title: A phase II trial of gemcitabine, 5-fluorouracil and leucovorin in advanced esophageal carcinoma.
abstract: BACKGROUND
  The aim of this study was to evaluate the overall response rate, toxicity and overall survival in patients with locally advanced or metastatic esophageal cancer treated with gemcitabine, 5-fluorouracil (5-FU) and leucovorin.
  
  
  METHODS
  Patients with either adenocarcinoma or squamous cell carcinoma of the esophagus could enroll; however, patients could not have received prior chemotherapy for metastatic disease. Treatment cycles consisted of infusions of all three agents at days 1, 8 and 15, repeated every 28 days. Patients received gemcitabine 1,000, leucovorin 25 and 5-FU 600 mg/m(2). Tumor assessment was performed every 2 cycles. Responses were assessed using the Eastern Cooperative Oncology Group solid tumor response criteria.
  
  
  RESULTS
  Thirty-five patients with metastatic or locally advanced esophageal cancer enrolled. One complete response and ten partial responses were observed for an overall response rate of 31.4%. An additional 11 patients had stable disease as their best response. The median survival was 9.8 months with a 1-year survival rate of 37.1%. Toxicity was predominately hematologic, with 58% of patients experiencing grade 3 or 4 neutropenia.
  
  
  CONCLUSIONS
  The combination of gemcitabine, 5-FU and leucovorin had activity in advanced esophageal cancer. Patients tolerated the regimen well, with myelosuppression occurring most commonly. The combination merits further investigation as a treatment for esophageal cancer.
authors.affiliation: University of Wisconsin Comprehensive Cancer Center, Madison, WI 53792, USA. slm@medicine.wisc.edu
authors.forename: Sherry
authors.initials: S
authors.lastname: Morgan-Meadows
authors.forename: Daniel
authors.initials: D
authors.lastname: Mulkerin
authors.forename: Jordan D
authors.initials: JD
authors.lastname: Berlin
authors.forename: Kyungmann
authors.initials: K
authors.lastname: Kim
authors.forename: Howard
authors.initials: H
authors.lastname: Bailey
authors.forename: Thomas
authors.initials: T
authors.lastname: Saphner
authors.forename: Alcee
authors.initials: A
authors.lastname: Jumonville
authors.forename: Richard
authors.initials: R
authors.lastname: Hansen
authors.forename: Harish
authors.initials: H
authors.lastname: Ahuja
authors.forename: Thomas
authors.initials: T
authors.lastname: McFarland
authors.forename: James P
authors.initials: JP
authors.lastname: Thomas
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine