Stephen A Deppen1, Jeffrey Blume2, Adam J Bobbey3, Chirayu Shah4, Michael M Graham5, Patricia Lee6, Dominique Delbeke7, Ronald C Walker8. 1. 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. 2. Department of Biostatistics, Vanderbilt University, Nashville, Tennessee. 3. Department of Radiology, Nationwide Children's Hospital, Columbus, Ohio. 4. Veterans Affairs Hospital, Tennessee Valley Healthcare System, Nashville, Tennessee Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee. 5. Department of Radiology, University of Iowa, Iowa City, Iowa; and. 6. Knowledge Management, Eskind Biomedical Library, Vanderbilt University Medical Center, Nashville, Tennessee. 7. Vanderbilt-Ingram Cancer Center, Nashville, Tennessee Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee. 8. Veterans Affairs Hospital, Tennessee Valley Healthcare System, Nashville, Tennessee Vanderbilt-Ingram Cancer Center, Nashville, Tennessee Department of Radiology, Nationwide Children's Hospital, Columbus, Ohio Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, Nashville, Tennessee ronald.walker@vanderbilt.edu.
Abstract
UNLABELLED: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
UNLABELLED: 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. METHODS: 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 gastroenteropancreaticNET 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. RESULTS: 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. CONCLUSION: 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.
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