Real-World Use Patterns, Effectiveness, and Tolerability of Sacituzumab Govitecan for Second-Line and Later-Line Treatment of Metastatic Triple-Negative Breast Cancer in the United States

Authors

Kevin Kalinsky
Laura Spring
Clinton Yam
Manali Ajay Bhave
Ioanna Ntalla
Catherine Lai
Nikoleta Sjekloca
Brian Stwalley
Michael Stokes
Aliki Taylor
Rita Nanda

Publication Date

11-1-2024

Journal

Breast Cancer Research and Treatment

Abstract

Purpose: Patients with metastatic triple-negative breast cancer (mTNBC) have poor prognosis and limited treatment options. Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies (≥ 1 in the metastatic setting) based on the ASCENT study (NCT02574455). The current study describes real-world SG use and outcomes in patients with mTNBC in the United States.

Methods: This retrospective, observational study included adult patients with mTNBC from the ConcertAI Patient360™ database who received SG in the second line (2L) and later from April 2020 to May 2022. SG use patterns, effectiveness, and tolerability are described.

Results: This analysis included 230 patients (median age 60 years, 26% Black, 17% with ECOG performance status ≥ 2, 66% in community settings; median of 2 prior lines of treatment in the metastatic setting); median follow-up was 7.2 months. Median (95% CI) real-world overall survival was 10.0 (8.3-11.1) months for all patients and 13.9 (9.8-not estimable) months in the 2L subgroup (n = 77). Granulocyte-colony stimulating factor (G-CSF) was administered concomitantly with SG in 134 (58%) patients; 35 (15%) received G-CSF for the first time. Median (IQR) time from SG start to G-CSF use was 8.5 (8.0-29.0) days. Seventeen (7%) patients discontinued SG due to toxicity.

Conclusions: Using a real-world, ethnically diverse population of patients with mTNBC presenting with poor prognosis, these data reinforced the findings from ASCENT. In routine clinical practice, SG is an effective treatment in the 2L setting, consistent with treatment guidelines.

Keywords

Humans, Triple Negative Breast Neoplasms, Middle Aged, Female, Antibodies, Monoclonal, Humanized, Retrospective Studies, Aged, United States, Camptothecin, Immunoconjugates, Adult, Neoplasm Metastasis, Treatment Outcome, Aged, 80 and over, Metastatic, Real-world clinical outcomes, Sacituzumab govitecan, Second-line, Treatment patterns, Triple-negative breast cancer

DOI

10.1007/s10549-024-07412-9

PMID

38904892

PMCID

PMC11452463

PubMedCentral® Posted Date

6-21-2024

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes