title: Herceptin and gemcitabine for metastatic pancreatic cancers that overexpress HER-2/neu.
abstract: OBJECTIVE
  To determine the response rate and toxicities of Herceptin and gemcitabine for patients with metastatic pancreatic adenocarcinomas that overexpress HER-2/neu.
  
  
  METHODS
  Patients with metastatic pancreatic cancer with 2+/3 + HER-2/neu expression by immunohistochemistry were eligible. Patients received gemcitabine, 1 g/m2/week, for 7 of 8 weeks followed by 3 of every 4 weeks, and Herceptin, 4 mg/kg loading dose, followed by 2 mg/kg/week.
  
  
  RESULTS
  Screening logs demonstrated the rate of HER-2/neu overexpression was 16%. Thirty-four patients were enrolled. Thirty patients (88%) had pancreatic cancers with 2+ overexpression and 4 patients (12%) had 3+ overexpression. Toxicity was similar to gemcitabine alone. Confirmed partial responses were observed in 2 of 32 patients (6%). Thirteen of 32 patients (41%) had either a partial response or a >50% reduction in CA 19-9. The median survival for all 34 patients was 7 months, and the 1-year survival was 19%.
  
  
  CONCLUSIONS
  The response rate of Herceptin and gemcitabine is similar to gemcitabine alone. The 7-month median survival in patients with metastatic pancreatic cancer suggests there may be a modest benefit for some patients. Infrequent HER-2/neu overexpression limits the role of targeting the HER-2/neu gene and prevents definitive conclusions on the addition of Herceptin to gemcibine for patients with pancreatic cancer.
authors.affiliation: The Brown University Oncology Group, Providence, Rhode Island, USA. hsafran@lifespan.org
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
authors.forename: David
authors.initials: D
authors.lastname: Iannitti
authors.forename: Ramesh
authors.initials: R
authors.lastname: Ramanathan
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Schwartz
authors.forename: Margaret
authors.initials: M
authors.lastname: Steinhoff
authors.forename: Chris
authors.initials: C
authors.lastname: Nauman
authors.forename: Paul
authors.initials: P
authors.lastname: Hesketh
authors.forename: Ritesh
authors.initials: R
authors.lastname: Rathore
authors.forename: Robert
authors.initials: R
authors.lastname: Wolff
authors.forename: Umadevi
authors.initials: U
authors.lastname: Tantravahi
authors.forename: T Marilyn
authors.initials: TM
authors.lastname: Hughes
authors.forename: Chris
authors.initials: C
authors.lastname: Maia
authors.forename: Terry
authors.initials: T
authors.lastname: Pasquariello
authors.forename: Lisa
authors.initials: L
authors.lastname: Goldstein
authors.forename: Thomas
authors.initials: T
authors.lastname: King
authors.forename: James Y
authors.initials: JY
authors.lastname: Tsai
authors.forename: Teresa
authors.initials: T
authors.lastname: Kennedy
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D000093542:Gemcitabine