Hematopoietic adverse events associated with PARP inhibitors: A FAERS database study

Area of Science:

• Pharmacovigilance
• Oncology
• Hematology

Background:

• PARP inhibitors are crucial in cancer therapy.
• Hematopoietic adverse drug reactions (ADRs) are a known concern with PARP inhibitors.
• Understanding the specific ADR profiles of different PARP inhibitors is essential for safe clinical use.

Purpose of the Study:

• To analyze hematopoietic ADR signals associated with PARP inhibitors (Olaparib, Niraparib, Rucaparib, Talazoparib).
• To inform clinical practice regarding the safe and rational use of these agents.
• To compare the incidence and characteristics of hematopoietic ADRs among different PARP inhibitors.

Main Methods:

• Utilized the FDA Adverse Event Reporting System (FAERS) database from Q1 2019 to Q2 2024.
• Employed Standardized Medical Queries (SMQ) and Preferred Terms (PT) for data standardization.
• Assessed ADR signals using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and MHRA methods, comparing SMQ ratios.

Main Results:

• Hematopoietic ADRs, including cytopenia and leukopenia, were most prevalent within 30 days post-treatment.
• Niraparib exhibited the highest adverse event count and signal intensity.
• Olaparib and Talazoparib also demonstrated significant hematotoxicity.

Conclusions:

• PARP inhibitors exhibit variable incidence and duration of hematopoietic ADRs.
• Personalized treatment strategies are necessary to optimize safety and ensure rational use of PARP inhibitors.
• Clinical monitoring for hematotoxicity is crucial during PARP inhibitor therapy.