Quantitative bone scan lesion area as an early surrogate outcome measure indicative of overall survival in metastatic prostate cancer.
Quantitative bone scan lesion area as an early surrogate outcome measure indicative of overall survival in metastatic prostate cancer.
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DOI：
10.1117/1.jmi.5.1.011017
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发表时间：
2018-01
期刊：
影响因子：
--
通讯作者：
Goldin JG
中科院分区：
文献类型：
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作者：
Brown MS;Kim GHJ;Chu GH;Ramakrishna B;Allen-Auerbach M;Fischer CP;Levine B;Gupta PK;Schiepers CW;Goldin JG
骨扫描病变区域（BSLA）作为转移性去势抵抗性前列腺癌（mCRPC）的定量成像生物标志物进行了临床验证。BSLA通过基线和治疗后第12周的198名mCRPC受试者（127名治疗组和71名安慰剂组）的全身骨显像计算，这些受试者来自一项临床试验，涉及与初始生物标志物开发不同的药物。BSLA计算包括自动图像归一化、病灶分割以及骨扫描AP和PA视图上分割病灶总面积的总和，作为肿瘤负荷的度量。作为一项预测性生物标志物，基线BSLA治疗的受试者比基线BSLA较高（和）的患者生存时间更长。作为替代结果的生物标志物，如果BSLA从基线到第12周增加了预先规定的30%或更多，则受试者被归类为进行性疾病（PD），否则归类为非PD。PD组和非PD组的总生存率有统计学差异（和）。在第12周没有PD的受试者比PD患者的生存时间更长：中位398天对280天。BSLA现已被证明是不同前列腺癌药物治疗中总生存率的早期替代结果。
A clinical validation of the bone scan lesion area (BSLA) as a quantitative imaging biomarker was performed in metastatic castration-resistant prostate cancer (mCRPC). BSLA was computed from whole-body bone scintigraphy at baseline and week 12 posttreatment in a cohort of 198 mCRPC subjects (127 treated and 71 placebo) from a clinical trial involving a different drug from the initial biomarker development. BSLA computation involved automated image normalization, lesion segmentation, and summation of the total area of segmented lesions on bone scan AP and PA views as a measure of tumor burden. As a predictive biomarker, treated subjects with baseline BSLA had longer survival than those with higher BSLA ( and ). As a surrogate outcome biomarker, subjects were categorized as progressive disease (PD) if the BSLA increased by a prespecified 30% or more from baseline to week 12 and non-PD otherwise. Overall survival rates between PD and non-PD groups were statistically different ( and ). Subjects without PD at week 12 had longer survival than subjects with PD: median 398 days versus 280 days. BSLA has now been demonstrated to be an early surrogate outcome for overall survival in different prostate cancer drug treatments.