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Introduction <p>Disease-free survival (DFS) is commonly a primary endpoint in clinical trials of investigational therapies for early stage and/or high-risk endometrial cancer and may be indicative of therapeutic benefit prior to maturity of overall survival (OS) data; however, its role as a predictor of OS in high-risk endometrial cancer is unknown. Therefore, this study estimates the individual-level correlation between DFS and OS and the association between recurrent disease and OS in patients with high-risk endometrial cancer receiving adjuvant chemotherapy.</p> Methods <p>Medicare beneficiaries with high-risk endometrial cancer who underwent surgery followed by adjuvant chemotherapy were identified from Surveillance, Epidemiology, and End Results data (2007–2019). OS and DFS from adjuvant chemotherapy initiation were estimated by Kaplan–Meier (KM) analyses; correlation was evaluated using Kendall’s τ rank correlation. Multivariable Cox models were used to compare OS between recurrent and nonrecurrent patients at three landmark points and over the follow-up period.</p> Results <p>Among 771 patients, 250 (32.4%) experienced recurrence (median follow-up 3.6&#xa0;years). Median OS was not reached (5-year OS 72.7%); median DFS was 7.9&#xa0;years (5-year DFS 58.1%). A positive correlation between DFS and OS was observed [Kendall’s τ = 0.83; 95% confidence interval (CI) 0.79‒0.86; <i>p</i> &lt; 0.001]. Across landmark points, recurrent patients had 3.8–5.2-fold higher risk of mortality (all <i>p</i> &lt; 0.001). During follow-up, patients with recurrence had a higher risk of mortality than those without (hazard ratio 7.9; 95% CI 5.7‒10.8; <i>p</i> &lt; 0.001).</p> Conclusions <p>The findings of this study suggest that DFS may be a useful surrogate for OS in high-risk endometrial cancer, though validation in trial-level meta-analyses is needed, and highlight the substantial burden associated with recurrent disease, as evidenced by the four-fold to eight-fold higher risk of mortality across comparative assessments of OS. Effective novel therapies are needed to reduce the considerable burden of disease recurrence in this population.</p>

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Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月12日

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  • Kalé Kponee-Shovein,
  • Vimalanand S. Prabhu,
  • Yan Song,
  • Lei Chen,
  • Mu Cheng,
  • Yeran Li,
  • Yezhou Sun,
  • Annalise Hilts,
  • Qi Hua,
  • Jasmine Lichfield,
  • Linda Duska

摘要

Introduction

Disease-free survival (DFS) is commonly a primary endpoint in clinical trials of investigational therapies for early stage and/or high-risk endometrial cancer and may be indicative of therapeutic benefit prior to maturity of overall survival (OS) data; however, its role as a predictor of OS in high-risk endometrial cancer is unknown. Therefore, this study estimates the individual-level correlation between DFS and OS and the association between recurrent disease and OS in patients with high-risk endometrial cancer receiving adjuvant chemotherapy.

Methods

Medicare beneficiaries with high-risk endometrial cancer who underwent surgery followed by adjuvant chemotherapy were identified from Surveillance, Epidemiology, and End Results data (2007–2019). OS and DFS from adjuvant chemotherapy initiation were estimated by Kaplan–Meier (KM) analyses; correlation was evaluated using Kendall’s τ rank correlation. Multivariable Cox models were used to compare OS between recurrent and nonrecurrent patients at three landmark points and over the follow-up period.

Results

Among 771 patients, 250 (32.4%) experienced recurrence (median follow-up 3.6 years). Median OS was not reached (5-year OS 72.7%); median DFS was 7.9 years (5-year DFS 58.1%). A positive correlation between DFS and OS was observed [Kendall’s τ = 0.83; 95% confidence interval (CI) 0.79‒0.86; p < 0.001]. Across landmark points, recurrent patients had 3.8–5.2-fold higher risk of mortality (all p < 0.001). During follow-up, patients with recurrence had a higher risk of mortality than those without (hazard ratio 7.9; 95% CI 5.7‒10.8; p < 0.001).

Conclusions

The findings of this study suggest that DFS may be a useful surrogate for OS in high-risk endometrial cancer, though validation in trial-level meta-analyses is needed, and highlight the substantial burden associated with recurrent disease, as evidenced by the four-fold to eight-fold higher risk of mortality across comparative assessments of OS. Effective novel therapies are needed to reduce the considerable burden of disease recurrence in this population.