Sorafenib: A clinical and pharmacologic review

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 11, 2010, Pages 1943-1955

  Iyer, Renuka ^a   Fetterly, Gerald ^a   Lugade, Amit ^a   Thanavala, Yasmin ^a  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

Anti angiogenic; Hepatocellular cancer; Renal cell cancer; Sorafenib

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; AROMATASE INHIBITOR; CAPECITABINE; CARBOPLATIN; CISPLATIN; DOXORUBICIN; ERLOTINIB; FLUOROURACIL; FOLINIC ACID; GEFITINIB; GEMCITABINE; IRINOTECAN; KETOCONAZOLE; PACLITAXEL; PLATELET DERIVED GROWTH FACTOR BETA RECEPTOR; PROTEIN SERINE THREONINE KINASE; PROTEIN TYROSINE KINASE INHIBITOR; SORAFENIB; SUNITINIB; TYROSINE KINASE RECEPTOR; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2; VASCULOTROPIN RECEPTOR 3; ANTINEOPLASTIC AGENT; BENZENESULFONIC ACID DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIDINE DERIVATIVE;

ABDOMINAL PAIN; ACNE; ACUTE KIDNEY FAILURE; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; AMYLASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTHRALGIA; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BILIRUBIN BLOOD LEVEL; BLEEDING; BONE PAIN; BRAIN HEMORRHAGE; BREAST CANCER; CARCINOGENESIS; CONGESTIVE HEART FAILURE; CONSTIPATION; COUGHING; DECREASED APPETITE; DEHYDRATION; DEPRESSION; DESQUAMATION; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG BIOAVAILABILITY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG RECEPTOR BINDING; DRUG STRUCTURE; DRY SKIN; DYSPEPSIA; DYSPHAGIA; DYSPNEA; ECZEMA; EPISTAXIS; ERECTILE DYSFUNCTION; ERYTHEMA MULTIFORME; ESOPHAGUS VARICES BLEEDING; EXFOLIATIVE DERMATITIS; FATIGUE; FEVER; FLU LIKE SYNDROME; FLUSHING; FOLLICULITIS; GASTRITIS; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL REFLUX; GLOSSODYNIA; GYNECOMASTIA; HAND FOOT SYNDROME; HEADACHE; HEART ARRHYTHMIA; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HOARSENESS; HUMAN; HYPERTENSION; HYPERTENSIVE CRISIS; HYPOALBUMINEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; HYPOTHYROIDISM; INFECTION; INOPERABLE CANCER; JAUNDICE; KERATOACANTHOMA; KIDNEY CARCINOMA; KIDNEY FAILURE; LEUKOPENIA; LIVER CELL CARCINOMA; LIVER DYSFUNCTION; LUNG HEMORRHAGE; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MELANOMA; MOUTH PAIN; MUCOSA INFLAMMATION; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NEUTROPENIA; PAIN; PANCREATITIS; PLEURA EFFUSION; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PROTEINURIA; RASH; REVIEW; RHINORRHEA; SENSORY NEUROPATHY; SIDE EFFECT; SKIN ALLERGY; SKIN CANCER; SKIN MANIFESTATION; STOMATITIS; THROMBOCYTOPENIA; THROMBOEMBOLISM; THYROID CANCER; TINNITUS; TRANSIENT ISCHEMIC ATTACK; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; TUMOR GROWTH; TUMOR LYSIS SYNDROME; URTICARIA; VOICE CHANGE; VOMITING; WEIGHT REDUCTION; XEROSTOMIA; ADULT; CHILD; CLINICAL TRIAL; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; UNITED STATES;

ADULT; ANTINEOPLASTIC AGENTS; BENZENESULFONATES; CHILD; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS; PROTEIN KINASE INHIBITORS; PYRIDINES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77954781214     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.2010.496453     Document Type: Review

References (55)

