一项荟萃分析：在两项3期试验（TROPiCS-02和EVER-132-002）中，比较戈沙妥珠单抗与医生选择的治疗方案用于既往治疗过的激素受体阳性/人表皮生长因子受体2阴性转移性乳腺癌患者时患者报告的结局。

A Meta-Analysis of Patient-Reported Outcomes of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Previously Treated HR+/HER- mBC Using Two Phase 3 (TROPiCS-02 and EVER-132-002) Trials.

作者信息

Rugo Hope S, Xu Binghe, Dasgupta Anandaroop, Kaushik Ankita, Verret Wendy, Singh Barinder

机构信息

Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.

Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

出版信息

Cancers (Basel). 2025 Jun 4;17(11):1885. doi: 10.3390/cancers17111885.

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 ( < 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 ( < 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 ( < 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

在两项3期试验（TROPiCS-02、EVER-132-002）中，对接受戈沙妥珠单抗（SG）治疗的激素受体阳性/人表皮生长因子受体2阴性局部复发无法手术或转移性乳腺癌患者的患者报告结局（PRO）与化疗进行了比较。

方法

进行一项荟萃分析，以使用欧洲癌症研究与治疗组织核心生活质量问卷（EORTC QLQ-C30）和EQ-5D-5L视觉模拟量表（VAS）比较SG与化疗之间的基线变化（CFB）评分和恶化时间（TTD），分析总体人群、既往接受过细胞周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）治疗的人群和快速进展者人群。使用风险比（HR）和平均差异指标总结CFB和TTD分析的结果。

结果

在EORTC QLQ-C30的五个领域中，与化疗相比，SG治疗患者的CFB评分有统计学意义的改善（P<0.05）：身体领域（平均差异：2.64）、角色功能领域（平均差异：2.70）、疲劳领域（平均差异：-2.51）、疼痛领域（平均差异：-3.25）和呼吸困难领域（平均差异：-3.27），以及EQ-5D-5L VAS（平均差异：1.58）。在总体人群中，在EORTC QLQ-C30的六个领域中，与化疗相比，SG治疗患者的TTD更长（P<0.05）：总体健康状况/生活质量（HR：0.76）、身体领域（HR：0.72）、情绪功能领域（HR：0.73）、疲劳领域（HR：0.80）、疼痛领域（HR：0.82）和呼吸困难领域（HR：0.71）。EORTC QLQ-C30领域的结果在总体人群、既往接受过CDK4/6i治疗的人群和快速进展者人群中大多一致。在所有研究人群中，SG治疗患者的EQ-5D-5L-VAS的TTD比化疗更长（P<0.05）（HR范围：0.63-0.69）。在腹泻、恶心和呕吐领域，SG治疗患者的PRO显著恶化（腹泻、恶心和呕吐是SG常见的不良事件，可通过遵循既定指南进行管理）。