI  :  10.1002/cam4.3269

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown