A real-world study of oxaliplatin-induced hypersensitivity in colorectal cancer treatment based on the pharmacovigilance system in China: a cohort study.

Background: Oxaliplatin (OXA), a third-generation platinum-based chemotherapeutic agent, is commonly used in the treatment of colorectal cancer (CRC). However, there is growing recognition that OXA induced hypersensitivity poses a challenge to the continuity and safety of patient treatment. However, the risk factors for OXA-induced hypersensitivity reactions (HSRs) are not clear. This study aimed to investigate the incidence, characteristics, severity, and risk factors of OXA-induced HSRs among Chinese CRC patients, using data from the China Hospital Pharmacovigilance System (CHPS). Methods: This retrospective study analyzed adverse drug reaction reports related to OXA from the CHPS, focusing on patients treated for CRC between 2018 and 2022. The incidence rates of HSRs were assessed, and the demographic, clinical, and risk factors associated with HSRs were explored. Results: This study analyzed the records of 383 CRC patients who were treated with OXA-based regimens. A total of 124 (32.37%) HSRs related to OXA were reported, the majority of which were cutaneous reactions. Severe reactions, including anaphylaxis, occurred in 8% of the HSR cases. In this study, male gender, the eosinophil count, and serum albumin levels were risk factors associated with the occurrence of OXA-induced HSRs. Conclusions: OXA-induced HSRs are a significant adverse effect in the treatment of CRC. This study emphasizes the importance of identifying the risk factors associated with the occurrence of OXA-induced HSRs to optimize patient safety and treatment efficacy.