title: Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix.
  
  
  METHODS
  Eligible patients had cervical cancer, measurable disease, and GOG performance status ≤2. Treatment consisted of cetuximab 400 mg/m(2) initial dose followed by 250 mg/m(2) weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and response. The study used a 2-stage group sequential design.
  
  
  RESULTS
  Thirty-eight patients were entered with 3 exclusions, leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n=25, 71.4%) or 2 (n=10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n=5), GI (n=4), anemia (n=2), constitutional (n=3), infection (n=2), vascular (n=2), pain (n=2), and pulmonary, neurological, vomiting and metabolic (n=1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology.
  
  
  CONCLUSIONS
  Cetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology.
authors.affiliation: Yale University School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, New Haven, CT 06520-8063, USA. alessandro.santin@yale.edu
authors.forename: Alessandro D
authors.initials: AD
authors.lastname: Santin
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: D Scott
authors.initials: DS
authors.lastname: McMeekin
authors.forename: Mario M
authors.initials: MM
authors.lastname: Leitao
authors.forename: Jubilee
authors.initials: J
authors.lastname: Brown
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Sutton
authors.forename: Linda
authors.initials: L
authors.lastname: Van Le
authors.forename: Patricia
authors.initials: P
authors.lastname: Griffin
authors.forename: Cecelia H
authors.initials: CH
authors.lastname: Boardman
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D000068818:Cetuximab; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab