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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02989-6

摘要内容如下：

血管内皮生长因子途径在胃癌的发病机制中起关键作用。在多中心、双盲的3期Frutiga试验中，703例晚期胃癌或胃食管连接部腺癌患者在接受含氟尿嘧啶和铂的化疗后出现进展，这些患者被随机（1:1）接受呋喹替尼（一种血管内皮生长因子受体抑制剂-1/2/3；4mg口服，每日一次）或安慰剂治疗3周，停药1周，加用紫杉醇（80mg/m2静脉注射，每周期1/8/15天）。研究结果是积极的，因为满足了双主要终点之一，即无进展生存期（PFS）（中位PFS，呋喹替尼组为5.6个月，安慰剂组为2.7个月；风险比0.57；95%置信区间0.48-0.68；P<0.0001）。另一个双重主要终点，即总生存期（OS），未达到（中位OS，9.6个月对8.4个月；危害比0.96，95%可信区间0.81-1.13；P=0.6064）。最常见的≥3级不良事件为中性粒细胞减少、白细胞减少和贫血。呋喹替尼联合紫杉醇作为二线治疗可显著改善中国晚期胃癌或胃食管连接部腺癌患者的无进展生存期（PFS），但不能改善总生存期（OS），可能成为这些患者的另一种治疗选择。ClinicalTrials.gov注册：NCT03223376。

英文原文如下：

Abstracts

The vascular endothelial growth factor pathway plays a key role in the pathogenesis of gastric cancer. In the multicenter, double-blind phase 3 FRUTIGA trial, 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy were randomized (1:1) to receive fruquintinib (an inhibitor of vascular endothelial growth factor receptor-1/2/3; 4 mg orally, once daily) or placebo for 3 weeks, followed by 1 week off, plus paclitaxel (80 mg/m2 intravenously on days 1/8/15 per cycle). The study results were positive as one of the dual primary endpoints, progression-free survival (PFS), was met (median PFS, 5.6 months in the fruquintinib arm versus 2.7 months in the placebo arm; hazard ratio 0.57; 95% confidence interval 0.48-0.68; P < 0.0001). The other dual primary endpoint, overall survival (OS), was not met (median OS, 9.6 months versus 8.4 months; hazard ratio 0.96, 95% confidence interval 0.81-1.13; P = 0.6064). The most common grade ≥3 adverse events were neutropenia, leukopenia and anemia. Fruquintinib plus paclitaxel as a second-line treatment significantly improved PFS, but not OS, in Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma and could potentially be another treatment option for these patients. ClinicalTrials.gov registration: NCT03223376 .

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