title: A pilot trial of combination cisplatin, 5-fluorouracil and interferon-alpha in the treatment of advanced esophageal carcinoma.
abstract: OBJECTIVE
  Based on the synergistic effect between cisplatin and 5-fluorouracil (5-FU), and between 5-FU and interferon-alpha, we conducted a trial to assess the response rate and toxicity of the combination of cisplatin, 5-FU and interferon-alpha in patients with advanced esophageal cancer.
  
  
  METHODS
  Patients with locally advanced or metastatic squamous cell or adenocarcinoma of the esophagus were eligible. No prior chemotherapy or interferon were allowed. Patients received cisplatin 80 mg/m(2) on day 1, 5-FU 750 mg/m(2)/day by continuous intravenous infusion for 5 days, and interferon-alpha 5 x 10(6) units/m(2)/day by subcutaneous injection on days 1-5 of each cycle. Cycles were repeated every 21 days for a total of 6 cycles.
  
  
  RESULTS
  Forty patients were enrolled. Median age was 57.5 years (range 30-70). 33 had squamous carcinoma and 7 adenocarcinoma; 15 were male; the locoregional metastatic ratio was 1:39; median ECOG performance status was 2 (range 1-3). Grade 3-4 toxicities were: leukopenia (9 cases), thrombocytopenia (4), electrolyte imbalance (11), febrile neutropenia (11), vomiting (5), diarrhea (4), and mucositis (11). There were 3 early deaths, most probably related to therapy. Five patients (13%) achieved a complete response and 17 (42%) achieved a partial response, yielding an overall response rate of 55%. Response rates for squamous and adeno histology were 61% and 29%, respectively. Median survival was 6.4 months.
  
  
  CONCLUSIONS
  The combination of cisplatin, 5-FU and interferon-alpha produces a high response rate in advanced squamous cell esophageal carcinoma, but with considerable toxicity. A modified combination of the above agents is presently being evaluated at our institution.
authors.affiliation: Department of Oncology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. bazarbashi@kfshrc.edu.sa
authors.forename: Shouki
authors.initials: S
authors.lastname: Bazarbashi
authors.forename: Mohammed
authors.initials: M
authors.lastname: Rahal
authors.forename: Madras A
authors.initials: MA
authors.lastname: Raja
authors.forename: Amr
authors.initials: A
authors.lastname: El Weshi
authors.forename: Chandrashekar
authors.initials: C
authors.lastname: Pai
authors.forename: Adnan
authors.initials: A
authors.lastname: Ezzat
authors.forename: Dahish
authors.initials: D
authors.lastname: Ajarim
authors.forename: Mohammed
authors.initials: M
authors.lastname: Memon
authors.forename: Mohammed
authors.initials: M
authors.lastname: Al Fadda
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D002945:Cisplatin; D005472:Fluorouracil