Real-world safety data from the US expanded access program of 177Lu-DOTATATE showed that the safety profile was consistent with that previously described in clinical trials of patients with advanced midgut neuroendocrine tumors (NETs).
The US expanded access program (NCT02705313) assessed the safety profile of 177Lu-DOTATATE in a real-world population of US patients with somatostatin-receptor–positive advanced midgut NETs; the results of the trial were reported at the 2020 American Society of Clinical Oncology Virtual Scientific Program.
Eligibility criteria included adult patients with inoperable, histologically proven, somatostatin-receptor–positive, locally advanced or metastatic NETs of any origin, with Ki67 proliferation index ≤20%, and who had progressed after somatostatin analog therapy. Exclusion criteria included surgery, radiotherapy, or chemotherapy in the past 12 weeks; treatment with an interferon, mammalian target of rapamycin inhibitor, or other systemic therapy in the past 4 weeks, or ongoing octreotide therapy that could not be interrupted for peptide receptor radionuclide therapy; and impaired renal function. Eligible patients who received ≥1 cycles of 177Lu-DOTATATE between July 5, 2016, and December 21, 2018, were included in the analysis. A total of 299 patients were included in the US expanded access program; these patients had received a mean 177Lu-DOTATATE cumulative dose of 552 mCi (20.4 GBq; standard deviation [SD], 220 mCi [8.1 GBq]) over a mean of 2.8 cycles (SD, 1.1). The mean age of the study population was 60.8 years (SD, 11.7); 38.5% of patients were male. The mean follow-up duration was 130.8 days (SD, 86.9; range, 1-485 days).
Of the 299 patients, treatment-related adverse events (TRAEs) occurred in 146 patients (48.8%), the majority of which were mild or moderate in severity. Grade 1 TRAEs were reported in 80 patients (26.8%), grade 2 in 54 patients (18.1%), and grade 3 in 12 patients (4.0%); no grade 4/5 TRAEs were reported. The most common TRAEs of any grade that occurred in ≥5.0% of patients were nausea (31.1%), vomiting (13.7%), fatigue (9.4%), and thrombocytopenia (6.0%). Four treatment-related serious adverse events (AEs) occurred in 3 patients: 1 event each of grade 2 syncope, grade 3 carcinoid crisis, grade 3 dehydration, and grade 3 vomiting. Dose modification resulting from AEs occurred in 5 patients (1.7%); dose delays occurred in 19 patients (6.4%), most commonly due to nausea (2.0%) or thrombocytopenia (2.0%); and treatment discontinuation occurred in 4 patients (1.3%), resulting from thrombocytopenia (1.0%) and extravasation (0.3%).
Results of the US expanded access program in patients with advanced NETs showed that the safety profile of 177Lu-DOTATATE treatment was consistent with those previously described in the NETTER-1 trial1; the TRAEs were generally mild or moderate and gastrointestinal in nature.
Source: Auerbach MS, et al. J Clin Oncol. 2020;38(15_suppl). Abstract 4604.
Reference 1. Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376:125-135.
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