Department of General Medicine.
Department of Internal Medicine.
Medicine (Baltimore). 2021 May 7;100(18):e25756. doi: 10.1097/MD.0000000000025756.
We conducted a population-based cohort study enrolling patients with Stage II and III colon cancer receiving postoperative adjuvant chemotherapy with uracil and tegafur (UFT) or fluorouracil (5-FU) from the Taiwan National Health Insurance Research Database from 2000 to 2015. The outcomes of the current study were disease-free survival (DFS) and overall survival (OS). Hazard ratios (HRs) were calculated by multivariate Cox proportional hazard regression models. We compared our effectiveness results from the literature by meta-analysis, which provided the best evidence. Severe adverse events were compared in meta-analysis of reported clinical trials. In the nationwide cohort study, UFT (14,486 patients) showed DFS similar to postoperative adjuvant chemotherapy (adjusted HR 1.037; 95% confidence interval [CI] 0.954-1.126; P = .397) and OS (adjusted HR 0.964; 95% CI 0.891-1.041; P = .349) compared with the 5-FU (866 patients). Our meta-analysis confirmed the similarity of effectiveness and found the incidence of leucopaenia was statistically significantly reduced in UFT (risk ratio 0.12; 95% CI 0.02-0.67; I2 = 0%). Through our analysis, we have confirmed that UFT is a well-tolerated adjuvant therapy choice, and has similar treatment efficacy as 5-FU in terms of DFS and OS in patients with Stage II and III colon cancer.
我们开展了一项基于人群的队列研究，纳入了 2000 年至 2015 年间在台湾全民健康保险研究数据库中接受术后辅助化疗（UFT 或 5-FU）的 II 期和 III 期结肠癌患者。本研究的结局指标为无病生存（DFS）和总生存（OS）。采用多变量 Cox 比例风险回归模型计算风险比（HR）。我们通过荟萃分析比较了来自文献的有效性结果，荟萃分析提供了最佳证据。在报告的临床试验的荟萃分析中比较了严重不良事件。在全国性队列研究中，UFT（14486 例患者）的 DFS 与术后辅助化疗相似（调整 HR 1.037；95%置信区间 [CI]0.954-1.126；P=0.397）和 OS（调整 HR 0.964；95%CI 0.891-1.041；P=0.349）与 5-FU（866 例患者）相比。我们的荟萃分析证实了有效性的相似性，并发现 UFT 组白细胞减少症的发生率明显降低（风险比 0.12；95%CI 0.02-0.67；I2=0%）。通过我们的分析，我们已经证实 UFT 是一种耐受良好的辅助治疗选择，在 II 期和 III 期结肠癌患者中，DFS 和 OS 方面，UFT 与 5-FU 的治疗效果相似。
