Sunitinib for advanced pancreatic neuroendocrine tumors

Expert Review of Anticancer Therapy

Volumn 11, Issue 12, 2011, Pages 1817-1827

  Hubner, Richard A ^a   Valle, Juan W ^a,b  

^a CHRISTIE HOSPITAL   (United Kingdom)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

angiogenesis; pancreatic neuroendocrine tumor; sunitinib; VEGFR

Indexed keywords

ALPHA INTERFERON; IMATINIB; PLACEBO; SOMATOSTATIN DERIVATIVE; SUNITINIB;

ABDOMINAL PAIN; ADVANCED CANCER; ANEMIA; ANOREXIA; ARTICLE; BLEEDING; CANCER SURVIVAL; CARCINOGENESIS; CEREBROVASCULAR ACCIDENT; CONGESTIVE HEART FAILURE; DEPIGMENTATION; DIARRHEA; DISEASE ASSOCIATION; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ABSORPTION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; EPISTAXIS; ERYTHEMA; FACE EDEMA; FATIGUE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL STROMAL TUMOR; HAIR DISEASE; HAND FOOT SYNDROME; HEMATOLOGIC DISEASE; HEMOLYTIC ANEMIA; HUMAN; HYPERTENSION; HYPONATREMIA; HYPOTHYROIDISM; KIDNEY CARCINOMA; LUNG EMBOLISM; METASTASIS; MICROANGIOPATHY; MOLECULAR PATHOLOGY; NAUSEA; NEUROENDOCRINE TUMOR; NEUTROPENIA; NONHUMAN; OVERALL SURVIVAL; PANCREAS TUMOR; PERIPHERAL EDEMA; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SKIN DISEASE; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; THYROID DISEASE; VESICULAR RASH;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; INDOLES; NEUROENDOCRINE TUMORS; PANCREATIC NEOPLASMS; PYRROLES;

EID: 82355171773     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.11.171     Document Type: Article

References (56)

1. 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. 26, 3063-3072 (2008).
2. Yao JC, Eisner MP, Leary C et al. Population-based study of islet cell carcinoma. Ann. Surg. Oncol. 14, 3492-3500 (2007). (Pubitemid 350160130)
3. Ehehalt F, Saeger HD, Schmidt CM et al. Neuroendocrine tumors of the pancreas. Oncologist 14, 456-467 (2009).
4. Rinke A, Muller HH, Schade-Brittinger C et al. 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. 27, 4656-4663 (2009).
5. Modlin IM, Oberg K, Chung DC et al. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 9, 61-72 (2008).
6. Moertel CG, Hanley JA, Johnson LA. Streptozocin alone compared with streptozocin plus fluorouracil in the treatment of advanced islet-cell carcinoma. N. Engl. J. Med. 303, 1189-1194 (1980). (Pubitemid 11207582)
7. Kouvaraki MA, Ajani JA, Hoff P et al. Fluorouracil, doxorubicin, and streptozocin in the treatment of patients with locally advanced and metastatic pancreatic endocrine carcinomas. J. Clin. Oncol. 22, 4762-4771 (2004).
8. Kulke MH, Stuart K, Enzinger PC et al. Phase II study of temozolomide and thalidomide in patients with metastatic neuroendocrine tumors. J. Clin. Oncol. 24, 401-406 (2006). (Pubitemid 46630459)
9. Turner NC, Strauss SJ, Sarker D et al. Chemotherapy with 5-fluorouracil, cisplatin and streptozocin for neuroendocrine tumours. Br. J. Cancer 102, 1106-1112 (2010).
10. Mendel DB, Laird AD, Xin X et al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/ pharmacodynamic relationship. Clin. Cancer Res. 9, 327-337 (2003). (Pubitemid 36109749)
11. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N. Engl. J. Med. 356, 115-124 (2007). (Pubitemid 46089672)
12. Demetri GD, van Oosterom AT, Garrett CR et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 368, 1329-1338 (2006). (Pubitemid 44528723)
13. Sun L, Liang C, Shirazian S et al. Discovery of 5-[5-fluoro-2-oxo-1,2- dihydroindol-(3Z)-ylidenemethyl]-2,4- dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide, a novel tyrosine kinase inhibitor targeting vascular endothelial and platelet-derived growth factor receptor tyrosine kinase. J. Med. Chem. 46, 1116-1119 (2003). (Pubitemid 36428215)
14. Christofori G, Naik P, Hanahan D. Vascular endothelial growth factor and its receptors, flt-1 and flk-1, are expressed in normal pancreatic islets and throughout islet cell tumorigenesis. Mol. Endocrinol. 9, 1760-1770 (1995).
15. Terris B, Scoazec JY, Rubbia L et al. Expression of vascular endothelial growth factor in digestive neuroendocrine tumours. Histopathology 32, 133-138 (1998). (Pubitemid 28126179)
16. Turner HE, Harris AL, Melmed S et al. Angiogenesis in endocrine tumors. Endocr. Rev. 24, 600-632 (2003). (Pubitemid 37330584)
17. La Rosa S, Uccella S, Finzi G et al. Localization of vascular endothelial growth factor and its receptors in digestive endocrine tumors: correlation with microvessel density and clinicopathologic features. Hum. Pathol. 34, 18-27 (2003). (Pubitemid 36160017)
18. Inoue M, Hager JH, Ferrara N et al. VEGF-A has a critical, nonredundant role in angiogenic switching and pancreatic beta cell carcinogenesis. Cancer Cell 1(2), 193-202 (2002). (Pubitemid 41039165)
19. Casanovas O, Hicklin DJ, Bergers G et al. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 8, 299-309 (2005). (Pubitemid 41443415)
20. Albrecht I, Kopfstein L, Strittmatter K et al. Suppressive effects of vascular endothelial growth factor-B on tumor growth in a mouse model of pancreatic neuroendocrine tumorigenesis. PLoS One 5, e14109 (2010).
21. Chaudhry A, Papanicolaou V, Oberg K et al. Expression of platelet-derived growth factor and its receptors in neuroendocrine tumors of the digestive system. Cancer Res. 52, 1006-1012 (1992).
22. Pietras K, Hanahan D. A multitargeted, metronomic, and maximum-tolerated dose 'chemo-switch' regimen is antiangiogenic, producing objective responses and survival benefit in a mouse model of cancer. J. Clin. Oncol. 23, 939-952 (2005). (Pubitemid 46202314)
23. Bergers G, Song S, Meyer-Morse N et al. Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J. Clin. Invest. 111, 1287-1295 (2003). (Pubitemid 36554699)
24. Koch CA, Gimm O, Vortmeyer AO et al. Does the expression of c-kit (CD117) in neuroendocrine tumors represent a target for therapy? Ann. NY Acad. Sci. 1073, 517-526 (2006). (Pubitemid 44912046)
25. Chow LQ, Eckhardt SG: Sunitinib: from rational design to clinical efficacy. J. Clin. Oncol. 25, 884-896 (2007). (Pubitemid 350002890)
26. Osusky KL, Hallahan DE, Fu A et al. The receptor tyrosine kinase inhibitor SU11248 impedes endothelial cell migration, tubule formation, and blood vessel formation in vivo, but has little effect on existing tumor vessels. Angiogenesis 7, 225-233 (2004).
27. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 64, 7099-7109 (2004). (Pubitemid 39331023)
28. Podar K, Tonon G, Sattler M et al. The small-molecule VEGF receptor inhibitor pazopanib (GW786034B) targets both tumor and endothelial cells in multiple myeloma. Proc. Natl Acad. Sci. USA 103, 19478-19483 (2006). (Pubitemid 46026056)
29. Buchdunger E, Cioffi CL, Law N et al. Abl protein-tyrosine kinase inhibitor STI571 inhibits in vitro signal transduction mediated by c-kit and platelet-derived growth factor receptors. J. Pharmacol. Exp. Ther. 295, 139-145 (2000).
