Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial)
Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial)
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DOI：
10.1007/s10120-020-01101-4
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发表时间：
2020-06-28
期刊：
影响因子：
7.4
通讯作者：
Kang, Yoon-Koo
中科院分区：
文献类型：
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作者：
Lee, Keun-Wook;Chung, Ik-Joo;Kang, Yoon-Koo
背景在东亚，S-1加顺铂（SP）是转移性或复发性胃癌（MRGC）的标准一线化疗方案之一。奥沙利铂通常比顺铂毒性更小并且给药更方便。患者和方法 这是一项多中心、III 期研究，评估 S-1/奥沙利铂 (SOX) 在无进展生存期 (PFS) 方面是否不劣于/优于 SP。 MRGC 患者以 1:1 的比例随机接受 SOX（第 1-14 天 S-1 80 mg/m(2)/天；第 1 天奥沙利铂 130 mg/m(2)；每 3 周一次）或 SP（第 1-14 天 S-1 80 mg/m(2)/天；第 1 天顺铂 60 mg/m(2)；每 3 周 [SP3]）。结果 2012年10月至2014年10月期间，338名患者被随机分组。中位年龄为 56 岁，51% 的患者有可测量的病变。就 PFS 而言，SOX 显着不劣于 SP3，但并不优于 SP3 [中位数为 5.6 个月与 5.7 个月；风险比（HR）0.85； 95% 置信区间 (CI) 0.67-1.07]。在患有可测量疾病的患者中，SOX 和 SP3 的客观缓解率相似（58% 与 60%）。总体而言，两组的生存期没有差异（中位生存期为 12.9 个月与 11.4 个月；HR 0.86；95% CI 0.66-1.11）。双臂的治疗耐受性良好。贫血、白细胞减少、中性粒细胞减少、发热性中性粒细胞减少和口腔粘膜炎在 SP3 中更为常见。相比之下，SOX 引起的血小板减少、恶心、呕吐和周围神经病变更为常见。结论 SOX 不劣于 SP3。两种方案的耐受性良好，但毒性特征不同。 SOX 方案可推荐作为 MRGC 的一线治疗。
Background In East Asia, S-1 plus cisplatin (SP) is one of the standard first-line chemotherapy regimens for metastatic or recurrent gastric cancer (MRGC). Oxaliplatin is generally less toxic and more convenient to administer than cisplatin. Patients and methods This was a multicenter, phase III study assessing whether S-1/oxaliplatin (SOX) was non-inferior/superior to SP in terms of progression-free survival (PFS). Patients with MRGC were randomized 1:1 to receive either SOX (S-1 80 mg/m(2)/day on days 1-14; oxaliplatin 130 mg/m(2)on day 1; every 3 weeks) or SP (S-1 80 mg/m(2)/day on days 1-14; cisplatin 60 mg/m(2)on day 1; every 3 weeks [SP3]). Results Between October 2012 and October 2014, 338 patients were randomized. The median age was 56 years, and 51% of patients had measurable lesions. SOX was significantly non-inferior but not superior to SP3 in terms of PFS [median 5.6 versus 5.7 months; hazard ratio (HR) 0.85; 95% confidence interval (CI) 0.67-1.07]. In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%). Overall, the survival in both groups did not differ (median 12.9 versus 11.4 months; HR 0.86; 95% CI 0.66-1.11). Treatment was well tolerated in both arms. Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis were more common with SP3. In contrast, thrombocytopenia, nausea, vomiting, and peripheral neuropathy were more common with SOX. Conclusions SOX was non-inferior to SP3. The two regimens were well tolerated with different toxicity profiles. The SOX regimen can be recommended as a first-line treatment for MRGC.