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Background <p>Denosumab, a bone-modifying agent, reduces the incidence of skeletal-related events (SREs), but its optimal use in real-world metastatic castration-resistant prostate cancer (mCRPC) settings remains unclear.</p> Methods <p>We conducted a retrospective cohort study of 235 patients with bone mCRPC treated with denosumab between 2015 and 2024. The primary endpoint was identification of risk factors associated with symptomatic skeletal events (SSEs) after denosumab initiation. Secondary endpoints were risk factors for SREs occurring prior to denosumab. Multivariate Cox regression analyses assessed independent predictors.</p> Results <p>Over a median follow-up of 11&#xa0;months, 27 patients (11.5%) developed an SSE. The most common events were EBRT to bone (7.7%) and pathologic fractures (4.3%). The 2-year SSE-free survival rate was 79.4%. A prior history of SREs was independently associated with a significantly increased risk of subsequent SSEs (hazard ratio [HR]: 2.09; 95% confidence interval: 1.02–4.92; p = 0.047). In a separate analysis of SREs occurring prior to denosumab, grade 2 and ≥ 3 disease at the time of bone metastasis diagnosis were associated with higher risk (HR: 2.62 and 2.32, respectively; both p &lt; 0.05). Denosumab was discontinued in 62.6% of patients, primarily due to clinical deterioration, death, or difficulty attending appointments.</p> Conclusion <p>In this real-world study, approximately 10% of patients with bone mCRPC developed SSEs during denosumab therapy, mostly within the first year. A prior SRE and high baseline bone tumor burden were significant predictors of skeletal complications, underscoring the importance of early risk stratification and timely initiation of bone-targeted therapies.</p>

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Clinical profiles and predictors of symptomatic skeletal events in patients with metastatic castration-resistant prostate cancer receiving denosumab

  • 期刊论文

  • 发表日期：

    2025年12月9日

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  • Mana Nakata,
  • Fumihiko Urabe,
  • Yu Imai,
  • Kosuke Iwatani,
  • Yuzo Inaba,
  • Juria Nakano,
  • Kensuke Fujiwara,
  • Masaki Hashimoto,
  • Yuhei Koike,
  • Yuya Iwamoto,
  • Shuhei Hara,
  • Keiichiro Miyajima,
  • Wataru Fukuokaya,
  • Mahito Atsuta,
  • Kagenori Ito,
  • Keiichiro Mori,
  • Takafumi Yanagisawa,
  • Masaya Murakami,
  • Kojiro Tashiro,
  • Shunsuke Tsuzuki,
  • Masato Yamaguchi,
  • Tatsuya Shimomura,
  • Jun Miki,
  • Takahiro Kimura

摘要

Background

Denosumab, a bone-modifying agent, reduces the incidence of skeletal-related events (SREs), but its optimal use in real-world metastatic castration-resistant prostate cancer (mCRPC) settings remains unclear.

Methods

We conducted a retrospective cohort study of 235 patients with bone mCRPC treated with denosumab between 2015 and 2024. The primary endpoint was identification of risk factors associated with symptomatic skeletal events (SSEs) after denosumab initiation. Secondary endpoints were risk factors for SREs occurring prior to denosumab. Multivariate Cox regression analyses assessed independent predictors.

Results

Over a median follow-up of 11 months, 27 patients (11.5%) developed an SSE. The most common events were EBRT to bone (7.7%) and pathologic fractures (4.3%). The 2-year SSE-free survival rate was 79.4%. A prior history of SREs was independently associated with a significantly increased risk of subsequent SSEs (hazard ratio [HR]: 2.09; 95% confidence interval: 1.02–4.92; p = 0.047). In a separate analysis of SREs occurring prior to denosumab, grade 2 and ≥ 3 disease at the time of bone metastasis diagnosis were associated with higher risk (HR: 2.62 and 2.32, respectively; both p < 0.05). Denosumab was discontinued in 62.6% of patients, primarily due to clinical deterioration, death, or difficulty attending appointments.

Conclusion

In this real-world study, approximately 10% of patients with bone mCRPC developed SSEs during denosumab therapy, mostly within the first year. A prior SRE and high baseline bone tumor burden were significant predictors of skeletal complications, underscoring the importance of early risk stratification and timely initiation of bone-targeted therapies.