S-1 联合奥沙利铂新辅助化疗治疗胃癌临床 T4 或 N2-3 的 II 期研究。

Phase II study of neoadjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer clinical T4 or N2-3.

机构信息

Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan.

Department of Chemotherapy and Palliative Care, Tokyo Women's Medical University, 8-1 Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan.

出版信息

Med Oncol. 2021 Jul 24;38(9):98. doi: 10.1007/s12032-021-01549-z.

DOI:10.1007/s12032-021-01549-z

PMID:34302539

Abstract

In Japan, the standard treatment for stage II or III gastric cancer is D2 gastrectomy followed by administration of S-1 for one year. However, patients with stage III disease have unsatisfactory survival rates. The purpose of this study was to evaluate the efficacy and safety of neoadjuvant chemotherapy consisting of S-1 and oxaliplatin for advanced gastric cancer. Patients with cT4 or cN2-3 gastric cancer were scheduled to receive two courses of chemotherapy (130 mg/m oxaliplatin on Day 1, 80 mg/m S-1 per day twice daily for 14 days) followed by surgery. The primary endpoint was the R0 resection rate. The secondary endpoints were rates of completion of protocol treatment, pathological response, and adverse events; and 3-year overall survival, 5-year overall survival, and 5-year recurrence-free survival. Between May 2016 and March 2019, 30 patients were enrolled in the study, all of whom completed the protocol treatment. The R0 resection rate (primary endpoint) was 93.3% (95% confidence interval: 77.9-99.2). The pathological response rate was 63.3%. Grade 3-4 toxicities included anemia (3.3%), anorexia (6.7%), and fatigue (3.3%). Relative dose intensities were 91.2% and 94.2% for S-1 and oxaliplatin, respectively. Neoadjuvant S-1 and oxaliplatin is highly effective, achieving an acceptable R0 resection rate with relatively few severe toxicities and good compliance.Trial registration: Registry name: A prospective intervention study on the availability of preoperative SOX therapy for T4 or N2-3 gastric cancer. Trial ID: UMIN: UMIN000024656. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R00002836.

摘要

在日本，Ⅱ期或Ⅲ期胃癌的标准治疗方法是 D2 胃切除术，随后用 S-1 治疗一年。然而，Ⅲ期疾病患者的生存率并不理想。本研究旨在评估 S-1 和奥沙利铂新辅助化疗治疗晚期胃癌的疗效和安全性。cT4 或 cN2-3 胃癌患者计划接受两周期化疗（第 1 天 130mg/m 奥沙利铂，80mg/m S-1 每日两次，持续 14 天），然后进行手术。主要终点是 R0 切除率。次要终点是方案治疗完成率、病理反应率和不良事件发生率；以及 3 年总生存率、5 年总生存率和 5 年无复发生存率。2016 年 5 月至 2019 年 3 月，共 30 例患者入组本研究，所有患者均完成了方案治疗。R0 切除率（主要终点）为 93.3%（95%置信区间：77.9-99.2）。病理反应率为 63.3%。3-4 级毒性包括贫血（3.3%）、厌食（6.7%）和疲劳（3.3%）。S-1 和奥沙利铂的相对剂量强度分别为 91.2%和 94.2%。新辅助 S-1 和奥沙利铂治疗非常有效，实现了可接受的 R0 切除率，且毒性相对较轻，患者依从性良好。