Background: The patient-reported outcomes (PROs) of sacituzumab govitecan (SG) were compared with chemotherapy using two phase 3 trials (TROPiCS-02, EVER-132-002) involving patients with HR+/HER2− locally recurrent inoperable or metastatic breast cancer. Methods: A meta-analysis was performed to compare change from baseline (CFB) scores and time-to-deterioration (TTD) between SG and chemotherapy using EORTC QLQ-C30 and EQ-5D-5L VAS in the overall, prior CDK4/6i-treated, and fast-progressor populations. Results of CFB and TTD analyses were summarized using hazard ratio (HR) and mean difference measures. Results: Statistically significant improvement (p< 0.05) in CFB scores was observed with SG over chemotherapy in five EORTC QLQ-C30 domains: physical (mean difference: 2.64), role functioning (mean difference: 2.70), fatigue (mean difference: −2.51), pain (mean difference: −3.25) and dyspnea (mean difference: −3.27), and EQ-5D-5L VAS (mean difference: 1.58). In the overall population, longer TTD (p< 0.05) was observed with SG versus chemotherapy on six domains of EORTC QLQ-C30: GHS/QoL (HR: 0.76), physical (HR: 0.72), emotional functioning (HR: 0.73), fatigue (HR: 0.80), pain (HR: 0.82), and dyspnea (HR: 0.71). Results from EORTC QLQ-C30 domains were mostly consistent among the overall, prior CDK4/6i treated and fast-progressor populations. SG demonstrated longer TTD (p< 0.05) over chemotherapy for EQ-5D-5L-VAS across all studied populations (HR range: 0.63–0.69). PROs significantly worsened with SG in the domains of diarrhea and nausea and vomiting (commonly reported adverse events of SG, manageable by following established guidelines). Conclusions: SG significantly improved PROs versus chemotherapy for several subdomains of EORTC QLQ-C30 and EQ-5D-5L-VAS. The consistency of these results in the overall population and subgroups supports the generalizability of the meta-analytic evidence and reinforces the PRO benefits associated with SG versus chemotherapy.
背景：基于两项涉及HR+/HER2−局部复发不可手术或转移性乳腺癌患者的3期临床试验（TROPiCS-02、EVER-132-002），比较了戈沙妥珠单抗（SG）与化疗的患者报告结局（PROs）。方法：通过荟萃分析，使用EORTC QLQ-C30量表和EQ-5D-5L视觉模拟评分（VAS），在总体人群、既往接受过CDK4/6抑制剂治疗人群和快速进展人群中，比较SG与化疗的基线变化评分（CFB）和至恶化时间（TTD）。CFB和TTD分析结果采用风险比（HR）和均数差进行汇总。结果：在EORTC QLQ-C30量表的五个维度中，SG较化疗在CFB评分上显示出统计学显著改善（p<0.05）：躯体功能（均数差：2.64）、角色功能（均数差：2.70）、疲乏（均数差：-2.51）、疼痛（均数差：-3.25）和呼吸困难（均数差：-3.27），EQ-5D-5L VAS评分亦显著改善（均数差：1.58）。在总体人群中，SG较化疗在EORTC QLQ-C30量表的六个维度上表现出更长的TTD（p<0.05）：总体健康状况/生活质量（HR：0.76）、躯体功能（HR：0.72）、情绪功能（HR：0.73）、疲乏（HR：0.80）、疼痛（HR：0.82）和呼吸困难（HR：0.71）。EORTC QLQ-C30各维度的结果在总体人群、既往CDK4/6抑制剂治疗人群和快速进展人群中基本一致。在所有研究人群中，SG较化疗在EQ-5D-5L-VAS评分上均显示出更长的TTD（p<0.05）（HR范围：0.63–0.69）。SG在腹泻、恶心呕吐维度（SG常见不良事件，按既定指南可管理）的PROs显著恶化。结论：与化疗相比，SG在EORTC QLQ-C30和EQ-5D-5L-VAS的多个子维度上显著改善了PROs。这些结果在总体人群和亚组中的一致性支持了荟萃分析证据的普适性，并强化了SG相较于化疗的PRO获益。
肿瘤(癌症)患者之家