曲妥珠单抗 - 德鲁克斯坦对日本HER2阳性晚期胃癌患者的现实有效性和安全性（EN-DEAVOR研究）
Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study)
影响因子:5.10000
分区:医学2区 / 胃肠肝病学2区 肿瘤学2区
发表日期:2025 Jan
作者:
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,
摘要
根据《命运 - 加斯特里克斯特（Destiny-Gastric01）试验》的结果，批准了日本HER2阳性晚期胃癌患者的HER2阳性患者，批准了Trastuzumab-deruxtecan（T-DXD）。这项研究旨在收集现实世界数据并评估T-DXD的有效性和安全性。在T-DXD给药开始时，患者≥20岁，并在组织病理学上确定了HER2阳性无法切除的晚期胃或胃食食管（Gej）在此研究的诊断。 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％的患者中有43.3％的腹水，最初的T-DXD剂量在78.2％的患者中> 5.4-≤6.4mg/kg。中值（95％置信区间）OS，RWPF和TTF（月）分别为8.9（8.0-11.0），4.6（4.0-5.1）和3.9（3.4-4.2）。患有靶病变的患者的缓解率为42.9％。总共有48.4％的患者经历了A≥3级AE，2.6％的患者经历了5级AES和60.9％的AES经历，导致T-DXD剂量调整（降低：36.9％，中断：34.0％：34.0％或中断：23.7％）。未检测到新的安全信号。T-DXD有效，并且在日本临床实践中针对HER2阳性胃或GEJ癌症患者的第三或更高版本治疗可管理的安全性。UMIN000049032。
Abstract
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.