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Objective <p>This study aimed to analyze the adverse effects (AEs) of sacituzumab govitecan (SG) through multiple sources of data to provide a reference for clinical safety management.</p> Methods <p>Clinical trials of SG with available safety data were retrieved and included in the pooled analysis. The adverse drug reaction (ADR) signals of SG were collected from the FDA Adverse Event Reporting System (FAERS) database. Drug interactions with SG in the DDInter database were summarized.</p> Results <p>A total of 6 clinical trials involving 1737 patients were included in the pooled analysis, and the most common AEs of ≥ grade 3 were neutropenia (46%), leukopenia (13%), and anemia (8%). In the pharmacovigilance study, 1024 AE reports were extracted, and the most common toxicities of SG were hematologic and gastrointestinal. AEs not included in the drug instructions also presented high signals, such as meningitis, colitis and lymphedema. A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.</p> Conclusions <p>This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases. Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions, and potential drugs that can induce drug–drug interactions.</p>

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Toxicities Associated with Sacituzumab Govitecan: Data from Clinical Trials and a Real-World Pharmacovigilance Database

  • 期刊论文

  • 发表日期：

    2025年3月25日

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  • Qiao-yun Tan,
  • Xiang-ping Mei,
  • Yue Hu,
  • Hong-ge Wu,
  • Lin-ka Xie,
  • Jie Xiong,
  • Jing Yao

摘要

Objective

This study aimed to analyze the adverse effects (AEs) of sacituzumab govitecan (SG) through multiple sources of data to provide a reference for clinical safety management.

Methods

Clinical trials of SG with available safety data were retrieved and included in the pooled analysis. The adverse drug reaction (ADR) signals of SG were collected from the FDA Adverse Event Reporting System (FAERS) database. Drug interactions with SG in the DDInter database were summarized.

Results

A total of 6 clinical trials involving 1737 patients were included in the pooled analysis, and the most common AEs of ≥ grade 3 were neutropenia (46%), leukopenia (13%), and anemia (8%). In the pharmacovigilance study, 1024 AE reports were extracted, and the most common toxicities of SG were hematologic and gastrointestinal. AEs not included in the drug instructions also presented high signals, such as meningitis, colitis and lymphedema. A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.

Conclusions

This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases. Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions, and potential drugs that can induce drug–drug interactions.