Safety review: Dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors

Advances in Therapy

Volumn 28, Issue 10, 2011, Pages 825-841

  Ludlam, William H ^a   Anthony, Lowell ^b  

^a SWEDISH MEDICAL CENTER   (United States)

^b UNIVERSITY OF KENTUCKY   (United States)

Author keywords

acromegaly; dose optimization; lanreotide; neuroendocrine tumors; octreotide; safety; somatostatin analogs

Indexed keywords

ANGIOPEPTIN; BROMOCRIPTINE; CABERGOLINE; DOPAMINE RECEPTOR STIMULATING AGENT; GROWTH HORMONE; OCTREOTIDE; PEGVISOMANT; PLACEBO; SOMATOMEDIN C; SOMATOSTATIN DERIVATIVE;

ABDOMINAL PAIN; ACROMEGALY; ALOPECIA; ANOREXIA; ARTHROPATHY; ASTHENIA; BILE DUCT DILATATION; BIOCHEMISTRY; BLOATING; BRADYCARDIA; CHEMOEMBOLIZATION; CHOLELITHIASIS; CONSTIPATION; CYTOREDUCTIVE SURGERY; DIARRHEA; DISEASE CONTROL; DIZZINESS; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FLATULENCE; GALLBLADDER DISEASE; GALLSTONE; HEADACHE; HEART ARRHYTHMIA; HEART MUSCLE CONDUCTION DISTURBANCE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; HYPOTHYROIDISM; INDIVIDUALIZATION; INJECTION SITE PAIN; INJECTION SITE REACTION; LOOSE FECES; MEDICAL LITERATURE; MEDICAL RESEARCH; MEDLINE; META ANALYSIS (TOPIC); METHODOLOGY; NAUSEA; NEUROENDOCRINE TUMOR; PAIN; PATIENT CARE; PATIENT COMPLIANCE; PATIENT MONITORING; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; QUALITY OF LIFE; RADIOFREQUENCY ABLATION; REVIEW; RISK ASSESSMENT; SYSTEMATIC REVIEW; TRANSSPHENOIDAL SURGERY; TREATMENT OUTCOME; VOMITING;

ACROMEGALY; ANTINEOPLASTIC AGENTS; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOXICITY; HUMANS; NEUROENDOCRINE TUMORS; OCTREOTIDE; PEPTIDES, CYCLIC; SOMATOSTATIN;

EID: 82355175321     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-011-0062-9     Document Type: Review

References (62)

