title: Phase II study of gefitinib in patients with advanced salivary gland cancers.
abstract: BACKGROUND
  The purpose of this study was to determine the antitumor activity of the epidermal growth factor receptor (EGFR) inhibitor gefitinib in patients with recurrent/metastatic salivary gland cancer.
  
  
  METHODS
  We conducted a phase II study in adenoid cystic carcinoma (ACC) and non-ACC. Gefitinib was administered 250 mg orally daily. The primary endpoint was tumor response. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and disease control rates. EGFR and human epidermal growth factor receptor 2 (HER2) expression were evaluated and correlated with outcomes.
  
  
  RESULTS
  Thirty-seven patients were enrolled in this study, and 36 were evaluable (18 with ACC and 18 with non-ACC). No responses were observed. Median PFS was 4.3 months and 2.1 months, and median OS was 25.9 months and 16 months for patients with ACC and non-ACC, respectively. The disease control rate at 8 weeks was higher in patients with ACC. No unexpected toxicities occurred. EGFR and HER2 overexpression did not correlate with outcomes.
  
  
  CONCLUSIONS
  We did not observe significant clinical activity of gefitinib in advanced salivary gland cancer. NCT00509002.
authors.affiliation: Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas; Hematology/Medical Oncology Division, Northeast Ohio Medical University, Medina, Ohio.
authors.forename: John A
authors.initials: JA
authors.lastname: Jakob
authors.forename: Merrill S
authors.initials: MS
authors.lastname: Kies
authors.forename: Bonnie S
authors.initials: BS
authors.lastname: Glisson
authors.forename: Michael E
authors.initials: ME
authors.lastname: Kupferman
authors.forename: Diane D
authors.initials: DD
authors.lastname: Liu
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: Adel K
authors.initials: AK
authors.lastname: El-Naggar
authors.forename: Ana M
authors.initials: AM
authors.lastname: Gonzalez-Angulo
authors.forename: George R
authors.initials: GR
authors.lastname: Blumenschein
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003528:Carcinoma, Adenoid Cystic / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011799:Quinazolines / Q000627:therapeutic use*; D012074:Remission Induction; D012468:Salivary Gland Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib
keywords: adenoid cystic carcinoma; gefitinib; non-adenoid cystic carcinoma; response to therapy; salivary gland cancer