与安慰剂加化疗相比，一线佐贝妥昔单抗加化疗（SPOTLIGHT、mFOLFOX6；GLOW、CAPOX）可显着改善人类表皮生长因子受体 2 阴性、局部晚期不可切除或无法切除的患者的无进展生存期 (PFS) 和总生存期 (OS) III 期 SPOTLIGHT (NCT03504397) 和 GLOW (NCT03653507) 研究中肿瘤呈密蛋白 18 亚型 2 阳性的转移性胃或胃食管交界腺癌。我们展示了这些研究中患者报告的结果 (PRO)。使用欧洲癌症研究和治疗组织癌症患者生活质量核心问卷 (QLQ-) 在完整的分析集中测量了健康相关的生活质量 (HRQoL)。 C30) 和食管胃模块 (QLQ-OG25)、全身疼痛和 5 级 EQ-5D (EQ-5D-5L) 问卷。分析重点关注关键 PRO 领域：全球健康状况 (GHS)/QoL、身体机能、腹痛和不适以及恶心/呕吐。对 SPOTLIGHT 和 GLOW 以及个别研究的最小二乘均值 (LSM) 相对于基线的变化以及首次明确恶化的时间 (TTDD) 进行了综合评估。 SPOTLIGHT 和 GLOW 独立评估确认恶化时间 (TTCD)。组合分析集包括 1072 名患者（佐贝妥昔单抗加化疗，537 例；安慰剂加化疗，535 例）。治疗组之间的依从率相似。在 zolbetuximab 组与安慰剂组中，关键 PRO 领域的 LSM 相对于基线的变化也观察到了类似的趋势，没有出现有临床意义的恶化。恶心/呕吐在最初的几个佐贝妥昔单抗周期中恶化，但后来恢复到基线水平。两项研究中各组之间的总体 TTCD 和 TTDD 结果相似。SPOTLIGHT 和 GLOW 中的患者在化疗中添加一线佐贝妥昔单抗治疗时，相对于基线维持测量的 HRQoL。与安慰剂加化疗相比，Zolbetuximab 加化疗可改善 PFS 和 OS，且不会对关键 PRO 领域的 HRQoL 产生负面影响。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

First-line zolbetuximab plus chemotherapy (SPOTLIGHT, mFOLFOX6; GLOW, CAPOX) significantly improved progression-free survival (PFS) and overall survival (OS) versus placebo plus chemotherapy in patients with human epidermal growth factor receptor 2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors were claudin 18 isoform 2-positive in the phase III SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies. We present patient-reported outcomes (PROs) from these studies.Health-related quality of life (HRQoL) was measured in the full analysis sets using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients Core Questionnaire (QLQ-C30) and Oesophago-Gastric Module (QLQ-OG25), Global Pain, and 5-level EQ-5D (EQ-5D-5L) questionnaires. Analyses focused on key PRO domains: global health status (GHS)/QoL, physical functioning, abdominal pain and discomfort, and nausea/vomiting. Least squares mean (LSM) changes from baseline and time to first definitive deterioration (TTDD) were evaluated combined across SPOTLIGHT and GLOW and for individual studies. Time to confirmed deterioration (TTCD) was evaluated independently for SPOTLIGHT and GLOW.The combined analysis set included 1072 patients (zolbetuximab plus chemotherapy, 537; placebo plus chemotherapy, 535). Compliance rates were similar between treatment arms. Similar trends were observed in the zolbetuximab versus placebo arms for LSM changes from baseline in key PRO domains, with no clinically meaningful deterioration. Nausea/vomiting worsened during the first few zolbetuximab cycles but later returned to baseline levels. Overall TTCD and TTDD results were similar between arms in both studies.Patients in SPOTLIGHT and GLOW maintained measured HRQoL relative to baseline when treated with first-line zolbetuximab added to chemotherapy. Zolbetuximab plus chemotherapy improved PFS and OS without negatively affecting HRQoL in key PRO domains compared with placebo plus chemotherapy.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.