Impact of hepatotoxicity and lipid metabolism–related toxicity on survival and quality of life in patients with high-volume metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial: a post hoc analysis
Year: 2026
Type: article
Abstract: BACKGROUND: The CHART study demonstrated that rezvilutamide plus androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) versus bicalutamide plus ADT in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC), with an acceptable safety profile. This post hoc analysis evaluates the impact of hepatotoxicity and lipid metabolism-related toxicity (LMRT) on long-term survival and quality of life (QoL) in this population. METHODS: Data from 323 patients with high-volume mHSPC who received rezvilutamide plus ADT were analyzed. Hepatotoxicity was defined as elevations in γ-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, or bilirubin, whereas LMRT included hypertriglyceridemia, hypercholesterolemia, and weight gain. All P values were nominal. RESULTS: Any-grade hepatotoxicity and LMRT occurred in 24.6% (79/323) and 56.7% (183/323) of patients, respectively. No significant differences in rPFS (hazard ratio [HR], 0.716; 95% confidence interval [CI], 0.434-1.181; P = 0.1908), OS (HR, 0.890; 95% CI, 0.532-1.489; P = 0.6569), or QoL were observed between patients with and without hepatotoxicity. In contrast, patients who developed LMRT showed longer rPFS (HR, 0.594; 95% CI, 0.400-0.883; P = 0.0100) and OS (HR, 0.594; 95% CI, 0.383-0.922; P = 0.0201) than those without LMRT. Patients experiencing grade ≥3 LMRT demonstrated greater improvements in QoL scores from baseline. CONCLUSIONS: This is the first study to evaluate the association of hepatotoxicity and LMRT with clinical outcomes in patients with high-volume mHSPC treated with rezvilutamide plus ADT. Hepatotoxicity was not significantly associated with survival or QoL, whereas LMRT was associated with prolonged rPFS and OS, and grade ≥3 LMRT was associated with more pronounced improvements in QoL. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03520478.
Source: BMC Medicine
Authors: Jun-Long Wu, Shu-Suan Jiang, Hong Luo, Pei Dong, Zeng-Jun Wang, Nian-Zeng Xing, Tao Ma, Zhi-Ping Wang, Xin-Quan Gu, Guang-Chen Zhou, Xue-Yi Xue, Zhong-Quan Sun, Yong Yang, Chun-Xi Wang, Guang-Yi Shan, Ai-Li Zhang, De-Gang Ding, Li-Ping Wang, Xiao-Hui Duan, Ting-Ting Wang, Ting He, Chao-Yu Lin, Xin-Wei Zhong, Jian-Po Lian, Wen-Liang Wang, Ding-Wei Ye, Bo Dai
Institutions: Fudan University Shanghai Cancer Center, Hunan Cancer Hospital, Chongqing University, Chongqing Cancer Hospital, Sun Yat-sen University Cancer Center, Lanzhou University Second Hospital, Jiangsu Province Hospital, Lanzhou University, Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, Affiliated Hospital of Hebei University, Hebei University, Jilin University, First Affiliated Hospital of Fujian Medical University, Fudan University, Huadong Hospital, Peking University Cancer Hospital, First Hospital of Jilin University, First Bethune Hospital of Jilin University, Liaoning Cancer Hospital & Institute, Hebei Medical University, Fourth Hospital of Hebei Medical University, Henan Provincial People's Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,190
OpenAlex ID: W7166681970