Abstract：
We examined data from US Veterans with prostate cancer (PC) to assess disease response to immune checkpoint inhibitors (ICI) as monotherapy or combined with abiraterone or enzalutamide to assess ICI efficacy in the real-world. We queried the VA corporate data warehouse (CDW) to identify Veterans with a diagnosis of PC who received ICI for any malignancy and had ≥1 PSA measurement while receiving ICI. To evaluate ICI monotherapy, we restricted analysis to Veterans who had not received LHRH agonists/antagonists, PC-directed medical therapy, or radiation/extirpative surgery of the bladder/prostate within and preceding the duration of ICI administration. For ICI combination analysis, we identified Veterans who received abiraterone or enzalutamide for PC while on ICI. We calculated rates of tumor (PSA) growth (g-rates), comparing them to a 1:2 matched reference cohort. We identified 787 Veterans with PC and ≥1 PSA measurement while receiving an ICI. Median duration of ICI therapy was 155 days. 223 Veterans received ICI monotherapy, with only 17(8%) having a reduction in PSA (median decline = 43%). 12 (5%) had PSA declines >30% (PSA30) which included 6 (3%) who had PSA reductions greater than 50% (PSA50). Median g-rates for ICI plus abiraterone (n = 20) or enzalutamide (n = 31) were 0.000689/d-1 and 0.002819/d-1, respectively, and were statistically insignificant compared to g-rates of matched cohorts receiving abiraterone (g = 0.000925/d-1, P = 0.73) or enzalutamide (g = 0.001929/d-1, P = 0.58) alone. Our data align with clinical trial data in PC, demonstrating limited benefit from ICI monotherapy and predicting no survival benefit from simultaneous abiraterone or enzalutamide with an ICI using g-rate.
摘要：
我们检查了美国退伍军人前列腺癌（PC）的数据，以评估疾病对免疫检查点抑制剂（ICI）的单药治疗或与阿比特龙或恩扎鲁他胺联合治疗的反应，以评估现实世界中的ICI疗效。我们查询了VA公司数据仓库（CDW），以识别诊断为PC的退伍军人，这些退伍军人因任何恶性肿瘤而接受ICI，并且在接受ICI时PSA测量≥1。为了评估ICI单一疗法，我们限制分析未接受LHRH激动剂/拮抗剂的退伍军人，PC指导的药物治疗，或在ICI给药持续时间内和之前对膀胱/前列腺进行放射/摘除术。对于ICI组合分析，我们确定了在ICI期间接受阿比特龙或恩扎鲁他胺治疗PC的退伍军人.我们计算了肿瘤(PSA)增长率(g-rates)，将它们与1:2匹配的参考队列进行比较。我们确定了787名退伍军人在接受ICI时接受PC和≥1PSA测量。ICI治疗的中位持续时间为155天。223名退伍军人接受ICI单一疗法，只有17人（8%）PSA下降（中位数下降=43%）。12例(5%)PSA下降>30%(PSA30),其中包括6例(3%)PSA下降大于50%(PSA50)。ICI加阿比特龙（n=20）或恩杂鲁胺（n=31）的中位数g率分别为0.000689/d-1和0.002819/d-1，与仅接受阿比特龙(g=0.000925/d-1,P=0.73)或恩杂鲁胺(g=0.001929/d-1,P=0.58)的匹配队列的g-率相比,差异无统计学意义.我们的数据与PC中的临床试验数据一致，显示ICI单药治疗的获益有限，并预测阿比曲酮或恩扎鲁他胺与使用g率的ICI同时无生存获益。
