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.
背景：晚期子宫内膜癌与不良生存预后相关。随着分子分型及新型全身疗法（包括免疫治疗和靶向药物）的出现，治疗方案日趋复杂。尽管这些治疗手段旨在提高生存率，但也可能带来长期毒性和治疗负担，因此将健康相关生活质量（HRQoL）和患者报告结局（PROs）纳入临床试验至关重要。
方法：本研究对ClinicalTrials.gov注册并截至2025年11月30日发表的、评估全身治疗的晚期、复发性或转移性子宫内膜癌III期随机对照试验进行了系统综述。提取的数据包括研究特征、HRQoL评估工具、报告形式、对CONSORT-PRO声明的遵循情况，以及HRQoL结果的发表时间（相对于主要疗效报告）。
结果：共纳入2020年至2024年间发表的8项III期随机对照试验。虽然HRQoL均被列为次要终点，但在关键疗效出版物中的报告十分有限。大多数报告使用EORTC QLQ-C30、QLQ-EN24和EQ-5D-5L量表呈现了相对于基线的平均变化。所有主要报告均未报告至恶化时间分析或患者改善/恶化的比例。对CONSORT-PRO声明的遵循程度较低，仅少数条目得到满足。专门的生活质量出版物在主要疗效报告发布后延迟长达25个月，且通常发表于影响因子较低的期刊。
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