David Mankoff, Soňa Balogová, Lisa Dunnwald, Farrokh Dehdashti, Erik DeVries, Laura Evangelista, Michel Van Krutchen, Sofia Carrilho Vaz, Amy Fowler, Hannah Linden, Gary A. Ulaner
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The ER-targeting imaging agent 16α-[<sup>18</sup>F]fluoro-17β-estradiol ([<sup>18</sup>F]FES) is approved for clinical use by regulatory agencies in France and the United States. Multiple studies suggest the advantages of [<sup>18</sup>F]FES PET in assessing tumor ER expression, the ability of both qualitative and quantitative [<sup>18</sup>F]FES PET measures to predict response to ER-targeted therapy, and the ability of [<sup>18</sup>F]FES PET to clarify equivocal staging and restaging results in patients with ER-expressing cancers. [<sup>18</sup>F]FES PET/CT may also be helpful in staging invasive lobular breast cancer and low-grade ER-expressing invasive ductal cancers and, in some cases, may be a substitute for biopsy. The Society of Nuclear Medicine and Molecular Imaging and the European Association of Nuclear Medicine in June 2023 released a procedure standard/practice guideline for [<sup>18</sup>F]FES PET ER imaging of patients with breast cancer. The goal of the standard/guideline is to assist physicians in recommending, performing, interpreting, and reporting the results of [<sup>18</sup>F]FES PET studies for patients with breast cancer and to provide clinicians with the best available evidence, inform them about areas where robust evidence is lacking, and help them deliver the best possible diagnostic efficacy and study quality for their patients. Also reviewed are standardized quality control, quality assurance, and imaging procedures for [<sup>18</sup>F]FES PET. The authors emphasize the importance of precision, accuracy, repeatability, and reproducibility for both clinical management of patients and for use of [<sup>18</sup>F]FES PET in multicenter trials. A standardized imaging procedure, in combination with already published appropriate-use criteria, will help promote the use of [<sup>18</sup>F]FES PET and enhance subsequent research. 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引用次数: 0
摘要
雌激素受体(ER)是一种对女性生理非常重要的类固醇激素受体,是乳腺癌发生和发展的重要因素,因此也是重要的治疗靶点。大约 70% 的乳腺癌在发病时会表达 ER,通过组织检测(通常是免疫组化法)确定 ER 表达是新诊断乳腺癌标准治疗的一部分。ER表达对于指导治疗方法非常重要,尤其是随着相关系统疗法的增加。ER靶向成像剂16α-[18F]氟-17β-雌二醇([18F]FES)已获法国和美国监管机构批准用于临床。多项研究表明,[18F]FES PET 在评估肿瘤 ER 表达方面具有优势,[18F]FES PET 的定性和定量指标都能预测 ER 靶向治疗的反应,[18F]FES PET 还能澄清 ER 表达癌症患者不明确的分期和重新分期结果。[18F]FES PET/CT 还有助于对浸润性小叶乳腺癌和低级别表达 ER 的浸润性导管癌进行分期,在某些情况下可替代活组织检查。2023 年 6 月,核医学与分子成像学会和欧洲核医学协会发布了乳腺癌患者[18F]FES PET ER 成像的程序标准/实践指南。该标准/指南的目标是协助医生推荐、执行、解释和报告乳腺癌患者的[18F]FES PET 研究结果,并为临床医生提供现有的最佳证据,告知他们缺乏有力证据的领域,帮助他们为患者提供最佳的诊断效果和研究质量。此外,还回顾了[18F]FES PET 的标准化质量控制、质量保证和成像程序。作者强调了精确性、准确性、可重复性和可再现性对患者临床管理和在多中心试验中使用[18F]FES PET的重要性。标准化成像程序与已公布的适当使用标准相结合,将有助于促进[18F]FES PET 的使用并加强后续研究。本文简要回顾了联合标准/指南的内容,全文可在 https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=6414&navItemNumbe=10790 上查阅。
Summary: SNMMI Procedure Standard/EANM Practice Guideline for Estrogen Receptor Imaging of Patients with Breast Cancer Using 16α-[18F]Fluoro-17β-Estradiol PET
The estrogen receptor (ER), a steroid hormone receptor important in female physiology, is a significant contributor to breast carcinogenesis and progression and, as such, is an important therapeutic target. Approximately 70% of breast cancers will express ER at presentation, and the determination of ER expression by tissue assay, usually by immunohistochemistry, is part of the standard of care for newly diagnosed breast cancer. ER expression is important in guiding the approach to treatment, especially with the increase in relevant systemic therapies. The ER-targeting imaging agent 16α-[18F]fluoro-17β-estradiol ([18F]FES) is approved for clinical use by regulatory agencies in France and the United States. Multiple studies suggest the advantages of [18F]FES PET in assessing tumor ER expression, the ability of both qualitative and quantitative [18F]FES PET measures to predict response to ER-targeted therapy, and the ability of [18F]FES PET to clarify equivocal staging and restaging results in patients with ER-expressing cancers. [18F]FES PET/CT may also be helpful in staging invasive lobular breast cancer and low-grade ER-expressing invasive ductal cancers and, in some cases, may be a substitute for biopsy. The Society of Nuclear Medicine and Molecular Imaging and the European Association of Nuclear Medicine in June 2023 released a procedure standard/practice guideline for [18F]FES PET ER imaging of patients with breast cancer. The goal of the standard/guideline is to assist physicians in recommending, performing, interpreting, and reporting the results of [18F]FES PET studies for patients with breast cancer and to provide clinicians with the best available evidence, inform them about areas where robust evidence is lacking, and help them deliver the best possible diagnostic efficacy and study quality for their patients. Also reviewed are standardized quality control, quality assurance, and imaging procedures for [18F]FES PET. The authors emphasize the importance of precision, accuracy, repeatability, and reproducibility for both clinical management of patients and for use of [18F]FES PET in multicenter trials. A standardized imaging procedure, in combination with already published appropriate-use criteria, will help promote the use of [18F]FES PET and enhance subsequent research. This brief summary article reviews the content of the joint standard/guideline, which is available in its entirety at https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=6414&navItemNumbe=10790.