Early development of sunitinib in hepatocellular carcinoma

Expert Review of Anticancer Therapy

Volumn 9, Issue 1, 2009, Pages 143-150

  Zhu, Andrew X ^a   Raymond, Eric ^b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BEAUJON HOSPITAL   (France)

Author keywords

Antiangiogenesis; Clinical trials; Hepatocellular carcinoma; Multitargeted receptor tyrosine kinase inhibitor; Receptor tyrosine kinase; Sunitinib; SUTENT

Indexed keywords

CAPECITABINE; DOCETAXEL; PLACEBO; PLATELET DERIVED GROWTH FACTOR ALPHA RECEPTOR; PLATELET DERIVED GROWTH FACTOR BETA RECEPTOR; SORAFENIB; SUNITINIB; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2; VASCULOTROPIN RECEPTOR 3; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; PYRROLE DERIVATIVE;

ADVANCED CANCER; ANOREXIA; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER CONTROL; CANCER GROWTH; CANCER INHIBITION; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; DIARRHEA; DRUG DESIGN; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; GASTROINTESTINAL STROMAL TUMOR; HUMAN; INOPERABLE CANCER; KIDNEY CARCINOMA; LIVER CARCINOGENESIS; LIVER CELL CARCINOMA; LUNG CANCER; NAUSEA; NEOVASCULARIZATION (PATHOLOGY); OUTCOME ASSESSMENT; OVERALL SURVIVAL; REVIEW; SOLID TUMOR; LIVER TUMOR;

ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; CARCINOMA, HEPATOCELLULAR; HUMANS; INDOLES; LIVER NEOPLASMS; PYRROLES;

EID: 61449426233     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.9.1.143     Document Type: Review

References (60)

