The purpose of this study was to evaluate ¹⁸F-FDG PET/CT scanning as an early predictor of response to immune checkpoint inhibitors (ICIs) in patients with advanced melanoma. Methods: Twenty patients with advanced melanoma receiving ICI prospectively underwent ¹⁸F-FDG PET/CT at 3 scan intervals: before treatment initiation (SCAN-1), at days 21–28 (SCAN-2), and at 4 mo (SCAN-3). This study was approved by the institutional review board, and informed consent was received from all patients who were enrolled between April 2012 and December 2013. Tumor response at each posttreatment time point was assessed according to RECIST 1.1, immune-related response criteria, PERCIST (PERCIST 1.0), and European Organization for Research and Treatment of Cancer (EORTC) criteria. Performance characteristics of each metric to predict best overall response (BOR) at ≥ 4 mo were assessed. Results: Twenty evaluable patients were treated with ipilimumab (n = 16), BMS-936559 (n = 3), or nivolumab (n = 1). BOR at ≥ 4 mo included complete response (n = 2), partial response (n = 2), stable disease (n = 1), and progressive disease (n = 15). Response evaluations at SCAN-2 using RECIST 1.1, immune-related response criteria, PERCIST, and EORTC criteria demonstrated accuracies of 75%, 70%, 70%, and 65%, respectively, to predict BOR at ≥ 4 mo. Interestingly, the optimal PERCIST and EORTC threshold values at SCAN-2 to predict BOR were >15.5% and >14.7%, respectively. By combining anatomic and functional imaging data collected at SCAN-2, we developed criteria to predict eventual response to ICI with 100% sensitivity, 93% specificity, and 95% accuracy. Conclusion: Combining functional and anatomic imaging parameters from ¹⁸F-FDG PET/CT scans performed early in ICI appears predictive for eventual response in patients with advanced melanoma. These findings require validation in larger cohorts.

这项研究的目的是评估¹⁸ F-FDG PET / CT扫描作为晚期黑色素瘤患者对免疫检查点抑制剂（ICIs）反应的早期预测指标。方法：前瞻性接受ICI的20例晚期黑色素瘤患者接受了¹⁸F-FDG PET / CT的扫描间隔为3个扫描间隔：治疗开始前（SCAN-1），第21-28天（SCAN-2）和4 mo（SCAN-3）。这项研究已获得机构审查委员会的批准，并在2012年4月至2013年12月之间接受了所有患者的知情同意。根据RECIST 1.1，免疫相关反应标准，PERCIST（ PERCIST 1.0）和欧洲癌症研究与治疗组织（EORTC）标准。评估了用于预测≥4 mo的最佳总体响应（BOR）的每个指标的性能特征。结果： 20例可评估患者接受了ipilimumab（n = 16），BMS-936559（n = 3）或nivolumab（n= 1）。≥4 mo的BOR包括完全缓解（n = 2），部分缓解（n = 2），稳定疾病（n = 1）和进行性疾病（n = 15）。使用RECIST 1.1，免疫相关反应标准，PERCIST和EORTC标准在SCAN-2上进行的反应评估表明，预测BOR≥4 mo的准确度分别为75％，70％，70％和65％。有趣的是，在SCAN-2上预测BOR的最佳PERCIST和EORTC阈值分别> 15.5％和> 14.7％。通过结合在SCAN-2处收集的解剖和功能成像数据，我们制定了预测对ICI的最终反应的标准，灵敏度为100％，特异性为93％，准确度为95％。结论：在ICI早期进行^18次F-FDG PET / CT扫描的功能和解剖学成像参数的组合，似乎可以预测晚期黑色素瘤患者的最终反应。这些发现需要在更大的队列中进行验证。