title: Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial.
abstract: BACKGROUND
  The AMPLIFY trial compared apixaban with enoxaparin followed by warfarin for the treatment of acute venous thromboembolism (VTE).
  
  
  OBJECTIVE
  To perform a subgroup analysis to compare the efficacy and safety of apixaban and enoxaparin followed by warfarin for the treatment of VTE in patients with cancer enrolled in AMPLIFY.
  
  
  METHODS
  Patients with symptomatic VTE were randomized to a 6-month course of apixaban or enoxaparin followed by warfarin. The primary efficacy outcome and principal safety outcome were recurrent VTE or VTE-related death and major bleeding, respectively.
  
  
  RESULTS
  Of the 5395 patients randomized, 169 (3.1%) had active cancer at baseline, and 365 (6.8%) had a history of cancer without active cancer at baseline. Among patients with active cancer, recurrent VTE occurred in 3.7% and 6.4% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (relative risk [RR] 0.56, 95% confidence interval [CI] 0.13-2.37); major bleeding occurred in 2.3% and 5.0% of evaluable patients, respectively (RR 0.45, 95% CI 0.08-2.46). Among patients with a history of cancer, recurrent VTE occurred in 1.1% and 6.3% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (RR 0.17, 95% CI 0.04-0.78); major bleeding occurred in 0.5% and 2.8% of treated patients, respectively (RR 0.20, 95% CI 0.02-1.65).
  
  
  CONCLUSIONS
  The results of this subgroup analysis suggest that apixaban is a convenient option for cancer patients with VTE. However, additional studies are needed to confirm this concept and to compare apixaban with low molecular weight heparin in these patients.
authors.affiliation: Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia, Perugia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Agnelli
authors.affiliation: Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: H R
authors.initials: HR
authors.lastname: Buller
authors.affiliation: Guy's and St Thomas Hospital's, King's College, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Cohen
authors.affiliation: Department of Haematology, SA Pathology at Flinders Medical Centre & Flinders University, Adelaide, Australia.
authors.forename: A S
authors.initials: AS
authors.lastname: Gallus
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: T C
authors.initials: TC
authors.lastname: Lee
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: R
authors.initials: R
authors.lastname: Pak
authors.affiliation: College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
authors.forename: G E
authors.initials: GE
authors.lastname: Raskob
authors.affiliation: McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada.
authors.forename: J I
authors.initials: JI
authors.lastname: Weitz
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: T
authors.initials: T
authors.lastname: Yamabe
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000150:complications*; D016017:Odds Ratio; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D011728:Pyridones / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D014859:Warfarin
keywords: anticoagulants; apixaban; cancer; enoxaparin; venous thromboembolism