Adjuvant Chemotherapy with Etoposide, Adriamycin and Cisplatin Compared with Surgery Alone in the Treatment of Gastric Cancer: A Phase III Randomized, Multicenter, Clinical Trial

作者：Kulig J^*; Kolodziejczyk P; Sierzega M; Bobrzynski L; Jedrys J; Popiela T; Dadan J; Drews M; Jeziorski A; Krawczyk M; Starzynska T; Wallner G

来源：Oncology, 2010, 78(1): 54-61.

DOI：10.1159/000292360

• Gastric cancer
• Adjuvant chemotherapy
• Etoposide
• Doxorubicin
• Cisplatin
• Etoposide-Adriamycin-cisplatin regimen

Objective: The aim of this study was to evaluate the efficacy of adjuvant chemotherapy with etoposide, Adriamycin and cisplatin (EAP) after potentially curative resections for gastric cancer. Methods: After surgery, patients were randomly assigned to the EAP or control arm. Chemotherapy included 3 courses, administered every 28 days. Each cycle consisted of doxorubicin (20 mg/m(2)) on days 1 and 7, cisplatin (40 mg/m(2)) on days 2 and 8, and etoposide (120 mg/m(2)) on days 4, 5, and 6. Results: Of 309 eligible patients, 141 were allocated to chemotherapy and 154 to the supportive care group. Four (2.8%) treatment-related deaths were recorded, including 3 due to septic complications of myelosuppression and 1 due to cardiocirculatory failure. Grade 3 or 4 toxicities were found in 17 (22%) patients. According to the intention-to-treat analysis, the median survival was 41.3 months (95% confidence interval, 24.5-58.2) and 35.9 months (95% confidence interval, 25.5-46.3) in the chemotherapy and control group, respectively (p = 0.398). Subgroup analysis revealed survival benefit from chemotherapy in patients with tumors infiltrating the serosa and in those with 7-15 metastatic lymph nodes. Conclusion: Three cycles of EAP regimen postoperatively offer no survival advantage in gastric cancer patients.

• 出版日期2010