Phase 3 Trial of <sup>177</sup> Lu-Dotatate for Midgut Neuroendocrine Tumors

Jonathan Strosberg(Moffitt Cancer Center), Ghassan El‐Haddad(Moffitt Cancer Center), Edward M. Wolin(University of Kentucky), Andrew Hendifar(Moffitt Cancer Center), James C. Yao(The University of Texas MD Anderson Cancer Center), Beth Chasen(The University of Texas MD Anderson Cancer Center), Erik Mittra(Moffitt Cancer Center), Pamela L. Kunz(Moffitt Cancer Center), Matthew H. Kulke(Moffitt Cancer Center), Heather A. Jacene(Dana-Farber Cancer Institute), David Bushnell(University of Iowa), Thomas M. O’Dorisio(University of Iowa), Richard P. Baum(Zentralklinik Bad Berka), Harshad Kulkarni(Moffitt Cancer Center), Martyn Caplin(Moffitt Cancer Center), Rachida Lebtahi(Moffitt Cancer Center), Timothy J. Hobday(Moffitt Cancer Center), Ebrahim S. Delpassand(Excel Diagnostics Imaging), Eric Van Cutsem(KU Leuven), Al B. Benson(Robert H. Lurie Comprehensive Cancer Center of Northwestern University), Rajaventhan Srirajaskanthan(Moffitt Cancer Center), Marianne Pavel(Charité - Universitätsmedizin Berlin), Jaime Font de Mora(Bellvitge University Hospital), Jordan Berlin(Vanderbilt University Medical Center), Enrique Grande(Moffitt Cancer Center), Nicholas S. Reed(Moffitt Cancer Center), Ettore Seregni(Fondazione IRCCS Istituto Nazionale dei Tumori), Kjell Öberg(Moffitt Cancer Center), Maribel Lopera Sierra(Moffitt Cancer Center), Paola Santoro(Moffitt Cancer Center), Thomas Thevenet(Moffitt Cancer Center), Jack L. Erion(Moffitt Cancer Center), Philippe Ruszniewski(Hôpital Beaujon), Dik J. Kwekkeboom(Moffitt Cancer Center), Eric P. Krenning(Moffitt Cancer Center)
New England Journal of Medicine
January 11, 2017
10.1056/nejmoa1607427
Cited by 3,136Open Access
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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 .).

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