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No Overall Survival Benefit for 177Lu-Dotatate in Neuroendocrine Tumors
Gastrointestinal neuroendocrine tumors are rare and heterogeneous, with clinical behavior ranging from slow growing and indolent to rapidly progressive and virulent. Most such tumors express cell surface somatostatin receptors which can be targeted with somatostatin analogues.
Investigators now report final survival results from the NETTER-1 trial, an industry-sponsored, open-label, randomized phase 3 trial comparing treatment with lutetium 177 (177Lu)-Dotatate (a radiolabeled somatostatin analogue) combined with long-acting octreotide (30 mg) to high-dose long-acting octreotide (60 mg). The trial enrolled 231 patients with midgut neuroendocrine tumors that had progressed on prior therapy with fixed-dose long-acting octreotide. The investigators previously reported superior progression-free survival in the 177Lu-Dotatate arm (hazard ratio, 0.18; P< 0.0001; NEJM JW Oncol Hematol Mar 2017 and N Engl J Med 2017; 376:125).
Most patients (94%) had received prior octreotide therapy at a dose of 30 mg, 26% had received octreotide therapy for less than 6 months prior to enrollment, and 39% had received additional prior treatments. The median time from diagnosis was shorter in the 177Lu-Dotatate group than in the control group (3.8 vs. 4.8 years)
At a median follow-up of 76 months, median overall survival did not differ significantly in the 177Lu-Dotatate and control groups (48.0 and 36.3 months; HR, 0.84; 95% CI, 0.60–1.17). However, survival per year favored 177Lu-Dotatate (e.g., survival at 1 year, 91.0% vs. 79.7%; 3 years, 61.4% vs. 50.1%; 5 years, 37.1% vs. 35.4%). In the control group, 36% of patients crossed over to receive 177Lu-Dotatate. No new safety signals were observed; there were two cases of myelodysplastic syndrome with 177Lu-Dotatate.
177Lu-Dotatate is approved to treat gastrointestinal neuroendocrine cancers with progression on prior somatostatin analogue therapy. Although no clear long-term survival benefit was observed for 177Lu-Dotatate in this study, the high crossover rate limits interpretation of the survival outcome. The improvement in progression-free survival and response to this agent support its continued use.
Strosberg JR et al.
Title: 177Lu-Dotatate plus long-acting octreotide versus high–dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): Final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial.
Source: Lancet Oncol 2021 Dec 1; [e-pub]. (Abstract/FREE Full Text)