# Drug-Induced Liver Injury Caused by Abiraterone Acetate in Patients With Prostate Cancer

## TL;DR

This study reports severe liver injury caused by abiraterone acetate in prostate cancer patients, emphasizing the need for close monitoring during treatment.

## Contribution

The study identifies risk factors and timing of severe liver injury in patients receiving abiraterone acetate for prostate cancer.

## Key findings

- Severe liver injury occurred in 6.2% of patients treated with abiraterone acetate.
- Liver injury typically developed between the fourth and eighth week of treatment.
- Liver metastases and elevated gamma-glutamyl transpeptidase levels were significant risk factors for severe liver injury.

## Abstract

Background: Abiraterone acetate is indicated for high-risk metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC). However, abiraterone acetate is significantly associated with drug-induced liver injury (DILI). In this study, we report severe cases of abiraterone acetate-induced liver injury in patients with prostate cancer.

Methods: This retrospective study uses medical records from September 2014 to November 2023. During this period, abiraterone acetate was administered to 126 patients at the Showa University Hospital in Japan. Of these, 113 patients were included in this study for analysis of the incidence of DILI. The incidence, timing, grade, and treatment of abiraterone-induced liver injury were investigated.

Results: The median age of the included patients was 76 years. There were 32 cases of upfront therapy, 63 cases of pre-docetaxel therapy, and 18 cases of post-docetaxel therapy. Seven patients had ≥ grade 3 DILIs and comprised three cases of upfront therapy, three of pre-docetaxel therapy, and one of post-docetaxel therapy. There were four cases of the hepatocellular type and three cases of the cholestatic type of DILI. Liver injury developed in all cases from the fourth week to the eighth week since drug administration. Abiraterone acetate was immediately discontinued in all patients with liver injury. The incidence of DILI in the upfront therapy group of this study was significantly higher. Liver metastases (OR = 6.667, p = 0.043, 95% CI (1.063-41.773)) and gamma-glutamyl transpeptidase levels (OR = 7.556, p = 0.013, 95% CI (1.534-37.214)) were significantly associated with grade ≥ 3 DILI in a single logistic regression analysis.

Conclusion: Severe DILI is a potential complication of the administration of abiraterone acetate. We recommend close monitoring for liver injury during abiraterone acetate therapy, especially in the first few months.