Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/125256
Title: | Phase 3 Trial Of Lu-177-dotatate For Midgut Neuroendocrine Tumors |
Author: | Strosberg, Jonathan El-haddad, Ghassan Wolin, Edward Hendifar, Andrew Yao, James Chasen, Beth Mittra, Erik Kunz, Pamela L. Kulke, Matthew H. Jacene, Heather Bushnell, David O'Dorisio, Thomas M. Baum, Richard P. Kulkarni, Harshad R. Caplin, Martyn Lebtahi, Rachida Hobday, Timothy Delpassand, Ebrahim Cutsem, Eric Van Benson, Al Srirajaskanthan, Rajaventhan Pavel, Marianne Mora Salvador, Jaume Berlin, Jordan Grande, Enrique Reed, Nicholas Seregni, Ettore Öberg, Kjell Lopera Sierra, Maribel Santoro, Paola Thevenet, Thomas Erion, Jack L. Ruszniewski, Philippe Kwekkeboom, Dik Krenning, Eric NETTER-1 Trial Investigators |
Keywords: | Tumors Intestins Intestines |
Issue Date: | 12-Jan-2017 |
Publisher: | Massachusetts Medical Society |
Abstract: | BACKGROUND: Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 (Lu-177)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. METHODS: We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either Lu-177-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) (Lu-177-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: At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the Lu-177-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the Lu-177-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the Lu-177-Dotatate group and 26 in the control group (P = 0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the Lu-177-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS: Treatment with Lu-177-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the Lu-177-Dotatate group. |
Note: | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1607427 |
It is part of: | New England Journal of Medicine, 2017, vol. 376, num. 2, p. 125-135 |
URI: | http://hdl.handle.net/2445/125256 |
Related resource: | https://doi.org/10.1056/NEJMoa1607427 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
StrosbergJ.pdf | 246.4 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.