title: Bleeding after bevacizumab treatment in patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  To evaluate the adverse events (AEs) of bleeding caused by bevacizumab/5-fluorouracil/leucovorin (5-FU/LV) combination chemotherapy with addition of irinotecan or oxaliplatin in patients with metastatic colorectal cancer (mCRC).
  
  
  METHODS
  A retrospective study was conducted to evaluate the bleeding AEs associated with bevacizumab and to explore potential associations between bleeding and baseline patient characteristics. The National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 were used to classify the severity of AEs. AEs were divided into five grades: grade 1, mild: intervention not indicated; grade 2, moderate: medical intervention or minor cauterization indicated; grade 3, severe: transfusion, radiological, endoscopic or elective surgical intervention indicated; grade 4, life threatening: urgent intervention indicated; and grade 5, death.
  
  
  RESULTS
  Sixty-two patients were evaluated. Bleeding occurred in 26 (41%) patients; the incidence of grade 3 bleeding was 1.6% while no grade 4-5 bleeding occurred. Grade 1 epistaxis and grade 2 hemoptysis events were observed in 25.8% and 3.2% of patients, respectively. Hematochezia events occurred in 12 (19.4%) patients, one (1.6%) of whom required bevacizumab discontinuation. The incidence of hematochezia was higher in patients with unresected primary tumors, prior intestinal bleeding, and tumor response (p&lt;0.05).
  
  
  CONCLUSIONS
  These data provide important information about the incidence of clinically significant bleeding AEs, including minor mucocutaneous hemorrhage and major tumor-related bleeding such as hemoptysis and hematochezia in bevacizumab-treated mCRC patients. In addition, unresected primary tumor, prior bleeding, and tumor response were significant risk factors for hematochezia.
authors.affiliation: Department of Medical Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu - China.
authors.forename: Dan
authors.initials: D
authors.lastname: Cao
authors.forename: Chun-Hong
authors.initials: CH
authors.lastname: Guo
authors.forename: Jie-Wei
authors.initials: JW
authors.lastname: Liu
authors.forename: Xi
authors.initials: X
authors.lastname: Yang
authors.forename: Qiu
authors.initials: Q
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D004844:Epistaxis / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006469:Hemoptysis / Q000139:chemically induced; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D015994:Incidence; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068258:Bevacizumab; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin