title: A multicenter phase II trial of single-agent cetuximab in advanced esophageal and gastric adenocarcinoma.
abstract: BACKGROUND
  Epidermal growth factor receptor (EGFR) is overexpressed in a significant proportion of esophageal and gastric carcinomas. Although previous studies have examined tyrosine kinase inhibitors of EGFR, there remains limited data regarding the role of EGFR-directed monoclonal antibody therapy in these malignancies. We carried out a multi-institutional phase II study of cetuximab, a monoclonal antibody against EGFR, in patients with unresectable or metastatic esophageal or gastric adenocarcinoma.
  
  
  METHODS
  Thirty-five patients with previously treated metastatic esophageal or gastric adenocarcinoma were treated with weekly cetuximab, at an initial dose of 400 mg/m(2) followed by weekly infusions at 250 mg/m(2). Patients were followed for toxicity, treatment response, and survival.
  
  
  RESULTS
  Treatment with cetuximab was well tolerated; no patients were taken off study due to drug-related adverse events. One (3%) partial treatment response was noted. Two (6%) patients had stable disease after 2 months of treatment. Median progression-free survival and overall survival were 1.6 and 3.1 months, respectively.
  
  
  CONCLUSIONS
  Although well tolerated, cetuximab administered as a single agent had minimal clinical activity in patients with metastatic esophageal and gastric adenocarcinoma. Ongoing studies of EGFR inhibitors in combination with other agents may define a role for these agents in the treatment of esophageal and gastric cancer.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School. Electronic address: jang@partners.org.
authors.forename: J A
authors.initials: JA
authors.lastname: Chan
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Division of Hematology/Oncology, Department of Medicine.
authors.forename: L S
authors.initials: LS
authors.lastname: Blaszkowsky
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: P C
authors.initials: PC
authors.lastname: Enzinger
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Division of Hematology/Oncology, Department of Medicine.
authors.forename: D P
authors.initials: DP
authors.lastname: Ryan
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: T A
authors.initials: TA
authors.lastname: Abrams
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Division of Hematology/Oncology, Department of Medicine.
authors.forename: A X
authors.initials: AX
authors.lastname: Zhu
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Division of Hematology/Oncology, Department of Medicine.
authors.forename: J S
authors.initials: JS
authors.lastname: Temel
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: D
authors.initials: D
authors.lastname: Schrag
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: P
authors.initials: P
authors.lastname: Bhargava
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: J A
authors.initials: JA
authors.lastname: Meyerhardt
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: B M
authors.initials: BM
authors.lastname: Wolpin
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Division of Hematology/Oncology, Department of Medicine.
authors.forename: P
authors.initials: P
authors.lastname: Fidias
authors.affiliation: Department of Hematology/Oncology, Harvard Medical School; Biostatistics Center, Massachusetts General Hospital, Boston, USA.
authors.forename: H
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.
authors.forename: S
authors.initials: S
authors.lastname: Florio
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.
authors.forename: E
authors.initials: E
authors.lastname: Regan
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston; Department of Medicine, Brigham and Women's Hospital, Boston; Department of Hematology/Oncology, Harvard Medical School.
authors.forename: C S
authors.initials: CS
authors.lastname: Fuchs
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab