Sunitinib in the treatment of advanced solid tumors

Recent Results in Cancer Research

Volumn 201, Issue , 2015, Pages 165-184

  Imbulgoda, Amal ^a   Heng, Daniel Y C ^a   Kollmannsberger, Christian ^b  

^a TOM BAKER CANCER CENTRE   (Canada)

^b BRITISH COLUMBIA CANCER AGENCY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

APREPITANT; BIOLOGICAL MARKER; CARBAMAZEPINE; DILTIAZEM; FLUOXETINE; GLIBENCLAMIDE; HYPERICUM PERFORATUM EXTRACT; KETOCONAZOLE; PHENYTOIN; PLACEBO; PROPRANOLOL; RIFAMPICIN; SUNITINIB; TROGLITAZONE; VERAPAMIL; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; PLATELET DERIVED GROWTH FACTOR RECEPTOR; PYRROLE DERIVATIVE; VASCULOTROPIN RECEPTOR;

ADVANCED CANCER; ARTICLE; BINDING AFFINITY; BINDING SITE; BLEEDING; BREAST TUMOR; CANCER FATIGUE; CANCER INHIBITION; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL EFFECTIVENESS; COLORECTAL CANCER; CONTINUOUS INFUSION; DIARRHEA; DRUG EFFICACY; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG RESPONSE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; GASTROINTESTINAL STROMAL TUMOR; GRAPEFRUIT JUICE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOTHYROIDISM; IC50; KIDNEY CARCINOMA; METASTASIS; METASTASIS POTENTIAL; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NON SMALL CELL LUNG CANCER; NONHUMAN; OVARY CANCER; OVERALL SURVIVAL; PANCREATIC NEUROENDOCRINE TUMOR; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN DISCOLORATION; SOLID TUMOR; STOMATITIS; SURVIVAL RATE; THYROID CANCER; ANIMAL; DRUG ANTAGONISM; NEOPLASM; REVIEW;

ANIMALS; ANTINEOPLASTIC AGENTS; HUMANS; INDOLES; NEOPLASMS; PYRROLES; RECEPTORS, PLATELET-DERIVED GROWTH FACTOR; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR;

EID: 84906929565     PISSN: 00800015     EISSN: 21976767     Source Type: Book Series    
DOI: 10.1007/978-3-642-54490-3_9     Document Type: Article

References (103)

1. ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma. http://clinicaltrials.gov/ct2/show/NCT00326898
2. Azizi M, Chedid A, Oudard S (2008) Home blood-pressure monitoring in patients receiving sunitinib. N Engl J Med 358:95–97
3. Banks RE, Tirukonda P, Taylor C et al (2006) Genetic and epigenetic analysis of von Hippel–Lindau (VHL) gene alterations and relationship with clinical variables in sporadic renal cancer. Cancer Res 66:2000–2011
4. Barrios CH, Liu MC, Lee SC et al (2010) Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat 121:121–131
5. Bergh J, Bondarenko IM, Lichinitser MR et al (2012) First-line treatment of advanced breast cancer with sunitinib in combination with docetaxel versus docetaxel alone: results of a prospective, randomized phase III study. J Clin Oncol 30:921–929
6. Biagi JJ, Oza AM, Grimshaw R et al (2008) A phase II study of sunitinib (SU11248) in patients (pts) with recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma—NCIC CTG IND 185. J Clin Oncol 26:5522
7. Blanke CD, Rankin C, Demetri GD et al (2008) Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol 26:626–632
8. Brauch H, Weirich G, Brieger J et al (2000) VHL alterations in human clear cell renal cell carcinoma: association with advanced tumor stage and a novel hot spot mutation. Cancer Res 60:1942–1948
9. Bukowski RM, Kabbinavar FF, Figlin RA et al (2007) Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol 25:4536–4541
10. Burstein HJ, Elias AD, Rugo HS et al (2008) Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 26:1810–1816
11. Carr LL, Mankoff DA, Goulart BH et al (2010) Phase II study of daily sunitinib in FDG-PETpositive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res 16:5260–5268
12. Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M et al (2013) Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol 31:1341–1347
13. Casanovas O, Hicklin DJ, Bergers G et al (2005) Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 8:299–309
14. Chaudhry A, Papanicolaou V, Oberg K et al (1992) Expression of platelet-derived growth factor and its receptors in neuroendocrine tumors of the digestive system. Cancer Res 52:1006–1012
15. Choueiri TK, Plantade A, Elson P et al (2008) Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol 26:127–131
16. Chow LQ, Eckhardt SG (2007) Sunitinib: from rational design to clinical efficacy. J Clin Oncol 25:884–896
17. Christensen JG (2007) A preclinical review of sunitinib, a multitargeted receptor tyrosine kinase inhibitor with anti-angiogenic and antitumour activities. Ann Oncol 18(10):3–10
18. Clifford SC, Prowse AH, Affara NA et al (1998) Inactivation of the von Hippel–Lindau (VHL) tumour suppressor gene and allelic losses at chromosome arm 3p in primary renal cell carcinoma: evidence for a VHL-independent pathway in clear cell renal tumourigenesis. Genes Chromosomes Cancer 22:200–209
19. Cohen HT, McGovern FJ (2005) Renal-cell carcinoma. N Engl J Med 353:2477–2490
20. Cohen EE, Needles BM, Cullen KJ et al (2008) Phase 2 study of sunitinib in refractory thyroid cancer. J Clin Oncol 26(9)
21. Cooney MM, Garcia J, Brell J et al (2007) A phase I study of bevacizumab in combination with sunitinib in advanced solid tumors. J Clin Oncol 25:15532
22. Coppin C, Porzsolt F, Awa A et al (2005) Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev (1):CD001425
23. Coppin C, Le L, Porzsolt F et al (2008) Targeted therapy for advanced renal cell carcinoma. Cochrane Database Syst Rev (2):CD006017
24. Corless CL, Fletcher JA, Heinrich MC (2004) Biology of gastrointestinal stromal tumors. J Clin Oncol 22:3813–3825
25. Davis MP, Goldstein D, George S et al (2011) Asthenia and fatigue as predictors of sunitinib efficacy in gastrointestinal stromal tumour (GIST). Eur J Cancer 47(1140)
26. Dematteo RP, Gold JS, Saran L et al (2008) Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer 112:608–615
27. Demetri GD, von Mehren M, Blanke CD et al (2002) Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347:472–480
28. Demetri GD, van Oosterom AT, Garrett CR et al (2006) Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 368:1329–1338
29. DePrimo SE, Huang X, Blackstein ME et al (2009) Circulating levels of soluble KIT serve as a biomarker for clinical outcome in gastrointestinal stromal tumor patients receiving sunitinib following imatinib failure. Clin Cancer Res 15:5869–5877
30. Donskov F, Cams A, Barrios CH et al (2011a) Neutropenia and thrombocytopenia during treatment as biomarkers of sunitinib efficacy in patients with metastatic renal cell carcinoma (mRCC). Eur J Cancer 47(1141)
31. Donskov F, von Mehren M, Cams A et al (2011b) Neutropenia as a biomarker of sunitinib efficacy in patients (Pts) with gastrointestinal stromal tumour (GIST). Eur J Cancer 47(1138)
32. Donskov F, Michaelson MD, Puzanov I et al (2012) Comparative assessment of sunitinibassociated adverse events as potential biomarkers of efficacy in metastatic renal cell carcinoma (mRCC). Ann Oncol 23(785)
33. Ehehalt F, Saeger HD, Schmidt CM et al (2009) Neuroendocrine tumors of the pancreas. Oncologist 14:456–467
34. Faivre S, Delbaldo C, Vera K et al (2006) Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 24:25–35
35. Feldman DR, Kondagunta GV, Ronnen EA et al (2007) Phase I trial of bevacizumab plus sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol 25:5099
36. Figlin RA, Hutson TE, Tomczak P et al (2008) Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J Clin Oncol 26:5024
37. Fjällskog ML, Lejonklou MH, Oberg KE et al (2003) Expression of molecular targets for tyrosine kinase receptor antagonists in malignant endocrine pancreatic tumors. Clin Cancer Res 9:1469–1473
38. Fjällskog ML, Hessman O, Eriksson B et al (2007) Upregulated expression of PDGF receptor beta in endocrine pancreatic tumors and metastases compared to normal endocrine pancreas. Acta Oncol 46:741–746
39. Foster K, Prowse A, van den Berg A et al (1994) Somatic mutations of the von Hippel–Lindau disease tumour suppressor gene in non-familial clear cell renal carcinoma. Hum Mol Genet 3:2169–2173
40. Garcia-Donas J, Esteban E, Leandro-García LJ et al (2011) Single nucleotide polymorphism associations with response and toxic effects in patients with advanced renal-cell carcinoma treated with first-line sunitinib: a multicentre, observational, prospective study. Lancet Oncol 12:1143–1150
41. George S, Blay JY, Casali PG et al (2008) Continuous daily dosing (CDD) of sunitinib (SU) in pts with advanced GIST: updated efficacy, safety, PK and pharmacodynamic analysis. J Clin Oncol 26:10554
42. George S, Merriam P, Maki RG et al (2009) Multicenter phase II trial of sunitinib in the treatment of nongastrointestinal stromal tumor sarcomas. J Clin Oncol 27:3154–3160
43. George S, Reichardt P, Lechner T et al (2012) Hypertension as a potential biomarker of efficacy in patients with gastrointestinal stromal tumor treated with sunitinib. Ann Oncol 23:3180–3187
44. Gnarra JR, Tory K, Weng Y et al (1994) Mutations of the VHL tumour suppressor gene in renal carcinoma. Nat Genet 7:85–90
45. Goodman VL, Rock EP, Dagher R et al (2007) Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res 13:1367–1373
46. Gore ME, Porta C, Oudard S et al (2007) Sunitinib in metastatic renal cell carcinoma (mRCC): preliminary assessment of toxicity in an expanded access trial with subpopulation analysis. J Clin Oncol 25:5010
47. Halfdanarson TR, Rabe KG, Rubin J et al (2008) Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol 19:1727–1733
48. Hansel DE, Rahman A, Hermans J et al (2003) Liver metastases arising from well-differentiated pancreatic endocrine neoplasms demonstrate increased VEGF-C expression. Mod Pathol 16:652–659
49. Heinrich MC, Corless CL, Demetri GD et al (2003) Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 21:4342–4349
50. Heinrich MC, Maki RG, Corless CL et al (2008) Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol 26:5352–5359
51. Heng DY, Bukowski RM (2007) Renal cell carcinoma: evolving approaches to advanced nonclear cell carcinoma. Oncol Rev 1:170–176
52. Houk B, Garrett M, Bello C (2005) Population pharmacokinetics of SU011248 and its primary metabolite SU12662 in oncology patients and healthy volunteers. In: Presented at the EORTC/AACR/NCI molecular targets meeting, Philadelphia, PA, 14–18 Nov 2005
