Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study).

IF 6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastric Cancer Pub Date : 2024-10-10 DOI:10.1007/s10120-024-01555-w

Hisato Kawakami, Koki Nakanishi, Akitaka Makiyama, Hirotaka Konishi, Satoshi Morita, Yukiya Narita, Naotoshi Sugimoto, Keiko Minashi, Motohiro Imano, Rin Inamoto, Yasuhiro Kodera, Hiroki Kume, Keita Yamaguchi, Wataru Hashimoto, Kei Muro

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引用次数: 0

Abstract

Background: Trastuzumab-deruxtecan (T-DXd) was approved for the treatment of HER2-positive patients with advanced gastric cancer in Japan based on the results of the DESTINY-Gastric01 trial. This study aimed to collect real-world data and evaluate the effectiveness and safety of T-DXd.

Methods: Patients aged ≥ 20 years at the start of T-DXd administration with a histopathologically confirmed diagnosis of HER2-positive unresectable advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma that had worsened after chemotherapy were enrolled in this retrospective cohort study. Key outcomes included T-DXd treatment status, overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate and frequency of grade ≥ 3 adverse events (AEs).

Results: Of the 312 patients included in the analysis, 75.3% were male, the median (range) age was 70.0 (27.0-89.0) years, 12.2% had an ECOG PS ≥ 2, 43.3% had ascites and the initial T-DXd dose was > 5.4- ≤ 6.4 mg/kg in 78.2% of patients. The median (95% confidence interval) OS, rwPFS and TTF (months) was 8.9 (8.0-11.0), 4.6 (4.0-5.1) and 3.9 (3.4-4.2), respectively. The response rate was 42.9% in patients with a target lesion. In total, 48.4% of patients experienced a grade ≥ 3 AE, 2.6% experienced grade 5 AEs and 60.9% experienced AEs leading to T-DXd dose adjustments (reduction: 36.9%, interruption: 34.0% or discontinuation: 23.7%). No new safety signals were detected.

Conclusions: T-DXd was effective and had a manageable safety profile as a third- or later-line treatment for patients with HER2-positive gastric or GEJ cancer in Japanese clinical practice.

Clinical trial registration: UMIN000049032.

查看原文本刊更多论文

在日本 HER2 阳性晚期胃癌患者中使用曲妥珠单抗-得舒坦的实际有效性和安全性（EN-DEAVOR 研究）。

背景：根据DESTINY-Gastric01试验的结果，日本批准曲妥珠单抗-德鲁司康（Trastuzumab-deruxtecan，T-DXd）用于治疗HER2阳性的晚期胃癌患者。本研究旨在收集真实世界的数据，评估T-DXd的有效性和安全性：这项回顾性队列研究招募了开始服用 T-DXd 时年龄≥ 20 岁、组织病理学确诊为 HER2 阳性不可切除的晚期或复发性胃癌或胃食管交界处（GEJ）腺癌且化疗后病情恶化的患者。主要结果包括T-DXd治疗状态、总生存期（OS）、实际无进展生存期（rwPFS）、治疗失败时间（TTF）、客观反应率和≥3级不良事件（AEs）频率：在纳入分析的312例患者中，75.3%为男性，中位（范围）年龄为70.0（27.0-89.0）岁，12.2%的患者ECOG PS≥2，43.3%的患者有腹水，78.2%的患者初始T-DXd剂量> 5.4-≤ 6.4 mg/kg。OS、rwPFS和TTF的中位数（95%置信区间）分别为8.9（8.0-11.0）、4.6（4.0-5.1）和3.9（3.4-4.2）个月。靶病灶患者的应答率为42.9%。共有48.4%的患者出现了≥3级AE，2.6%出现了5级AE，60.9%出现了导致T-DXd剂量调整的AE（减量：36.9%，中断：34.0%或停药：23.7%）。未发现新的安全信号：结论：在日本临床实践中，T-DXd作为HER2阳性胃癌或胃食管癌患者的三线或后线治疗药物，疗效显著，安全性可控：临床试验注册：UMIN000049032。

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.