Combination of sorafenib and doxorubicin in patients with advanced hepatocellular carcinoma: Results from a phase I extension trial

European Journal of Cancer

Volumn 45, Issue 4, 2009, Pages 579-587

  Richly, H ^a   Schultheis, B ^b   Adamietz, I A ^b   Kupsch, P ^a   Grubert, M ^a   Hilger, R A ^a   Ludwig, M ^c   Brendel, E ^c   Christensen, O ^d   Strumberg, D ^b  

^a UNIVERSITY OF DUISBURG ESSEN   (Germany)

^b RUHR UNIVERSITY BOCHUM   (Germany)

^c BAYER PHARMA AG   (Germany)

^d BAYER CORPORATION   (United States)

Author keywords

Doxorubicin; Hepatocellular carcinoma; Multikinase inhibitor; Safety; Sorafenib

Indexed keywords

DOXORUBICIN; SORAFENIB;

ABDOMINAL PAIN; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; AMYLASE BLOOD LEVEL; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASCITES; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ATRIOVENTRICULAR JUNCTION ARRHYTHMIA; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CONSCIOUSNESS LEVEL; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE CONTROL; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EMBOLISM; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HAND FOOT SKIN REACTION; HEMOGLOBIN BLOOD LEVEL; HEPATIC ENCEPHALOPATHY; HUMAN; HYPERURICEMIA; HYPOALBUMINEMIA; HYPOGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; KIDNEY FAILURE; LEUKOPENIA; LIVER CELL CARCINOMA; LIVER DYSFUNCTION; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PARTIAL THROMBOPLASTIN TIME; PRIORITY JOURNAL; SIDE EFFECT; SINUS BRADYCARDIA; SINUS TACHYCARDIA; SKIN MANIFESTATION; STOMATITIS; THORAX PAIN; THROMBOSIS; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARCINOMA, HEPATOCELLULAR; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LIVER NEOPLASMS; MALE; MIDDLE AGED; PYRIDINES; TREATMENT OUTCOME;

EID: 60449093312     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2008.10.039     Document Type: Article

References (40)

