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Impact of liver tum...
Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with Lu-177-Dotatate : an analysis of the NETTER-1 study
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- Strosberg, Jonathan (author)
- H Lee Moffitt Canc Ctr & Res Inst, Neuroendocrine Tumor Div, Gastrointestinal Dept, Tampa, FL 33612 USA.
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- Kunz, Pamela L. (author)
- Stanford Univ, Med Ctr, Dept Med Med Oncol, Stanford, CA 94305 USA.
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- Hendifar, Andrew (author)
- Cedars Sinai Med Ctr, Dept Internal Med Hematol Oncol, Los Angeles, CA 90048 USA.
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- Yao, James (author)
- Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Houston, TX 77030 USA.
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- Bushnell, David (author)
- Univ Iowa, Dept Radiol, Iowa City, IA 52242 USA.
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- Kulke, Matthew H. (author)
- Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA.
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- Baum, Richard P. (author)
- Zent Klin Bad Berka, Dept Nucl Med, Bad Berka, Germany.
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- Caplin, Martyn (author)
- Royal Free Hosp, Dept Gastroenterol & Tumour Neuroendocrinol, London, England.
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- Ruszniewski, Philippe (author)
- Hop Beaujon, Div Gastroenterol & Pancreatol, Clichy, France.
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- Delpassand, Ebrahim (author)
- Excel Diagnost Imaging Clin, Dept Clin Nucl Med, Houston, TX USA.
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- Hobday, Timothy (author)
- Mayo Clin, Coll Med, Dept Oncol, Rochester, MN USA.
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- Verslype, Chris (author)
- Univ Hosp, Dept Hepatol, Leuven, Belgium.;Katholieke Univ Leuven, Leuven, Belgium.
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- Benson, Al (author)
- Robert H Lurie Comprehens Canc Ctr, Div Hematol Oncol, Chicago, IL USA.
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- Srirajaskanthan, Rajaventhan (author)
- Kings Coll Hosp NHS Fdn Trust, Dept Gastroenterol & Gen Internal Med, London, England.
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- Pavel, Marianne (author)
- Charite Univ Med Berlin, Div Gastroenterol & Hepatol, Berlin, Germany.
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- Mora, Jaume (author)
- Hosp Univ Bellvitge, Dept Nucl Med, Barcelona, Spain.
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- Berlin, Jordan (author)
- Vanderbilt Univ, Med Ctr, Dept Med, Nashville, TN USA.
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- Grande, Enrique (author)
- MD Anderson Canc Ctr, Dept Med Oncol, Madrid, Spain.
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- Reed, Nicholas (author)
- Beatson Oncol Ctr, Dept Med Oncol, Glasgow, Lanark, Scotland.
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- Seregni, Ettore (author)
- Ist Nazl Tumori, Fdn Ist Ric & Cura Carattere Sci, Dept Nucl Med Therapy & Endocrinol, Milan, Italy.
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- Paganelli, Giovanni (author)
- IRCCS, Ist Sci Romagnolo Studio & Cura Tumori IRST, Dept Med Oncol, Meldola, Italy.
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- Severi, Stefano (author)
- IRCCS, Ist Sci Romagnolo Studio & Cura Tumori IRST, Dept Med Oncol, Meldola, Italy.
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- Morse, Michael (author)
- Duke Univ, Med Ctr, Dept Surg, Durham, NC 27710 USA.
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- Metz, David C. (author)
- Hosp Univ Penn, GI Div, 3400 Spruce St, Philadelphia, PA 19104 USA.
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- Ansquer, Catherine (author)
- Univ Hosp, Hotel Dieu, Dept Nucl Med, Nantes, France.
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- Courbon, Frederic (author)
- Oncol Univ, Inst Claudius Regaud, Med Imaging, Toulouse, France.
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- Al-Nahhas, Adil (author)
- Imperial Coll London, Div Imaging & Intervent Radiol, London, England.
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- Baudin, Eric (author)
- Inst Gustave Roussy, Dept Endocrine Oncol & Nucl Med, Villejuif, France.
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- Giammarile, Francesco (author)
- IAEA, Dept Nucl Sci & Applicat, Vienna, Austria.
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- Taieb, David (author)
- Hop La Timone, Dept Nucl Med, Marseille, France.
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- Mittra, Erik (author)
- Oregon Hlth & Sci Univ, Dept Nucl Med, Portland, OR 97201 USA.
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- Wolin, Edward (author)
- Icahn Sch Med Mt Sinai, Dept Med Hematol & Med Oncol, New York, NY 10029 USA.
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- O'Dorisio, Thomas M. (author)
- Univ Iowa, Dept Internal Med, Iowa City, IA 52242 USA.
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- Lebtahi, Rachida (author)
- Royal Free Hosp, Dept Nucl Med, London, England.
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- Deroose, Christophe M. (author)
- Univ Hosp, Dept Nucl Med, Leuven, Belgium.;Katholieke Univ Leuven, Leuven, Belgium.
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- Grana, Chiara M. (author)
- Ist Europeo Oncol, Div Nucl Med, Milan, Italy.
