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Adverse reactions associated with immune checkpoint inhibitors and bevacizumab: A pharmacovigilance analysis

Tianqi Gu1, Aimin Jiang2, Chaozheng Zhou1

  • 1Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

International Journal of Cancer
|October 24, 2022
PubMed

Insights

Combination immunotherapy with bevacizumab increases risks for interstitial lung disease, hypertension, and gastrointestinal bleeding in cancer patients. Endocrine ADRs also rose, highlighting the need for individualized patient management.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Immunotherapy

Background:

  • Immune checkpoint inhibitors (ICIs) combined with bevacizumab represent a promising cancer immunotherapy strategy.
  • However, the safety profile and potential adverse drug reactions (ADRs) of this combination therapy are not well-established.
  • Limited research exists on ADRs associated with combination therapy in cancer patients.

Purpose of the Study:

  • To investigate the safety of combining ICIs with bevacizumab in cancer patients.
  • To identify and quantify the risk of specific ADRs associated with this combination therapy.
  • To provide recommendations for individualized patient management based on ADR profiles.

Main Methods:

  • A large-scale retrospective study using FDA Adverse Event Reporting System (FAERS) data from Q1 2012 to Q4 2021.
  • Analysis of 2094 de-identified ADR reports for combination therapy, excluding chemotherapy use.
  • Reporting Odds Ratio (ROR) was used to monitor ADR signals and assess risk in Pan-cancer patients.

Main Results:

  • Combination therapy was significantly associated with increased risks of interstitial lung disease (OR: 8.62), hypertension (OR: 1.35), and gastrointestinal bleeding (OR: 3.16).
  • A subgroup analysis indicated elevated risks for endocrine system-related ADRs across different combination regimens and tumor types.
  • The study identified specific ADR patterns linked to treatment strategies and cancer types.

Conclusions:

  • Combination therapy of ICIs and bevacizumab is an independent risk factor for severe ADRs including interstitial lung disease, hypertension, and gastrointestinal bleeding.
  • Endocrine-related ADRs are a notable concern, varying with specific treatment combinations and cancer types.
  • Findings underscore the necessity for careful monitoring and individualized management strategies for patients receiving this combined immunotherapy.
Keywords:
FAERSadverse drug reactionsbevacizumabimmune checkpoint inhibitorsretrospective study

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