Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Ann Oncol. 2021 Mar;32(3):368-374. doi: 10.1016/j.annonc.2020.11.017. Epub 2020 Dec 3.
Adjuvant chemotherapy and chemoradiotherapy are some of the standards of care for gastric cancer (GC). The Adjuvant chemoRadioTherapy In Stomach Tumors (ARTIST) 2 trial compares two adjuvant chemotherapy regimens and chemoradiotherapy in patients with D2-resected, stage II or III, node-positive GC.
The ARTIST 2 compared, in a 1:1:1 ratio, three adjuvant regimens: oral S-1 (40-60 mg twice daily 4 weeks on/2 weeks off) for 1 year, S-1 (2 weeks on/1 week off) plus oxaliplatin 130 mg/m every 3 weeks (SOX) for 6 months, and SOX plus chemoradiotherapy 45 Gy (SOXRT). Randomization was stratified according to surgery type (total or subtotal gastrectomy), pathologic stage (II or III), and Lauren histologic classification (diffuse or intestinal/mixed). The primary endpoint was disease-free survival (DFS) at 3 years; a reduction of 33% in the hazard ratio (HR) for DFS with SOX or SOXRT, when compared with S-1, was considered clinically meaningful. The trial is registered at clinicaltrials.gov (NCT0176146).
A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively. Median follow-up period was 47 months, with 178 DFS events observed. Estimated 3-year DFS rates were 64.8%, 74.3%, and 72.8% in the S-1, SOX, and SOXRT arms, respectively. HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 versus SOX, 0.692 (P = 0.042) and S-1 versus SOXRT, 0.724 (P = 0.074). No difference in DFS was found between SOX and SOXRT (HR 0.971; P = 0.879). Adverse events were as anticipated in each arm, and were generally well-tolerated and manageable.
In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX or SOXRT was effective in prolonging DFS, when compared with S-1 monotherapy. The addition of radiotherapy to SOX did not significantly reduce the rate of recurrence after D2 gastrectomy.
辅助化疗和放化疗是胃癌（GC）治疗的标准之一。Adjuvant chemoRadioTherapy In Stomach Tumors（ARTIST）2 试验比较了两种辅助化疗方案和放化疗在接受 D2 切除、Ⅱ期或Ⅲ期、淋巴结阳性 GC 患者中的应用。
ARTIST 2 以 1:1:1 的比例比较了三种辅助治疗方案：口服 S-1（40-60mg，每日 2 次，4 周用药/2 周停药）1 年，S-1（2 周用药/1 周停药）加奥沙利铂 130mg/m2，每 3 周 1 次（SOX）6 个月，以及 SOX 加 45Gy 放化疗（SOXRT）。随机分组根据手术类型（全胃或胃大部切除术）、病理分期（Ⅱ期或Ⅲ期）和 Lauren 组织学分类（弥漫型或肠型/混合型）进行分层。主要终点为 3 年无病生存率（DFS）；与 S-1 相比，SOX 或 SOXRT 降低 DFS 风险比（HR）33%被认为具有临床意义。该试验在 clinicaltrials.gov 注册（NCT0176146）。
2013 年 2 月至 2018 年 1 月共招募了 546 例患者，分别纳入 S-1、SOX 和 SOXRT 组，每组 182、181 和 183 例。中位随访时间为 47 个月，共观察到 178 例 DFS 事件。S-1、SOX 和 SOXRT 组 3 年 DFS 率分别为 64.8%、74.3%和 72.8%。DFS 的 HR 在对照组（S-1）中比 SOX 和 SOXRT 组更短：S-1 与 SOX 相比，0.692（P=0.042），S-1 与 SOXRT 相比，0.724（P=0.074）。SOX 和 SOXRT 之间的 DFS 无差异（HR 0.971；P=0.879）。每个治疗组的不良事件均与预期一致，且通常可耐受和管理。
在接受 D2 根治性切除、Ⅱ/Ⅲ期、淋巴结阳性 GC 的患者中，与 S-1 单药治疗相比，辅助 SOX 或 SOXRT 可延长 DFS。在 SOX 中加入放疗并不能显著降低 D2 胃切除术后的复发率。
