A phase II study of etoposide, doxorubicin, and carboplatin in the treatment of advanced gastric cancer.

Many phase II studies have reported improved response rates with severe toxicity of etoposide, doxorubicin (Adriamycin), and cisplatin in advanced gastric cancer. In an attempt to obtain a better regimen with high efficacy and less toxicity, a combination regimen of etoposide, doxorubicin, and carboplatin (EAC) had been developed and evaluated in this phase II study. Forty-six patients with advanced gastric cancer were enrolled in the study. The treatment consisted of doxorubicin 20 mg/m2 given intravenously on days 1 and 7, etoposide 70 mg/m2 intravenously on days 4, 5, and 6, and carboplatin 200 mg/m2 intravenously on days 2 and 8. Therapy was repeated every 4 weeks. Patients who had stable disease or who responded, received an additional two to six cycles of therapy. Among 45 patients evaluable for response and toxicity, there was a 49% objective response rate, including 7% complete remission and 42% partial response. There was 11% stable disease and 27% progressive disease. Among 11 patients with lymph node metastasis only after a curative gastrectomy, there was an 82% objective response rates with 27% having complete remission and 55% having partial response. The median follow-up was 16 months. The median survival duration of all 45 patients was 11 months. The median time to progression was 5 months. The main toxicity was myelosuppression, with a high incidence of 82% leukopenia but only 9% of grades III to IV. Gastrointestinal toxicity was mild, with a low incidence of 42% nausea and vomiting and only 2% of grades III to IV. There were no chemotherapy-related deaths. With mild and tolerable toxicity, the EAC regimen in our study has active antitumor activity in advanced gastric cancer, which may have a positive influence on long-term survival time. It has a high efficacy, especially in patients with lymph node metastasis only after a curative gastrectomy. This regimen deserves further clinical studies for testing activity and toxicity in advanced gastric cancer.