CHICAGO — NETTER-1 trial results of the somatostatin analogue peptide, 177Lu-DOTA0-Tyr3-octreotate (177Lu-Dotatate), suggest a potential survival benefit in patients with advanced midgut neuroendocrine tumors (NETs), attendees at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting were told.1
The agent results in clinically meaningful and statistically significant increases in progression-free survival and objective radiographic response rates, with a favorable safety profile, said Jonathan R. Strosberg, MD, Moffitt Cancer Center, Tampa, Florida.
Currently, therapeutic options for patients with advanced midgut NETs who progress on first-line somatostatin analog therapy are limited.
The study randomly assigned 230 patients with grade 1-2 metastatic midgut NETs to 177Lu-Dotatat 7.4 GBq every 8 weeks (x 4 administrations) vs octreotide LAR 60 mg every 4 weeks.
In the intent-to-treat population, median progression-free survival, the primary end point, was not reached for 177Lu-Dotatate and was 8.4 months in the control arm (HR, 0.21; 95% CI, 0.13-0.33; P < .0001).
Dr. Strosberg reported that there were 23 centrally confirmed disease progressions or deaths in the 177Lu-DOTA0-Tyr3-Octreotate arm and 67 in the Octreotide LAR 60 mg arm.
Objective radiographic response rate was 18% with 177Lu-Dotatate and 3% with the control (P = .0008).
Interim overall survival analysis revealed 14 deaths in 177Lu-Dotatate arm and 26 in the control arm (HR, 0.398; 95% CI, 0.21-0.77; P = .043), which suggests increased overall survival, which will be confirmed by final analysis.
Six patients (5%) experienced dose modifying toxicity with 177Lu-Dotatate. Grade 3 or 4 neutropenia (1%), thrombocytopenia (2%), and lymphopenia (9%) occurred in the 177Lu-Dotatate arm compared with 0% in the control arm.
1. Strosberg JR, Wolin EM, Chasen, B et al. NETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. Oral presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.