1st Department of Surgery, Jagiellonian University Medical College, 40 Kopernika Street, PL-31-501 Krakow, Poland.
Oncology. 2010;78(1):54-61. doi: 10.1159/000292360. Epub 2010 Mar 6.
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.
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.
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.
Three cycles of EAP regimen postoperatively offer no survival advantage in gastric cancer patients.
本研究旨在评估表柔比星、阿霉素和顺铂（EAP）辅助化疗在根治性胃切除术后的疗效。
手术后，患者被随机分配到 EAP 或对照组。化疗包括 3 个疗程，每 28 天进行一次。每个周期包括多柔比星（20mg/m²）第 1 天和第 7 天，顺铂（40mg/m²）第 2 天和第 8 天，依托泊苷（120mg/m²）第 4、5 和 6 天。
在 309 例符合条件的患者中，141 例被分配到化疗组，154 例分配到支持治疗组。有 4 例（2.8%）与治疗相关的死亡，包括 3 例因骨髓抑制的败血症并发症和 1 例因心循环衰竭死亡。17 例（22%）患者出现 3 级或 4 级毒性。根据意向治疗分析，化疗组和对照组的中位生存期分别为 41.3 个月（95%置信区间，24.5-58.2）和 35.9 个月（95%置信区间，25.5-46.3）（p=0.398）。亚组分析显示，EAP 方案化疗在侵犯浆膜的肿瘤患者和转移淋巴结 7-15 个的患者中具有生存获益。
EAP 方案术后 3 个周期的化疗在胃腺癌患者中没有生存优势。