30. Baratte S, Sarati S, Frigerio E et al. Quantitation of SU1 1248, an oral multi-target tyrosine kinase inhibitor, and its metabolite in monkey tissues by liquid chromatograph with tandem mass spectrometry following semi-automated liquid-liquid extraction. J. Chromatogr. A. 1024, 87-94 (2004). (Pubitemid 37532538)
31. O'Farrell AM, Foran JM, Fiedler W et al. An innovative Phase I clinical study demonstrates inhibition of FLT3 phosphorylation by SU11248 in acute myeloid leukemia patients. Clin. Cancer Res. 9, 5465-5476 (2003). (Pubitemid 37499464)
32. Faivre S, Delbaldo C, Vera K et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J. Clin. Oncol. 24, 25-35 (2006). (Pubitemid 46630490)
33. Motzer RJ, Michaelson MD, Redman BG et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J. Clin. Oncol. 24, 16-24 (2006). (Pubitemid 46630489)
34. Escudier B, Roigas J, Gillessen S et al. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J. Clin. Oncol. 27, 4068-4075 (2009).
35. Deprimo SE, Bello CL, Smeraglia J et al. Circulating protein biomarkers of pharmacodynamic activity of sunitinib in patients with metastatic renal cell carcinoma: modulation of VEGF and VEGF-related proteins. J. Transl. Med. 5, 32 (2007).
36. George S, Blay JY, Casali PG et al. Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure. Eur. J. Cancer 45, 1959-1968 (2009).
37. Novello S, Scagliotti GV, Rosell R et al. Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Br. J. Cancer 101, 1543-1548 (2009).
38. Kulke MH, Lenz HJ, Meropol NJ et al. Activity of sunitinib in patients with advanced neuroendocrine tumors. J. Clin. Oncol. 26, 3403-3410 (2008).
39. 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. 92, 205-216 (2000). (Pubitemid 30099779)
40. Hobday TJ, Rubin J, Holen K et al. MC044h, a Phase II trial of sorafenib in patients with metastatic neuroendocrine tumours (NET): a Phase II Consortium (P2C) study. J. Clin. Oncol. 25, 199s (2007) (Abstract 4504).
41. Phan AT, Yao JC, Fogelman DR et al. A prospective, multi-institutional Phase II study of GW786034 (pazopanib) and depot octreotide (sandostatin LAR) in advanced low-grade neuroendocrine carcinoma (LGNEC). J. Clin. Oncol. 28, 301s (2010) (Abstract 4001).
42. Raymond E, Dahan L, Raoul JL et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N. Engl. J. Med. 364, 501-513 (2011).
43. Van Cutsem E, Seitz JF, Raoul JL et al. Evaluation of progression-free survival by blinded independent central review in patients with progressive, well-differentiated pancreatic neuroendocrine tumours treated with sunitinib or placebo. J. Clin. Oncol. 29(Suppl. 4), (2011) (Abstract 219).
44. Raymond E, Niccoli P, Raoul JL et al. Updated overall survival and progression-free survival by blinded independent central review of sunitinib versus placebo for patients with advanced unresectable pancreatic neuroendocrine tumours. J. Clin. Oncol. 29 (2011) (Abstract 4008).
45. Desai J, Dileo P, Morgan JA et al. Hypothyroidism may accompany SU11248 therapy in a subset of patients (pts) with metastatic (met) gastrointestinal stromal tumors (GIST) and is manageable with replacement therapy. J. Clin. Oncol. 23, 201s (2005) (Abstract 3040).
46. Rini BI, Tamaskar I, Shaheen P et al. Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J. Natl Cancer Inst. 99, 81-83 (2007).
47. Sutent®, Summary of product characteristics. Pfizer Ltd, NY, USA (2010).
48. Yao JC, Shah MH, Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumors. N. Engl. J. Med. 364, 514-523 (2011).
49. Missiaglia E, Dalai I, Barbi S et al. Pancreatic endocrine tumors: expression profiling evidences a role for AKT-mTOR pathway. J. Clin. Oncol. 28, 245-255 (2010).
50. Von Wichert G, Jehle PM, Hoeflich A et al. Insulin-like growth factor-I is an autocrine regulator of chromogranin A secretion and growth in human neuroendocrine tumor cells. Cancer Res. 60, 4573-4581 (2000). (Pubitemid 32103642)
51. Zitzmann K, De Toni EN, Brand S et al. The novel mTOR inhibitor RAD001 (everolimus) induces antiproliferative effects in human pancreatic neuroendocrine tumor cells. Neuroendocrinology 85, 54-60 (2007). (Pubitemid 46550026)
52. Yao JC, Lombard-Bohas C, Baudin E et al. Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: a Phase II trial. J. Clin. Oncol. 28, 69-76 (2010).
53. Yao JC, Phan AT, Fogelman DR et al. Randomized run-in study of bevacizumab (B) and everolimus (E) in low- to intermediate-grade neuroendocrine tumours (LGNETs) using perfusion CT as functional biomarker. J. Clin. Oncol. 28 (2010) (Abstract 4002).
54. Kunz PL, Kuo T, Zahn JM et al. A Phase II study of capecitabine, oxaliplatin, and bevacizumab for metastatic or unresectable neuroendocrine tumors. J. Clin. Oncol. 28 (2010) (Abstract 41040).
55. Kulke MH, Siu LL, Tepper JE et al. Future directions in the treatment of neuroendocrine tumors: consensus report of the National Cancer Institute Neuroendocrine Tumor clinical trials planning meeting. J. Clin. Oncol. 29, 934-943 (2011).
56. Yao JC, Shah MH, Ito T et al. Phase III randomised trial of everolimus (RAD001) vs placebo in advanced pancreatic NET (RADIANT-3). Presented at: 35th ESMO Congress. Milan, Italy, 8-11 October 2010 (Abstract LBA9).