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Phase III study of ...
Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues
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- Wolin, Edward M. (author)
- Univ Kentucky, Markey Canc Ctr, Lexington, KY 40536 USA.
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- Jarzab, Barbara (author)
- Maria Sklodowska Curie Mem Canc Ctr, Dept Nucl Med & Endocrine Oncol, Gliwice, Poland.;Inst Oncol, Gliwice Branch, Gliwice, Poland.
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- Eriksson, Barbro (author)
- Uppsala universitet,Endokrin Onkologi
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- Walter, Thomas (author)
- Hop Edouard Herriot, Dept Med Oncol, Lyon, France.
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- Toumpanakis, Christos (author)
- Royal Free Hosp, Gastroenterol & Neuroendocrine Tumours, London NW3 2QG, England.
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- Morse, Michael A. (author)
- Duke Univ, Med Ctr, Dept Med Oncol, Durham, NC USA.
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- Tomassetti, Paola (author)
- Univ Hosp St Orsola, Dept Med & Surg Sci, Bologna, Italy.
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- Weber, Matthias M. (author)
- Johannes Gutenberg Univ Mainz, Med Klin & Poliklin, D-55122 Mainz, Germany.
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- Fogelman, David R. (author)
- Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Houston, TX 77030 USA.
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- Ramage, John (author)
- North Hampshire Hosp, Gastroenterol Unit, Basingstoke, Hants, England.
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- Poon, Donald (author)
- Raffles Hosp, Dept Med Oncol, Singapore, Singapore.;Duke NUS Grad Med Sch, Singapore, Singapore.
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- Gadbaw, Brian (author)
- Novartis Pharmaceut, E Hanover, NJ USA.
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- Li, Jiang (author)
- Novartis Pharmaceut, E Hanover, NJ USA.
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- Pasieka, Janice L. (author)
- Foothills Prov Gen Hosp, Surg & Oncol Fac Med, Calgary, AB T2N 2T9, Canada.
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- Mahamat, Abakar (author)
- CHU Nice, Hop Archet, Dept Gastrointestinal Oncol, F-06202 Nice, France.
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- Swahn, Fredrik (author)
- Karolinska Univ Sjukhuset, Dept Clin Sci Intervent & Technol, Stockholm, Sweden.
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- Newell-Price, John (author)
- Univ Sheffield, Sch Med & Biomed Sci, Dept Human Metab, Sheffield, S Yorkshire, England.;Sheffield Teaching Hosp NHS Fdn Trust, Sheffield, S Yorkshire, England.
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- Mansoor, Wasat (author)
- Christie NHS Fdn Trust, Dept Med Oncol, Manchester, Lancs, England.
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- Öberg, Kjell (author)
- Uppsala universitet,Endokrin Onkologi
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Univ Kentucky, Markey Canc Ctr, Lexington, KY 40536 USA Maria Sklodowska Curie Mem Canc Ctr, Dept Nucl Med & Endocrine Oncol, Gliwice, Poland.;Inst Oncol, Gliwice Branch, Gliwice, Poland. (creator_code:org_t)
- 2015
- 2015
- English.
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In: Drug Design, Development and Therapy. - 1177-8881. ; 9, s. 5075-5086
- Related links:
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.2...
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Abstract
Subject headings
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- In a randomized, double-blind, Phase III study, we compared pasireotide long-acting release (pasireotide LAR) with octreotide long-acting repeatable (octreotide LAR) in managing carcinoid symptoms refractory to first-generation somatostatin analogues. Adults with carcinoid tumors of the digestive tract were randomly assigned (1:1) to receive pasireotide LAR (60 mg) or octreotide LAR (40 mg) every 28 days. Primary outcome was symptom control based on frequency of bowel movements and flushing episodes. Objective tumor response was a secondary outcome. Progression-free survival (PFS) was calculated in a post hoc analysis. Adverse events were recorded. At the time of a planned interim analysis, the data monitoring committee recommended halting the study because of a low predictive probability of showing superiority of pasireotide over octreotide for symptom control (n=43 pasireotide LAR, 20.9%; n=45 octreotide LAR, 26.7%; odds ratio, 0.73; 95% confidence interval [CI], 0.27-1.97; P=0.53). Tumor control rate at month 6 was 62.7% with pasireotide and 46.2% with octreotide (odds ratio, 1.96; 95% CI, 0.89-4.32; P=0.09). Median (95% CI) PFS was 11.8 months (11.0 - not reached) with pasireotide versus 6.8 months (5.6 - not reached) with octreotide (hazard ratio, 0.46; 95% CI, 0.20-0.98; P=0.045). The most frequent drug-related adverse events (pasireotide vs octreotide) included hyperglycemia (28.3% vs 5.3%), fatigue (11.3% vs 3.5%), and nausea (9.4% vs 0%). We conclude that, among patients with carcinoid symptoms refractory to available somatostatin analogues, similar proportions of patients receiving pasireotide LAR or octreotide LAR achieved symptom control at month 6. Pasireotide LAR showed a trend toward higher tumor control rate at month 6, although it was statistically not significant, and was associated with a longer PFS than octreotide LAR.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- neuroendocrine tumors
- carcinoid syndrome
- somatostatin analogues
- pasireotide
- symptom control
- progression-free survival
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Wolin, Edward M.
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Jarzab, Barbara
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Eriksson, Barbro
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Walter, Thomas
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Toumpanakis, Chr ...
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Morse, Michael A ...
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show more...
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Tomassetti, Paol ...
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Weber, Matthias ...
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Fogelman, David ...
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Ramage, John
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Poon, Donald
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Gadbaw, Brian
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Li, Jiang
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Pasieka, Janice ...
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Mahamat, Abakar
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Swahn, Fredrik
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Newell-Price, Jo ...
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Mansoor, Wasat
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Öberg, Kjell
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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 Cancer and Oncol ...
- Articles in the publication
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Drug Design, Dev ...
- By the university
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Uppsala University