Graham Michael M, Gu Xiaomei, Ginader Timothy, Breheny Patrick, Sunderland John J
Division of Nuclear Medicine, Department of Radiology, University of Iowa, Iowa City, Iowa
Hardin Library for the Health Sciences, University of Iowa, Iowa City, Iowa; and.
J Nucl Med. 2017 Sep;58(9):1452-1458. doi: 10.2967/jnumed.117.191197. Epub 2017 Mar 9.
Ga-DOTATOC, a somatostatin receptor-targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be quite sensitive and effective for clinical management decision making. This metaanalysis summarizes the efficacy of Ga-DOTATOC for several distinct indications and is intended to support approval of this agent by the U.S. Food and Drug Administration. The major electronic medical databases were searched for relevant papers over the period from January 2001 to November 2015. Papers were selected for review in 3 categories: clinical trials that reported sensitivity and specificity, comparison studies with In-octreotide, and change of management studies. All the eligible papers underwent Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment, which was useful in the final selection of papers for review. The initial search yielded 468 papers. After detailed evaluation, 17 papers were finally selected. Five types of studies emerged: workup of patients with symptoms and biomarker findings suggestive of NET, but with negative conventional imaging (3 papers, yield was only 13%); sensitivity (12 papers; sensitivity, 92%) and specificity (7 papers; specificity, 82%); identification of site of unknown primary in patients with metastatic NET (4 papers, yield was 44%); impact on subsequent NET patient management (4 papers, change in management in 51%); and comparison with In-octreotide (2 papers, sensitivity of DOTATOC on a per-lesion basis was 100%, for In-octreotide it was 78.2%; specificity was not available). Safety was not explicitly addressed in any study, but there were no reports of adverse events. Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging and restaging and for assisting in treatment decision making for patients with NET. It is also effective in locating the site of an unknown primary in NET patients who present with metastatic NET, but no known primary tumor. It also appears to be more accurate than In-octreotide. Although Ga-DOTATOC would seem to be useful in evaluating patients with suggestive symptoms and biomarker findings, it does not perform well in this setting and has low yield. Overall, it appears to be an excellent imaging agent to assess patients with known NET and frequently leads to a change in management.
钆喷酸奥曲肽（Ga-DOTATOC）是一种靶向生长抑素受体的配体，在过去十年中已在欧洲临床用于神经内分泌肿瘤（NETs）的成像。它在临床管理决策方面似乎相当敏感且有效。这项荟萃分析总结了Ga-DOTATOC在几种不同适应症中的疗效，旨在支持美国食品药品监督管理局批准该药物。检索了2001年1月至2015年11月期间主要的电子医学数据库以查找相关论文。论文被分为3类进行综述：报告敏感性和特异性的临床试验、与铟-奥曲肽的比较研究以及管理变化研究。所有符合条件的论文都接受了诊断准确性研究质量评估（QUADAS）评估，这对最终选择进行综述的论文很有帮助。初步检索产生了468篇论文。经过详细评估，最终选择了17篇论文。出现了5种类型的研究：对有提示NET的症状和生物标志物发现但传统成像为阴性的患者进行检查（3篇论文，检出率仅为13%）；敏感性（12篇论文；敏感性为92%）和特异性（7篇论文；特异性为82%）；对转移性NET患者中未知原发灶部位的识别（4篇论文，检出率为44%）；对后续NET患者管理的影响（4篇论文，51%的管理有变化）；以及与铟-奥曲肽的比较（2篇论文，基于每个病灶的DOTATOC敏感性为100%，铟-奥曲肽为78.2%；特异性数据不可用）。任何研究均未明确提及安全性，但没有不良事件报告。Ga-DOTATOC可用于评估疾病的存在和范围以进行分期和再分期，并协助NET患者的治疗决策。它在定位出现转移性NET但无已知原发肿瘤的NET患者中未知原发灶部位方面也很有效。它似乎也比铟-奥曲肽更准确。尽管Ga-DOTATOC在评估有提示症状和生物标志物发现的患者时似乎有用，但在此情况下表现不佳且检出率低。总体而言，它似乎是评估已知NET患者的一种优秀成像剂，并且经常会导致管理方式的改变。
