Phase II trial of neoadjuvant cisplatin, 5-fluorouracil and interferon-alpha in operable squamous cell carcinoma of the esophagus

Chemotherapy. 2008;54(4):315-22. doi: 10.1159/000151353. Epub 2008 Aug 14.

Abstract

Background: The combination of 5-fluorouracil (5-FU), cisplatin and interferon (IFN)-alpha was found to result in a high response rate in advanced esophageal squamous cell carcinoma (SCC).

Methods: Resectable cases of esophageal SCC were treated with 3 cycles of chemotherapy consisting of cisplatin 70 mg/m(2) i.v. on day 1, 5-FU 500 mg/m(2)/day i.v. as a continuous infusion on days 1-5 and IFN-alpha 4 million units/m(2)/day s.c. on days 1-5. Cycles were repeated every 21 days. Esophagectomy was performed 3-5 weeks after the 3rd cycle of chemotherapy.

Results: Thirty patients were enrolled in the trial. Toxic death was observed in 1 patient because of esophageal perforation. Pathologically, complete response was observed in 4 of 23 patients who had esophagectomy. At a median follow-up period of 21.4 months, median progression-free survival was 11.5 months and median overall survival was 26.3 months.

Conclusion: This regimen has substantial activity in localized SCC of the esophagus with encouraging survival duration.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / surgery
  • Cisplatin / adverse effects
  • Cisplatin / therapeutic use*
  • Dose-Response Relationship, Drug
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / pathology
  • Esophageal Neoplasms / surgery
  • Esophagectomy
  • Female
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use*
  • Humans
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use*
  • Male
  • Middle Aged
  • Neoadjuvant Therapy / adverse effects
  • Neoplasm Metastasis / drug therapy
  • Neoplasm Metastasis / pathology
  • Recurrence
  • Survival Rate

Substances

  • Interferon-alpha
  • Cisplatin
  • Fluorouracil