A PHASE-II EVALUATION OF HIGH-DOSE CISPLATIN AND ETOPOSIDE IN PATIENTS WITH ADVANCED ESOPHAGEAL ADENOCARCINOMA

BACKGROUND. In patients with advanced esophageal adenocarcinoma, the e fficacy and palliative role of systemic chemotherapy are not well defi ned. The primary objective of this Phase II trial was to evaluate the antitumor activity and toxicity of a multiday chemotherapy schedule of high dose cisplatin and etoposide in patients with unresectable or me tastatic esophageal adenocarcinoma. A secondary objective was to asses s the efficacy of this regimen in palliating dysphagia. METHODS. Twent y-seven eligible patients with unresectable locoregional or metastatic esophageal adenocarcinoma were treated with cisplatin, 30 mg/m(2)/day , and etoposide, 60 mg/m(2)/day, intravenously daily for 5 days, every 3 weeks. After three cycles of chemotherapy, all patients were assess ed for response. Patients with responding metastatic disease were give n one additional cycle of chemotherapy, and patients with locoregional disease received radiation and concurrent continuous infusion of 5-fl uorouracil at 300 mg/m(2)/day for the duration of radiation therapy. P atients were questioned about dysphagia symptoms initially and then we ekly during chemotherapy. RESULTS. The major toxicities included myelo suppression, nausea and vomiting, and peripheral sensory neuropathy, w ith one treatment-related death. Major responses were observed in 13 p atients (48%; 95% confidence intervals, 36-74%), including 5 complete and 8 partial responses. Dysphagia relief occurred in 89% of 18 sympto matic patients within a median time of 16 days. The median survival du ration for all patients was 9.8 months, and the actuarial 3-year survi val rate was 22%. CONCLUSIONS. Multiday chemotherapy with high dose ci splatin and etoposide is active in patients with advanced esophageal a denocarcinoma. Toxicities associated with this regimen are substantial but manageable. (C) 1996 American Cancer Society.