Background

Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma.

Methods

Patients were randomized to ZOL/EOX or EOX alone. Patients could receive ≤ 8 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1/cycle 1, day 1/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM).

Results

The per protocol population included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS (p = 0.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (p = 0.0181 favoring EOX).

Conclusions

ZOL/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.

中文翻译：

---

唑贝妥昔单抗联合 EOX 与单独 EOX 相比作为转移性 CLDN18.2+ 胃食管腺癌患者的一线治疗的 II 期 FAST 试验的患者报告结果

背景

在 FAST 试验中，与单独使用 EOX 相比，佐贝妥昔单抗加一线 EOX（表柔比星、奥沙利铂、卡培他滨；ZOL/EOX）显着延长了无进展生存期和总生存期。我们报告了 FAST 在晚期胃食管腺癌患者中的患者报告结果 (PRO)。

方法

患者被随机分配到 ZOL/EOX 或单独的 EOX。患者可以接受 ≤ 8 个 EOX 周期并继续使用唑贝妥昔单抗直至疾病进展。使用 EORTC QLQ-C30 和 QLQ-STO22 在给药前在第 1 天/第 1 个周期、第 1 天/第 5 个周期、EOX 治疗结束和此后 q12w 收集 PRO，直至疾病进展。分析了单个 QLQ-C30/QLQ-STO22 评分中的恶化时间 (TTD)，定义为从基线开始的第一个有意义的恶化。使用重复测量的混合效应模型 (MMRM) 分析了基线评分的纵向变化。

结果

符合方案的人群包括 143 名（ZOL/EOX：69；EOX：74）患者。两组的基线 QLQ-C30 和 STO22 评分具有可比性，表示中高生活质量 (QoL)、中低全球健康状况 (GHS) 和低症状负担。描述性分析显示，在 EOX 结束之前，两组之间没有差异，但唑贝妥昔单抗的维持治疗与更好的 QoL 和此后更少的症状负担相关。大多数分数的 TTD 有利于 ZOL/EOX 胜过 EOX，并且达到了 GHS 的统计显着性 ( p  = 0.008)。MMRM 结果支持 TTD 结果；除了恶心和呕吐（p  = 0.0181 有利于 EOX），两组之间在任何评分中均未观察到统计学上的显着差异。

结论

与单独使用 EOX 相比，ZOL/EOX 使患者能够更长时间地保持良好的 QoL 和低症状负担。