KEY TAKEAWAYS
- The phase 3 trial aimed to assess the impact of liver/metabolic toxicities on survival and QoL in high-volume mHSPC pts with rezvilutamide.
- The result concluded that metabolic toxicity was linked to extended survival in mHSPC with rezvilutamide & enhanced QoL.
The CHART trial demonstrated that using rezvilutamide with androgen deprivation therapy (ADT) is better for survival in high-volume metastatic hormone-sensitive prostate cancer (mHSPC) patients (pts) compared to using bicalutamide with ADT.
Herein, Dingwei Ye and other researchers presented a follow-up analysis that explores how liver and metabolic issues impact survival and quality of life (QoL) in the pts taking rezvilutamide.
Researchers in the CHART trial randomly assigned mHSPC pts (1:1) to receive either rezvilutamide or bicalutamide along with ADT. In this subsequent analysis, liver toxicity was defined by increased levels of γ-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, or blood bilirubin. Metabolic toxicity included hypertriglyceridemia, hypercholesterolemia, and weight gain. The study examined the link between these toxicities and survival outcomes and QoL.
In the interventional study, pts receiving rezvilutamide with ADT, 24.6% experienced liver toxicity and 56.7% had metabolic issues. These toxicities were mainly grade 1 or 2 and improved without treatment changes. Pts with metabolic toxicity showed prolonged progression-free survival (PFS) (HR=0.594, 95%CI 0.400, 0.883, P=0.010) and overall survival (OS) (HR=0.594, 95%CI 0.383, 0.922, P=0.020) compared to those without. However, there was no survival difference between pts with or without liver toxicity. Notably, individuals with grade 3 metabolic toxicity had better QoL than those without.
The result concluded that the study marks the initial investigation uncovering a connection between metabolic toxicity and extended PFS and OS in mHSPC pts treated with rezvilutamide in conjunction with ADT. This correlation results in an improved QoL.
This study is sponsored by Jiangsu HengRui Medicine Co., Ltd.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/32
Clinical trial: https://clinicaltrials.gov/study/NCT03520478
Jiang S, Ye D, Luo H, et al. “Effect of liver and metabolic toxicity on survival and quality of life in patients with high-volume, metastatic hormone-sensitive prostate cancer receiving rezvilutamide in the CHART trial” Presented at ESMO Asia Congress 2023. (Abstract: 261MO).
