title: Cetuximab combined with FOLFOX4 as the first-line treatment for advanced gastric cancer: report of 25 cases from a single institution.
abstract: OBJECTIVE
  To assess efficacy and safety of cetuximab with FOLFOX4 as first-line treatment for advanced gastric cancer.
  
  
  METHODS
  Cetuximab was administered at 400mg/m2 followed by 250mg/m2 weekly, or 500mg/m2 every 2 weeks. FOLFOX4 regimen was given every 2 weeks (oxaliplatin 85mg/m2, LFA 200mg/m2, 5-FU 400mg/m2 bolus and 600mg/m2 22-hour continuous infusion), for a maximum of 12 cycles, or until the occurrence of untolerated toxicities or disease progression.
  
  
  RESULTS
  Twenty-five patients enrolled from April 2007 to September 2010. With the median treatment of six cycles, patients with complete response, partial response, stable disease and progressive disease were 0, 9, 12 and 4, respectively, according to RECIST criteria. ORR and DCR were 36.0% (95% CI=17%-55%) and 84.0% (95% CI=70%-98%), respectively. The median PFS was 6.5 months (95% CI=5.0-8.0 months) and median OS was 10.6 months (95% CI=4.4-16.7 months). Grade 3-4 toxicities including leucopenia (24%), neutropenia (16%), febrile neutropenia (16%), acne-like rash (16%), sensory neuropathy (8%), diarrhea (4%), nausea and vomiting (4%), asthenia (4%) as well as stomatitis (4%) were observed.
  
  
  CONCLUSIONS
  The combination of cetuximab and FOLFOX4 is active and well tolerated as the 1st line treatment for advanced gastric cancer. Grade 3-4 toxicities were uncommon. Large scale clinical trial is necessary to get more evidence to identify its efficacy. The potential predictive biomarkers for this regimen in treating advanced gastric cancer need to be further identified.
authors.affiliation: Department of Surgery, Shanghai Jiaotong University School of Medicine, Shanghai, Japan.
authors.forename: Min
authors.initials: M
authors.lastname: Shi
authors.forename: Jun
authors.initials: J
authors.lastname: Ji
authors.forename: Jun
authors.initials: J
authors.lastname: Wu
authors.forename: Tao
authors.initials: T
authors.lastname: Ma
authors.forename: Ying
authors.initials: Y
authors.lastname: Liu
authors.forename: Chen-Fei
authors.initials: CF
authors.lastname: Zhou
authors.forename: Yang
authors.initials: Y
authors.lastname: Su
authors.forename: Zheng-Bao
authors.initials: ZB
authors.lastname: Ye
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Zheng-Gang
authors.initials: ZG
authors.lastname: Zhu
mesh_terms: 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 / Q000627:therapeutic use*; D000068818:Cetuximab; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011518:Proto-Oncogene Proteins / Q000235:genetics; D016283:Proto-Oncogene Proteins p21(ras); D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D018631:ras Proteins / Q000235:genetics
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C117307:KRAS protein, human; D009944:Organoplatinum Compounds; D011518:Proto-Oncogene Proteins; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil