title: Thrombotic events in metastatic colorectal cancer patients treated with leucovorin, fluorouracil and irinotican (FOLFIRI) plus bevacizumab.
abstract: OBJECTIVE
  To determine the incidence and risk factors for thrombotic events (TEs) in patients with metastatic colorectal cancer (mCRC) who received bevacizumab (BV) and FOLFIRI (leucovorin, fluorouracil and irinotican) compared to FOLFIRI alone.
  
  
  METHODS
  Single institution retrospective study of 450 mCRC patients who received either BV plus FOLFIRI or FOLFIRI alone between April 2004 and August 2012. Demographics, TE risk factors, and treatment data were abstracted from patients' records. Multivariate analysis was used to identify factors that contributed to thromboembolism.
  
  
  RESULTS
  Two-hundred-sixty-one mCRC patients received BV plus FOLFIRI [64.8% males, mean body mass index (BMI) of 27.6] compared to 189 control patients who received FOLFIRI alone (61.9% males, BMI 27.2). The incidence of TEs was 14.9% in the BV plus FOLFIRI group, compared to 15.9% in the control group. Multivariate analysis controlling for age, BMI, gender, malignancy, metastatic sites, line of treatment, and risk factors did not suggest a significant increase in the risk of TE with the addition of BV (OR =0.83 95% CI: 0.40-1.70; P=0.602). No difference in the site of TEs was observed between the treatment groups. The only statistically significant risk factor for thrombosis in the FOLFIRI plus BV group was increased BMI (OR =1.05; 95% CI: 1.01-1.10; P=0.01).
  
  
  CONCLUSIONS
  This study does not support a significant increase in the risk of TE in patients with mCRC who received BV in addition to FOLFIRI. Increased BMI may be a risk factor for thrombosis in patients treated with BV.
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Humaid O
authors.initials: HO
authors.lastname: Al-Shamsi
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Abdulaziz
authors.initials: A
authors.lastname: Al Farsi
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Mahraz
authors.initials: M
authors.lastname: Anjum
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Hua
authors.initials: H
authors.lastname: Shen
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Kevin
authors.initials: K
authors.lastname: Zbuk
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Cook
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Lori-Ann
authors.initials: LA
authors.lastname: Linkins
authors.affiliation: 1 Department of Oncology, McMaster University, Hamilton, Ontario, Canada ; 2 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada ; 3 Department of Medicine, Sheikh Zayed Military Hospital, Abu Dhabi, United Arab Emirates ; 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Major
keywords: Metastatic colorectal cancer (mCRC); bevacizumab (BV); chemotherapy; thrombosis; venous thromboembolism (VTE)