Toxicity-benefit analysis of advanced prostate cancer trials using weighted toxicity scoring.

ABSTRACT:

Objective

The weighted toxicity score (WTS) is a metric suitable for comparing the toxicity burden in experimental versus control arms of randomized controlled trials (RCTs). When paired with clinical endpoints, the WTS offers a framework to evaluate the toxicity-benefit profile of anti-cancer agents. This study applied the WTS to phase III advanced prostate cancer (PC) clinical trials.

Design

Select phase III PC RCTs with adverse event (AE) data were compiled. The WTS was calculated for each trial arm using 2 approaches: (1) all AEs (A-WTS) and (2) symptomatic AEs (S-WTS). Percent change in WTS between trial arms quantified the toxicity burden, while hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) were used to assess efficacy.

Results

SUBMITTER: Gill JK 

PROVIDER: S-EPMC12517751 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature