Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues

Drug Design, Development and Therapy

Volumn 9, Issue , 2015, Pages 5075-5086

  Wolin, Edward M ^a   Jarzab, Barbara ^b   Eriksson, Barbro ^c   Walter, Thomas ^d   Toumpanakis, Christos ^e   Morse, Michael A ^f   Tomassetti, Paola ^g   Weber, Matthias M ^h   Fogelman, David R ⁱ   Ramage, John ^j   Poon, Donald ^k   Gadbaw, Brian ^l   Li, Jiang ^l   Pasieka, Janice L ^m   Mahamat, Abakar ⁿ   Swahn, Fredrik ^o   Newell Price, John ^p   Mansoor, Wasat ^q   Öberg, Kjell ^c  

^a UNIVERSITY OF KENTUCKY   (United States)

^b INSTITUTE OF ONCOLOGY   (Poland)

^c UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^d EDOUARD HERRIOT HOSPITAL   (France)

^e ROYAL FREE HOSPITAL   (United Kingdom)

^f DUKE UNIVERSITY MEDICAL CENTER   (United States)

^g UNIVERSITY OF BOLOGNA   (Italy)

^h JOHANNES GUTENBERG UNIVERSITY   (Germany)

ⁱ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^j NORTH HAMPSHIRE HOSPITAL   (United Kingdom)

^k DUKE NUS MEDICAL SCHOOL   (Singapore)

^l NOVARTIS PHARMA AG   (Switzerland)

^m FOOTHILLS HOSPITAL   (Canada)

ⁿ CENTRE HOSPITALIER UNIVERSITAIRE DE NICE   (France)

^o KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^p UNIVERSITY OF SHEFFIELD   (United Kingdom)

^q CHRISTIE HOSPITAL   (United Kingdom)

more..

Author keywords

Carcinoid syndrome; Neuroendocrine tumors; Pasireotide; Progression free survival; Somatostatin analogues; Symptom control

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ANGIOPEPTIN; ANTIDIABETIC AGENT; ASPARTATE AMINOTRANSFERASE; HEMOGLOBIN A1C; OCTREOTIDE; PASIREOTIDE; ANTINEOPLASTIC AGENT; DELAYED RELEASE FORMULATION; SOMATOSTATIN;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BRADYCARDIA; CANCER CONTROL; CANCER SURVIVAL; CARCINOID; CHOLELITHIASIS; COLON TUMOR; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIABETES MELLITUS; DIARRHEA; DIGESTIVE SYSTEM TUMOR; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG RELEASE; DRUG RESPONSE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSESTHESIA; FATIGUE; FEMALE; FLATULENCE; HEMOGLOBIN BLOOD LEVEL; HOT FLUSH; HUMAN; HYPERGLYCEMIA; HYPERHIDROSIS; HYPERTRANSAMINASEMIA; HYPOKALEMIA; INJECTION SITE PAIN; LIVER TUMOR; LUNG TUMOR; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROENDOCRINE TUMOR; ORTHOSTATIC HYPOTENSION; PAIN; PANCREAS TUMOR; PHASE 3 CLINICAL TRIAL; POST HOC ANALYSIS; PREDICTIVE VALUE; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SMALL INTESTINE TUMOR; STOMACH CARCINOID; STOMACH TUMOR; SURVIVAL TIME; TREATMENT DURATION; UNCONSCIOUSNESS; URINE LEVEL; ANALOGS AND DERIVATIVES; CARCINOID TUMOR; CLINICAL TRIAL; COMPARATIVE STUDY; DELAYED RELEASE FORMULATION; DIGESTIVE SYSTEM NEOPLASMS; DISEASE FREE SURVIVAL; DRUG RESISTANCE; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; ODDS RATIO; PATHOLOGY; PROPORTIONAL HAZARDS MODEL; SECONDARY; STATISTICAL MODEL; TIME FACTOR; TREATMENT OUTCOME; TUMOR VOLUME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOID TUMOR; DELAYED-ACTION PREPARATIONS; DIGESTIVE SYSTEM NEOPLASMS; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; DRUG RESISTANCE, NEOPLASM; DRUG SUBSTITUTION; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LOGISTIC MODELS; MALE; MIDDLE AGED; OCTREOTIDE; ODDS RATIO; PROPORTIONAL HAZARDS MODELS; SOMATOSTATIN; TIME FACTORS; TREATMENT OUTCOME; TUMOR BURDEN;

EID: 84940995259     PISSN: 11778881     EISSN: 11778881     Source Type: Journal    
DOI: 10.2147/DDDT.S84177     Document Type: Article

References (19)

1. Vinik AI, Woltering EA, Warner RR, et al; North American Neuroendocrine Tumor Society (NANETS). NANETS consensus guidelines for the diagnosis of neuroendocrine tumor. Pancreas. 2010;39(6):713-734.
2. Yao JC, Hassan M, Phan A, et al. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008;26(18):3063-3072.
3. Klöppel G. Tumour biology and histopathology of neuroendocrine tumours. Best Pract Res Clin Endocrinol Metab. 2007;21(1):15-31.
4. National Cancer Institute. General Information about Gastrointestinal Carcinoid Tumors. NCI Web site. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/gastrointestinalcarcinoid/HealthProfessional/page1#Section_231. Accessed August 25, 2014.
5. National Comprehensive Cancer Network. Clinical practice Guideline in Oncology. Neuroendocrine Tumors Version 2. 2014. NCCN Web site. Available from: http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed August 25, 2014.
6. Modlin IM, Kidd M, Latich I, Zikusoka MN, Shapiro MD. Current status of gastrointestinal carcinoids. Gastroenterology. 2005;128(6):1717-1751.
7. Pavel M, Baudin E, Couvelard A, et al; Barcelona Consensus Conference participants. ENETS consensus guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012;95(2):157-176.
8. Kvols LK, Moertel CG, O'Connell MJ, Schutt AJ, Rubin J, Hahn RG. Treatment of the malignant carcinoid syndrome: evaluation of a long-acting somatostatin analogue. N Engl J Med. 1986;315(11):663-666.
9. Vinik A, Wolin EM, Audry H, Gomez-Panzani EL; ELECT Study Group. ELECT: a phase 3 study of efficacy and safety of lanreotide autogel/depot (LAN) treatment for carcinoid syndrome in patients with neuroendocrine tumors (NETs) [abstract]. J Clin Oncol. 2014;32(3 suppl):268.
10. Öberg KE. The management of neuroendocrine tumours: current and future medical therapy options. Clin Oncol (R Coll Radiol). 2012;24(4):282-293.
11. Schmid HA. Pasireotide (SOM230): development, mechanism of action and potential applications. Mol Cell Endocrinol. 2008;286(1-2):69-74.
12. Plöckinger U, Wiedenmann B. Treatment of gastroenteropancreatic neuroendocrine tumors. Virchows Arch. 2007;451(suppl 1):S71-S80.
13. Kvols LK, Oberg KE, O'Dorisio TM, et al. Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study. Endocr-Relat Cancer. 2012;19(5):657-666.
14. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92(3):205-216.
15. National Cancer Institute. Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Cancer Therapy Evaluation Program Web site. Available from: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed August 25, 2014.
16. Toumpanakis C, Caplin ME. Update on the role of somatostatin analogs for the treatment of patients with gastroenteropancreatic neuroendocrine tumors. Semin Oncol. 2013;40(1):56-68.
17. Rinke A, Müller HH, Schade-Brittinger C, et al; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009;27(28):4656-4663.
18. Caplin ME, Pavel M, Ćwikła JB, et al; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224-233.
19. Strosberg JR, Jump H, Valone T, Weber J, Khandelwal V, Kunz P. Phase II clinical trial of pasireotide LAR in patients with metastatic neuroendocrine tumors [abstract]. J Clin Oncol. 2014;32(3 suppl):241.