Abstract
1507
Background: Several retrospective studies have demonstrated the impact of Ga-68 DOTATOC PET/CT in management of patients with neuroendocrine tumors; however, a retrospective approach may introduce bias due to loss of follow-up and potentially may underestimate the changes in management that have not been clearly documented in patients’ charts. Our goal in this study was to prospectively evaluate the change in management of patients with NETs after Ga-68 DOTATOC PET/CT scan.
Methods: An IRB-approved, prospective, Phase II, single center, open label study was conducted. The primary eligibility criterion was a histologically proven tumor with positive immunohistochemical staining for somatostatin receptor subtype 2. All study participants received a Ga-68 DOTATOC PET/CT imaging study. The primary end-point of the study was the change in management of patients based on findings of the Ga-68 DOTATOC PET/CT scan. Referring physicians completed a pre-scan form that included the current management of the patient before the Ga-68 DOTATOC PET/CT scan. They subsequently completed a post-scan form after the results of the scans were reviewed. Change in management after Ga-68 DOTATOC PET/CT scan was categorized at three levels of change: no change, minor change (additional imaging, supportive care), or major change (somatostatin analogue treatment, tumor biopsy, surgery, PRRT, chemotherapy, biological therapy, liver directed therapy, external beam radiation). If a major change was recorded, patients were presented in a tumor board to confirm or reject the major change. Safety assessments were also performed on all subjects.
Results: A major change in management was recommended for 54/114 subjects (47.3%) , minor change in 6/114(5.3%) subjects, and no change in 54/114 (47.3%) subjects, with 95% exact confidence intervals of 38-57%, 2-11%, and 38-57%, respectively. A total of 26 of the 114 subjects experienced a Grade I adverse event (nausea, headache, back pain, diarrhea); one grade 2 (petechiae) and one grade 3 (abdominal pain) event were observed. None of these adverse events were considered related to the study drug and none required intervention.
Conclusions: Ga-68 DOTATOC PET/CT has a significant impact on management of patients with NETs, similar to Ga-68 DOTATATE PET/CT.
