可切除食管胃腺癌围手术期FLOT与ECX/EOX化疗方案的比较:真实世界数据分析。

IF 2.7 3区 医学 Q3 ONCOLOGY Acta Oncologica Pub Date : 2024-05-14 DOI:10.2340/1651-226X.2024.35431
Kristian Egebjerg, Tobias Sørup Andersen, Lene Bæksgaard, Rajendra Garbyal, Mette Siemsen, Michael Achiam, Paul Morten Mau-Sørensen
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引用次数: 0

摘要

背景和目的:根据随机试验,推荐对可切除的食管胃腺癌采用围手术期 5-FU、亮菌素、奥沙利铂和多西他赛(FLOT)治疗。然而,由于随机试验存在选择偏倚,限制了其普遍性,因此FLOT在常规临床实践中的有效性仍不得而知。本研究旨在评估FLOT在现实世界患者中的实施情况:方法:对实施FLOT之前或之后接受治疗的连续患者的回顾性数据进行分析。主要终点是完全病理反应(pCR),次要终点是无边缘切除(R0)、总生存期(OS)、无复发生存期(RFS)、化疗耐受性和手术并发症:接受FLOT治疗的患者(n = 205)的平均随访时间为37.7个月,而接受表柔比星、顺式或奥沙利铂和卡培他滨(ECX/EOX,n = 186)治疗的患者的平均随访时间为47.0个月。ECX/EOX组和FLOT组的手术切除率分别为88.0%对92.0%;PCR观察率分别为3.8%对2.4%;R0切除率分别为78.0%对86.0%(P = 0.03)。生存期分析表明,各组间的RFS(p = 0.17)或OS(p = 0.37)无明显差异,但表现状态为0的患者OS有增加趋势(危险比[HR] = 0.73,95%置信区间[CI]:0.50-1.04)。更多接受ECX/EOX治疗的患者完成了化疗(39%对28%,P = 0.02)。发热性中性粒细胞减少症在FLOT队列中更为常见(3.8%对11%,P = 0.0086)。90天死亡率(1.2% 对 0%)和吻合口漏发生率(8% 对 6%)相同且较低:解释:接受FLOT治疗的患者pCR、RFS或OS均无改善。然而,R0率有所提高,PS良好的患者的OS有改善的趋势。
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Implementation of perioperative FLOT compared to ECX/EOX chemotherapy regimens in resectable esophagogastric adenocarcinomas: an analysis of real-world data.

Background and purpose: 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.

Methods: 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.

Results: 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.

Interpretation: 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.

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来源期刊
Acta Oncologica
Acta Oncologica 医学-肿瘤学
CiteScore
4.30
自引率
3.20%
发文量
301
审稿时长
3 months
期刊介绍: Acta Oncologica is a journal for the clinical oncologist and accepts articles within all fields of clinical cancer research. Articles on tumour pathology, experimental oncology, radiobiology, cancer epidemiology and medical radio physics are also welcome, especially if they have a clinical aim or interest. Scientific articles on cancer nursing and psychological or social aspects of cancer are also welcomed. Extensive material may be published as Supplements, for which special conditions apply.
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