Background:The FLOT4-AIO trial (2019) showed improved survival with perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) compared to anthracyclin triplets in gastric cancer treatment. It is unclear whether these results extend to real-world scenarios in the Netherlands. This study aimed to compare outcomes of perioperative FLOT to anthracyclin triplets in a real-world Dutch gastric cancer population.Methods:Patients diagnosed with resectable (cT2-4a/cTxN0-3/NxM0) gastric or gastro-esophageal junction carcinoma between 2015–2021 who received neoadjuvant FLOT or anthracyclin triplets were selected from the Netherlands Cancer Registry. The primary outcome was overall survival (OS), analyzed through multivariable Cox regression. Secondary outcomes included pathological complete response (pCR), neoadjuvant chemotherapy cycle completion, surgical resection rates, and adjuvant therapy.Results:Adjusted OS showed no significant survival benefit (HR = 0.88, 95% CI 0.77–1.01,p= 0.07), even though the median OS was numerically improved by 8 months with FLOT compared to anthracyclin triplets (48.1 vs. 39.9 months,p= 0.16). FLOT patients were more likely to undergo diagnostic staging laparoscopies (74.2% vs. 44.1%,p< 0.001), had higher rates of completing neoadjuvant chemotherapy (OR = 1.35, 95% CI 1.09–1.68,p= 0.007), receiving adjuvant therapy (OR = 1.34, 95% CI 1.08–1.66,p= 0.08), and achieving pCR (OR = 1.52, 95% CI 1.05–2.20,p= 0.03). No significant differences were observed in (radical) resection rates.Conclusion(s):Real-world data showed no significant OS improvement for FLOT-treated patients compared to anthracyclin triplets, despite more staging laparoscopies. However, FLOT patients demonstrated higher rates of neoadjuvant therapy completion, proceeding to adjuvant therapy, and increased pCR rates. Therefore, we recommend the continued use of neoadjuvant FLOT therapy in the current clinical setting.
背景:FLOT4-AIO试验(2019年)显示,在胃癌治疗中,围手术期使用氟尿嘧啶、亚叶酸、奥沙利铂和多西他赛(FLOT)方案相较于蒽环类三联方案可改善患者生存。目前尚不清楚这些结果是否适用于荷兰的真实世界场景。本研究旨在比较荷兰真实世界胃癌人群中围手术期FLOT方案与蒽环类三联方案的疗效差异。 方法:从荷兰癌症登记处筛选2015年至2021年间诊断为可切除(cT2-4a/cTxN0-3/NxM0)胃或胃食管结合部癌、并接受新辅助FLOT或蒽环类三联方案治疗的患者。主要结局指标为总生存期(OS),通过多变量Cox回归进行分析。次要结局指标包括病理完全缓解(pCR)、新辅助化疗周期完成率、手术切除率及辅助治疗情况。 结果:校正后的OS分析显示,尽管FLOT组中位OS在数值上较蒽环类三联方案组延长8个月(48.1个月 vs. 39.9个月,p=0.16),但未观察到显著的生存获益(HR=0.88,95% CI 0.77–1.01,p=0.07)。FLOT组患者更常接受诊断性分期腹腔镜检查(74.2% vs. 44.1%,p<0.001),其新辅助化疗完成率(OR=1.35,95% CI 1.09–1.68,p=0.007)、辅助治疗接受率(OR=1.34,95% CI 1.08–1.66,p=0.08)及pCR率(OR=1.52,95% CI 1.05–2.20,p=0.03)均显著更高。两组在(根治性)切除率方面未见显著差异。 结论:真实世界数据显示,尽管FLOT治疗组接受了更多分期腹腔镜检查,但其OS相较于蒽环类三联方案组并未显著改善。然而,FLOT组患者在新辅助治疗完成率、后续辅助治疗接受率及pCR率方面表现更优。因此,我们建议在当前临床实践中继续采用新辅助FLOT治疗方案。