53. Houk BE, Bello CL, Michaelson MD et al (2007) Exposure-response of sunitinib in metastatic renal cell carcinoma (mRCC): a population pharmacokinetic/pharmacodynamic (PKPD) approach. J Clin Oncol 25:5027
54. Inoue M, Hager JH, Ferrara N et al (2002) VEGF-A has a critical, nonredundant role in angiogenic switching and pancreatic beta cell carcinogenesis. Cancer Cell 1:193–202
55. Je Y, Schutz FA, Choueiri TK (2009) Risk of bleeding with vascular endothelial growth factor receptor tyrosine-kinase inhibitors sunitinib and sorafenib: a systematic review and metaanalysis of clinical trials. Lancet Oncol 10:967–974
56. Kenck C, Wilhelm M, Bugert P et al (1996) Mutation of the VHL gene is associated exclusively with the development of non-papillary renal cell carcinomas. J Pathol 179:157–161
57. Klimstra DS, Arnold R, Capella C et al (2010) Neuroendocrine neoplasms of the pancreas. WHO classification of tumours of the digestive system, pp 322–326
58. Kollmannsberger C, Heng DY, Murray N et al (2007a) A population-based study evaluating metastatic renal cell cancer (mRCC) patients treated with interferon (IFN) alone, first-line IFN then second-line sunitinib, or sunitinib alone. J Clin Oncol 25:15572
59. Kollmannsberger C, Soulieres D, Wong R et al (2007b) Sunitinib therapy for metastatic renal cell carcinoma: recommendations for management of side effects. Can Urol Assoc J 1:41–54
60. Kondo K, Yao M, Yoshida M et al (2002) Comprehensive mutational analysis of the VHL gene in sporadic renal cell carcinoma: relationship to clinicopathological parameters. Genes Chromosomes Cancer 34:58–68
61. Kovacs G, Akhtar M, Beckwith BJ et al (1997) The Heidelberg classification of renal cell tumours. J Pathol 183:131–133
62. Kulke MH, Lenz HJ, Meropol NJ et al (2008) Activity of sunitinib in patients with advanced neuroendocrine tumors. J Clin Oncol 26:3403–3410
63. La Rosa S, Uccella S, Finzi G et al (2003) 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
64. Laird AD, Vajkoczy P, Shawver LK et al (2000) SU6668 is a potent antiangiogenic and antitumor agent that induces regression of established tumors. Cancer Res 60:4152–4160
65. Maki RG, Fletcher JA, Heinrich MC et al (2005) Results from a continuation trial of SU11248 in patients (pts) with imatinib (IM)-resistant gastrointestinal stromal tumor (GIST). J Clin Oncol 23:9011
66. Mansour JC, Chen H (2004) Pancreatic endocrine tumors. J Surg Res 120:139–161
67. McDermott DF, Regan MM, Clark JI et al (2005) Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 23:133–141
68. Mendel DB, Laird AD, Xin X et al (2003) 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
69. Modlin IM, Oberg K, Chung DC et al (2008) Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol 9:61–72
70. Motzer RJ, Bacik J, Murphy BA et al (2002) Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol 20:289–296
71. Motzer RJ, Michaelson MD, Redman BG et al (2006a) 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
72. Motzer RJ, Rini BI, Bukowski RM et al (2006b) Sunitinib in patients with metastatic renal cell carcinoma. JAMA 295:2516–2524
73. Motzer RJ, Hutson TE, Tomczak P et al (2007) Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115–124
74. Negrier S, Escudier B, Lasset C et al (1998) Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe francais d’immunotherapie. N Engl J Med 338:1272–1278
75. Negrier S, Perol D, Ravaud A et al (2007) Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer 110:2468–2477
76. Nowain A, Bhakta H, Pais S et al (2005) Gastrointestinal stromal tumors: clinical profile, pathogenesis, treatment strategies and prognosis. J Gastroenterol Hepatol 20:818–824
77. Randomized study of sunitinib plus FOLFOX versus bevacizumab plus FOLFOX in metastatic colorectal cancer. http://clinicaltrials.gov/show/NCT00609622
78. Ravaud A, de la Fouchardière C, Asselineau J et al (2010) Efficacy of sunitinib in advanced medullary thyroid carcinoma: intermediate results of phase II THYSU. Oncologist 15:212–213
