Abstract
Purpose: Neuroendocrine tumors (NETs) are uncommon but with increasing incidence and prevalence. Current reports suggest 68Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared to 111In-DTPA-octreotide (octreotide) and conventional imaging. We performed a systematic review of 68Ga-DOTATATE for safety and efficacy compared to octreotide and conventional imaging to determine if available evidence supports US FDA approval. Methods: Medline, EMBASE, Web of Science and Cochran Reviews electronic databases were searched from January 1999, through September 2014, following PRISMA guidelines. Results were restricted to human studies comparing diagnostic accuracy of 68Ga-DOTATATE to octreotide and conventional imaging for pulmonary or gastroenteropancreatic (GEP) NET, and for human studies reporting safety/toxicity for 68Ga-DOTATATE with ≥10 subjects. Direct communication with corresponding authors provided missing information including toxicity. Abstracts meeting eligibility criteria were collected by a research librarian and reviewed independently by two reviewers. Results: Database and bibliography searches yielded 2380 articles, of which 36 were eligible. One unpublished comparative study was conducted prospectively. Three studies compared the two radiopharmaceuticals in the same patient and found 68Ga-DOTATATE to be more sensitive than octreotide. Eight studies compared 68Ga-DOTATATE to conventional imaging. 68Ga-DOTATATE estimated sensitivity 90.3% (95%CI: 80.8%, 95.8%) and 90.6% (95%CI: 79.0%, 96.1%) specificity were high. Eleven studies were retained for safety reporting. Report of harm possibly related to 68Ga-DOTATATE was rare (4 of 681), and no study reported major toxicity or safety issues. Conclusion: No direct comparison of octreotide and 68Ga-DOTATATE 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 68Ga-DOTATATE for imaging of NETs where it is available.
- Neuroendocrine
- Oncology: GI
- Radiopharmaceuticals
- DOTATATE
- Octreotide
- meta-analysis
- neuroendocrine
- systematic review
- Copyright © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.