The development of programmed cell death receptor-1 and its ligand (PD-L1) have offered new treatment options for several cancers, but the clinical benefit of tislelizumab in the gastroesophageal junction (GEJ) adenocarcinoma is still murky. Thus, we aim to investigate the efficacy and safety of tislelizumab combined with chemotherapy in patients with GEJ cancer. In this study, 90 GEJ patients were retrospectively enrolled including 45 patients who received chemotherapy plus tislelizumab while 45 underwent chemotherapy only. Overall response rate (ORR), overall survival (OS), and progression-free survival (PFS) were estimated and safety was assessed by treatment-related adverse events between two arms. The ORR was significantly higher in the tislelizumab group than in patients with chemotherapy alone (71.1 vs. 44.4%). The PFS [54.7% (47.2-62.2) vs. 33.3% (26.3-40.3), P = 0.047] and OS [62.1% (54.5-69.7) vs. 40.0% (32.5-47.5), P = 0.031] were also significantly improved in patients with concomitant use of tislelizumab. When stratified by PD-L1 combined positive score (CPS), patients with PD-L1 CPS ≥ 1 also with significantly higher PFS and OS when taking tislelizumab (P = 0.015 and P = 0.038). The incidence of hematologic toxicity was similar in the combination arm compared to the chemotherapy alone arm and the number of adverse events was not significantly increased by adding tislelizumab (all P > 0.05). Concomitant use of tislelizumab and chemotherapy in GEJ patients may be with optimal therapeutic effect and similar incidence of adverse events than chemotherapy alone. Further studies with larger number of patients are warranted to confirm it.

中文翻译：

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替雷利珠单抗联合化疗是晚期胃食管连接部腺癌二线治疗的最佳选择。

程序性细胞死亡受体-1及其配体（PD-L1）的开发为多种癌症提供了新的治疗选择，但替雷利珠单抗在胃食管交界处（GEJ）腺癌中的临床疗效仍不清楚。因此，我们的目的是研究替雷利珠单抗联合化疗治疗 GEJ 癌患者的疗效和安全性。在这项研究中，回顾性纳入了 90 名 GEJ 患者，其中 45 名接受化疗加替雷利珠单抗的患者，45 名仅接受化疗。评估总体缓解率（ORR）、总体生存期（OS）和无进展生存期（PFS），并通过两组之间治疗相关的不良事件评估安全性。替雷利珠单抗组的 ORR 显着高于仅接受化疗的患者（71.1% vs. 44.4%）。 PFS [54.7% (47.2-62.2) vs. 33.3% (26.3-40.3), P = 0.047] 和 OS [62.1% (54.5-69.7) vs. 40.0% (32.5-47.5), P = 0.031] 也联合使用替雷利珠单抗的患者的病情显着改善。按 PD-L1 联合阳性评分 (CPS) 分层时，PD-L1 CPS ≥ 1 的患者在服用替雷利珠单抗时也具有显着较高的 PFS 和 OS（P = 0.015 和 P = 0.038）。与单独化疗组相比，联合组的血液学毒性发生率相似，并且添加替雷利珠单抗后不良事件的数量并未显着增加（均 P > 0.05）。 GEJ 患者联合使用替雷利珠单抗和化疗可能比单独化疗具有最佳治疗效果，且不良事件发生率相似。需要对大量患者进行进一步的研究来证实这一点。