A randomized trial comparing fluorocholine-PET/CT with conventional imaging in prostate cancer.
A randomized trial comparing fluorocholine-PET/CT with conventional imaging in prostate cancer.
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一项比较前列腺癌氟胆碱 PET/CT 与传统成像的随机试验。
DOI：
10.1200/jco.2019.37.7_suppl.2
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发表时间：
2019
影响因子：
45.3
通讯作者：
R. Hicks
中科院分区：
文献类型：
--
作者：
S. Williams;J. Beauregard;P. Roselt;K. Moody;R. Fisher;E. Drummond;R. Hicks
2背景：我们进行了一项随机试验，比较了18氟胆碱PET/CT（FCH）与计算机断层扫描（腹部和骨盆）加99 mTc全身骨扫描（常规成像[CIM]），以确定前列腺癌（PC）的成像性能。研究方法：这项前瞻性两组1：1随机试验招募了新诊断或生化复发PC的男性患者，接受CI m或FCH一线成像（FLI）。没有转移证据的参与者使用替代成像策略进行二线成像（SLI）。主要目的是确定FCH作为FLI方法在改变管理方面是否更有效。次要终点包括SLI的增量效用和基于无进展生存期（PFS）的阴性预测值（NPV）。澳大利亚新西兰临床试验注册中心ACTRN 12608000641392。结果：108名男性入组; 44%为新诊断的PC分期，中位随访时间为43个月。32.4%的男性（95% CI=23.7-42.1%）的临床管理受到影像学影响，其中大多数为FLI（n=30）。FCH病例中有27.8%（95% CI=16.5-41.6%）发生了高影响管理变化，而CI组中有11.1%（95% CI=4.2-22.6%）发生了高影响管理变化（p=0.032）。在98.1%（95%CI = 90.1-100%）的病例和92.6%（95%CI = 82.1-97.9%）的CIm病例中使用FCH得出最终管理计划（p=0.242）。在22.2%（95% CI = 12-35.6%）和16.7%（95% CI = 7.9-29.3%; p= 0.531）的CIm病例中，FLI伴FCH明确显示N1或M1疾病。TxN 0 M0期的总体NPV（来自所有成像）为26.3%（95% CI：13.9 - 41.2%），两组间无显著差异（p=0.9）。对于N1 M0病例，NPV为14.3%（95%CI：7.1 - 35.7%）。通过FCH识别N1 M0导致至识别疾病进展的时间更长，中位PFS为32个月（95% CI=2- 68个月），而在Cim N1 M0队列中为3个月（95% CI=1-16个月）（p=0.05）。结论：作为一线成像，FCH-PET/CT比CIM识别出更多的高临床影响病变。所有的影像学检查都不能很好地预测随后的疾病进展。孤立性淋巴结阳性的FCH患者复发时间较长，但复发率相似，提示存在提前期偏倚。临床试验信息：ACTRN 12608000641392。
2 Background: We conducted a randomised trial comparing 18Flourocholine-PET/CT (FCH) to Computed Tomography (abdomen and pelvis) plus 99mTc-Whole Body Bone Scan (Conventional Imaging [CIm]) to determine imaging performance in prostate cancer (PC). Methods: This prospective two-arm 1:1 randomised trial enrolled men with newly diagnosed or biochemically recurrent PC to first-line imaging (FLI) with either CIm or FCH. Participants without evidence of metastases proceeded to second-line imaging (SLI) using the alternative imaging strategy. The primary aim was to determine whether FCH was more effective as a FLI approach in changing management. Secondary endpoints included incremental utility of SLI and negative predictive value (NPV) based on progression-free survival (PFS). Australian New Zealand Clinical Trials Registry ACTRN12608000641392. Results: 108 men were enrolled; 44% were for staging of newly-diagnosed PC and median follow-up 43 months. Imaging impacted clinical management in 32.4% of men (95% CI=23.7-42.1%), mostly with FLI (n=30). High-impact management changes occurred in 27.8% (95% CI=16.5-41.6%) of FCH cases compared with 11.1% (95% CI=4.2-22.6%) in the CIm arm (p=0.032). The final management plan was derived using FCH in 98.1% (95% CI = 90.1-100%) of cases and 92.6% (95%CI = 82.1-97.9%) of CIm cases (p=0.242). FLI with FCH showed unequivocally N1 or M1 disease in 22.2% (95% CI = 12-35.6%), and 16.7% (95% CI = 7.9-29.3%; p= 0.531) of CIm cases. The overall NPV for stage TxN0M0 (from all imaging) was 26.3% (95% CI: 13.9 - 41.2%), with no significant difference between arms (p=0.9). For N1M0 cases, the NPV was 14.3% (95% CI: 7.1 - 35.7%). The identification of N1M0 by FCH resulted in a longer time to identification of progressive disease, with a median PFS of 32 months (95% CI=2-68months) compared with 3 months (95% CI=1-16 months) in the CIm N1M0 cohort (p=0.05). Conclusions: FCH-PET/CT identifies more high-clinical-impact lesions than CIm as first-line imaging. All imaging modalities were poor at predicting subsequent progressive disease. Isolated node-positive disease seen with FCH is associated with a longer time to - but similarly high rates of - recurrence, suggesting a lead-time bias. Clinical trial information: ACTRN12608000641392.