title: Front-line bevacizumab in combination with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) in patients with metastatic colorectal cancer: a multicenter phase II study.
abstract: OBJECTIVE
  To evaluate the efficacy and the toxicity of front line FOLFOX4 combined with bevacizumab in patients with metastatsic CRC (mCRC).
  
  
  METHODS
  Chemotherapy-naïve patients with mCRC, received bevacizumab (5 mg/kg every 2 weeks d1), oxaliplatin (85 mg/m2 on d1), leucovorin (200 mg/m2) on days 1 and 2 and 5-Fluorouracil (400 mg/m2 as i.v. bolus and 600 mg/m2 as 22 h i.v. continuous infusion on days 1 and 2) every 2 weeks.
  
  
  RESULTS
  Fifty three patients (46 with a PS 0-1) were enrolled. Complete and partial response was achieved in eight (15.1%) and 28 (52.8%) patients, respectively (ORR: 67.9%; 95% C.I.: 53.8%-92%); 11 (20.7%) patients had stable disease and six (11.3%) progressive disease. With a median follow up period of 13.5 months, time to tumor progression was 11 months while the median survival has not yet been reached; the probability of 1-, 2- and 3- year survival was 79.8%, 63.8% and 58.3%, respectively; Two patients relapsed during the follow up period. Eight (15%) patients underwent metastasectomy with R0 resections. Grade 3-4 neutropenia occurred in 15.1% of patients and one (1.9%) of them presented febrile neutropenia. Non-hematologic toxicity included grade 3 diarrhea (7.6%) and grade 2 and 3 neurotoxicity in 16.9 and 15.1% of patients, respectively. One (1.9%) patient presented pulmonary embolism and one (1.9%) cardiac ischaemia. There was one (1.9%) sudden death after the first cycle.
  
  
  CONCLUSIONS
  The combination of FOLFOX4/bevacizumab appears to be highly effective, well tolerated and merits further evaluation in patients with mCRC.
authors.affiliation: Department of Medical Oncology, Interbalkan Medical Center, Thessaloniki, Greece. georgsec@med.uoc.gr <georgsec@med.uoc.gr>
authors.forename: Christos
authors.initials: C
authors.lastname: Emmanouilides
authors.forename: Georgia
authors.initials: G
authors.lastname: Sfakiotaki
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Androulakis
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christophylakis
authors.forename: Antonia
authors.initials: A
authors.lastname: Kalykaki
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Sofia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Eleni
authors.initials: E
authors.lastname: Diamandidou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Touroutoglou
authors.forename: Adam
authors.initials: A
authors.lastname: Chatzidakis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
authors.forename: John
authors.initials: J
authors.lastname: Souglakos
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008113:Liver Neoplasms / Q000556:secondary / Q000601:surgery; D008175:Lung Neoplasms / Q000556:secondary / Q000601:surgery; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil