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Background <p>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.</p> Methods <p>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 <i>P</i> values were nominal.</p> Results <p>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; <i>P</i> = 0.1908), OS (HR, 0.890; 95% CI, 0.532–1.489; <i>P</i> = 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; <i>P</i> = 0.0100) and OS (HR, 0.594; 95% CI, 0.383–0.922; <i>P</i> = 0.0201) than those without LMRT. Patients experiencing grade ≥3 LMRT demonstrated greater improvements in QoL scores from baseline.</p> Conclusions <p>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.</p> Trial registration: <p>ClinicalTrials.gov, NCT03520478.</p>

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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

  • 期刊论文

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  • 发表日期：

    2026年6月30日

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  • 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

摘要

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.