Adenis Antoine, Samalin Emmanuelle, Mazard Thibault, Portales Fabienne, Mourregot Anne, Ychou Marc
Institut du cancer de Montpellier, 208, avenue des Apothicaires, 34298 Montpellier, France; IRCM, Inserm, Université Montpellier, ICM, Montpellier, France.
Institut du cancer de Montpellier, 208, avenue des Apothicaires, 34298 Montpellier, France.
Bull Cancer. 2020 Jan;107(1):54-60. doi: 10.1016/j.bulcan.2019.12.005. Epub 2020 Jan 21.
FLOT-4 study recently reports that in patients with gastric cancer, perioperative chemotherapy with 5-fluorouracile, leucovorin, oxaliplatin and docetaxel (FLOT regimen) increases survival over standard ECF/ECX regimen (epirubicine, cisplatine and 5-fluorouracile [or capecitabine]). Does this study, make FLOT a new standard of perioperative chemotherapy for localized gastric cancer? Seven hundred and sixteen patients were included into that randomized study. Thirty seven per cent and 46% of the patients received the full planned treatment in the ECF/ECX group and in the FLOT group, respectively. The primary aim of FLOT-4 was met as FLOT significantly reduced the relative risk of death vs. ECF/ECX (HR: 0.77; 95% CI: 0.63-0.94; P=0.012). Median survival is increased by 15 months with FLOT (50 months vs. 35 months). FLOT also provided better complete resection rates, better complete pathological response rates, and better disease-free survival than ECF/ECX. FLOT is more likely associated with the following adverse events: diarrheas, leuco-neutropenia (including 51% of severe ones), infections (including 18% of severe ones), and peripheral neuropathy. On the contrary, ECF/ECX provided more likely severe nausea and vomiting, severe anemia, and thromboembolic events. Overall, the number of patients with related serious adverse events (including those that occurred during hospital stay for surgery) was similar in the two groups, as was the number of toxic deaths and postoperative deaths. FLOT should be regarded as the recommended perioperative chemotherapy for patients with gastric cancer or adenocarcinoma of the gastro-esophageal junction. However, some doubts remain as regards of its use in the daily practice for unselected patients.
FLOT-4研究最近报告称,在胃癌患者中,采用5-氟尿嘧啶、亚叶酸钙、奥沙利铂和多西他赛的围手术期化疗(FLOT方案)比标准的ECF/ECX方案(表柔比星、顺铂和5-氟尿嘧啶[或卡培他滨])能提高生存率。这项研究是否使FLOT成为局限性胃癌围手术期化疗的新标准呢?716例患者被纳入该随机研究。ECF/ECX组和FLOT组分别有37%和46%的患者接受了完整的计划治疗。FLOT-4的主要目标得以实现,因为与ECF/ECX相比,FLOT显著降低了死亡相对风险(风险比:0.77;95%置信区间:0.63 - 0.94;P = 0.012)。使用FLOT方案时,中位生存期延长了15个月(50个月对35个月)。与ECF/ECX相比,FLOT还具有更高的完全切除率、更好的完全病理缓解率和无病生存率。FLOT更可能与以下不良事件相关:腹泻、白细胞减少性中性粒细胞减少(包括51%的严重病例)、感染(包括18%的严重病例)和周围神经病变。相反,ECF/ECX更可能导致严重恶心和呕吐、严重贫血以及血栓栓塞事件。总体而言,两组中发生相关严重不良事件(包括手术住院期间发生的事件)的患者数量相似,毒性死亡和术后死亡的患者数量也相似。FLOT应被视为胃癌或胃食管交界腺癌患者围手术期化疗的推荐方案。然而,对于在日常实践中未经选择的患者使用该方案仍存在一些疑问。