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根治性胃切除术后术中出血量对晚期胃癌长期预后的负面影响:JCOG1001 三期临床试验的探索性分析。

Negative impact of intraoperative blood loss on long-term outcome after curative gastrectomy for advanced gastric cancer: exploratory analysis of the JCOG1001 phase III trial.

机构信息

Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden Chikusa-ku, Nagoya, 464-8681, Japan.

Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.

出版信息

Gastric Cancer. 2022 Mar;25(2):459-467. doi: 10.1007/s10120-021-01266-6. Epub 2021 Nov 19.

Abstract

BACKGROUND

Recent retrospective studies have shown that increased intraoperative blood loss (IBL) during curative gastrectomy for patients with advanced gastric cancer is a negative prognostic indicator for recurrence. However, there are no reliable reports assessing this with a large-scale prospective cohort. This study aimed to evaluate the impact of IBL on long-term outcomes using data from the JCOG1001 phase III trial, which was designed to determine if bursectomy led to improved survival vs. nonbursectomy in patients with cT3/4a gastric cancer.

METHODS

This study included 1203 of the 1204 patients enrolled in the JCOG1001. From the tertiles of IBL (196 ml, 400 ml), we divided the patients into three groups: IBL < 200 ml representing small blood loss (SBL, n = 404), 200 ml ≤ IBL < 400 ml representing medium blood loss (MBL, n = 393), and IBL ≥ 400 ml representing large blood loss (LBL, n = 406). The impact of IBL on relapse-free survival (RFS) was evaluated with univariable comparisons and multivariable Cox regression analyses.

RESULTS

Three-year RFS after SBL, MBL, and LBL was 81.7%, 74.8%, and 70.6%, respectively. Multivariable analysis identified IBL, Eastern Cooperative Oncology Group performance status, pT, pN, and postoperative adjuvant chemotherapy as independent predictors of RFS. Compared with SBL as a reference, the hazard ratios of MBL and LBL were 1.461 (P = 0.012) and 1.520 (P = 0.009), respectively.

CONCLUSIONS

Based on the analysis of data from a large-scale prospective study, an IBL of ≥ 200 ml after curative surgery for patients with cT3/4a gastric cancer was an independent predictor of reduced RFS.

摘要

背景

最近的回顾性研究表明,在根治性胃切除术治疗进展期胃癌患者时,术中出血量(IBL)增加是复发的负预后指标。然而,目前尚无可靠的报告使用大规模前瞻性队列评估这一点。本研究旨在使用 JCOG1001 三期试验的数据评估 IBL 对长期结果的影响,该试验旨在确定在 cT3/4a 胃癌患者中,行胆囊切除术是否比不行胆囊切除术生存获益。

方法

本研究纳入了 JCOG1001 试验中 1204 例患者中的 1203 例。根据 IBL 的三分位数(196ml,400ml),我们将患者分为三组:IBL<200ml 表示小量失血(SBL,n=404),200ml≤IBL<400ml 表示中量失血(MBL,n=393),IBL≥400ml 表示大量失血(LBL,n=406)。使用单变量比较和多变量 Cox 回归分析评估 IBL 对无复发生存率(RFS)的影响。

结果

SBL、MBL 和 LBL 后的 3 年 RFS 分别为 81.7%、74.8%和 70.6%。多变量分析确定 IBL、东部肿瘤协作组体能状态、pT、pN 和术后辅助化疗是 RFS 的独立预测因素。与 SBL 作为参考相比,MBL 和 LBL 的危险比分别为 1.461(P=0.012)和 1.520(P=0.009)。

结论

基于对大规模前瞻性研究数据的分析,cT3/4a 胃癌根治性手术后 IBL≥200ml 是 RFS 降低的独立预测因素。

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