Outcomes for metastatic triple-negative breast cancer patients treated with sacituzumab govitecan in clinical studies and real-world studies: a single-arm meta-analysis.

BACKGROUND

Clinical trials have demonstrated favorable outcomes with sacituzumab govitecan (SG) in metastatic triple-negative breast cancer (mTNBC). However, significant differences between trial settings and routine clinical practice raise concerns about the real-world prognosis of patients with mTNBC. To address this gap, we conducted the first comprehensive single-arm meta-analysis integrating clinical trials and real-world studies (RWSs) to evaluate clinical outcomes and treatment experiences in mTNBC patients receiving SG.

METHODS

Relevant studies were searched systematically in seven databases as of November 2024. Clinical trials and RWS of patients receiving SG for mTNBC were included. The primary outcomes of this study were overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and adverse events (AEs).

RESULTS

The meta-analysis included 1 randomized controlled trial (RCT), 4 single-arm trials and 9 RWSs with a total of 1387 patients. Direct meta-analysis results showed that the overall random-effects pooled prevalence of OS, PFS, and ORR were 11.26 months (95% CI: 9.68-12.84), 4.88 months (95% CI: 4.34-5.41) and 32% (95% CI: 29%-35%) respectively. Clinical study group demonstrated outcomes of OS: 12.93 months (95% CI: 11.51-14.35), PFS: 5.67 months (95% CI: 5.10-6.25), and ORR: 34% (95% CI: 30%-38%), in contrast to RWS group, with OS: 9.7 months (95% CI: 8.63-10.77), PFS: 4.32 months (95% CI: 3.86-4.79), and ORR: 30% (95% CI: 25%-34%). The most common treatment-related adverse events from SG were neutropenia, nausea, anemia and fatigue.

CONCLUSION

This single-arm analysis aims to compile scientific evidence on SG to provide valuable insights into the management of patients with mTNBC. Further randomized trials to analyze its effectiveness and safety are needed.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/ , identifier CRD42024553989.