PREOPERATIVE CHEMORADIOTHERAPY FOR CARCINOMA OF THE ESOPHAGUS AND GASTROESOPHAGEAL JUNCTION

PURPOSE To determine whether combination 5-fluorouracil, cisplatin, an d interferon alfa, an active regimen in advanced esophageal cancer, is efficacious as induction therapy before esophagectomy. MATERIALS AND METHODS Forty-four patients with potentially resectable esophageal/gas troesophageal junction adenocarcinoma or squamous cell carcinoma were entered into a phase I/II study of this chemotherapeutic regimen and c oncurrent external-beam radiotherapy before resection. The initial 16 patients were treated with prolonged-infusion 5-fluorouracil (300 mg/m (2) on days 1 to 28), cisplatin (20 mg/m(2) on days 1 to 5 and 24 to 2 8), interferon alfa (3 x 10(6) U/m(2) intravenously on days 1 to 5 and 24 to 28; subcutaneous injection every other day on days 6 to 23), an d radiation (4000 cGy). The subsequent 28 patients were treated over 2 1 days with two modifications: dose escalation of 5-fluorouracil (250 to 350 mg/m(2)) and double-fractionated radiotherapy to a total dose o f 4500 cGy. RESULTS Forty-one patients completed chemoradiotherapy and were evaluable for toxicity. Adverse events were substantial but tole rable, and most toxic episodes were hematologic and gastrointestinal. Three patients died, and one patient had progressive disease before re section. Of the 37 patients eligible for Native resection, 36 had all gross tumor removed. Thirty-three (80%) patients had a major pathologi c response: 10 (24%) with no residual tumor and 23 with only microscop ic residual tumor. Median survival for all patients was 27 months and for responders was 36 months. CONCLUSIONS This combination regimen is active but yields results similar to those of other chemoradiotherapy phase II trials; therefore, the contribution of interferon alfa to tre atment efficacy remains uncertain. The true worth of preoperative chem oradiotherapy is unknown pending results of phase III trials.