Matsumoto Toshihiko, Yamamura Shogo, Ikoma Tatsuki, Kurioka Yusuke, Doi Keitaro, Yasuda Tomoyo, Boku Shogen, Kawai Takashi, Shibata Nobuhiro, Nagai Hiroki, Tsuduki Takao, Shimada Takanobu, Matsumoto Yusuke, Tsumura Takehiko, Takatani Masahiro, Yasui Hisateru, Satake Hironaga
Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.
Clin Med Insights Oncol. 2022 Nov 14;16:11795549221137135. doi: 10.1177/11795549221137135. eCollection 2022.
A trial with trifluridine/tipiracil (FTD/TPI) versus placebo in patients with heavily pretreated metastatic gastric cancer showed that FTD/TPI is effective with manageable toxicity in these patients. However, real-world data on the effects of FTD/TPI in patients with advanced gastric cancer (AGC) are limited.
We retrospectively collected and analyzed the clinicopathological data of patients with AGC who received FTD/TPI monotherapy at our institutions (Kobe City Medical Center General Hospital, Osaka Red Cross Hospital, Himeji Red Cross Hospital, and Kansai Medical University Hospital) between September 2019 and July 2021. Tumor responses were evaluated based on the Response Evaluation Criteria in Solid Tumors, version 1.1. Overall survival (OS) and progression-free survival were estimated using the Kaplan-Meier method.
A total of 53 patients were included in the study. The median age was 70 (range, 37-85) years; 39 patients (74%) were men; the numbers of patients with Eastern Cooperative Oncology Group performance status scores of 0, 1, and 2 were 10 (19%), 39 (74%), and 4 (8%), respectively; and 27 patients (51%) had diffuse-type histology. A total of 29 patients (56%) had ascites. Prior nivolumab therapy was administered to 49 patients (92%). The response rate and disease control rate (DCR) were 2% and 35%, respectively. The median progression-free survival was 2.4 months, and OS was 5.8 months. Patients with ascites exhibited significantly shorter OS (8.6 vs 4.7 months, = .0291) than those without ascites, and DCR (54% vs 18%, = .0055) was significantly worse in patients with ascites. There was no significant difference in the frequency of adverse events of grade 3 or higher between patients with and without ascites.
In a real-world setting, FTD/TPI has similar effectiveness as late-line chemotherapy for patients with AGC, including those who previously had received nivolumab.
一项关于曲氟尿苷/替匹嘧啶（FTD/TPI）对比安慰剂治疗多线治疗后的转移性胃癌患者的试验表明，FTD/TPI对这些患者有效且毒性可控。然而，FTD/TPI对晚期胃癌（AGC）患者疗效的真实世界数据有限。
我们回顾性收集并分析了2019年9月至2021年7月期间在我们机构（神户市立医疗中心总医院、大阪红十字医院、姬路红十字医院和关西医科大学医院）接受FTD/TPI单药治疗的AGC患者的临床病理数据。根据实体瘤疗效评价标准1.1版评估肿瘤反应。采用Kaplan-Meier法估计总生存期（OS）和无进展生存期。
本研究共纳入53例患者。中位年龄为70岁（范围37 - 85岁）；39例（74%）为男性；东部肿瘤协作组体能状态评分为0、1和2的患者数量分别为10例（19%）、39例（74%）和4例（8%）；27例（51%）为弥漫型组织学类型。共有29例（56%）患者有腹水。49例（92%）患者之前接受过纳武利尤单抗治疗。缓解率和疾病控制率（DCR）分别为2%和35%。中位无进展生存期为2.4个月，OS为5.8个月。有腹水的患者OS显著短于无腹水的患者（8.6个月对4.7个月，P = 0.0291），且有腹水患者的DCR（54%对18%，P = 0.0055）显著更差。有腹水和无腹水患者3级及以上不良事件的发生率无显著差异。
在真实世界中，FTD/TPI对AGC患者（包括之前接受过纳武利尤单抗治疗的患者）的疗效与晚期化疗相似。
