Deppen Stephen A, Blume Jeffrey, Bobbey Adam J, Shah Chirayu, Graham Michael M, Lee Patricia, Delbeke Dominique, Walker Ronald C
Veterans Affairs Hospital, Tennessee Valley Healthcare System, Nashville, Tennessee Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.
J Nucl Med. 2016 Jun;57(6):872-8. doi: 10.2967/jnumed.115.165803. Epub 2016 Jan 14.
Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared with (111)In-DTPA-octreotide and conventional imaging. We performed a systematic review of (68)Ga-DOTATATE for safety and efficacy compared with octreotide and conventional imaging to determine whether available evidence supports U.S. Food and Drug Administration approval.
Medline, EMBASE, Web of Science, and Cochrane Reviews electronic databases were searched from January 1999 to September 2015. Results were restricted to human studies comparing diagnostic accuracy of (68)Ga-DOTATATE with octreotide or conventional imaging for pulmonary or gastroenteropancreatic NET and for human studies reporting safety/toxicity for (68)Ga-DOTATATE with 10 subjects or more thought to have NETs. Direct communication with corresponding authors was attempted to obtain missing information. Abstracts meeting eligibility criteria were collected by a research librarian and assembled for reviewers; 2 reviewers independently determined whether or not to include each abstract. If either reviewer chose inclusion, the abstract was accepted for review.
Database and bibliography searches yielded 2,479 articles, of which 42 were eligible. Three studies compared the 2 radiopharmaceuticals in the same patient, finding (68)Ga-DOTATATE to be more sensitive than octreotide. Nine studies compared (68)Ga-DOTATATE with conventional imaging. (68)Ga-DOTATATE estimated sensitivity, 90.9% (95% confidence interval, 81.4%-96.4%), and specificity, 90.6% (95% confidence interval, 77.8%-96.1%), were high. Five studies were retained for safety reporting only. Report of harm possibly related to (68)Ga-DOTATATE was rare (6 of 974), and no study reported major toxicity or safety issues.
No direct comparison of octreotide and (68)Ga-DOTATATE imaging for diagnosis and staging in an unbiased population of NETs has been published. Available information in the peer-reviewed literature regarding diagnostic efficacy and safety supports the use of (68)Ga-DOTATATE for imaging of NETs where it is available.
神经内分泌肿瘤（NETs）是一种发病率和患病率不断上升的罕见肿瘤。目前的报告表明，与铟 - 111标记的二乙三胺五醋酸奥曲肽（In - DTPA - octreotide）及传统成像相比，镓 - 68标记的奥曲肽（Ga - DOTATATE）PET/CT成像可改善NETs的诊断和分期。我们对Ga - DOTATATE与奥曲肽及传统成像相比的安全性和有效性进行了系统评价，以确定现有证据是否支持美国食品药品监督管理局的批准。
检索了1999年1月至2015年9月的Medline、EMBASE、科学引文索引（Web of Science）和Cochrane系统评价数据库。结果仅限于比较Ga - DOTATATE与奥曲肽或传统成像对肺或胃肠胰神经内分泌肿瘤诊断准确性的人体研究，以及报告了10名或更多疑似患有NETs患者使用Ga - DOTATATE安全性/毒性的人体研究。尝试与通讯作者直接沟通以获取缺失信息。符合纳入标准的摘要由一名研究馆员收集并整理供评审人员审阅；两名评审人员独立决定是否纳入每篇摘要。若任何一名评审人员选择纳入，则该摘要将被接受评审。
数据库和文献检索共获得2479篇文章，其中42篇符合条件。三项研究在同一患者中比较了这两种放射性药物，发现Ga - DOTATATE比奥曲肽更敏感。九项研究将Ga - DOTATATE与传统成像进行了比较。Ga - DOTATATE的估计敏感性为90.9%（95%置信区间，81.4% - 96.4%），特异性为90.6%（95%置信区间，77.8% - 96.1%），均较高。仅保留了五项安全性报告研究。与Ga - DOTATATE可能相关的不良事件报告很少（974例中有6例），且没有研究报告重大毒性或安全性问题。
尚未发表在无偏倚的NETs人群中对奥曲肽和Ga - DOTATATE成像进行诊断和分期的直接比较。同行评审文献中关于诊断效能和安全性的现有信息支持在可获得Ga - DOTATATE的情况下将其用于NETs成像。
