A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for gefitinib and docetaxel.

Background: In recent years, gefitinib and docetaxel, as targeted and chemotherapeutic agents, respectively, have been widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety of these drugs remains a significant concern in clinical practice. Comparative studies on the safety of these two drugs have yet to be fully explored. This study aimed to analyze adverse event (AE) signals associated with gefitinib and docetaxel in the treatment of NSCLC using the FDA Adverse Event Reporting System (FAERS), providing insights for clinical practice and package insert.

Methods: Adverse events for gefitinib and docetaxel were retrieved from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 (2004 Q1) through the fourth quarter of 2024 (2024 Q4). The reporting odds ratio method was used to identify risk signals. The results were standardized and classified using the System Organ Class (SOC) and Preferred Terms (PT) in the 26.1 version of the Medical Dictionary for Regulatory Activities (MedDRA) and compared with the package insert.

Results: The FAERS received 8214 and 42,453 AE reports for gefitinib and docetaxel, respectively. An analysis of the top 100 AEs ranked by signal strength revealed 64 positive PTs for gefitinib, spanning 14 SOCs, 45 of which were not mentioned in the package insert. For docetaxel, 61 positive PTs were identified, involving 15 SOCs, with 33 AEs not mentioned in the package insert. The top 5 PTs with the highest signal strength for gefitinib were PRIDE syndrome, drug resistance, lymphangiosis carcinomatosa, xeroderma, and skin disorder. For docetaxel, the top 5 PTs were lacrimal structure injury, madarosis, hair disorder, variations in hair color, and psychological trauma.

Conclusion: The potential adverse reactions of gefitinib and docetaxel are not fully covered in their package insert. The newly identified AE signals provide critical evidence for the improvement of the package insert. These findings have significant implications for individualized clinical treatment.