Cyclin-dependent kinase 4/6 inhibitor-associated pulmonary toxicity: a disproportionality analysis from 2015 to 2023...

Area of Science:

• Oncology
• Pharmacovigilance
• Pulmonary Medicine

Background:

• Cyclin-dependent kinase 4/6 inhibitors (CDK 4/6 inhibitors) are crucial in breast cancer treatment.
• Pulmonary toxicity is a potential adverse event associated with these therapies.
• Understanding the specific risks of palbociclib, ribociclib, and abemaciclib is essential for patient safety.

Purpose of the Study:

• To investigate and characterize the pulmonary toxicity associated with CDK 4/6 inhibitors (palbociclib, ribociclib, abemaciclib).
• To identify specific patterns and risk factors for pulmonary adverse events in patients receiving these drugs for breast cancer.

Main Methods:

• Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
• Performed disproportionality analysis on 83,505 reported adverse events related to CDK 4/6 inhibitors.
• Analyzed clinical characteristics, onset times, drug combinations, and comorbidities.

Main Results:

• Identified 437 cases of pneumonitis, 555 of pulmonary edema, and 181 of pulmonary thrombosis linked to CDK 4/6 inhibitors.
• Abemaciclib showed the strongest signal for pneumonitis and pulmonary thrombosis; ribociclib for pulmonary edema.
• Pulmonary toxicity was disproportionately observed in females and patients over 60 years old.

Conclusions:

• Abemaciclib and ribociclib exhibit distinct pulmonary toxicity profiles.
• The order of association with pulmonary toxicity is abemaciclib, ribociclib, and palbociclib.
• Pulmonary adverse events necessitate careful monitoring in specific patient populations receiving CDK 4/6 inhibitors.