1. I.M. Modlin I. Latich M. Kidd M. Zikusoka G. Eick 2006 Therapeutic options for gastrointestinal carcinoids Clin Gastroenterol Hepatol 4 526 547 16630755 10.1016/j.cgh.2005.12.008 1:CAS:528:DC%2BD28XlsVeqsrg%3D
2. S.M. Webb 2006 Quality of life in acromegaly Neuroendocrinology 83 224 229 17047387 10.1159/000095532 1:CAS:528:DC%2BD28XhtV2hu7vI (Pubitemid 44578876)
3. S. Melmed A. Colao A. Barkan, et al. 2009 Guidelines for acromegaly management: an update J Clin Endocrinol Metab 94 1509 1517 19208732 10.1210/jc.2008-2421 1:CAS:528:DC%2BD1MXlvVCqsbk%3D
4. E.T. Janson H. Sorbye S. Welin, et al. 2010 Nordic Guidelines 2010 for diagnosis and treatment of gastroenteropancreatic neuroendocrine tumours Acta Oncol 49 740 756 20553100 10.3109/0284186X.2010.492791 1:CAS:528: DC%2BC3cXos1KjsLs%3D
5. L. Anthony P.U. Freda 2009 From somatostatin to octreotide LAR: evolution of a somatostatin analogue Curr Med Res Opin 25 2989 2999 19842996 10.1185/03007990903328959 1:CAS:528:DC%2BD1MXhsVCrsLvE
6. W. Bauer U. Briner W. Doepfner, et al. 1982 SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action Life Sci 31 1133 1140 6128648 10.1016/0024-3205(82)90087-X 1:CAS:528: DyaL38XlslGhtLg%3D (Pubitemid 13243115)
7. T. Delaunoit J. Rubin F. Neczyporenko C. Erlichman T.J. Hobday 2005 Somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine tumors Mayo Clin Proc 80 502 506 15819288 10.4065/80.4.502 1:CAS:528: DC%2BD2MXjsF2jurY%3D (Pubitemid 40471383)
8. H.A. Schmid 2008 Pasireotide (SOM230): development, mechanism of action and potential applications Mol Cell Endocrinol 286 69 74 17977644 10.1016/j.mce.2007.09.006 1:CAS:528:DC%2BD1cXmtVSmtbs%3D (Pubitemid 351680237)
9. S. Melmed F. Casanueva F. Cavagnini, et al. 2005 Consensus statement: medical management of acromegaly Eur J Endocrinol 153 737 740 16322377 10.1530/eje.1.02036 1:CAS:528:DC%2BD28XjtVWnsQ%3D%3D (Pubitemid 43020222)
10. NCCN Practice Guidelines in Oncology? Neuroendocrine Tumors (Version 1.0). 2011 National Comprehensive Cancer Network, Inc. 2011. Available at: http://www.nccn.org. Last accessed September 5, 2011.
11. K. Oberg 2004 Neuroendocrine tumors Ann Oncol 15 iv293 iv2989 15477324 10.1093/annonc/mdh216 (Pubitemid 39004355)
12. A.F. Daly M. Rixhon C. Adam A. Dempegioti M.A. Tichomirowa A. Beckers 2006 High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium J Clin Endocrinol Metab 91 4769 4775 16968795 10.1210/jc.2006-1668 1:CAS:528:DC%2BD28XhtlGru77F (Pubitemid 44917305)
13. I.M. Holdaway C. Rajasoorya 1999 Epidemiology of acromegaly Pituitary 2 29 41 11081170 10.1023/A:1009965803750 1:STN:280:DC%2BD3M%2FksFKjtA%3D%3D
14. H.J. Schneider C. Sievers B. Saller H.U. Wittchen G.K. Stalla 2008 High prevalence of biochemical acromegaly in primary care patients with elevated IGF-1 levels Clin Endocrinol (Oxf) 69 432 435 10.1111/j.1365-2265.2008.03221.x 1:CAS:528:DC%2BD1cXhtFentbzP
15. S. Melmed 2006 Medical progress: Acromegaly N Engl J Med 355 2558 2573 17167139 10.1056/NEJMra062453 1:CAS:528:DC%2BD28XhtlWqsbzK (Pubitemid 44917504)
16. J. Ayuk M.C. Sheppard 2008 Does acromegaly enhance mortality? Rev Endocr Metab Disord 9 33 39 18075787 10.1007/s11154-007-9067-8
17. I.M. Holdaway M.J. Bolland G.D. Gamble 2008 A metaanalysis of the effect of lowering serum levels of GH and IGF-I on mortality in acromegaly Eur J Endocrinol 159 89 95 18524797 10.1530/EJE-08-0267 1:CAS:528:DC%2BD1cXhtVOhs7vL
