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DC Field | Value | Language |
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dc.contributor.author | Strosberg, Jonathan | - |
dc.contributor.author | El-haddad, Ghassan | - |
dc.contributor.author | Wolin, Edward | - |
dc.contributor.author | Hendifar, Andrew | - |
dc.contributor.author | Yao, James | - |
dc.contributor.author | Chasen, Beth | - |
dc.contributor.author | Mittra, Erik | - |
dc.contributor.author | Kunz, Pamela L. | - |
dc.contributor.author | Kulke, Matthew H. | - |
dc.contributor.author | Jacene, Heather | - |
dc.contributor.author | Bushnell, David | - |
dc.contributor.author | O'Dorisio, Thomas M. | - |
dc.contributor.author | Baum, Richard P. | - |
dc.contributor.author | Kulkarni, Harshad R. | - |
dc.contributor.author | Caplin, Martyn | - |
dc.contributor.author | Lebtahi, Rachida | - |
dc.contributor.author | Hobday, Timothy | - |
dc.contributor.author | Delpassand, Ebrahim | - |
dc.contributor.author | Cutsem, Eric Van | - |
dc.contributor.author | Benson, Al | - |
dc.contributor.author | Srirajaskanthan, Rajaventhan | - |
dc.contributor.author | Pavel, Marianne | - |
dc.contributor.author | Mora Salvador, Jaume | - |
dc.contributor.author | Berlin, Jordan | - |
dc.contributor.author | Grande, Enrique | - |
dc.contributor.author | Reed, Nicholas | - |
dc.contributor.author | Seregni, Ettore | - |
dc.contributor.author | Öberg, Kjell | - |
dc.contributor.author | Lopera Sierra, Maribel | - |
dc.contributor.author | Santoro, Paola | - |
dc.contributor.author | Thevenet, Thomas | - |
dc.contributor.author | Erion, Jack L. | - |
dc.contributor.author | Ruszniewski, Philippe | - |
dc.contributor.author | Kwekkeboom, Dik | - |
dc.contributor.author | Krenning, Eric | - |
dc.contributor.author | NETTER-1 Trial Investigators | - |
dc.date.accessioned | 2018-10-10T12:14:54Z | - |
dc.date.available | 2018-10-10T12:14:54Z | - |
dc.date.issued | 2017-01-12 | - |
dc.identifier.uri | http://hdl.handle.net/2445/125256 | - |
dc.description.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. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1607427 | - |
dc.relation.ispartof | New England Journal of Medicine, 2017, vol. 376, num. 2, p. 125-135 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1607427 | - |
dc.rights | (c) Massachusetts Medical Society, 2017 | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Tumors | - |
dc.subject.classification | Intestins | - |
dc.subject.other | Intestines | - |
dc.title | Phase 3 Trial Of Lu-177-dotatate For Midgut Neuroendocrine Tumors | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2018-07-24T12:11:51Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 28076709 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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StrosbergJ.pdf | 246.4 kB | Adobe PDF | View/Open |
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