title: Phase II evaluation of recombinant alpha-2a-interferon and continuous infusion fluorouracil in previously untreated metastatic colorectal adenocarcinoma.
abstract: BACKGROUND
  Thirty-nine patients with advanced measurable metastatic colorectal carcinoma were entered in a clinical trial of recombinant alpha-2a-interferon (r alpha-2a-IFN) and continuous-infusion 5-fluorouracil (5-FU). Patients had not been treated previously with chemotherapy and had bidimensionally measurable disease.
  
  
  METHODS
  A course of therapy consisted of a 5-day continuous infusion of 5-FU, 750 mg/m2/day, with r alpha-2a-IFN, 9 x 10(6) IU, subcutaneously, on days 1, 3 and 5 of the 5-FU infusion. A course of therapy was repeated every 15 days, and patients were examined for response after receiving four courses of therapy.
  
  
  RESULTS
  One patient had a complete response, and 11 patients experienced partial responses, for an overall response rate of 31% (95% confidence interval [CI], 17-48%). The median duration of response was 7.5 months (range, 2-13 months). Fifty-two percent of the patients entered in this trial are alive at time of this writing, with a median follow-up duration of 12.2 months (range, 6-24 months). Grade 3-4 toxicities included mucositis (nine patients), diarrhea (two patients), granulocytopenia (two patients), and fatigue (three patients).
  
  
  CONCLUSIONS
  This regimen of 5-FU with r alpha-2a-IFN administration does not appear to be superior to previously published schedules of 5-FU with r alpha-2a-IFN or to other methods that modulate 5-FU.
authors.affiliation: Section of Gastrointestinal Oncology and Digestive Diseases, University of Texas M. D. Anderson Cancer Center, Houston 77030.
authors.forename: R
authors.initials: R
authors.lastname: Pazdur
authors.forename: J A
authors.initials: JA
authors.lastname: Ajani
authors.forename: Y Z
authors.initials: YZ
authors.lastname: Patt
authors.forename: J
authors.initials: J
authors.lastname: Gomez
authors.forename: B
authors.initials: B
authors.lastname: Bready
authors.forename: B
authors.initials: B
authors.lastname: Levin
mesh_terms: D000008:Abdominal Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000628:therapy; D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary / Q000628:therapy*; D000328:Adult; D000368:Aged; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000628:therapy*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000628:therapy; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000628:therapy; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000628:therapy*; D012074:Remission Induction
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D005472:Fluorouracil