真实 FLOT 观察性前瞻性研究的结果。
Results of the observational prospective RealFLOT study.
机构信息
Medical Oncology Unit, AOU Careggi, Florence, Italy.
Division of Medical Oncology, Department of Precision Medicine, University of Study of Campania "L. Vanvitelli", Naples, Italy.
出版信息
BMC Cancer. 2021 Oct 8;21(1):1086. doi: 10.1186/s12885-021-08768-7.
BACKGROUND
Perioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone.
METHODS
RealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status.
RESULTS
Of 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3-4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR (p = 0.009 and p = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients.
CONCLUSIONS
These real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.
背景
围手术期 FLOT（氟尿嘧啶、奥沙利铂和多西紫杉醇）最近已成为可手术治疗的胃（GC）或胃食管（GEJ）腺癌患者的金标准治疗方法，使患者 5 年总生存率（OS）达到 45%，而单独手术治疗的 5 年 OS 仅为 23%。
方法
真实 FLOT 是一项意大利多中心观察性研究，收集了接受围手术期 FLOT 治疗的可切除 GC 或 GEJ 腺癌患者的数据。该研究的目的是描述在未经选择的真实世界人群中 FLOT 的可行性和安全性、病理完全缓解率（pCR）、手术结果和总体缓解率（ORR）。此外，还分析了 pCR 与生存之间的相关性以及微卫星不稳定性（MSI）状态的预后作用。
结果
在 15 家意大利中心接受围手术期 FLOT 治疗的 206 名患者中，124 名（60.2%）至少接受了 4 个全剂量周期的治疗，190 名（92.2%）接受了手术，142 名（68.9%）开始了术后阶段。在开始术后阶段的患者中，105 名（51.0%）接受了 FLOT，而 37 名（18%）根据临床情况或先前的毒性反应接受了减量化疗方案。有 7.3%的病例达到了 pCR。安全性与文献一致。中性粒细胞减少是最常见的 G3-4 级不良事件（AE）：术前阶段为 19.9%，术后阶段为 16.9%。未观察到治疗相关死亡，术后 30 天死亡率为 1.0%。ORR 为 45.6%，疾病控制率（DCR）为 94.2%。pCR 的患者无病生存期（DFS）和 OS 显著延长（p=0.009 和 p=0.023）。MSI-H 患者的 DFS 也有改善的趋势。
结论
这些真实世界的数据证实了在未经选择的人群中应用 FLOT 的可行性，这些患者代表了临床实践中的情况。pCR 率低于预期，但我们确认 pCR 是生存的预测参数。此外，MSI-H 状态似乎也是接受含紫杉烷三联方案治疗的患者的一个阳性预后标志物。
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