Intraoperative corticosteroid administration for resectable gastric cancer: a multicenter, randomized, open-label, phase II/III study.

IF 5.1 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastric Cancer Pub Date : 2025-09-01 Epub Date: 2025-07-10 DOI:10.1007/s10120-025-01635-5

Takaomi Hagi, Yukinori Kurokawa, Takeshi Omori, Yusuke Akamaru, Keijiro Sugimura, Masaaki Motoori, Jin Matsuyama, Takuro Saito, Kazuyoshi Yamamoto, Tsuyoshi Takahashi, Toshio Shimokawa, Hidetoshi Eguchi, Yuichiro Doki

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引用次数: 0

Abstract

Background: Excessive surgical stress induces inflammatory cytokine release, negatively impacting prognosis in patients with malignancies. This study aimed to determine whether the anti-inflammatory effect of a corticosteroid (CS) would improve prognosis when administered intraoperatively to patients with resectable gastric cancer.

Methods: In this multicenter, randomized, open-label, phase II/III study, patients with cStage II-III gastric cancer were randomized to CS administration or non-administration (control) groups. Patients in the CS group received 5 mg/kg of methylprednisolone just before the skin incision during surgery. The primary endpoints were the highest postoperative serum level of C-reactive protein (CRP_max) in the phase II portion, and recurrence-free survival (RFS) in the phase III portion.

Results: Between December 2016 and February 2019, 410 patients were enrolled. In the phase II portion, CRP_max was significantly lower in the CS group than in the control group (mean, 10.7 vs 14.3 mg/dL, respectively; P = 0.009). In the phase III portion, 3-year RFS rates in the CS (n = 202) and control (n = 204) groups were 67.2% and 63.0%, respectively, indicating no significant difference (hazard ratio, 0.807 [95% confidence interval, 0.590-1.105]; log-rank P = 0.182). Subgroup analysis showed that both histological type and clinical stage had significant interactions with RFS, suggesting a potential survival benefit of CS administration in patients with differentiated histological-type or cStage III gastric cancer.

Conclusions: Intraoperative CS administration mitigated postoperative CRP elevation but did not result in significantly improved survival in patients with cStage II-III gastric cancer. The study is registered with UMIN-CTR, number UMIN000024465.

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术中皮质类固醇给药治疗可切除胃癌：一项多中心、随机、开放标签、II/III期研究

背景：过度的手术应激诱导炎症细胞因子的释放，对恶性肿瘤患者的预后产生负面影响。本研究旨在确定术中给药皮质类固醇（CS）是否能改善可切除胃癌患者的预后。方法：在这项多中心、随机、开放标签、II/III期研究中，II-III期胃癌患者被随机分为给药组和非给药组（对照组）。CS组患者在手术中皮肤切口前接受5 mg/kg甲基强的松龙。主要终点是II期患者术后血清c反应蛋白（CRPmax）最高水平和III期患者无复发生存期（RFS）。结果：在2016年12月至2019年2月期间，纳入了410名患者。在II期部分，CS组的CRPmax显著低于对照组(平均值分别为10.7和14.3 mg/dL；p = 0.009)。在III期部分，CS组（n = 202）和对照组（n = 204）的3年RFS率分别为67.2%和63.0%，差异无统计学意义(风险比为0.807[95%可信区间，0.590-1.105]；log-rank P = 0.182)。亚组分析显示，组织学类型和临床分期均与RFS有显著的相互作用，提示分化组织学类型或c期胃癌患者给予CS有潜在的生存获益。结论：术中给药CS减轻了ii期- iii期胃癌患者术后CRP升高，但没有显著提高患者的生存率。本研究注册号为UMIN-CTR，注册号为UMIN000024465。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gastric Cancer 医学-胃肠肝病学

CiteScore

14.70

自引率

2.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.