International journal of clinical oncology · 2025
Clinical profiles and predictors of symptomatic skeletal events in patients with metastatic castration-resistant prostate cancer receiving denosumab.
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Nakata Mana, Urabe Fumihiko, Imai Yu, Iwatani Kosuke, Inaba Yuzo, Nakano Juria, Fujiwara Kensuke, Hashimoto Masaki, Koike Yuhei, Iwamoto Yuya, Hara Shuhei, Miyajima Keiichiro, Fukuokaya Wataru, Atsuta Mahito, Ito Kagenori, Mori Keiichiro, Yanagisawa Takafumi, Murakami Masaya, Tashiro Kojiro, Tsuzuki Shunsuke, Yamaguchi Masato, Shimomura Tatsuya, Miki Jun, Kimura Takahiro, JIKEI-YAYOI Collaborative Group
Аннотация
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.
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.