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Adverse reactions associated with nivolumab and small molecule antiangiogenic drugs: A pharmacovigilance analysis

Haiyang Li1, Zhaohui Ruan2, Yanan Jia3

  • 1Department of Otorhinolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.

British Journal of Clinical Pharmacology
|September 17, 2024
PubMed
Abstract

Insights

Combination immunotherapy with checkpoint inhibitors and TKIs increases risks for sensitive skin and renal cell carcinoma. This study identifies key adverse drug reactions to aid oncologists in patient management.

Area of Science:

  • Oncology
  • Pharmacology
  • Immunotherapy

Background:

  • Immune checkpoint inhibitors (ICIs) combined with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs) show promise for cancer treatment.
  • Combination therapy may lead to specific adverse drug reactions (ADRs), but research in this area is limited.
  • Assessing the safety profile of this combination strategy is crucial for clinical application.

Purpose of the Study:

  • To evaluate the safety and identify adverse drug reactions (ADRs) associated with the combination of ICIs and TKIs.
  • To analyze ADR risk signals and compare the incidence of fatal ADRs across different tumor types.

Main Methods:

  • A large-scale retrospective study using the FDA Adverse Event Reporting System database (Q1 2012 - Q3 2023).
  • Analysis of ADR reports for combination therapy involving ICIs and TKIs.
  • Evaluation of ADR risk signals using the reporting odds ratio (ROR) and Ro/e ratio.

Main Results:

  • Combination therapy significantly increased the risk of sensitive skin (ROR: 231.43), metastatic renal cell carcinoma (ROR: 220.71), and renal cell carcinoma (ROR: 188.22).
  • Differences in ADRs were observed based on specific TKI combinations and tumor types.
  • Characteristics of patients prone to fatal ADRs were analyzed.

Conclusions:

  • The findings enhance understanding of ADRs associated with ICI-TKI combination therapy.
  • Results can assist oncologists in developing screening protocols for patients receiving this treatment.
Keywords:
FAERSadverse drug reactionsnivolumabretrospective studysmall molecule antiangiogenic drugs

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