食管胃癌治疗规划：随机维持治疗试验 (PLATFORM) 是一项适应性 II 期研究，评估维持治疗在晚期食管胃癌 (OG) 腺癌中的作用。我们评估了抗程序性死亡配体 1 (PD-L1) 抑制剂 durvalumab 在这些患者中的作用。患有人表皮生长因子受体 2 阴性局部晚期或转移性 OG 腺癌且疾病控制或对 18 周铂类药物有反应的患者基于一线化疗的患者被随机分配至主动监测组或维持性 durvalumab 组。主要终点是无进展生存期（PFS）。对所有已开始监测访视或接受至少一剂 durvalumab 的患者进行安全性评估。根据 PD-L1 综合阳性评分 (CPS) 和免疫（生物标志物阳性）或血管生成主导（生物标志物阴性）肿瘤微环境 (TME) 表型进行探索性生存分析。2015 年 3 月至 2020 年 4 月期间，205 名患者被随机分组监测 (n = 100) 和 durvalumab (n = 105)。监测和 durvalumab 之间的 PFS [风险比 (HR) 0.84，P = 0.13] 和总生存期（OS；HR 0.98，P = 0.45）没有显着差异。与监测组相比，随机接受 durvalumab 治疗的 5 名患者表现出增强的放射学反应。 77 名 (76.2%) 接受 durvalumab 治疗的患者发生了治疗相关的不良事件。分别与 CPS <5 和生物标志物阴性亚组相比，在 CPS ≥5 和免疫生物标志物阳性患者中观察到 durvalumab 对 OS 的监测具有良好效果：CPS ≥5 与 <5：HR 0.63，95% 置信区间 (CI ) 0.32-1.22 对比 HR 0.93，95% CI 0.44-1.96；生物标志物阳性与阴性：HR 0.60，95% CI 0.29-1.23 对比 HR 0.84，95% CI 0.42-1.65。对于对一线化疗有反应但在患者的一个子集。 TME 表征可以在单独 PD-L1 CPS 之上完善抗 PD-L1 治疗的患者选择。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

PLAnning Treatment For Oesophago-gastric Cancer: a Randomised Maintenance Therapy Trial (PLATFORM) is an adaptive phase II study assessing the role of maintenance therapies in advanced oesophago-gastric (OG) adenocarcinoma. We evaluated the role of the anti-programmed death-ligand 1 (PD-L1) inhibitor durvalumab in these patients.Patients with human epidermal growth factor receptor 2-negative locally advanced or metastatic OG adenocarcinoma with disease control or response to 18 weeks of platinum-based first-line chemotherapy were randomised to active surveillance or maintenance durvalumab. The primary endpoint was progression-free survival (PFS). Safety was assessed in all patients who had commenced surveillance visits or received at least one dose of durvalumab. Exploratory survival analyses according to PD-L1 Combined Positive Score (CPS) and immune (biomarker-positive) or angiogenesis dominant (biomarker-negative) tumour microenvironment (TME) phenotypes were conducted.Between March 2015 and April 2020, 205 patients were randomised to surveillance (n = 100) and durvalumab (n = 105). No significant differences were seen in PFS [hazard ratio (HR) 0.84, P = 0.13] and overall survival (OS; HR 0.98, P = 0.45) between surveillance and durvalumab. Five patients randomised to durvalumab demonstrated incremental radiological responses compared with none with surveillance. Treatment-related adverse events occurred in 77 (76.2%) durvalumab-assigned patients. A favourable effect in OS with durvalumab over surveillance in CPS ≥5 and immune biomarker-positive patients was observed compared with CPS <5 and biomarker-negative subgroups, respectively: CPS ≥5 versus <5: HR 0.63, 95% confidence interval (CI) 0.32-1.22 versus HR 0.93, 95% CI 0.44-1.96; biomarker-positive versus negative: HR 0.60, 95% CI 0.29-1.23 versus HR 0.84, 95% CI 0.42-1.65.Maintenance durvalumab does not improve PFS in patients with OG adenocarcinoma who respond to first-line chemotherapy but induced incremental radiological responses in a subset of patients. TME characterisation could refine patient selection for anti-PD-L1 therapy above PD-L1 CPS alone.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.