Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. k.
Acta Oncol. 2024 May 14;63:322-329. doi: 10.2340/1651-226X.2024.35431.
Perioperative 5-FU, leucovorin, oxaliplatin, and docetaxel (FLOT) is recommended in resectable esophagogastric adenocarcinoma based on randomised trials. However, the effectiveness of FLOT in routine clinical practice remains unknown as randomised trials are subject to selection bias limiting their generalisability. The aim of this study was to evaluate the implementation of FLOT in real-world patients.
Retrospectively collected data were analysed in consecutive patients treated before or after the implementation of FLOT. The primary endpoint was complete pathological response (pCR) and secondary endpoints were margin-free resection (R0), overall survival (OS), relapse-free survival (RFS) tolerability of chemotherapy and surgical complications.
Mean follow-up time for patients treated with FLOT (n = 205) was 37.7 versus 47.0 months for epirubicin, cis- or oxaliplatin, and capecitabine (ECX/EOX, n = 186). Surgical resection was performed in 88.0% versus 92.0%; pCR were observed in 3.8% versus 2.4%; and R0 resections were achieved in 78.0% versus 86.0% (p = 0.03) in the ECX/EOX and FLOT cohorts, respectively. Survival analysis indicated no significant difference in RFS (p = 0.17) or OS (p = 0.37) between the cohorts with a trend towards increased OS in performance status 0 (hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.50-1.04). More patients treated with ECX/EOX completed chemotherapy (39% vs. 28%, p = 0.02). Febrile neutropenia was more common in the FLOT cohort (3.8% vs. 11%, p = 0.0086). 90-days mortality (1.2% vs. 0%) and frequency of anastomotic leakage (8% vs. 6%) were equal and low.
Patients receiving FLOT did not demonstrate improved pCR, RFS or OS. However, R0 rate was improved and patients in good PS trended towards improved OS.
基于随机试验,围手术期氟尿嘧啶、亚叶酸钙、奥沙利铂和多西紫杉醇(FLOT)被推荐用于可切除的食管胃腺癌。然而,由于随机试验受到选择偏倚的限制,其普遍性有限,因此 FLOT 在常规临床实践中的有效性尚不清楚。本研究的目的是评估 FLOT 在真实患者中的应用。
对接受 FLOT 治疗前后连续患者的回顾性收集数据进行分析。主要终点是完全病理缓解(pCR),次要终点是无边缘切除(R0)、总生存期(OS)、无复发生存期(RFS)、化疗的耐受性和手术并发症。
接受 FLOT 治疗的患者(n=205)的中位随访时间为 37.7 个月,而接受表柔比星、顺铂或奥沙利铂和卡培他滨(ECX/EOX,n=186)治疗的患者为 47.0 个月。88.0%的患者行手术切除,92.0%的患者行手术切除(p=0.03);pCR 分别为 3.8%和 2.4%;R0 切除率分别为 78.0%和 86.0%(p=0.03)。生存分析表明,两组间 RFS(p=0.17)或 OS(p=0.37)无显著差异,表现状态 0 的 OS 呈增加趋势(风险比[HR]=0.73,95%置信区间[CI]:0.50-1.04)。接受 ECX/EOX 治疗的患者中,更多患者完成了化疗(39% vs. 28%,p=0.02)。FLOT 组发热性中性粒细胞减少症更为常见(3.8% vs. 11%,p=0.0086)。90 天死亡率(1.2% vs. 0%)和吻合口漏的发生率(8% vs. 6%)相等且较低。
接受 FLOT 治疗的患者并未显示出改善的 pCR、RFS 或 OS。然而,R0 率得到改善,表现状态良好的患者 OS 呈改善趋势。