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Phase 3 Trial of Lu...
Phase 3 Trial of Lu-177-Dotatate for Midgut Neuroendocrine Tumors
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- Strosberg, J. (author)
- H Lee Moffitt Canc Ctr & Res Inst, 12902 Magnolia Dr, Tampa, FL 33612 USA.
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- El-Haddad, G. (author)
- H Lee Moffitt Canc Ctr & Res Inst, 12902 Magnolia Dr, Tampa, FL 33612 USA.
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- Wolin, E. (author)
- Univ Kentucky, Markey Canc Ctr, Lexington, KY USA.
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- Hendifar, A. (author)
- Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA.
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- Yao, J. (author)
- Univ Texas Hlth Sci Ctr Houston, Houston, TX 77030 USA.
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- Chasen, B. (author)
- Univ Texas Hlth Sci Ctr Houston, Houston, TX 77030 USA.
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- Mittra, E. (author)
- Stanford Univ, Sch Med, Stanford, CA 94305 USA.
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- Kunz, P. L. (author)
- Stanford Univ, Sch Med, Stanford, CA 94305 USA.
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- Kulke, M. H. (author)
- Dana Farber Canc Inst, Boston, MA 02115 USA.
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- Jacene, H. (author)
- Dana Farber Canc Inst, Boston, MA 02115 USA.
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- Bushnell, D. (author)
- Univ Iowa, Iowa City, IA USA.
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- O'Dorisio, T. M. (author)
- Univ Iowa, Iowa City, IA USA.
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- Baum, R. P. (author)
- Zentralklin, Bad Berka, Germany.
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- Kulkarni, H. R. (author)
- Zentralklin, Bad Berka, Germany.
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- Caplin, M. (author)
- Royal Free Hosp, London, England.
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- Lebtahi, R. (author)
- Hop Beaujon, Clichy, France.
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- Hobday, T. (author)
- Mayo Clin Coll Med, Rochester, MN USA.
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- Delpassand, E. (author)
- Excel Diagnost Imaging Clin, Houston, TX USA.
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- Van Cutsem, E. (author)
- Univ Hosp, Leuven, Belgium.;Katholieke Univ Leuven, Leuven, Belgium.
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- Benson, A. (author)
- Robert H Lurie Comprehens Canc Ctr, Chicago, IL USA.
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- Srirajaskanthan, R. (author)
- Kings Coll Hosp NHS FDN Trust, London, England.
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- Pavel, M. (author)
- Charite, Berlin, Germany.
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- Mora, J. (author)
- Hosp Univ Bellvitge, Barcelona, Spain.
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- Berlin, J. (author)
- Vanderbilt Univ, Med Ctr, Nashville, TN USA.
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- Grande, E. (author)
- Hosp Univ Ramon & Cajal, Madrid, Spain.
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- Reed, N. (author)
- Beatson Oncol Ctr, Glasgow, Lanark, Scotland.
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- Seregni, E. (author)
- Ist Nazl Tumori, Fdn Ist Ricovero & Cura Carattere Sci, Milan, Italy.
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- Öberg, Kjell (author)
- Uppsala universitet,Endokrin tumörbiologi
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- Sierra, M. Lopera (author)
- Adv Accelerator Applicat USA, New York, NY USA.
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- Santoro, P. (author)
- Adv Accelerator Applicat USA, New York, NY USA.
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- Thevenet, T. (author)
- Adv Accelerator Applicat, St Genis Pouilly, France.
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- Erion, J. L. (author)
- Adv Accelerator Applicat USA, New York, NY USA.
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- Ruszniewski, P. (author)
- Hop Beaujon, Clichy, France.
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- Kwekkeboom, D. (author)
- Erasmus MC, Rotterdam, Netherlands.
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- Krenning, E. (author)
- Erasmus MC, Rotterdam, Netherlands.
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H Lee Moffitt Canc Ctr & Res Inst, 12902 Magnolia Dr, Tampa, FL 33612 USA Univ Kentucky, Markey Canc Ctr, Lexington, KY USA. (creator_code:org_t)
- 2017
- 2017
- English.
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 376:2, s. 125-135
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.)
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Strosberg, J.
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El-Haddad, G.
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Wolin, E.
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Hendifar, A.
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Yao, J.
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Chasen, B.
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show more...
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Mittra, E.
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Kunz, P. L.
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Kulke, M. H.
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Jacene, H.
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Bushnell, D.
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O'Dorisio, T. M.
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Baum, R. P.
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Kulkarni, H. R.
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Caplin, M.
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Lebtahi, R.
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Hobday, T.
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Delpassand, E.
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Van Cutsem, E.
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Benson, A.
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Srirajaskanthan, ...
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Pavel, M.
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Mora, J.
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Berlin, J.
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Grande, E.
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Reed, N.
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Seregni, E.
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Öberg, Kjell
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Sierra, M. Loper ...
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Santoro, P.
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Thevenet, T.
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Erion, J. L.
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Ruszniewski, P.
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Kwekkeboom, D.
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Krenning, E.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and General Practice
- Articles in the publication
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New England Jour ...
- By the university
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Uppsala University