Phase 3 Trial of <sup>177</sup> Lu-Dotatate for Midgut Neuroendocrine Tumors
Jonathan Strosberg, Ghassan El‐Haddad, Edward M. Wolin, Andrew Hendifar, James C. Yao, Beth Chasen, Erik Mittra, Pamela L. Kunz, Matthew H. Kulke, Heather A. Jacene, David Bushnell, Thomas M. O’Dorisio, Richard P. Baum, Harshad Kulkarni, Martyn Caplin, Rachida Lebtahi, Timothy J. Hobday, Ebrahim S. Delpassand, Eric Van Cutsem, Al B. Benson, Rajaventhan Srirajaskanthan, Marianne Pavel, Jaime Font de Mora, Jordan Berlin, Enrique Grande, Nicholas S. Reed, Ettore Seregni, Kjell Öberg, Maribel Lopera Sierra, Paola Santoro, Thomas Thevenet, Jack L. Erion, Philippe Ruszniewski, Dik J. Kwekkeboom, Eric P. Krenning
Abstract
BACKGROUND: Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. METHODS: Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. RESULTS: Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS: Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).