A Pilot Trial of Combination Cisplatin, 5-Fluorouracil and Interferon-α in the Treatment of Advanced Esophageal Carcinoma

Background/Objectives: Based on the synergistic effect between cisplatin and 5-fluorouracil (5-FU), and between 5-FU and interferon-α, we conducted a trial to assess the response rate and toxicity of the combination of cisplatin, 5-FU and interferon-α 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-α 5 × 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), vomitting (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. Conclusion: The combination of cisplatin, 5-FU and interferon-α 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.