title: A safety and survival analysis of neoadjuvant bevacizumab with standard chemoradiation in a phase I/II study compared with standard chemoradiation in locally advanced rectal cancer.
abstract: BACKGROUND
  Bevacizumab is increasingly being tested with neoadjuvant regimens in patients with localized cancer, but its effects on metastasis and survival remain unknown. This study examines the long-term outcome of clinical stage II/III rectal cancer patients treated in a prospective phase II study of bevacizumab with chemoradiation and surgery. As a benchmark, we used data from an analysis of 42 patients with locally advanced rectal cancer treated with a contemporary approach of preoperative fluoropyrimidine-based radiation therapy.
  
  
  METHODS
  Outcome analyses were performed on 32 patients treated prospectively with neoadjuvant bevacizumab, 5-fluorouracil, radiation therapy, and surgery as well as 42 patients treated with standard fluoropyrimidine-based chemoradiation.
  
  
  RESULTS
  Overall survival, disease-free survival, and local control showed favorable trends in patients treated with bevacizumab with chemoradiation followed by surgery. Acute and postoperative toxicity appeared acceptable.
  
  
  CONCLUSIONS
  Neoadjuvant bevacizumab with standard chemoradiation and surgery shows promising long-term efficacy and safety profiles in locally advanced rectal cancer patients.
authors.affiliation: Department of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA. christopher.willett@duke.edu
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Willett
authors.forename: Dan G
authors.initials: DG
authors.lastname: Duda
authors.forename: Marek
authors.initials: M
authors.lastname: Ancukiewicz
authors.forename: Mira
authors.initials: M
authors.lastname: Shah
authors.forename: Brian G
authors.initials: BG
authors.lastname: Czito
authors.forename: Rex
authors.initials: R
authors.lastname: Bentley
authors.forename: Martin
authors.initials: M
authors.lastname: Poleski
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujita
authors.forename: Gregory Y
authors.initials: GY
authors.lastname: Lauwers
authors.forename: Madeline
authors.initials: M
authors.lastname: Carroll
authors.forename: Douglas
authors.initials: D
authors.lastname: Tyler
authors.forename: Christopher
authors.initials: C
authors.lastname: Mantyh
authors.forename: Paul
authors.initials: P
authors.lastname: Shellito
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Chung
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clark
authors.forename: Rakesh K
authors.initials: RK
authors.lastname: Jain
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D005472:Fluorouracil