PHASE-II STUDY OF A MODIFIED COMBINATION OF ETOPOSIDE, DOXORUBICIN, AND CISPLATIN FOR PATIENTS WITH ADVANCED GASTRIC

Background: Based on the promising results of EAP (etoposide, doxorubi cin, and cisplatin) combination, a phase II study of modified EAP comb ination was performed in patients with advanced gastric cancer to eval uate the response, toxicity, and survival. Method: Fifty-two consecuti ve patients with measurable or evaluable advanced gastric cancer, who had no prior therapy except surgery, were treated every 28 days with e toposide 120 mg/m(2)/day, doxorubicin 25 mg/m(2)/day, and cisplatin 40 mg/m(2)/day on days 1 and 8, intravenously. Forty-seven patients were evaluable for response and toxicity. Results: Overall response rate w as 40.5% (95%CI = 37-54.7%), including 12.8% complete response. Respon ses were higher in patients with locally advanced disease (57.89%) as compared to those with distant metastases (28.57%) (P = 0.044). The me dian overall survivals of the entire group and the responders were 7 m onths and 11 months, respectively. Complete responders had significant ly longer and overall survival (31.5 months and 45,5 months, respectiv ely), as compared to partial responders (6 months and 9 months, respec tively). Six of the responders (31.6%) were alive at 2 years. Disease extension and pretreatment performance status had significant effects on survival. Grade 3-4 toxicity was observed in 33% of patients. There were no deaths related to toxicity. Conclusion: EAP as used in this t rial is an effective treatment in advanced gastric cancer. The effect is more pronounced in patients with locally advanced disease. (C) 1997 Wiley-Liss, Inc.