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- Bodei, Lisa (author)
- Mem Sloan Kettering Canc Ctr, Dept Nucl Med, 1275 York Ave, New York, NY 10021 USA.
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- Öberg, Kjell, 1946- (author)
- Uppsala universitet,Endokrin tumörbiologi
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- Polack, Berna Degirmenci (author)
- Adv Accelerator Applicat, Dept Med Informat, Geneva, Switzerland.
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- He, Beilei (author)
- Adv Accelerator Applicat, Geneva, Switzerland.
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- Mariani, Maurizio F. (author)
- Adv Accelerator Applicat, Res & Dev, Geneva, Switzerland.
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- Gericke, Germo (author)
- Adv Accelerator Applicat, Res & Dev, Geneva, Switzerland.
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- Santoro, Paola (author)
- Adv Accelerator Applicat, Dept Clin Dev, Geneva, Switzerland.
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- Erion, Jack L. (author)
- Adv Accelerator Applicat, Geneva, Switzerland.
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- Ravasi, Laura (author)
- Adv Accelerator Applicat, Res & Dev, Geneva, Switzerland.
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- Krenning, Eric (author)
- Erasmus Univ, Med Ctr, Cyclotron Rotterdam BV, Dept Nucl Med, Rotterdam, Netherlands.
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H Lee Moffitt Canc Ctr & Res Inst, Neuroendocrine Tumor Div, Gastrointestinal Dept, Tampa, FL 33612 USA Stanford Univ, Med Ctr, Dept Med Med Oncol, Stanford, CA 94305 USA. (creator_code:org_t)
- 2020-03-02
- 2020
- English.
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In: European Journal of Nuclear Medicine and Molecular Imaging. - : SPRINGER. - 1619-7070 .- 1619-7089. ; 47:10, s. 2372-2382
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Abstract
Subject headings
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- Purpose To assess the impact of baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size on treatment outcomes with Lu-177-Dotatate. Methods In the phase 3 NETTER-1 trial, patients with advanced, progressive midgut neuroendocrine tumours (NET) were randomised to 177Lu-Dotatate (every 8 weeks, four cycles) plus octreotide long-acting release (LAR) or to octreotide LAR 60 mg. Primary endpoint was progression-free survival (PFS). Analyses of PFS by baseline factors, including liver tumour burden, ALP elevation, and target lesion size, were performed using Kaplan-Meier estimates; hazard ratios (HRs) with corresponding 95% CIs were estimated using Cox regression. Results Significantly prolonged median PFS occurred with Lu-177-Dotatate versus octreotide LAR 60 mg in patients with low (< 25%), moderate (25-50%), and high (> 50%) liver tumour burden (HR 0.187, 0.216, 0.145), and normal or elevated ALP (HR 0.153, 0.177), and in the presence or absence of a large target lesion (diameter > 30 mm; HR, 0.213, 0.063). Within the Lu-177-Dotatate arm, no significant difference in PFS was observed amongst patients with low/moderate/high liver tumour burden (P = 0.7225) or with normal/elevated baseline ALP (P = 0.3532), but absence of a large target lesion was associated with improved PFS (P = 0.0222). Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden. Conclusions Lu-177-Dotatate demonstrated significant prolongation in PFS versus high-dose octreotide LAR in patients with advanced, progressive midgut NET, regardless of baseline liver tumour burden, elevated ALP, or the presence of a large target lesion. : NCT01578239, EudraCT: 2011-005049-11
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Radiologi och bildbehandling (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Radiology, Nuclear Medicine and Medical Imaging (hsv//eng)
Keyword
- Lu-177-Dotatate
- Liver tumour burden
- NETTER-1
- Neuroendocrine tumour
- Octreotide
Publication and Content Type
- ref (subject category)
- art (subject category)
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Strosberg, Jonat ...
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Kunz, Pamela L.
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Hendifar, Andrew
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Yao, James
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Bushnell, David
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Kulke, Matthew H ...
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Baum, Richard P.
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Caplin, Martyn
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Ruszniewski, Phi ...
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Delpassand, Ebra ...
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Hobday, Timothy
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Verslype, Chris
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Benson, Al
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Srirajaskanthan, ...
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Pavel, Marianne
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Mora, Jaume
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Berlin, Jordan
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Grande, Enrique
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Reed, Nicholas
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Seregni, Ettore
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Paganelli, Giova ...
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Severi, Stefano
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Morse, Michael
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Metz, David C.
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Ansquer, Catheri ...
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Courbon, Frederi ...
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Al-Nahhas, Adil
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Baudin, Eric
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Giammarile, Fran ...
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Taieb, David
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Mittra, Erik
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Wolin, Edward
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O'Dorisio, Thoma ...
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Lebtahi, Rachida
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Deroose, Christo ...
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Grana, Chiara M.
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Bodei, Lisa
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Öberg, Kjell, 19 ...
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Polack, Berna De ...
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He, Beilei
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Mariani, Maurizi ...
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Gericke, Germo
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Santoro, Paola
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Erion, Jack L.
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Ravasi, Laura
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Krenning, Eric
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Uppsala University