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Article / Publication Details AbstractIntroduction: Lutetium-177 (177Lu)-DOTATATE received FDA approval in 2018 to treat somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumors (NETs). Little data are available on response and outcomes for well differentiated (WD) high grade (HG) NETs treated with 177Lu-DOTATATE. Materials and Methods: Patients with WD HG NETs treated with 177Lu-DOTATATE at MSK from 2018-2020 were identified. Demographics, response (RECIST 1.1), progression-free survival (PFS) were determined. Next-generation sequencing (NGS) was performed in archival tumor. Results: Nineteen patients, all with progressive, heavily-treated disease, were identified. Site of tumor origin: pancreas (74%), small bowel (11%), rectal (11%), lung (5%); median Ki-67 32% (range 22-56). Thirteen patients (68%) completed all four 177Lu-DOTATATE cycles. Best response (N=18 evaluable): 5/18 (28%) partial response, 8/18 (44%) stable disease, 5/18 (28%) disease progression. Median PFS 13.1 months (95% CI 8.7-20.9). Most common treatment-related toxicities: thrombocytopenia (9 patients, 47%; G3/4, 1 patient, 5%), anemia (7 patients, 37%; G3/4, 2 patients, 11%), leukopenia (6 patients, 32%; G3/4, 0 patients), liver function test elevation (4 patients, 21%; G3/4, 0 patients). NGS results were available from 13/19 tumors (68%). The most observed alterations were in MEN1 (6/13, 46%), DAXX (4/13, 31%). No RB1 alterations identified. Conclusion: We observed a meaningful disease control rate of 72% during treatment of WD HG NETs with 177Lu-DOTATATE. In this heavily pre-treated population, more than half of patients received all four treatment cycles with toxicities largely bone-marrow related. As would be expected in WD NETs, the vast majority had alterations in chromatin remodeling genes and no RB1 alterations.
S. Karger AG, Basel
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