18. N.R. Biermasz A.M. Pereira J.W. Smit J.A. Romijn F. Roelfsema 2005 Morbidity after long-term remission for acromegaly: persisting joint-related complaints cause reduced quality of life J Clin Endocrinol Metab 90 2731 2739 15741257 10.1210/jc.2004-2297 1:CAS:528:DC%2BD2MXkt1Wgsbc%3D (Pubitemid 40686317)
19. I.M. Holdaway R.C. Rajasoorya G.D. Gamble 2004 Factors influencing mortality in acromegaly J Clin Endocrinol Metab 89 667 674 14764779 10.1210/jc.2003-031199 1:CAS:528:DC%2BD2cXhsFOjsLY%3D (Pubitemid 38269875)
20. A. Colao D. Ferone P. Marzullo G. Lombardi 2004 Systemic complications of acromegaly: epidemiology, pathogenesis, and management Endocr Rev 25 102 152 14769829 10.1210/er.2002-0022 1:CAS:528:DC%2BD2cXhvFOmt7w%3D (Pubitemid 38269977)
21. AACE Acromegaly Guidelines Task Force. 2004 AACE Medical Guidelines for Clinical Practice for the diagnosis and treatment of acromegaly Endocr Pract 10 213 225
22. A. Giustina A. Barkan F.F. Casanueva, et al. 2000 Criteria for cure of acromegaly: a consensus statement J Clin Endocrinol Metab 85 526 529 10690849 10.1210/jc.85.2.526 1:CAS:528:DC%2BD3cXhtlyhtLw%3D (Pubitemid 32273628)
23. C. Beauregard U. Truong J. Hardy O. Serri 2003 Long-term outcome and mortality after transsphenoidal adenomectomy for acromegaly Clin Endocrinol (Oxf) 58 86 91 10.1046/j.1365-2265.2003.01679.x (Pubitemid 36098853)
24. P. De D.A. Rees N. Davies, et al. 2003 Transsphenoidal surgery for acromegaly in wales: results based on stringent criteria of remission J Clin Endocrinol Metab 88 3567 3572 12915637 10.1210/jc.2002-021822 1:CAS:528:DC%2BD3sXmsFOksbs%3D (Pubitemid 37034496)
25. P. Nomikos M. Buchfelder R. Fahlbusch 2005 The outcome of surgery in 668 patients with acromegaly using current criteria of biochemical "cure" Eur J Endocrinol 152 379 387 15757854 10.1530/eje.1.01863 1:CAS:528: DC%2BD2MXivVClu7g%3D (Pubitemid 40439490)
26. I. Shimon Z.R. Cohen Z. Ram M. Hadani 2001 Transsphenoidal surgery for acromegaly: endocrinological follow-up of 98 patients Neurosurgery 48 1239 1243 11383725 1:STN:280:DC%2BD3MzhtV2qsg%3D%3D
27. S.M. Carlsen M. Lund-Johansen T. Schreiner, et al. 2008 Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial J Clin Endocrinol Metab 93 2984 2990 18492760 10.1210/jc.2008-0315 1:CAS:528:DC%2BD1cXpvVOmu70%3D
28. A. Colao R. Pivonello R.S. Auriemma, et al. 2006 Predictors of tumor shrinkage after primary therapy with somatostatin analogues in acromegaly: a prospective study in 99 patients J Clin Endocrinol Metab 91 2112 2118 16537687 10.1210/jc.2005-2110 1:CAS:528:DC%2BD28XlvVCgs7s%3D (Pubitemid 43854991)
29. S. Melmed R. Sternberg D. Cook, et al. 2005 A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly J Clin Endocrinol Metab 90 4405 4410 15827109 10.1210/jc.2004-2466 1:CAS:528: DC%2BD2MXmtlChs7k%3D (Pubitemid 41058228)
30. P.U. Freda L. Katznelson A.J. van der Lely C.M. Reyes S. Zhao D. Rabinowitz 2005 Long-acting somatostatin analog therapy of acromegaly: a meta-analysis J Clin Endocrinol Metab 90 4465 4473 15886238 10.1210/jc.2005-0260 1:CAS:528:DC%2BD2MXnvVWltL8%3D (Pubitemid 41159328)
31. Novartis Sandostatin LARDepot (octreotide acetate for injectable suspension) prescribing information. 2010. Available at: http://www.pharma.us. novartis.com/product/pi/pdf/sandostatin-lar.pdf. Last accessed September 5, 2011.
32. J. Ayuk M.C. Sheppard 2006 Growth hormone and its disorders Postgrad Med J 82 24 30 16397076 10.1136/pgmj.2005.036087 1:CAS:528:DC%2BD28Xht12htrc%3D (Pubitemid 43111799)
33. Somatuline Depot (lanreotide) injection prescribing information. Somatuline Depot (lanreotide) injection prescribing information. Ipsen. 2007.
34. P. Caron I. Morange-Ramos M. Cogne P. Jaquet 1997 Three year follow-up of acromegalic patients treated with intramuscular slow-release lanreotide J Clin Endocrinol Metab 82 18 22 8989225 10.1210/jc.82.1.18 1:CAS:528: DyaK2sXkt1SgsQ%3D%3D (Pubitemid 27021263)
35. T. Chen T.F. Miller P. Prasad, et al. 2000 Pharmacokinetics, pharmacodynamics, and safety of microencapsulated octreotide acetate in healthy subjects J Clin Pharmacol 40 475 481 10806600 10.1177/00912700022009242
36. M. Giusti E. Ciccarelli D. Dallabonzana, et al. 1997 Clinical results of long-term slow-release lanreotide treatment of acromegaly Eur J Clin Invest 27 277 284 9134375 10.1046/j.1365-2362.1997.1190659.x 1:CAS:528:DyaK2sXjtVajsbg%3D (Pubitemid 27163251)
37. A. Colao G. Lombardi 2010 Dose optimization of somatostatin analogues for acromegaly patients J Endocrinol Invest 33 125 127 20348838 1:CAS:528:DC%2BC3cXmsVKjtbo%3D
38. H.E. Turner V.A. Thornton-Jones J.A. Wass 2004 Systematic dose-extension of octreotide LAR: the importance of individual tailoring of treatment in patients with acromegaly Clin Endocrinol (Oxf) 61 224 231 10.1111/j.1365-2265. 2004.02084.x 1:CAS:528:DC%2BD2cXnslWlt78%3D (Pubitemid 39093118)
39. P. Chanson V. Boerlin C. Ajzenberg, et al. 2000 Comparison of octreotide acetate LAR and lanreotide SR in patients with acromegaly Clin Endocrinol (Oxf) 53 577 586 10.1046/j.1365-2265.2000.01134.x 1:CAS:528:DC%2BD3cXos1OqtrY%3D
40. R. Cozzi R. Attanasio M. Montini, et al. 2003 Four-year treatment with octreotide-long-acting repeatable in 110 acromegalic patients: predictive value of short-term results? J Clin Endocrinol Metab 88 3090 3098 12843148 10.1210/jc.2003-030110 1:CAS:528:DC%2BD3sXlslaitr8%3D (Pubitemid 36877477)
41. D.O. Yetkin S.N. Boysan O. Tiryakioglu A.S. Yalin P. Kadioglu 2007 Forty-month follow-up of persistent and difficultly controlled acromegalic patients treated with depot long acting somatostatin analog octreotide Endocr J 54 459 464 17495423 10.1507/endocrj.K06-100 1:CAS:528:DC%2BD2sXovFGmtLg%3D (Pubitemid 47105435)
42. C.L. Ronchi M. Boschetti E.C. Uberti, et al. 2007 Efficacy of a slow-release formulation of lanreotide (Autogel 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study Clin Endocrinol (Oxf) 67 512 519 1:CAS:528:DC%2BD2sXht1CltrzL (Pubitemid 47416307)
43. P. Chanson F. Borson-Chazot J.-M. Kuhn J. Blumberg P. Maisonobe B. Delemer 2008 Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly Clin Endocrinol (Oxf) 69 299 305 10.1111/j.1365-2265.2008.03208.x 1:CAS:528:DC%2BD1cXhtVarsL%2FJ (Pubitemid 352009031)
44. A. Giustina S. Bonadonna G. Bugari, et al. 2009 Highdose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial Eur J Endocrinol 161 331 338 19465485 10.1530/EJE-09-0372 1:CAS:528:DC%2BD1MXpvVyrs78%3D
45. K. Öberg L. Kvols M. Caplin, et al. 2004 Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system Ann Oncol 15 966 973 15151956 10.1093/annonc/ mdh216 (Pubitemid 39004355)
46. J.C. Yao M. Hassan A. Phan, et al. 2008 One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States J Clin Oncol 26 3063 3072 18565894 10.1200/JCO.2007.15.4377
47. T. Berge F. Linell 1976 Carcinoid tumours. Frequency in a defined population during a 12-year period Acta Pathol Microbiol Scand A 84 322 330 961424 1:STN:280:DyaE283nsVGjsg%3D%3D
48. G. Klöppel A. Perren P.U. Heitz 2004 The gastroenteropancreatic neuroendocrine cell system and its tumors: the WHO classification Ann N Y Acad Sci 1014 13 27 15153416 10.1196/annals.1294.002 (Pubitemid 38594787)