79. Raymond E, Dahan L, Raoul JL et al (2011) Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 364:501–513
80. Richards CJ, Je Y, Schutz FA et al (2011) Incidence and risk of congestive heart failure in patients with renal and nonrenal cell carcinoma treated with sunitinib. J Clin Oncol 29:3450–3456
81. Rini BI, Small EJ (2005) Biology and clinical development of vascular endothelial growth factortargeted therapy in renal cell carcinoma. J Clin Oncol 23:1028–1043
82. Rini BI, Tamaskar I, Shaheen P et al (2007) Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 99:81–83
83. Rini BI, Choueiri TK, Elson P et al (2008) Sunitinib-induced macrocytosis in patients with metastatic renal cell carcinoma. Cancer 113:1309–1314
84. Rini BI, Cohen DP, Lu DR et al (2011) Hypertension as a biomarker of efficacy in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 103:763–773
85. Robert NJ, Saleh MN, Paul D et al (2011) Sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for first-line treatment of patients with advanced breast cancer: a phase III, randomized, open-label trial. Clin Breast Cancer 11:82–92
86. Scagliotti GV, Krzakowski M, Szczesna A et al (2012) Sunitinib plus erlotinib versus placebo plus erlotinib in patients with previously treated advanced non-small-cell lung cancer: a phase III trial. J Clin Oncol 30:2070–2078
87. Schmidinger M, Vogl UM, Bojic M et al (2011) Hypothyroidism in patients with renal cell carcinoma: blessing or curse? Cancer 117:534–544
88. Shuin T, Kondo K, Torigoe S et al (1994) Frequent somatic mutations and loss of heterozygosity of the von Hippel–Lindau tumor suppressor gene in primary human renal cell carcinomas. Cancer Res 54:2852–2855
89. Siegel R, Naishadham D, Jemal A (2013) Cancer statistics, 2013. CA Cancer J Clin 63:11–30
90. Sun L, Liang C, Shirazian S et al (2003) 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
91. Sunitinib malate as maintenance therapy in treating patients with Stage III or Stage IV non-small cell lung cancer previously treated with combination chemotherapy. http://clinicaltrials.gov/show/NCT00693992
92. Terris B, Scoazec JY, Rubbia L et al (1998) Expression of vascular endothelial growth factor in digestive neuroendocrine tumours. Histopathology 32:133–138
93. Van Glabbeke M, Verweij J, Casali PG et al (2005) Initial and late resistance to imatinib in advanced gastrointestinal stromal tumors are predicted by different prognostic factors: a European Organisation for Research and Treatment of Cancer–Italian Sarcoma Group–Australasian Gastrointestinal Trials Group study. J Clin Oncol 23:5795–5804
94. Verweij J, Casali PG, Zalcberg J et al (2004) Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet 364:1127–1134
95. Vinik A, Van Cutsem E, Niccoli P et al (2012) Updated results from a phase III trial of suni tinibversus placebo in patients with progressive, unresectable, well-differentiated pancreatic neuroendocrine tumor (NET). J Clin Oncol 30(4118)
96. Weisberg E, Griffin JD (2003) Resistance to imatinib (Glivec): update on clinical mechanisms. Drug Resist Updat 6:231–238
97. Witteles RM, Telli ML, Fisher GA et al (2008) Cardiotoxicity associated with the cancer therapeutic agent sunitinib malate. J Clin Oncol 26:9597
98. Wolter P, Stefan C, Decallonne B et al (2008) The clinical implications of sunitinib-induced hypothyroidism: a prospective evaluation. Br J Cancer 99:448–454
99. Wong E, Rosen LS, Mulay M et al (2007) Sunitinib induces hypothyroidism in advanced cancer patients and may inhibit thyroid peroxidase activity. Thyroid 17:351–355
100. Wulbrand U, Wied M, Zöfel P et al (1998) Growth factor receptor expression in human gastroenteropancreatic neuroendocrine tumours. Eur J Clin Invest 28:1038–1049
101. Yang JC, Sherry RM, Steinberg SM et al (2003) Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 21:3127–3132
102. Yao JC, Shah MH, Ito T et al (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364:514–523
103. Yuasa T, Takahashi S, Hatake K et al (2011) Biomarkers to predict response to sunitinib therapy and prognosis in metastatic renal cell cancer. Cancer Sci 102:1949–1957