title: A randomized phase II trial of apixaban for the prevention of thromboembolism in patients with metastatic cancer.
abstract: BACKGROUND
  Cancer patients receiving chemotherapy are at increased risk for thrombosis. Apixaban, a factor Xa inhibitor, is oral and does not require laboratory monitoring.
  
  
  OBJECTIVE
  A pilot study was conducted to evaluate whether apixaban would be well tolerated and acceptable in cancer patients receiving chemotherapy.
  
  
  METHODS
  Subjects receiving either first-line or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian or prostate cancers, cancer of unknown origin, myeloma or selected lymphomas were randomized to 5 mg, 10 mg or 20 mg once daily of apixaban or placebo in a double-blind manner for 12 weeks. Use of the study drug began within 4 weeks of the start of chemotherapy. The primary outcome was either major bleeding or clinically relevant non-major (CRNM) bleeding. Secondary outcomes included venous thromboembolism (VTE) and grade III or higher adverse events related to the study drug. Thirty-two patients received 5 mg, 30 patients 10 mg, 33 patients 20 mg, and 30 patients placebo. In these groups, there were 0, 0, 2 and 1 major bleeds, respectively. The corresponding data for CRNM bleeds were 1, 1, 2, and 0. The rate of major bleeding in the 93 apixaban patients was 2.2% (95% confidence interval 0.26-7.5%). There were no fatal bleeds. Three placebo patients had symptomatic VTE.
  
  
  CONCLUSIONS
  Apixaban was well tolerated in our study population. These results support further study of apixaban in phase III trials to prevent VTE in cancer patients receiving chemotherapy.
authors.affiliation: Department of Oncology, McMaster University and Ontario Clinical Oncology Group, Hamilton, Ontario, Canada. mlevine@mcmaster.ca
authors.forename: M N
authors.initials: MN
authors.lastname: Levine
authors.forename: C
authors.initials: C
authors.lastname: Gu
authors.forename: H A
authors.initials: HA
authors.lastname: Liebman
authors.forename: C P
authors.initials: CP
authors.lastname: Escalante
authors.forename: S
authors.initials: S
authors.lastname: Solymoss
authors.forename: D
authors.initials: D
authors.lastname: Deitchman
authors.forename: L
authors.initials: L
authors.lastname: Ramirez
authors.forename: J
authors.initials: J
authors.lastname: Julian
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002170:Canada; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015951:Factor Xa / Q000378:metabolism; D065427:Factor Xa Inhibitors; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018570:Risk Assessment; D012307:Risk Factors; D013923:Thromboembolism / Q000097:blood / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D015951:Factor Xa