Comparison of Long-term Outcomes Between Upfront Surgery and Neoadjuvant Therapy Followed by Surgery in Patients with Node-Negative Gastric Cancer: a Propensity Score Matched International Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,081
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
Patients with lymph node-negative gastric cancer, the prognosis of patients who underwent neoadjuvant therapy was poor than that of those who had upfront surgery.
详细描述
We retrospectively analyzed the clinicopathological data of patients who underwent curative surgery for gastric cancer and were pathologically confirmed to have node-negative metastases between January 2010 and June 2021 at 8 institutions in China. Data from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) were used as the validation cohort. The patients were divided into two groups based on whether they received neoadjuvant therapy before surgery: the upfront surgery (UFS) group and the neoadjuvant therapy followed by surgery (NATS) group. A 1:1 propensity score matching analysis was employed to reduce the potential selection bias between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) underwent radical gastrectomy (R0) and D2 lymphadenectomy; (5) postoperative pathology confirmed no lymph node metastasis (i.e., lymph node-negative); and (6) follow-up for at least 3 years.
排除标准
- •(1) considered early-stage gastric cancer before surgery; (2) distant metastasis detected preoperatively or intraoperatively; (3) failure to achieve R0 resection and D2 lymphadenectomy during surgery; (4) concurrent diagnosis of other malignancies; (5) remnant gastric cancer; (6) death within 30 days postoperatively; and (7) incomplete baseline data or follow-up records.
结局指标
主要结局
survival
时间窗: Within 3 years after surgery
3-year overall survival , disease-specific survival，and disease-free survival
次要结局
未报告次要终点
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University