Background: Perioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) is a standard of care for patients with locally advanced gastro-oesophageal adenocarcinoma (GEA) in Western guidelines, but its use is limited in Asian patients. We report outcomes from a single Asian centre of perioperative FLOT with concomitant granulocyte colony-stimulating factor (GCSF) prophylaxis. Methods: A retrospective analysis of all 56 stage II to III GEA patients treated with perioperative FLOT at the National Cancer Centre Singapore between June 2017 and February 2024 was performed. All patients were discussed at a multidisciplinary tumour board, underwent preoperative laparoscopic staging, and received prophylactic GCSF with perioperative FLOT. Surgery was performed across four partner institutions. The primary endpoints were the tolerability of FLOT and pathological complete response (pCR). A univariate analysis of factors associated with survival and adverse events was also performed. Results: Overall, 33 patients (58.9%) completed eight cycles of pre- and postoperative FLOT, and 92.9% underwent resection. The commonest grade 3 to 4 adverse events (AEs) were diarrhoea (10.7%) and neutropenia (5.6%). The 30- and 90-day postoperative mortality rates were 0% and 1.9%, respectively. In resected tumours, the pCR was 15.4%. The median DFS was 27.5 months, but the median OS was not reached. The values for 1-, 2-, and 3-year DFS were 74.6%, 61.0%, and 46.5%, respectively. The values for 1-, 2-, and 3-year OS were 85.0%, 67.4%, and 61.0%, respectively. In the univariate analysis of patients who underwent resection, an ECOG status of 0 was associated with better DFS, while ypN0, R0 resection, and pathological stages 0-II were associated with better DFS and OS. Patients ≥ 65 years benefited from FLOT similarly to those <65 years in terms of DFS (HR 1.03;p= 0.940) and OS (HR 1.08;p= 0.869), with similar rates of grade 3 to 4 AEs. Patients with a higher housing index (HI) were less likely to experience ≥grade 3 AEs compared to those with a lower HI (OR 0.16,p= 0.029). Conclusions: This study presents a unique real-world Asian experience of perioperative FLOT with prophylactic GCSF use, with low rates of G3 to 4 neutropenia. The tolerability of FLOT was similar to that reported in Western populations. Furthermore, similar survival and rates of grade 3 to 4 AEs were observed in elderly patients. Patients of lower socioeconomic status were more likely to experience severe AEs, highlighting the need to proactively support vulnerable groups during treatment.
背景:根据西方指南,围手术期FLOT方案(5-氟尿嘧啶、奥沙利铂和多西他赛)是局部晚期胃食管腺癌的标准治疗方案,但在亚洲患者中的应用有限。本研究报告了亚洲单中心联合预防性使用粒细胞集落刺激因子的围手术期FLOT方案治疗结局。 方法:回顾性分析了2017年6月至2024年2月期间在新加坡国立癌症中心接受围手术期FLOT方案治疗的56例II至III期胃食管腺癌患者。所有病例均经多学科肿瘤委员会讨论,接受术前腹腔镜分期检查,并在FLOT治疗期间预防性使用GCSF。手术在四家合作机构完成。主要终点为FLOT方案的耐受性和病理完全缓解率。同时对生存和不良事件相关因素进行了单变量分析。 结果:总体而言,33例患者(58.9%)完成了术前术后共8个周期的FLOT治疗,92.9%的患者接受了手术切除。最常见的3-4级不良事件为腹泻(10.7%)和中性粒细胞减少(5.6%)。术后30天和90天死亡率分别为0%和1.9%。切除肿瘤的病理完全缓解率为15.4%。中位无病生存期为27.5个月,中位总生存期尚未达到。1年、2年和3年无病生存率分别为74.6%、61.0%和46.5%;总生存率分别为85.0%、67.4%和61.0%。对接受手术切除患者的单变量分析显示,ECOG评分0分与更好的无病生存期相关,而ypN0分期、R0切除和病理0-II期与更好的无病生存期和总生存期相关。年龄≥65岁患者与<65岁患者在无病生存期(风险比1.03;p=0.940)和总生存期(风险比1.08;p=0.869)方面获益相似,3-4级不良事件发生率也相近。与住房指数较低的患者相比,住房指数较高的患者发生≥3级不良事件的风险更低(比值比0.16;p=0.029)。 结论:本研究提供了亚洲人群围手术期FLOT方案联合预防性GCSF使用的独特真实世界经验,其3-4级中性粒细胞减少发生率较低。FLOT方案的耐受性与西方人群报告数据相似。此外,老年患者显示出相似的生存结局和3-4级不良事件发生率。社会经济地位较低的患者更易发生严重不良事件,这提示在治疗期间需要积极支持弱势群体。