RT Journal Article
SR Electronic
T1 NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy and Safety Results
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 629
OP 629
VO 57
IS supplement 2
A1 Jonathan Strosberg
A1 Edward Wolin
A1 Beth Chasen
A1 Matthew Kulke
A1 David Bushnell
A1 Martin Caplin
A1 Richard Baum
A1 Erik Mittra
A1 Timothy Hobday
A1 Andrew Hendifar
A1 Kjell Oberg
A1 Maribel Lopera Sierra
A1 Dik Kwekkeboom
A1 Philippe Ruszniewski
A1 Eric Krenning
YR 2016
UL http://jnm.snmjournals.org/content/57/supplement_2/629.abstract
AB 629Objectives To evaluate the activity and safety of 177Lu-DOTA0-Tyr3-Octreotate (Lutathera®) in patients with advanced, progressive, somatostatin-receptor positive midgut NETs.Methods 230 patients with grade 1-2 metastatic midgut NETs were randomized to receive either 177Lu-Dotatate, 7.4 GBq every 8 weeks (x4 administrations), or Octreotide LAR 60 mg every 4 weeks. The primary endpoint was PFS (RECIST 1.1). Secondary objectives included ORR, OS, toxicity, and QoL. Independent image reading center performed tumor assessment every 12 weeks.Results The median PFS was not reached for 177Lu-Dotatate and was 8.4 months in the control group, p<0.0001, HR 0.21. There were 23 centrally confirmed disease progressions or deaths in the 177Lu-Dotatate arm and 67 in the Octreotide LAR 60 mg arm. The objective radiographic response rate was 18% with 177Lu-Dotatate and 3% with control (p=0.0008). Interim OS analysis (13 deaths in 177Lu-Dotatate group and 22 in control group; p=0.019) strongly suggests an improvement in OS. Among patients treated with 177Lu-Dotatate, only 5% (6 patients) experienced dose modifying toxicity, 95% of the patients received a 7.4GBq (200 mCi) dose. Grade 3 or 4 neutropenia, thrombocytopenia and lymphopenia occurred in 1%, 2% and 9% of the patients in 177Lu-Dotatate arm vs. none in the control group.Conclusions The phase III NETTER-1 trial provides evidence for a clinically meaningful and statistically significant increase in PFS and ORR, and suggests an OS benefit in patients with advanced midgut NETs treated with 177Lu-Dotatate. 177Lu-Dotatate safety profile was found to be very favorable, with no clinically relevant findings especially regarding hematological, renal and hepatic parameters.