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

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.