三氟胞嘧啶/替匹妥胺与ramucirumab（RAM）VEGF抑制剂的联合应用在晚期胃癌（AGC）的前期II期试验中展示了良好的临床活性和可接受的毒副反应剖面，然而，关于其在临床实践中与三氟胞嘧啶/替匹妥胺单药治疗相比的疗效和安全性的了解仍然有限。我们进行了对三氟胞嘧啶/替匹妥胺联合RAM治疗和三氟胞嘧啶/替匹妥胺单药治疗作为第三线或更后期治疗AGC患者疗效和安全性的回顾性调查。 共分析了接受三氟胞嘧啶/替匹妥胺联合RAM治疗的41名患者和接受三氟胞嘧啶/替匹妥胺单药治疗的60名患者。在三氟胞嘧啶/替匹妥胺联合RAM组中，客观缓解率（ORR）和疾病控制率（DCR）分别为13.5％和64.9％；而在三氟胞嘧啶/替匹妥胺单药治疗组中，分别为3.8％和42.3％（ORR；P = 0.122，DCR；P = 0.052）。中位进展生存期（PFS）和中位总生存期（OS）在三氟胞嘧啶/替匹妥胺联合RAM组中分别为3.0个月和7.2个月；而在三氟胞嘧啶/替匹妥胺单药治疗组中分别为1.8个月和3.8个月（PFS HR = 0.66；P = 0.059，OS HR = 0.50；P = 0.007）。多变量分析显示与三氟胞嘧啶/替匹妥胺单药治疗组相比，三氟胞嘧啶/替匹妥胺联合RAM组的PFS（HR = 0.52；P = 0.011）和OS（HR = 0.51；P = 0.031）显著延长。两组患者均未观察到意外的不良事件。 三氟胞嘧啶/替匹妥胺联合RAM治疗可能与三氟胞嘧啶/替匹妥胺单药治疗相比，具有较好的抗肿瘤活性和可接受的毒副反应剖面，为AGC患者在挽救治疗线上提供了一种选择。该联合治疗需要在正在进行的随机对照试验中进一步评估。 © 2023年。本文作者经独家许可授予国际胃癌协会和日本胃癌协会。

Trifluridine/tipiracil plus VEGF inhibition with ramucirumab (RAM) for advanced gastric cancer (AGC) demonstrated clinical activity with an acceptable toxicity profile in previous phase II trial. However, little is known about its efficacy and safety in clinical practice in comparison with trifluridine/tipiracil monotherapy.We retrospectively investigated efficacy and safety of trifluridine/tipiracil plus RAM and trifluridine/tipiracil monotherapy as third or later line treatment for AGC patients.Forty-one patients receiving trifluridine/tipiracil plus RAM and 60 patients receiving trifluridine/tipiracil monotherapy were analyzed. The objective response rate (ORR) and the disease control rate (DCR) were 13.5% and 64.9% in the trifluridine/tipiracil plus RAM group, and 3.8% and 42.3% in the trifluridine/tipiracil monotherapy group, respectively (ORR; P = 0.122, DCR; P = 0.052). The median progression-free survival (PFS) and the median overall survival (OS) were 3.0 months and 7.2 months in the trifluridine/tipiracil plus RAM group, and 1.8 months and 3.8 months in the trifluridine/tipiracil monotherapy group, respectively (HR for PFS = 0.66; P = 0.059, HR for OS = 0.50; P = 0.007). Multivariate analysis showed significantly longer PFS (HR = 0.52; P = 0.011) and OS (HR = 0.51; P = 0.031) in the trifluridine/tipiracil plus RAM group compared to the trifluridine/tipiracil monotherapy group. No unexpected adverse events were observed in both groups.Trifluridine/tipiracil plus RAM might show favorable anti-tumor activity with an acceptable toxicity profile in comparison with trifluridine/tipiracil monotherapy, suggesting one treatment option for AGC patients in salvage line. The combination needs further evaluation in ongoing randomized trials.© 2023. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.