# Quality of Life Measures in Advanced Endometrial Cancer: A Systematic Review of Reporting Practices in Phase III Clinical Trials

## TL;DR

This paper reviews how quality of life is reported in clinical trials for advanced endometrial cancer and finds that reporting is inconsistent and often delayed.

## Contribution

The study systematically evaluates HRQoL reporting practices in phase III trials for advanced endometrial cancer, highlighting gaps in methodology and dissemination.

## Key findings

- HRQoL is often designated as a secondary endpoint but poorly reported in primary efficacy publications.
- Dedicated quality of life publications are delayed by up to 25 months after primary results.
- Low adherence to CONSORT-PRO guidelines was observed in most trials.

## Abstract

Recent progress in the management of advanced endometrial cancer, driven by molecular classification and the emergence of novel systemic therapies such as immunotherapy and targeted agents, has transformed the therapeutic landscape. Although these approaches aim to prolong survival, they can also lead to cumulative side effects and a considerable treatment burden. This highlights the importance of incorporating health-related quality of life (HRQoL) measures into clinical research. However, the collection and reporting of quality of life data in advanced endometrial cancer studies are often inconsistent, incomplete, or delayed, reducing their relevance for patient-centered decision-making. Timely, transparent, and methodologically robust evaluation and reporting of HRQoL outcomes are essential to contextualize clinical benefits, facilitate shared decision-making, and balance survival benefits with their real-world impact on patients’ daily lives in a rapidly evolving therapeutic landscape.

Background: Advanced endometrial cancer is associated with poor survival. With the advent of molecular classification and novel systemic therapies—including immunotherapy and targeted agents—treatment regimens have become increasingly complex. While these approaches aim to improve survival, they also potentially introduce long-term toxicities and treatment burden, reinforcing the importance of incorporating health-related quality of life (HRQoL) and patient-reported outcomes (PROs) into clinical trials. Methods: A systematic review was conducted of phase III randomized controlled trials (RCTs) in advanced, recurrent, or metastatic endometrial cancer evaluating systemic treatment registered on ClinicalTrials.gov and published up to 30 November 2025. Extracted data included study characteristics, HRQoL instruments, reporting formats, adherence to CONSORT-PRO, and timing of HRQoL dissemination (relative to primary efficacy reports). Results: Eight phase III RCTs published between 2020 and 2024 were included. Although HRQoL was consistently designated as a secondary endpoint, reporting within pivotal efficacy publications was limited. Most reports presented mean changes from baseline using the EORTC QLQ-C30, QLQ-EN24, and EQ-5D-5L. None of the primary reports reported time-to-deterioration analyses or the proportions of patients improving/deteriorating. Adherence to CONSORT-PRO was low, with only a minority of items addressed. Dedicated QoL publications were delayed by up to 25 months after primary efficacy reports and typically appeared in journals with lower impact factors. Conclusions: Despite routine inclusion of HRQoL measures in trial protocols, reporting remains inconsistent, limited in scope, and often delayed. Strengthening adherence to established frameworks is essential to ensure that HRQoL endpoints are predefined, analytically robust, and disseminated alongside efficacy data—particularly in a rapidly evolving therapeutic landscape.