ETOPOSIDE, DOXORUBICIN, AND CISPLATIN CHEMOTHERAPY FOR ADVANCED GASTRIC ADENOCARCINOMA - RESULTS OF A PHASE-II TRIAL

Purpose: A phase II study of etoposide, doxorubicin, and cisplatin (EAP) therapy in patients with advanced gastric carcinoma was performed in an attempt to confirm encouraging results reported by German investigators using an identical EAP regimen. Patients and Methods: Thirty-six consecutive, previously untreated patients with surgically unresectable, measurable gastric carcinoma were treated every 28 days with etoposide (120 mg/m2, days 4, 5, and 6), doxorubicin (20 mg/m2, days 1 and 7), and cisplatin (40 mg/m2, days 2 and 8). A total of 108 courses of treatment was given. Results: Therapy was associated with myelosuppression (median granulocyte nadir, 239/μL; median platelet nadir, 81,000/μL), which reached its maximum 14 days after the start of therapy and necessitated hospitalization after 24 of 108 (22%) treatment courses. Four of 36 (11%) patients died of treatment- related toxicity: three from sepsis and one from hemorrhage. Objective responses were observed in 12 of 36 (33%) patients; three (8%) patients experienced a clinical complete response. The median time to progression was 4 months for all 36 patients and 8 months for the 12 responding patients. Of the 13 patients with localized but unresectable disease, five subsequently underwent surgical resection; only one of these five was rendered disease- free. Conclusion: The EAP regimen is highly toxic and results in response rates and survival times no better than those of more easily tolerated treatment programs.