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

TL;DR

This study compares how sacituzumab govitecan affects patients' quality of life versus chemotherapy in advanced breast cancer, showing better outcomes in several key areas.

Contribution

The study provides meta-analytic evidence of patient-reported outcome benefits of sacituzumab govitecan over chemotherapy in HR+/HER2− metastatic breast cancer.

Findings

Sacituzumab govitecan improved physical and role functioning, and reduced fatigue, pain, and dyspnea compared to chemotherapy.

Time-to-deterioration was longer with sacituzumab govitecan in multiple quality-of-life domains across patient subgroups.

Results were consistent across overall, CDK4/6 inhibitor pre-treated, and fast-progressing disease populations.

Abstract

Breast cancer is the most common type of cancer among women, with HR+/HER2− disease representing ~70% of all breast cancers. There is a lack of documented evidence showing humanistic outcomes (changes in patient quality of life/functional status) associated with treatment in an HR+/HER2− population, which can be generalized to the global level. This study included two clinical studies, TROPiCS-02 and EVER-132-002, involving patients with HR+/HER2− locally recurrent inoperable or metastatic breast cancer who were treated with sacituzumab govitecan or chemotherapy of physician’s choice. We compared the patient-reported outcomes of sacituzumab govitecan versus chemotherapy in the overall population, the CDK4/6 inhibitor pre-treated population, and in patients with fast-progressing disease. Sacituzumab govitecan was found to demonstrate patient-reported outcome benefits compared with chemotherapy in different patient subgroups. These findings support the use of sacituzumab govitecan as a standard of care for pre-treated HR+/HER2− metastatic breast cancer regardless of previous CDK4/6 inhibitor treatment.

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.

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