1. Wilhelm S, Carter C, Lynch M, et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat Rev Drug Discov 2006;5:835-44
2. Erratum in: Nat Rev Drug Discov 2007;6:126
3. Wilhelm SM, Adnane L, Newell P, et al. Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Mol Cancer Ther 2008;7:3129-3140
4. Yu C, Bruzek LM, Meng XW, et al. The role of Mcl-1 downregulation in the proapoptotic activity of the multikinase inhibitor BAY 43-9006. Oncogene 2005;24:6861-6869
5. Himmelsbach K, Sauter D, Baumert TF, et al. New aspects of an anti-tumour drug: sorafenib efficiently inhibits HCV replication. Gut 2009;58:1644-1653
6. Molhoek KR, McSkimming CC, Olson WC, et al. Apoptosis of CD4(+) CD25(high) T cells in response to Sirolimus requires activation of T cell receptor and is modulated by IL-2. Cancer Immunol Immunother 2009;58:867-876
7. Strumberg D, Richly H, Hilger RA, et al. Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 2005;23:965-972
8. Clinical Pharmacology and Biopharmaceutics NDA Review for Sorafenib Tosylate (NDA 21 923), F.C.F.D.E.A. RESEARCH, Editor, 2005
9. BAY 43-9006 (sorafenib) Investigator's Brochure. Bayer Healthcare AG, Version 10.0, July 1, 2009
10. Richly H, Kupsch P, Passage K, et al. Results of a phase I trial of BAY 43-9006 in combination with doxorubicin in patients with primary hepatic cancer. Int J Clin Pharmacol Ther 2004;42:650-651
11. Richly H, Henning BF, Kupsch P, et al. Results of a phase I trial of sorafenib (BAY 43-9006) in combination with doxorubicin in patients with refractory solid tumors. Ann Oncol 2006;17:866-873
12. Adjei AA, Molina JR, Mandrekar SJ, et al. Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent non-small cell lung cancer. Clin Cancer Res 2007;13:2684-2691
13. Mross K, Steinbild S, Baas F, et al. Results from an in vitro and a clinical/pharmacological phase I study with the combination irinotecan and sorafenib. Eur J Cancer 2007;43:55-63
14. Duran I, Hotte SJ, Hirte H, et al. Phase I targeted combination trial of sorafenib and erlotinib in patients with advanced solid tumors. Clin Cancer Res 2007;13:4849-4857
15. Flaherty KT, Schiller J, Schuchter LM, et al. A phase I trial of the oral, multikinase inhibitor sorafenib in combination with carboplatin and paclitaxel. Clin Cancer Res 2008;14:4836-4842
16. Moretti LV, Montalvo RO. Elevated International Normalized Ratio associated with concurrent use of sorafenib and warfarin. Am J Health Syst Pharm 2009;66:2123-2125
17. Widemann BC, Fox E, Adamson PC, et al. Phase I study of sorafenib in children with refractory solid tumors: a Children's Oncology Group Phase I Consortium trial (abstract 10012). J Clin Oncol 2009;27(Suppl):15s
18. Miller AA, Murry DJ, Owzar K, et al. Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. J Clin Oncol 2009;27:1800-1805
19. Rey PM, Villavicencio H. Sorafenib: tolerance in patients on chronic hemodialysis: a single-center experience. Oncology 2008;74:245-246
20. Hilger RA, Richly H, Grubert M, et al. Pharmacokinetics of sorafenib in patients with renal impairment undergoing hemodialysis. Int J Clin Pharmacol Ther 2009;47:61-64
21. Blanchet B, Billemont B, Barete S, et al. Toxicity of sorafenib: clinical and molecular aspects. Expert Opin Drug Saf 2010;9:275-287
22. Llovet JM, Ricci S, Mazzaferro V, et al.; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-390
23. FDA. Center for drug evaluation and research approval package for: application number NDA 21-923-Pharmacology Review, 2005. Available from: www.accessdata.fda.gov/scripts/cder/ drugsatfda-docs/nda/2005/ 021923-s000-Nexavar-BioPharmR.pdf
24. Escudier B, Eisen T, Stadler WM, et al.; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125-34
25. Erratum in N Engl J Med 2007;357:203
26. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol 2009;27:3312-3318
27. Ratain MJ, Eisen T, Stadler WM, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006;24:2505-2512 (Pubitemid 46630627)
28. Ivy SP, Wick JY, Kaufman BM. An overview of small-molecule inhibitors of VEGFR signaling. Nat Rev Clin Oncol 2009;6:569-579
29. Llovet JM, Di Bisceglie AM, Bruix J, et al.; panel of experts in HCC-design clinical trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 2008;100:698-711
30. Escudier B. Sorafenib [corrected] in kidney cancer. Ann Oncol 2007;18(Suppl 9):90-93
31. Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol 2007;30:220-227
32. Escudier B, Szczylik C, Hutson TE, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:1280-1289
33. Dumont FJ, Staruch MJ, Fischer P, et al. Inhibition of T-cell activation by pharmacologic disruption of the MEK1/ERK MAP kinase or calcineurin signaling pathways results in differential modulation of cytokine production. J Immunol 1998;160:2579-2589
34. Hipp MM, Hilf N, Walter S, et al. Sorafenib, but not sunitinib, affects function of dendritic cells and induction of primary immune responses. Blood 2008;111:5610-5620
35. Alfaro C, Suarez N, Gonzalez A, et al. Influence of bevacizumab, sunitinib and sorafenib as single agents or in combination on the inhibitory effects of VEGF on human dendritic cell differentiation from monocytes. Br J Cancer 2009;100:1111-1119
36. Hoechst B, Ormandy LA, Ballmaier M, et al. A new population of myeloid-derived suppressor cells in hepatocellular carcinoma patients induces CD4(+)CD25(+)Foxp3(+) T cells. Gastroenterology 2008;135:234-243
37. Almand B, Clark JI, Nikitina E, et al. Increased production of immature myeloid cells in cancer patients: a mechanism of immunosuppression in cancer. J Immunol 2001;166:678-689
38. Serafini P, Borrello I, Bronte V. Myeloid suppressor cells in cancer: recruitment, phenotype, properties, and mechanisms of immune suppression. Semin Cancer Biol 2006;16:53-65
39. Ko HJ, Kim YJ, Kim YS, et al. A combination of chemoimmunotherapies can efficiently break self-tolerance and induce antitumor immunity in a tolerogenic murine tumor model. Cancer Res 2007;67:7477-7486
40. Dannull J, Su Z, Rizzieri D, et al. Enhancement of vaccine-mediated antitumor immunity in cancer patients after depletion of regulatory T cells. J Clin Invest 2005;115:3623-3633
41. Ozao-Choy J, Ma G, Kao J, et al. The novel role of tyrosine kinase inhibitor in the reversal of immune suppression and modulation of tumor microenvironment for immune-based cancer therapies. Cancer Res 2009;69:2514-2522
42. Finke JH, Rini B, Ireland J, et al. Sunitinib reverses type-1 immune suppression and decreases T-regulatory cells in renal cell carcinoma patients. Clin Cancer Res 2008;14:6674-6682
43. Cheng AL, Kang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol 2009;10:25-34
44. Torino F, Corsello SM, Longo R, et al. Hypothyroidism related to tyrosine kinase inhibitors: an emerging toxic effect of targeted therapy. Nat Rev Clin Oncol 2009;6:219-228
45. Antoun S, Birdsell L, Sawyer MB, et al. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol 2010;28:1054-1060
46. Newell P, Villanueva A, Friedman SL, et al. Experimental models of hepatocellular carcinoma. J Hepatol 2008;48:858-879
47. Abou-Alfa GK, Johnson P, Knox J, et al. Final results from a phase II (PhII), randomized, double-blind study of sorafenib plus doxorubicin (S+D) versus placebo plus doxorubicin (P+D) in patients (pts) with advanced hepatocellular carcinoma (AHCC) [abstract 128]. ASCO 2008 Gastrointestinal Cancers Symposium; January 2008; Orlando, FL, USA
48. Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer 2009;115:4646
49. Bianchi G, Loibl S, Zamagni C, et al. Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. Anticancer Drugs 2009;20:616-624
50. Blumenschein GR Jr, Gatzemeier U, Fossella F, et al. Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non-small-cell lung cancer. J Clin Oncol 2009;27:4274-4280
51. Maki RG, D'Adamo DR, Keohan ML, et al. Phase II study of sorafenib in patients with metastatic or recurrent sarcomas. J Clin Oncol 2009;27:3133-3140
52. Egberts F, Kahler KC, Livingstone E, Hauschild A. Metastatic melanoma: scientific rationale for sorafenib treatment and clinical results. Onkologie 2008;31:398-403
53. Lam ET, Ringel MD, Kloos RT, et al. Phase II clinical trial of sorafenib in metastatic medullary thyroid cancer. J Clin Oncol 2010;28(14):2323-2330
54. Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 2006;24:4293-4300
55. Massard C, Zonierek J, Gross-Goupil M, et al. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol 2010;21(5):1027-1031