Matsumoto Toshihiko, Yamamura Shogo, Ikoma Tatsuki, Kurioka Yusuke, Doi Keitaro, Boku Shogen, Shibata Nobuhiro, Nagai Hiroki, Shimada Takanobu, Tsuduki Takao, Tsumura Takehiko, Takatani Masahiro, Yasui Hisateru, Satake Hironaga
Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojimaminamimachi, Kobe 6500047, Japan.
Cancer Treatment Center, Kansai Medical University, 2-3-1, Shinmachi, Hirakata 5731191, Japan.
J Clin Med. 2022 Apr 17;11(8):2247. doi: 10.3390/jcm11082247.
Trastuzumab deruxtecan (T-DXd) has shown promising efficacy against positive advanced gastric cancer (AGC). However, data on its real-world efficacy in AGC patients are insufficient, and the predictive marker of T-DXd is unclear. In this multi-center retrospective study, we collected clinical information of 18 patients with -positive AGC who received T-DXd after intolerant or refractory responses to at least two prior regimens and analyzed predictive factors. The median age was 71 years (range: 51-85), 13 men were included, and ECOG performance status (PS): 0/1/2/3 was 9/6/2/1. A total of 11 patients (61%) received prior immune checkpoint inhibitors (ICIs), 14 patients were 3+, and 4 patients were 2+/FISH positive. The median trastuzumab (Tmab)-free interval was 7.7 months (range: 2.8-28.6). The overall response rate was 41%, and the disease control rate was 76%. Median progression-free survival (PFS) was 3.9 months (95% CI: 2.6-6.5), and median overall survival (OS) was 6.1 months (95% CI: 3.7-9.4). PFS (6.5 vs. 2.9 months, = 0.0292) and OS (9.2 vs. 3.7 months, = 0.0819) were longer in patients who received prior ICIs than in those who had not. PFS (6.5 vs. 3.4 months, = 0.0249) and OS (9.4 vs. 5.7 months, = 0.0426) were longer in patients with an 8 month or longer Tmab-free interval. In patients with ascites, PFS (6.5 vs. 2.75 months, = 0.0139) and OS (9.4 vs. 3.9 months, = 0.0460) were shorter. T-DXd showed promising efficacy in -positive AGC patients in a real-world setting. Pre-administration of ICIs and a sufficient Tmab-free interval may be predictive factors of T-DXd efficacy.
曲妥珠单抗德曲妥珠单抗（T-DXd）已显示出对HER2阳性晚期胃癌（AGC）有良好疗效。然而，其在AGC患者中的真实世界疗效数据不足，且T-DXd的预测标志物尚不清楚。在这项多中心回顾性研究中，我们收集了18例HER2阳性AGC患者的临床信息，这些患者在对至少两种先前治疗方案不耐受或难治后接受了T-DXd，并分析了预测因素。中位年龄为71岁（范围：51 - 85岁），包括13名男性，东部肿瘤协作组（ECOG）体能状态（PS）：0/1/2/3分别为9/6/2/1。共有11例患者（61%）接受过先前的免疫检查点抑制剂（ICI）治疗，14例患者为HER2 3+，4例患者为HER2 2+/FISH阳性。曲妥珠单抗（Tmab）无治疗间隔的中位时间为7.7个月（范围：2.8 - 28.6个月）。总缓解率为41%，疾病控制率为76%。中位无进展生存期（PFS）为3.9个月（95%CI：2.6 - 6.5），中位总生存期（OS）为6.1个月（95%CI：3.7 - 9.4）。接受过先前ICI治疗的患者的PFS（6.5个月对2.9个月，P = 0.0292）和OS（9.2个月对3.7个月，P = 0.0819）比未接受过的患者更长。Tmab无治疗间隔为8个月或更长时间的患者的PFS（6.5个月对3.4个月，P = 0.0249）和OS（9.4个月对5.7个月，P = 0.0426）更长。有腹水的患者的PFS（6.5个月对2.75个月，P = 0.0139）和OS（9.4个月对3.9个月，P = 0.0460）更短。在真实世界中，T-DXd在HER2阳性AGC患者中显示出良好疗效。ICI的预先给药和足够的Tmab无治疗间隔可能是T-DXd疗效的预测因素。
