根据 DESTINY-Gastric01 试验的结果，曲妥珠单抗-deruxtecan (T-DXd) 在日本被批准用于治疗 HER2 阳性晚期胃癌患者。本研究旨在收集真实世界数据并评估 T-DXd 的有效性和安全性。开始 T-DXd 给药时年龄≥20 岁且经组织病理学确诊为 HER2 阳性、不可切除的晚期或复发性胃或胃食管交界处的患者化疗后恶化的（GEJ）腺癌被纳入这项回顾性队列研究。主要结局包括T-DXd治疗状态、总生存期（OS）、现实世界无进展生存期（rwPFS）、治疗失败时间（TTF）、客观缓解率和 ≥ 3级不良事件（AE）频率。分析中纳入的 312 名患者中，75.3% 为男性，中位（范围）年龄为 70.0（27.0-89.0）岁，12.2% 的 ECOG PS ≥ 2，43.3% 有腹水，初始 T-DXd 剂量 > 78.2% 的患者为 5.4- ≤ 6.4 mg/kg。中位 OS、rwPFS 和 TTF（月）（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)。具有目标病变的患者的缓解率为 42.9%。总共，48.4% 的患者经历了 ≥ 3 级 AE，2.6% 经历了 5 级 AE，60.9% 经历了导致 T-DXd 剂量调整的 AE（减少：36.9%，中断：34.0% 或停药：23.7%）。没有检测到新的安全信号。在日本临床实践中，T-DXd 作为 HER2 阳性胃癌或 GEJ 癌患者的三线或后期治疗药物是有效的，并且具有可控的安全性。UMIN000049032.© 2024。作者（ s）。

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.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).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.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.UMIN000049032.© 2024. The Author(s).