Use and outcomes of trastuzumab deruxtecan in HER2-positive and HER2-low metastatic breast cancer in a real-world setting: a nationwide cohort study
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View abstract on PubMed
Summary
This summary is machine-generated.Trastuzumab deruxtecan (T-DXd) real-world use in France shows effectiveness in HER2-positive and HER2-low metastatic breast cancer. HER2-low patients experienced higher hospitalization rates for certain toxicities, necessitating proactive monitoring.
Area Of Science
- Oncology
- Pharmacovigilance
- Real-world evidence
Background
- Trastuzumab deruxtecan (T-DXd) is approved in France since 2020 for pre-treated HER2-positive and HER2-low metastatic breast cancer (mBC).
- Real-world data on T-DXd's effectiveness and safety in diverse patient populations are crucial.
Purpose Of The Study
- To describe clinical characteristics, outcomes, and toxicities of T-DXd in French patients with HER2-positive (2nd and 3rd line) and HER2-low (2nd line) mBC.
- To compare outcomes and toxicity profiles across different treatment lines and HER2 expression levels.
Main Methods
- Retrospective analysis of the French National Health Data System (SNDS) from September 2020 to December 2023.
- Inclusion of 5890 patients initiating T-DXd for mBC, categorized into HER2-positive 3rd line (HER2+ 3L), HER2-positive 2nd line (HER2+ 2L), and HER2-low 2nd line (HER2-low2L).
- Kaplan-Meier estimates for overall survival (OS) and incidence of hospitalizations for specific adverse events were calculated.
Main Results
- The cohort included 5890 patients: 34.1% HER2+ 3L, 21.4% HER2+ 2L, and 44.5% HER2-low2L. Patients were older with more comorbidities and brain metastases than trial participants.
- Median OS was 30.2 months for HER2+ 3L, not reached for HER2+ 2L, and 16.8 months for HER2-low2L.
- HER2-low patients showed higher hospitalization rates for cardiac, respiratory, digestive, and hematological disorders compared to HER2-positive patients.
Conclusions
- Real-world T-DXd use in France involves older patients with more comorbidities and brain metastases.
- T-DXd demonstrates effectiveness across HER2-positive and HER2-low mBC, but HER2-low patients face increased risks of specific toxicities.
- Proactive surveillance and timely management of T-DXd-related toxicities are essential due to its expanding indications.
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