Purpose To assess the standardized implementation and reporting of surveillance [18F]fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scan of the neck in locoregionally advanced head-and-neck squamous cell carcinoma (LAHNSCC) after concurrent chemoradiotherapy (CCRT). Patients and Methods We performed a prospective multicenter study of FDG-PET/CT scanning 12 weeks after CCRT in newly diagnosed patients with LAHNSCC (stage IVa/b) that used standardized reconstruction and Hopkins reporting criteria. The reference standard was histology or > 12 months of clinical follow-up. The primary outcome measure was the negative predictive value (NPV) of FDG-PET/CT scans and other supporting diagnostic test characteristics, including time dependency with increasing follow-up time. Results Of 152 patients, 125 had adequate primary tumor control after CCRT and entered follow-up (median, 20.4 months). Twenty-three (18.4%) had residual neck disease. Overall, NPV was 92.1% (95% CI, 86.9% to 95.3%; null hypothesis: NPV = 85%; P = .012) with sensitivity of 65.2% (95% CI, 44.9% to 81.2%), specificity of 91.2% (95% CI, 84.1% to 95.3%), positive predictive value of 62.5% (95% CI, 45.5% to 76.9%), and accuracy of 86.4% (95% CI, 79.3% to 91.3%). Sensitivity was time dependent and high for residual disease manifesting up to 9 months after imaging but lower (59.7%) for disease detected up to 12 months after imaging. Standardized reporting criteria reduced the number of equivocal reports (95% CI for the difference, 2.6% to 15.0%; P = .003). Test characteristics were not improved with the addition of lymph node CT morphology criteria. Conclusion FDG-PET/CT surveillance using Hopkins criteria 12 weeks after CCRT is reliable in LAHNSCC except for late manifesting residual disease, which may require an additional surveillance scan at 1 year after CCRT to be detected.

中文翻译：

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局部晚期头颈部鳞状细胞癌同步放化疗后氟脱氧葡萄糖-正电子发射断层扫描/计算机断层扫描：ECLYPS 研究

目的 评估同步放化疗后局部晚期头颈部鳞状细胞癌 (LAHNSCC) 颈部监测 [18F] 氟脱氧葡萄糖 - 正电子发射断层扫描/计算机断层扫描 (FDG-PET/CT) 扫描的标准化实施和报告。 CCRT）。患者和方法 我们使用标准化重建和霍普金斯报告标准对新诊断的 LAHNSCC 患者（IVa/b 期）在 CCRT 后 12 周进行了 FDG-PET/CT 扫描的前瞻性多中心研究。参考标准是组织学或 > 12 个月的临床随访。主要结果测量是 FDG-PET/CT 扫描的阴性预测值 (NPV) 和其他支持诊断测试特征，包括随随访时间增加的时间依赖性。结果 在 152 名患者中，125 人在 CCRT 后获得了足够的原发肿瘤控制并进入随访（中位数，20.4 个月）。23 人 (18.4%) 有残余颈部疾病。总体而言，NPV 为 92.1%（95% CI，86.9% 至 95.3%；零假设：NPV = 85%；P = .012），敏感性为 65.2%（95% CI，44.9% 至 81.2%），特异性为 91.2 %（95% CI，84.1% 至 95.3%），阳性预测值为 62.5%（95% CI，45.5% 至 76.9%），准确率为 86.4%（95% CI，79.3% 至 91.3%）。敏感性是时间依赖性的，对于成像后 9 个月内表现出的残留病灶具有高敏感性，但对于成像后 12 个月内检测到的疾病敏感性较低 (59.7%)。标准化报告标准减少了模棱两可的报告数量（差异的 95% CI，2.6% 至 15.0%；P = .003）。添加淋巴结 CT 形态标准并没有改善测试特征。