BMC medicine · 2026
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.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wu Jun-Long, Jiang Shu-Suan, Luo Hong, Dong Pei, Wang Zeng-Jun, Xing Nian-Zeng, Ma Tao, Wang Zhi-Ping, Gu Xin-Quan, Zhou Guang-Chen, Xue Xue-Yi, Sun Zhong-Quan, Yang Yong, Wang Chun-Xi, Shan Guang-Yi, Zhang Ai-Li, Ding De-Gang, Wang Li-Ping, Duan Xiao-Hui, Wang Ting-Ting, He Ting, Lin Chao-Yu, Zhong Xin-Wei, Lian Jian-Po, Wang Wen-Liang, Ye Ding-Wei, Dai Bo
Аннотация
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.
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.