於轉移性攝護腺癌病人使用Denosumab之臨床效果分析-觀察性研究

吳敏瑞、卓育慶、蒙恩、楊明昕

國防醫學院三軍總醫院外科部泌尿外科

Clinical effect of Denosumab in Metastatic Castration Resistant Prostate Cancer – Retrospective observational Study

Min-Jui, Wu, Yu-Ching Jhuo, En Meng, Ming‐ Hsin Yang

Division of Urology, Department of Surgery

Tri-Service General Hospital, National Defense Medical Center

Purpose    

Denosumab reduces the risk of skeletal-related events (SRE) in men with men with castration- resistant prostate cancer (mCRPC). However, it is still controversial about the survival benefit of denosumab in mCRPC patients. This retrospective study evaluates the effect of denosumab in mCRPC patients in an Asian real-world cohort.

Material and methods

Patients with mCRPC were retrospectively collected at Tri-Service General Hospital, Taipei, Taiwan. Patient characteristics, treatment patterns, SREs, and AEs were analyzed. Descriptive statistics showed baseline characteristics, SRE rates and denosumab use. Comparisons between groups used independent t-tests and Chi-square analyses. SRE-free survival (SRE-FS), time to opiate use survival, PSA progression free survival (PSA-PFS), and overall survival (OS) calculated by the Kaplan-Meier method and log-rank test. A Cox proportional hazards regression model was used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for univariate and multivariate analyses to identify the factors of SRE-FS, time to opiate use survival, PSA-PFS, and OS

Results

This study included 268 mCRPC patients. 156 men were treated with denosumab. Denosumab significantly reduced the incidence of SRE (p = 0.0008). Denosumab treatment prolonged SRE-FS (p < 0.001), prolonged opioid consumption (p = 0.047), and better OS (p = 0.047). However, there was no significant difference between the two groups in PSA-PFS (p = 0.069). Multivariate analysis demonstrated that denosumab treatment was correlated with longer duration of SRE (HR = 0.243, 95% CI 0.126-0.471, p < 0.001), longer duration of opioid consumption (HR = 0.515 , 95% CI = 0.344-0.770, p = 0.001), better PSA-PFS (HR = 0.573, 95% CI = 0.384-0.854, p = 0.006) and superior OS (HR = 0.512, 95% CI =0.334-0.785, p=0.002).

Conclusion

In men with mCRPC, denosumab treatment was associated with a lower risk of SRE, longer duration of opioid use, and longer time to first onset of SRE. Additionally, denosumab also prolonged survival after PsA progression and overall survival.