49. U. Plockinger G. Rindi R. Arnold, et al. 2004 Guidelines for the diagnosis and treatment of neuroendocrine gastrointestinal tumours. A consensus statement on behalf of the European Neuroendocrine Tumour Society (ENETS) Neuroendocrinology 80 394 424 15838182 10.1159/000085237 1:STN:280: DC%2BD2M3nt1Chtw%3D%3D (Pubitemid 40874886)
50. G. Rindi G. Kloppel H. Alhman, et al. 2006 TNM staging of foregut (neuro)endocrine tumors: a consensus proposal including a grading system Virchows Arch 449 395 401 16967267 10.1007/s00428-006-0250-1 1:STN:280:DC%2BD28rmtlGntA%3D%3D (Pubitemid 44451313)
51. G. Rindi G. Kloppel A. Couvelard, et al. 2007 TNM staging of midgut and hindgut (neuro) endocrine tumors: a consensus proposal including a grading system Virchows Arch 451 757 762 17674042 10.1007/s00428-007-0452-1 1:STN:280:DC%2BD2srnsVyjsw%3D%3D (Pubitemid 47497934)
52. I.M. Modlin S.F. Moss D.C. Chung R.T. Jensen E. Snyderwine 2008 Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors J Natl Cancer Inst 100 1282 1289 18780869 10.1093/jnci/djn275
53. G.A. Kaltsas G.M. Besser A.B. Grossman 2004 The diagnosis and medical management of advanced neuroendocrine tumors Endocr Rev 25 458 511 15180952 10.1210/er.2003-0014 1:CAS:528:DC%2BD2cXlvVeltLs%3D (Pubitemid 38780668)
54. I.M. Modlin K. Oberg D.C. Chung, et al. 2008 Gastroenteropancreatic neuroendocrine tumours Lancet Oncol 9 61 72 18177818 10.1016/S1470-2045(07) 70410-2 1:CAS:528:DC%2BD1cXivVOltQ%3D%3D
55. L.K. Kvols K.L. Brendtro 2010 The North American Neuroendocrine Tumor Society (NANETS) guidelines: mission, goals, and process Pancreas 39 705 706 20664469 10.1097/MPA.0b013e3181eb7451
56. M. Papotti S. Croce M. Bellò, et al. 2001 Expression of somatostatin receptor types 2, 3 and 5 in biopsies and surgical specimens of human lung tumours. Correlation with preoperative octreotide scintigraphy Virchows Arch 439 787 797 11787852 1:CAS:528:DC%2BD3MXoslSmtbk%3D (Pubitemid 33141324)
57. S.W. Lamberts A.J. van der Lely W.W. de Herder L.J. Hofland 1996 Octreotide N Engl J Med 334 246 254 8532003 10.1056/NEJM199601253340408 1:CAS:528:DyaK28Xhtl2rtrw%3D (Pubitemid 26030676)
58. A. Rinke H.-H. Müller C. Schade-Brittinger, et al. 2009 Placebo-controlled, double-blind, prospective, randomized study of 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 27 4656 4663 19704057 10.1200/JCO.2009.22.8510 1:CAS:528:DC%2BD1MXhtlGgtbnJ
59. L. Anthony D. Johnson K. Hande, et al. 1993 Somatostatin analogue phase I trials in neuroendocrine neoplasms Acta Oncol 32 217 223 7686764 10.3109/02841869309083915 1:STN:280:DyaK3szht1Grtw%3D%3D (Pubitemid 23188539)
60. P. Ruszniewski S. Ish-Shalom M. Wymenga, et al. 2004 Rapid and sustained relief from the symptoms of carcinoid syndrome: results from an open 6-month study of the 28-day prolonged-release formulation of lanreotide Neuroendocrinology 80 244 251 15627802 10.1159/000082875 1:CAS:528: DC%2BD2MXmsVOgug%3D%3D (Pubitemid 40187010)
61. S.H. Rosenoff N.Y. Gabrail R. Conklin, et al. 2006 A multicenter, randomized trial of long-acting octreotide for the optimum prevention of chemotherapy-induced diarrhea: results of the STOP trial J Support Oncol 4 289 294 16805331 1:CAS:528:DC%2BD28XmsVahsbc%3D (Pubitemid 44203632)
62. M.K. Chadha J. Lombardo T. Mashtare, et al. 2009 High-dose octreotide acetate for management of gastroenteropancreatic neuroendocrine tumors Anticancer Res 29 4127 4130 19846960 1:CAS:528:DC%2BD1MXhsVOlt7fP