EGFR靶向荧光分子成像用于术中切缘评估——一项II期试验。
EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial.
发表日期：2023 Aug 16
作者：
Jaron G de Wit, Jasper Vonk, Floris J Voskuil, Sebastiaan A H J de Visscher, Kees-Pieter Schepman, Wouter T R Hooghiemstra, Matthijs D Linssen, Sjoerd G Elias, Gyorgy B Halmos, Boudewijn E C Plaat, Jan J Doff, Eben L Rosenthal, Dominic Robinson, Bert van der Vegt, Wouter B Nagengast, Gooitzen M van Dam, Max J H Witjes
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要：
口腔鳞状细胞癌手术中常见出现不足的切口余量。荧光分子成像（FMI）已被用于术中余量评估，但数据仅限于一期研究。在这个单臂二期研究（NCT03134846）中，我们的主要终点是确定西妥昔单抗-800CW对于肿瘤阳性余量检测的敏感性、特异性和阳性预测值。次要终点是安全性、近切口检测率和固有的西妥昔单抗-800CW荧光。在65例患者的66个肿瘤中，西妥昔单抗-800CW耐受性良好。在信号背景比（SBR）≥2的手术余量中检测到的荧光点具有100％的敏感性、85.9％的特异性、58.3％的阳性预测值和100％的阴性预测值，可确定阳性余量。在SBR≥1.5的情况下，可检测到70.3％的近切口，特异性为76.1％，阳性预测值为60.5％，阴性预测值为83.1％。对SBR≥1.5的荧光点进行冰冻切片分析，可以安全地进行术中调整手术余量。© 2023. Springer Nature Limited.
Inadequate surgical margins occur frequently in oral squamous cell carcinoma surgery. Fluorescence molecular imaging (FMI) has been explored for intraoperative margin assessment, but data are limited to phase-I studies. In this single-arm phase-II study (NCT03134846), our primary endpoints were to determine the sensitivity, specificity and positive predictive value of cetuximab-800CW for tumor-positive margins detection. Secondary endpoints were safety, close margin detection rate and intrinsic cetuximab-800CW fluorescence. In 65 patients with 66 tumors, cetuximab-800CW was well-tolerated. Fluorescent spots identified in the surgical margin with signal-to-background ratios (SBR) of ≥2 identify tumor-positive margins with 100% sensitivity, 85.9% specificity, 58.3% positive predictive value, and 100% negative predictive value. An SBR of ≥1.5 identifies close margins with 70.3% sensitivity, 76.1% specificity, 60.5% positive predictive value, and 83.1% negative predictive value. Performing frozen section analysis aimed at the fluorescent spots with an SBR of ≥1.5 enables safe, intraoperative adjustment of surgical margins.© 2023. Springer Nature Limited.