1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J. Clin. 55, 74-108 (2005).
2. McGlynn KA, London WT. Epidemiology and natural history of hepatocellular carcinoma. Best Pract. Res. Clin. Gastroenterol. 19, 3-23 (2005).
3. El-Serag HB, Rudolph KL. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 132, 2557-2576 (2007).
4. Yu MC, Yuan JM. Environmental factors and risk for hepatocellular carcinoma. Gastroenterology 127, S72-S78 (2004).
5. Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 9, 331-338 (2003).
6. Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet 362, 1907-1917 (2003).
7. Grieco A, Pompili M, Caminiti G et al. Prognostic factors for survival in patients with early-intermediate hepatocellular carcinoma undergoing non-surgical therapy: comparison of Okuda, CLIP, and BCLC staging systems in a single Italian centre. Gut 54, 411-418 (2005).
8. Bruix J, Sherman M, Llovet JM et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J. Hepatol. 35, 421-430 (2001).
9. Zhu AX. Systemic therapy of advanced hepatocellular carcinoma: how hopeful should we be? Oncologist 11, 790-800 (2006).
10. Wang BL, Chen XP, Zhai SP, Chen DF. Clinical significance of mrp gene in primary hepatocellular carcinoma. Hepatobiliary Pancreat. Dis. Int. 2, 397-403 (2003).
11. 2b/ doxorubicin/fluorouracil (PIAF) combination chemotherapy for unresectable hepatocellular carcinoma. J. Natl Cancer Inst. 97, 1532-1538 (2005).
12. Lee J, Park JO, Kim WS et al. Phase II study of doxorubicin and cisplatin in patients with metastatic hepatocellular carcinoma. Cancer Chemother. Pharmacol. 54, 385-390 (2004).
13. Taïeb J, Bonyhay L, Golli L et al. Gemcitabine plus oxaliplatin for patients with advanced hepatocellular carcinoma using two different schedules. Cancer 98, 2664-2670 (2003).
14. Ikeda M, Okusaka T, Ueno H, Takezako Y, Morizane C. A Phase II trial of continuous infusion of 5-fluorouracil, mitoxantrone, and cisplatin for metastatic hepatocellular carcinoma. Cancer 103, 756-762 (2005).
15. Lopez PM, Patel P, Uva P, Villanueva A, Llovet JM. Current management of liver cancer. Eur. J. Cancer Suppl. 5, 444-446 (2007).
16. Folkman J. Fundamental concepts of the angiogenic process. Curr. Mol. Med. 3, 643-651 (2003).
17. Hicklin DJ, Ellis LM. Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J. Clin. Oncol. 23, 1011-1027 (2005).
18. Wada H, Nagano H, Yamamoto H et al. Expression pattern of angiogenic factors and prognosis after hepatic resection in hepatocellular carcinoma: importance of angiopoietin-2 and hypoxia-induced factor-1α. Liver Int. 26, 414-423 (2006).
19. Yang LY, Lu WQ, Huang GW, Wang W. Correlation between CD105 expression and postoperative recurrence and metastasis of hepatocellular carcinoma. BMC Cancer 6, 110 (2006).
20. Tugues S, Fernandez-Varo G, Muñoz- Luque J et al. Antiangiogenic treatment with sunitinib ameliorates inflammatory infiltrate, fibrosis, and portal pressure in cirrhotic rats. Hepatology 46, 1919-1926 (2007).
21. Zhang ZL, Liu ZS, Sun Q. Expression of angiopoietins, Tie2 and vascular endothelial growth factor in angiogenesis and progression of hepatocellular carcinoma. World J. Gastroenterol. 12, 4241-4245 (2006).
22. Yao DF, Wu XH, Zhu Y et al. Quantitative analysis of vascular endothelial growth factor, microvascular density and their clinicopathologic features in human hepatocellular carcinoma. Hepatobiliary Pancreat. Dis. Int. 4, 220-226 (2005).
23. Amaoka N, Saio M, Nonaka K et al. Expression of vascular endothelial growth factor receptors is closely related to the histological grade of hepatocellular carcinoma. Oncol. Rep. 16, 3-10 (2006).
24. Poon RT, Ho JW, Tong CS, Lau C, Ng IO, Fan ST. Prognostic significance of serum vascular endothelial growth factor and endostatin in patients with hepatocellular carcinoma. Br. J. Surg. 91, 1354-1360 (2004).
25. Chao Y, Li CP, Chau GY et al. Prognostic significance of vascular endothelial growth factor, basic fibroblast growth factor, and angiogenin in patients with resectable hepatocellular carcinoma after surgery. Ann. Surg. Oncol. 10, 355-362 (2003).
26. 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).
27. Stock P, Monga D, Tan X, Micsenyi A, Loizos N, Monga SP. Platelet-derived growth factor receptor-α: a novel therapeutic target in human hepatocellular cancer. Mol. Cancer Ther. 6, 1932-1941 (2007).
28. Zhang T, Sun HC, Xu Y et al. Overexpression of platelet-derived growth factor receptor-a in endothelial cells of hepatocellular carcinoma associated with high metastatic potential. Clin. Cancer Res. 11, 8557-8563 (2005).
