Phase II study of a modified combination of etoposide, doxorubicin, and cisplatin for patients with advanced gastric cancer.

Background: Based on the promising results of EAP (etoposide, doxorubicin, and cisplatin) combination, a phase II study of modified EAP combination was performed in patients with advanced gastric cancer to evaluate the response, toxicity, and survival.

Method: Fifty-two consecutive patients with measurable or evaluable advanced gastric cancer, who had no prior therapy except surgery, were treated every 28 days with etoposide 120 mg/m2/day, doxorubicin 25 mg/m2/day, and cisplatin 40 mg/m2/day on days 1 and 8, intravenously. Forty-seven patients were evaluable for response and toxicity.

Results: Overall response rate was 40.5% (95% CI = 37-54.7%), including 12.8% complete response. Responses were higher in patients with locally advanced disease (57.89%) as compared to those with distant metastases (28.57%) (P = 0.044). The median overall survivals of the entire group and the responders were 7 months and 11 months, respectively. Complete responders had significantly longer response duration and overall survival (31.5 months and 45.5 months, respectively), as compared to partial responders (6 months and 9 months, respectively). 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.

Conclusions: EAP as used in this trial is an effective treatment in advanced gastric cancer. The effect is more pronounced in patients with locally advanced disease.