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Background <p>Recently published phase III clinical trials documented that darolutamide could improve the prognosis of patients with metastatic hormone-sensitive prostate cancer (mHSPC). This meta-analysis aims to assess the efficacy of darolutamide in mHSPC based on subgroups and reconstructed individual-level data.</p> Methods <p>Literature was searched using PubMed, Embase, Cochrane Library and ClinicalTrials.gov. The primary outcome was overall survival (OS), while the secondary outcomes included risk to castration-resistant prostate cancer (CRPC) and adverse event. The risk ratio (RR) with 95% confidence interval (CI) was selected as effect size. Survival analysis was performed using Kaplan-Meier method and Cox hazards model based on the reconstructed individual patient data (IPD). Z test and Bonferroni correction were applied for the comparison between subgroups. <i>I</i><sup><i>2</i></sup> ≤ 50% was regarded as low heterogeneity.</p> Results <p>The data of 1974 patients from two III phase trials, ARASENS and ARANOTE, were analyzed. For 1-year OS, the risk of death was 0.56 (95% CI: 0.41–0.78) in the darolutamide group comparing with the placebo group. The risk of death were 0.76 (95% CI: 0.64–0.91) and 0.75 (95% CI: 0.67–0.85) in the darolutamide group for 2-year OS and 3-year OS respectively. Darolutamide also decreased the risk of progression to CRPC within 3 years. Moreover, darolutamide demonstrated consistent OS benefits across different subgroups stratified by demographic and clinical characteristics with acceptable safety profile. Survival analyses demonstrated darolutamide improved OS and delayed disease progression even after adjusting for background therapy.</p> Conclusions <p>Darolutamide provides survival benefits and postpones the progression from mHSPC to the castration-resistant phase. The consistent efficacy across subgroups suggest that darolutamide could be a promising addition to combination therapy for mHSPC. Further investigation using original IPD is warranted to confirm these findings.</p>

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Assessing the efficacy of darolutamide in metastatic hormone-sensitive prostate cancer based on subgroup meta-analysis and reconstructed individual patient data

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月5日

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  • Fuxun Zhang,
  • Zhirong Luo,
  • Qi Xue,
  • Xuyan Guo,
  • Qiang Fu,
  • Wei Zhang,
  • Yang Xiong,
  • Pati-Alam Alisha,
  • Uzoamaka Adaobi Okoli,
  • Geng Zhang,
  • Yong Jiao

摘要

Background

Recently published phase III clinical trials documented that darolutamide could improve the prognosis of patients with metastatic hormone-sensitive prostate cancer (mHSPC). This meta-analysis aims to assess the efficacy of darolutamide in mHSPC based on subgroups and reconstructed individual-level data.

Methods

Literature was searched using PubMed, Embase, Cochrane Library and ClinicalTrials.gov. The primary outcome was overall survival (OS), while the secondary outcomes included risk to castration-resistant prostate cancer (CRPC) and adverse event. The risk ratio (RR) with 95% confidence interval (CI) was selected as effect size. Survival analysis was performed using Kaplan-Meier method and Cox hazards model based on the reconstructed individual patient data (IPD). Z test and Bonferroni correction were applied for the comparison between subgroups. I2 ≤ 50% was regarded as low heterogeneity.

Results

The data of 1974 patients from two III phase trials, ARASENS and ARANOTE, were analyzed. For 1-year OS, the risk of death was 0.56 (95% CI: 0.41–0.78) in the darolutamide group comparing with the placebo group. The risk of death were 0.76 (95% CI: 0.64–0.91) and 0.75 (95% CI: 0.67–0.85) in the darolutamide group for 2-year OS and 3-year OS respectively. Darolutamide also decreased the risk of progression to CRPC within 3 years. Moreover, darolutamide demonstrated consistent OS benefits across different subgroups stratified by demographic and clinical characteristics with acceptable safety profile. Survival analyses demonstrated darolutamide improved OS and delayed disease progression even after adjusting for background therapy.

Conclusions

Darolutamide provides survival benefits and postpones the progression from mHSPC to the castration-resistant phase. The consistent efficacy across subgroups suggest that darolutamide could be a promising addition to combination therapy for mHSPC. Further investigation using original IPD is warranted to confirm these findings.