Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Hospital, Incheon 405-706, Republic of Korea.
Cancer Chemother Pharmacol. 2012 Aug;70(2):277-84. doi: 10.1007/s00280-012-1912-0. Epub 2012 Jun 30.
This study was performed to determine the recommended dose (RD) and dose-limiting toxicity (DLT) associated with epirubicin, oxaliplatin, and S-1 (EOS) combination therapy in patients with previously untreated advanced gastric cancer (AGC).
Previously untreated patients with histologically proven metastatic AGC, with an ECOG performance status of 0-2, were enrolled in this study. A fixed dose of epirubicin (50 mg/m(2)) and oxaliplatin (130 mg/m(2)) was intravenously administered on day 1 of treatment, followed by oral S-1 administration twice daily on days 1-14. The S-1 dose was escalated according to the following schedule: level I, 35 mg/m(2); level II, 40 mg/m(2); level III, 45 mg/m(2); Level IV, 50 mg/m(2). Each cycle was repeated every 21 days. DLTs were evaluated during the first two cycles of treatment.
Nineteen patients with a median age of 53 years (range, 40-71 years) were enrolled in this study. One case of DLT (grade 4 neutropenia lasting more than 5 days) developed from among the six dose level II patients, while 2 DLTs (grade 3 diarrhea and nausea) were observed among the 4 dose level III patients. Based on these results, dose level II was determined as the RD. Of the 13 patients with measurable lesions, eight achieved partial response, three showed stable disease, and the objective response rate was 61.5 % (95 % confidence interval (CI), 13.3-66.6 %). The median progression-free survival and overall survival of all patients was 6.8 months (95 % CI, 1.4-9.5 months) and 13.3 months (95 % CI, 1.9-24.6 months), respectively.
The RD of the EOS regimen in patients with previously untreated AGC was 50 mg/m(2) of epirubicin and 130 mg/m(2) of oxaliplatin on day 1, with administration of 40 mg/m(2) of S-1 twice a day on days 1-14 for each 21-day cycle. The EOS regimen described produced promising results.
本研究旨在确定表柔比星、奥沙利铂和 S-1（EOS）联合治疗未经治疗的晚期胃癌（AGC）患者的推荐剂量（RD）和剂量限制毒性（DLT）。
本研究纳入了组织学证实的转移性 AGC 且 ECOG 体能状态为 0-2 的未经治疗的患者。在治疗的第 1 天，给予固定剂量的表柔比星（50mg/m²）和奥沙利铂（130mg/m²）静脉给药，然后在第 1-14 天每天口服 S-1 两次。S-1 剂量根据以下方案递增：水平 I，35mg/m²；水平 II，40mg/m²；水平 III，45mg/m²；水平 IV，50mg/m²。每个周期每 21 天重复一次。在治疗的前两个周期评估 DLT。
本研究纳入了 19 名中位年龄为 53 岁（范围，40-71 岁）的患者。在 6 名接受剂量水平 II 的患者中，有 1 例发生 DLT（持续超过 5 天的 4 级中性粒细胞减少症），而在 4 名接受剂量水平 III 的患者中，有 2 例发生 DLT（3 级腹泻和恶心）。基于这些结果，确定剂量水平 II 为 RD。在 13 名可测量病变的患者中，8 名患者达到部分缓解，3 名患者疾病稳定，客观缓解率为 61.5%（95%置信区间，13.3-66.6%）。所有患者的中位无进展生存期和总生存期分别为 6.8 个月（95%置信区间，1.4-9.5 个月）和 13.3 个月（95%置信区间，1.9-24.6 个月）。
在未经治疗的 AGC 患者中，EOS 方案的 RD 为第 1 天给予表柔比星 50mg/m²和奥沙利铂 130mg/m²，每个 21 天周期的第 1-14 天给予 S-1 40mg/m²，每天口服两次。描述的 EOS 方案产生了有前景的结果。
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