29. Gollob JA, Wilhelm S, Carter C, Kelley SL. Role of Raf kinase in cancer: therapeutic potential of targeting the Raf/MEK/ERK signal transduction pathway. Semin. Oncol. 33, 392-406 (2006).
30. Avila MA, Berasain C, Sangro B, Prieto J. New therapies for hepatocellular carcinoma. Oncogene 25, 3866-3884 (2006).
31. Stöckl L, Berting A, Malkowski B et al. Integrity of c-Raf-1/ MEK signal transduction cascade is essential for hepatitis B virus gene expression. Oncogene 22, 2604-2610 (2003).
32. Zhu AX. Development of sorafenib and other molecularly targeted agents in hepatocellular carcinoma. Cancer 112, 250-259 (2008).
33. Nexavar® (sorafenib) tablets oral [package insert]. Bayer Pharmaceuticals, West Haven, CT, USA (2007).
34. 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).
35. Abou-Alfa GK, Schwartz L, Ricci S et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J. Clin. Oncol. 24, 4293-4300 (2006).
36. Llovet J, Ricci S, Mazzaferro V et al. Sorafenib in advanced hepatocellular carcinoma. N. Engl. J. Med. 359, 378-390 (2008).
37. Cheng A, Kang Y, Chen Z et al. Randomized Phase III trial of sorafenib versus placebo in Asian patients with advanced hepatocellular carcinoma. J. Clin. Oncol. (Meeting Abstracts) 26 (2008) (Abstract 4509).
38. Chow LQM, Eckhardt SG. Sunitinib: from rational design to clinical efficacy. J. Clin. Oncol. 25, 884-896 (2007).
39. 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).
40. Faivre S, Demetri G, Sargent W et al. Molecular basis for sunitinib efficacy and future clinical development. Nat. Rev. Drug Discov. 6, 734-745 (2007).
41. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor-β in preclinical models of human small cell lung cancer. Mol. Cancer Ther. 2, 471-478 (2003).
42. 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).
43. Murray LJ, Abrams TJ, Long KR et al. SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model. Clin. Exp. Metastasis 20, 757-766 (2003).
44. O'Farrell AM, Abrams TJ, Yuen HA et al. SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 101, 3597-3605 (2003).
45. Kim DW, Jo YS, Jung HS et al. An orally administered multitarget tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/papillary thyroid cancer kinases. J. Clin. Endocrinol. Metab. 91, 4070-4076 (2006).
46. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus interferon-a in metastatic renal-cell carcinoma. N. Engl. J. Med. 356, 115-124 (2007).
47. 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).
48. Osusky KL, Hallahan DE, Fu A, Ye F, Shyr Y, Geng L. 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).
49. Potapova O, Laird AD, Nannini MA et al. Contribution of individual targets to the antitumor efficacy of the multitargeted receptor tyrosine kinase inhibitor SU11248. Mol. Cancer Ther. 5, 1280-1289 (2006).
50. Marzola P, Degrassi A, Calderan L et al. Early antiangiogenic activity of SU11248 evaluated in vivo by dynamic contrastenhanced magnetic resonance imaging in an experimental model of colon carcinoma. Clin. Cancer Res. 11, 5827-5832 (2005).
51. Zhu A, Sahani D, di Tomaso E et al. Efficacy, safety, and changes in blood markers following sunitinib monotherapy in patients with advanced hepatocellular carcinoma: experience from a multidisciplinary Phase II study. Presented at: 99th AACR Annual Meeting. San Diego, CA, USA, 12-16 April 2008.
52. Faivre S, DePrimo S, Cheng AL et al. Correlation of outcome and tumour imaging parameters with circulating biomarkers of sunitinib malate in patients with unresectable hepatocellular carcinoma. Presented at: 33rd ESMO Congress. Stockholm, Sweden, 12-16 September 2008.
53. Wood LS. Managing the side effects of sorafenib and sunitinib. Community Oncol. 3, 558-562 (2006).
54. 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).
55. Choi H, Charnsangavej C, Faria SC et al. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J. Clin. Oncol. 25, 1753-1759 (2007).
56. Benjamin RS, Choi H, Macapinlac HA et al. We should desist using RECIST, at least in GIST. J. Clin. Oncol. 25, 1760-1764 (2007).
57. Siegel AB, Cohen EI, Ocean A et al. Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma. J. Clin. Oncol. 26, 2992-2998 (2008).
58. Zhu AX, Blaszkowsky LS, Ryan DP et al. Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma. J. Clin. Oncol. 24, 1898-1903 (2006).
59. Christensen JG. A preclinical review of sunitinib, a multitargeted receptor tyrosine kinase inhibitor with anti-angiogenic and antitumour activities. Ann. Oncol. 18(Suppl. 10), 3-10 (2007).
60. Wilhelm S, Carter C, Lynch M et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat. Rev. Drug Discov. 5, 835-844 (2006).