1. Thomas MB, Chadha R, Iwasaki M, et al. The combination of bevacizumab and erlotinib shows significant biological activity in patients with advanced hepatocellular carcinoma [abstract 4567]. J Clin Oncol, 2007 ASCO Annual Meeting Proceedings 2007;25(suppl):214s.
2. Llovet J.M., Ricci S., Mazzaferro V., et al. Sorafenib in advanced hepatocellular carcinoma. New Engl J Med 359 (2008) 378-390
3. McGlynn K.A., and London W.T. Epidemiology and natural history of hepatocellular carcinoma. Best Pract Res Clin Gastroenterol 19 (2005) 3-23
4. Deuffic S., Poynard T., Buffat L., et al. Trends in primary liver cancer. Lancet 351 (1998) 214-215
5. El-Serag H.B., and Mason A.C. Rising incidence of hepatocellular carcinoma in the United States. New Engl J Med 340 (1999) 745-750
6. El-Serag H.B., Davila J.A., Petersen N.J., et al. The continuing increase in the incidence of hepatocellular carcinoma in the United States: an update. Ann Intern Med 139 (2003) 817-823
7. Stroffolini T., Andreone P., Andriulli A., et al. Characteristics of hepatocellular carcinoma in Italy. J Hepatol 29 (1998) 944-952
8. Taylor-Robinson S.D., Foster G.R., Arora S., et al. Increase in primary liver cancer in the UK, 1979-1994. Lancet 350 (1997) 1142-1143
9. Llovet J.M., Bruix J., and Gores G.J. Surgical resection versus transplantation for early hepatocellular carcinoma: clues for the best strategy. Hepatology 31 (2000) 1019-1021
10. Bruix J., and Sherman M. Management of hepatocellular carcinoma. Hepatology 42 (2005) 1208-1236
11. Nerenstone S.R., Ihde D.C., and Friedman M.A. Clinical trials in primary hepatocellular carcinoma: current status and future directions. Cancer Treat Rev 15 (1988) 1-31
12. Okada S. Chemotherapy in hepatocellular carcinoma. Hepatogastroenterology 45 3 (1998) 1259-1263
13. Levy J.B., Pauloski N., Braun D., et al. Analysis of transcription and protein expression changes in the 786-O human renal cell carcinoma tumor xenograft model in response to treatment with the multi-kinase inhibitor sorafenib (BAY-9006) [abstract 906]. Proc Am Assoc Cancer Res 47 (2006) 213-214
14. Lierman E., Folens C., Stover E.H., et al. Sorafenib is a potent inhibitor of FIP1L1-PDGFRalpha and the imatinib-resistant FIP1L1-PDGFRalpha T674I mutant. Blood 108 (2006) 1374-1376
15. Wilhelm S.M., 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 (2004) 7099-7109
16. Liu L., Cao Y., Chen C., et al. Sorafenib blocks the RAF/MEK/ERK pathway, inhibits tumor angiogenesis, and induces tumor cell apoptosis in hepatocellular carcinoma model PLC/PRF/5. Cancer Res 66 (2006) 11851-11858
17. Murphy D.A., Makonnen S., Lassoued W., et al. Inhibition of tumor endothelial ERK activation, angiogenesis, and tumor growth by sorafenib (BAY43-9006). Am J Pathol 169 (2006) 1875-1885
18. Yoshiji H., Kuriyama S., Yoshii J., et al. Halting the interaction between vascular endothelial growth factor and its receptors attenuates liver carcinogenesis in mice. Hepatology 39 (2004) 1517-1524
19. Huynh H., Nguyen T.T., Chow K.H., et al. Over-expression of the mitogen-activated protein kinase (MAPK) kinase (MEK)-MAPK in hepatocellular carcinoma: its role in tumor progression and apoptosis. BMC Gastroenterol 3 (2003) 19
20. Farazi P.A., and DePinho R.A. Hepatocellular carcinoma pathogenesis: from genes to environment. Nat Rev Cancer 6 (2006) 674-687
21. Staib F., Hussain S.P., Hofseth L.J., et al. TP53 and liver carcinogenesis. Human Mutat 21 (2003) 201-216
22. Abou-Alfa G.K., Schwartz L., Ricci S., et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 24 (2006) 4293-4300
23. Llovet J, Ricci S, Mazzaferro V, et al. Sorafenib improves survival in advanced hepatocellular carcinoma: results of a phase III randomized placebo-controlled trial (SHARP trial) [abstract LBA1]. J Clin Oncol, 2007 ASCO Annual Meeting Proceedings 2007;25(suppl):1s.
24. Vincent P, Zhang X, Chen CM, et al. Preclinical chemotherapy with the Raf kinase inhibitor BAY 43-9006 in combination with gefitinib, venorelbine, gemcitabine or doxorubicin [abstract 719]. Proc Am Assoc Cancer Res, 2nd ed. 2003;44:138.
25. Richly H., Henning B.F., 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 17 (2006) 866-873
26. Furuse J., Ishii H., Nakachi K., et al. Phase I study of sorafenib in Japanese patients with hepatocellular carcinoma. Cancer Sci 99 (2008) 159-165
27. Akaza H., Tsukamoto T., Murai M., et al. Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Jpn J Clin Oncol 37 (2007) 755-762
28. Doxorubicin prescribing information update, 2003. .
29. Yeo W., Mok T.S., Zee B., et al. A randomized phase III study of doxorubicin versus cisplatin/interferon alpha-2b/doxorubicin/fluorouracil (PIAF) combination chemotherapy for unresectable hepatocellular carcinoma. J Natl Cancer Inst 97 (2005) 1532-1538
30. Schwartz R.G., McKenzie W.B., Alexander J., et al. Congestive heart failure and left ventricular dysfunction complicating doxorubicin therapy. Seven-year experience using serial radionuclide angiocardiography. Am J Med 82 (1987) 1109-1118
31. Nousiainen T., Jantunen E., Vanninen E., et al. Early decline in left ventricular ejection fraction predicts doxorubicin cardiotoxicity in lymphoma patients. Brit J Cancer 86 (2002) 1697-1700
32. Gharib M.I., and Burnett A.K. Chemotherapy-induced cardiotoxicity: current practice and prospects of prophylaxis. Eur J Heart Fail 4 (2002) 235-242
33. Escudier B., Eisen T., Stadler W.M., et al. Sorafenib in advanced clear-cell renal-cell carcinoma. New Engl J Med 356 (2007) 125-134
34. Hong R.L., and Tseng Y.L. A phase II and pharmacokinetic study of pegylated liposomal doxorubicin in patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol 51 (2003) 433-438
35. Llovet J.M. Updated treatment approach to hepatocellular carcinoma. J Gastroenterol 40 (2005) 225-235
36. Vogel C.L., Bayley A.C., Brooker R.J., et al. A phase II study of adriamycin (NSC 123127) in patients with hepatocellular carcinoma from Zambia and the United States. Cancer 39 (1977) 1923-1929
37. Avila M.A., Berasain C., Sangro B., et al. New therapies for hepatocellular carcinoma. Oncogene 25 (2006) 3866-3884
38. Weinstein-Oppenheimer C.R., Henriquez-Roldan C.F., Davis J.M., et al. Role of the Raf signal transduction cascade in the in vitro resistance to the anticancer drug doxorubicin. Clin Cancer Res 7 (2001) 2898-2907
39. Zhong J., Troppmair J., and Rapp U.R. Independent control of cell survival by Raf-1 and Bcl-2 at the mitochondria. Oncogene 20 (2001) 4807-4816
40. Abou-Alfa G.K., Johnson P., Knox J., et al. Preliminary results from a phase II, randomized, double-blind study of sorafenib plus doxorubicin versus placebo plus doxorubicin in patients with advanced hepatocellular carcinoma [abstract 3500]. Eur J Cancer Suppl 5 (2007) 259