Assessing taxane-associated adverse events using the FDA adverse event reporting system database

Area of Science:

• Pharmacovigilance
• Oncology
• Drug Safety

Background:

• Taxanes are vital antineoplastic agents for cancer treatment.
• Hypersensitivity reactions, bone marrow toxicity, and peripheral neuropathy are common taxane adverse events.
• These toxicities can necessitate chemotherapy discontinuation.

Purpose of the Study:

• To evaluate the real-world safety profile of taxanes.
• To compare the incidence and severity of adverse events among different taxane formulations.
• To identify specific taxanes associated with increased toxicity risks.

Main Methods:

• Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database (2004-2019).
• Analyzed taxane-associated adverse events using preferred terms from the Medical Dictionary for Regulatory Activities.
• Employed multiple statistical signal detection algorithms (ROR, PRR, MGPS, BCPNN) to assess adverse event signals.
• Compared adverse outcome and death rates between taxane groups using Pearson's χ2 test.

Main Results:

• Nab-paclitaxel demonstrated significantly higher reporting odds ratios (ROR) for bone marrow toxicity (6.45) and peripheral neuropathy (12.78) compared to paclitaxel and docetaxel.
• Analysis revealed substantial data for hypersensitivity reactions (966), bone marrow toxicity (1109), and peripheral neuropathy (1374).
• Nab-paclitaxel showed the highest risk signals across multiple detection algorithms for both bone marrow toxicity and peripheral neuropathy.

Conclusions:

• Bone marrow toxicity and peripheral neuropathy are significant adverse events associated with taxane chemotherapy.
• Nab-paclitaxel presents a higher risk profile for these taxane-associated adverse events in real-world settings.
• Further investigation is needed to elucidate the mechanisms behind taxane-induced toxicities and inform clinical practice.