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Phase 3 Trial of Lu-177-Dotatate for Midgut Neuroendocrine Tumors

The New England journal of medicine, 2017-01, Vol.376 (2), p.125 [Peer Reviewed Journal]

ISSN: 1533-4406 ;ISSN: 0028-4793 ;EISSN: 1533-4406 ;DOI: 10.1056/NEJMoa1607427

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  • Title:
    Phase 3 Trial of Lu-177-Dotatate for Midgut Neuroendocrine Tumors
  • Author: Strosberg, J. ; El-Haddad, G. ; Wolin, E. ; Hendifar, A. ; Yao, J. ; Chasen, B. ; Mittra, E. ; Kunz, P. L. ; Kulke, M. H. ; Jacene, H. ; Bushnell, D. ; O'Dorisio, T. M. ; Baum, R. P. ; Kulkarni, H. R. ; Caplin, M. ; Lebtahi, R. ; Hobday, T. ; Delpassand, E. ; Van Cutsem, E. ; Benson, A. ; Srirajaskanthan, R. ; Pavel, M. ; Mora, J. ; Berlin, J. ; Grande, E. ; Reed, N. ; Seregni, E. ; Öberg, Kjell ; Sierra, M. Lopera ; Santoro, P. ; Thevenet, T. ; Erion, J. L. ; Ruszniewski, P. ; Kwekkeboom, D. ; Krenning, E.
  • Is Part Of: The New England journal of medicine, 2017-01, Vol.376 (2), p.125
  • Description: 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. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials. gov number, NCT01578239; EudraCT number 2011-005049-11.)
  • Language: English
  • Identifier: ISSN: 1533-4406
    ISSN: 0028-4793
    EISSN: 1533-4406
    DOI: 10.1056/NEJMoa1607427
  • Source: ProQuest One Psychology
    ProQuest Central
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