title: Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: results from a large German community-based observational cohort study.
abstract: BACKGROUND
  After approval of bevacizumab in Germany in 2005 for the treatment of unresectable advanced or refractory colorectal cancer (CRC), this observational cohort study was initiated to assess the efficacy and safety of bevacizumab with various chemotherapy regimen in patients with metastatic CRC (mCRC).
  
  
  METHODS
  To facilitate enrolment of a typical mCRC population, eligibility criteria were minimised. Choice of chemotherapy regimen was at the physicians' discretion, but influenced by current registration status. Predefined endpoints were treatment characteristics, response rate, progression-free survival (PFS), overall survival (OS) and adverse events assessed as potentially related to bevacizumab treatment. Patients were followed for up to four years.
  
  
  RESULTS
  In total 1777 eligible patients were enrolled at 261 sites from January 2005 to June 2008. Median age: 64 years (range 19-100); male 62%; ECOG performance status 0-1/≥ 2 89%/11%. Chemotherapy choice was fluoropyrimidine (FU) 12%, FU/oxaliplatin 18%, FU/irinotecan 64%, no chemotherapy concurrent to bevacizumab 2% and other 4%. Best investigator-assessed response rate was 60% (complete response 10%, partial response 51%). Median PFS was 10.2 months and median OS was 24.8 months.
  
  
  CONCLUSIONS
  The efficacy and safety profile of bevacizumab in this population of mCRC patients with different chemotherapy regimens is consistent with that observed in other patient registries/non-randomised trials and also corresponds well with data from similar treatment arms of phase III trials.
authors.affiliation: Department of Oncology, Hematology, BMT with section Pneumology, University Medical Center Hamburg-Eppendorf , Hamburg , Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Stein
authors.forename: Volker
authors.initials: V
authors.lastname: Petersen
authors.forename: Mathias
authors.initials: M
authors.lastname: Schulze
authors.forename: Jörg
authors.initials: J
authors.lastname: Seraphin
authors.forename: Heinz-Gert
authors.initials: HG
authors.lastname: Hoeffkes
authors.forename: Anette R
authors.initials: AR
authors.lastname: Valdix
authors.forename: Jan
authors.initials: J
authors.lastname: Schroeder
authors.forename: Julia
authors.initials: J
authors.lastname: Herrenberger
authors.forename: Frank
authors.initials: F
authors.lastname: Boxberger
authors.forename: Barbara
authors.initials: B
authors.lastname: Leutgeb
authors.forename: Axel
authors.initials: A
authors.lastname: Hinke
authors.forename: Andreas
authors.initials: A
authors.lastname: Kutscheidt
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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 / Q000098:blood supply / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005858:Germany; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068258:Bevacizumab; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin