Abstract：
BACKGROUND: This retrospective observational study explored the therapeutic potential of combined androgen blockade (CAB) with bicalutamide (Bic-CAB) as an initial treatment for metastatic hormone-sensitive prostate cancer (mHSPC) in Japan.
METHODS: The electronic health records of 159 patients with mHSPC from three Japanese institutions who received initial treatment with Bic-CAB between 2007 and 2017 were analyzed. The time to prostate-specific antigen (PSA) progression, duration of Bic-CAB treatment, and overall survival (OS), with various definitions for PSA progression, were assessed. A multivariate Cox proportional hazards model was constructed using clinical parameters to predict time to the end of Bic-CAB treatment and OS.
RESULTS: The median observation period was 46.4 months, and the median age of patients at diagnosis was 71 years. A total of 46.5% patients experienced PSA progression with a median survival duration of 29 months (according to Prostate Cancer Clinical Trials Working Group 3 criteria), and 49.1% patients achieved a PSA nadir < 0.2 ng/mL in a median time of 4.7 months. When stratified by PSA nadir and PSA change, patients at low risk for disease progression with a small PSA change due to low initial PSA had a 5-year OS of 100% and a 10-year OS of 75%. The OS during the observation period was 72.9 months.
CONCLUSIONS: These findings highlight the potential effect of Bic-CAB in patients with mHSPC who were at low risk for disease progression. Initial treatment with Bic-CAB and adjusting treatment early based on PSA dynamics may be a reasonable treatment plan for these patients.
METHODS: The electronic health records of 159 patients with mHSPC from three Japanese institutions who received initial treatment with Bic-CAB between 2007 and 2017 were analyzed. The time to prostate-specific antigen (PSA) progression, duration of Bic-CAB treatment, and overall survival (OS), with various definitions for PSA progression, were assessed. A multivariate Cox proportional hazards model was constructed using clinical parameters to predict time to the end of Bic-CAB treatment and OS.
RESULTS: The median observation period was 46.4 months, and the median age of patients at diagnosis was 71 years. A total of 46.5% patients experienced PSA progression with a median survival duration of 29 months (according to Prostate Cancer Clinical Trials Working Group 3 criteria), and 49.1% patients achieved a PSA nadir < 0.2 ng/mL in a median time of 4.7 months. When stratified by PSA nadir and PSA change, patients at low risk for disease progression with a small PSA change due to low initial PSA had a 5-year OS of 100% and a 10-year OS of 75%. The OS during the observation period was 72.9 months.
CONCLUSIONS: These findings highlight the potential effect of Bic-CAB in patients with mHSPC who were at low risk for disease progression. Initial treatment with Bic-CAB and adjusting treatment early based on PSA dynamics may be a reasonable treatment plan for these patients.
摘要：
背景：这项回顾性观察性研究探索了雄激素阻断（CAB）与比卡鲁胺（Bic-CAB）联合作为日本转移性激素敏感性前列腺癌（mHSPC）的初始治疗的治疗潜力。
方法：分析了2007年至2017年间来自三个日本机构接受Bic-CAB初始治疗的159例mHSPC患者的电子健康记录。前列腺特异性抗原（PSA）进展的时间，Bic-CAB治疗的持续时间，和总生存率（OS），对PSA进展有不同的定义，被评估。使用临床参数构建多变量Cox比例风险模型来预测Bic-CAB治疗结束时间和OS。
结果：中位观察期为46.4个月，诊断时患者的中位年龄为71岁.46.5％的患者出现PSA进展，中位生存期为29个月（根据前列腺癌临床试验工作组3标准）。49.1%患者的PSA最低点<0.2ng/mL,中位时间为4.7个月.当按PSA最低点和PSA变化分层时，由于初始PSA较低,PSA变化较小,疾病进展风险较低的患者的5年OS为100%,10年OS为75%.观察期间的OS为72.9个月。
结论：这些发现强调了Bic-CAB对疾病进展风险较低的mHSPC患者的潜在作用。Bic-CAB的初始治疗和基于PSA动力学的早期调整治疗可能是这些患者的合理治疗方案。
方法：分析了2007年至2017年间来自三个日本机构接受Bic-CAB初始治疗的159例mHSPC患者的电子健康记录。前列腺特异性抗原（PSA）进展的时间，Bic-CAB治疗的持续时间，和总生存率（OS），对PSA进展有不同的定义，被评估。使用临床参数构建多变量Cox比例风险模型来预测Bic-CAB治疗结束时间和OS。
结果：中位观察期为46.4个月，诊断时患者的中位年龄为71岁.46.5％的患者出现PSA进展，中位生存期为29个月（根据前列腺癌临床试验工作组3标准）。49.1%患者的PSA最低点<0.2ng/mL,中位时间为4.7个月.当按PSA最低点和PSA变化分层时，由于初始PSA较低,PSA变化较小,疾病进展风险较低的患者的5年OS为100%,10年OS为75%.观察期间的OS为72.9个月。
结论：这些发现强调了Bic-CAB对疾病进展风险较低的mHSPC患者的潜在作用。Bic-CAB的初始治疗和基于PSA动力学的早期调整治疗可能是这些患者的合理治疗方案。
