奥沙利铂和 S-1 辅助化疗治疗病理分期 III 期胃癌：一项多中心 II 期研究（TOSA 试验）方案。
Treatment using oxaliplatin and S-1 adjuvant chemotherapy for pathological stage III gastric cancer: a multicenter phase II study (TOSA trial) protocol.
机构信息
Department of Surgery, Kochi Medical School, Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan.
Cancer Treatment Center, Kochi Medical School Hospital, Kochi, Japan.
出版信息
BMC Cancer. 2018 Feb 13;18(1):186. doi: 10.1186/s12885-018-4109-z.
BACKGROUND
Recent studies demonstrated the efficacy of S-1-based adjuvant chemotherapy administered for six months after curative surgery for stage III gastric cancer; however, it is unproven whether this type of combination chemotherapy is more effective than the standard adjuvant chemotherapy of S-1 for one year.
METHODS
This multicenter phase II study evaluate the efficacy and safety of adjuvant chemotherapy using S-1 plus oxaliplatin followed by S-1 for up to one year for curatively resected stage III gastric cancer in patients aged over 20 years. Treatment initially comprises oral fluoropyrimidine S-1 (80 mg/m) administered twice daily for the first 2 weeks of a 3-week cycle. On day 1 of a second 3-week cycle, patients will receive 100 mg/m of intravenous oxaliplatin followed by 80 mg/m of S-1 (maximum 8 cycles). Then, the patients will receive 80 mg/m of S-1 daily for 4 weeks, followed by 2 weeks of no chemotherapy. This 6-week cycle will be repeated during the first year after surgery. The primary endpoint is relapse-free survival for 3 years and secondary endpoints are safety, including the incidence of adverse events, and grading of neuropathy with each treatment cycle. The planned sample size of 75 patients is appropriate for this trial. The data will be analyzed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance.
DISCUSSION
In contrast to previous trials, the current study involves administration of S-1 until one year after surgery in addition to prior S-1 plus oxaliplatin, and is the first study to evaluate the safety and efficacy of S-1 plus oxaliplatin followed by S-1 for up to one year in patients with curatively resected stage III gastric cancer.
TRIAL REGISTRATION
This trial is registered in the University Hospital Medical Information Network's Clinical Trials Registry (UMIN-CTR) registration number, R000029656 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656 ). Registered January 24, 2017.
背景
最近的研究表明，对于 III 期胃癌患者，在根治性手术后进行 S-1 为基础的辅助化疗 6 个月是有效的；然而，这种联合化疗是否比 S-1 标准辅助化疗 1 年更有效尚不清楚。
方法
这项多中心 II 期研究评估了 S-1 加奥沙利铂辅助化疗，然后在根治性切除的 III 期胃癌患者中使用 S-1 进行长达 1 年的治疗，患者年龄在 20 岁以上。治疗最初包括口服氟嘧啶 S-1（80mg/m），每 2 周为一个周期，每天两次。在第二个 3 周周期的第 1 天，患者将接受 100mg/m 的静脉奥沙利铂，然后接受 80mg/m 的 S-1（最多 8 个周期）。然后，患者将接受 80mg/m 的 S-1 每天一次，持续 4 周，然后进行 2 周无化疗。在手术后的第一年，将重复进行这种 6 周的周期。主要终点是 3 年无复发生存率，次要终点是安全性，包括每个治疗周期的不良事件发生率和神经病变分级。计划的 75 例患者的样本量适合该试验。将根据意向治疗进行数据分析，假设双侧检验，显著性水平为 5%。
讨论
与以往的试验不同，目前的研究在 S-1 加奥沙利铂治疗后，还包括手术前的 S-1 治疗，并且是第一项评估在根治性切除的 III 期胃癌患者中，使用 S-1 加奥沙利铂治疗后再使用 S-1 治疗长达 1 年的安全性和有效性的研究。
试验注册
该试验在大学医院医疗信息网络临床试验注册处（UMIN-CTR）注册，注册号为 R000029656（https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi？recptno=R000029656）。2017 年 1 月 24 日注册。
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