Phase II trial of sorafenib combined with concurrent transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma

Journal of Clinical Oncology

Volumn 29, Issue 30, 2011, Pages 3960-3967

  Pawlik, Timothy M ^a   Reyes, Diane K ^a   Cosgrove, David ^a   Kamel, Ihab R ^a   Bhagat, Nikhil ^a   Geschwind, Jean Francois H ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; SORAFENIB; TRIACYLGLYCEROL LIPASE;

ACUTE KIDNEY FAILURE; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BRAIN DISEASE; CANCER COMBINATION CHEMOTHERAPY; CANCER SIZE; CANCER STAGING; CELLULITIS; CHEMOEMBOLIZATION; CLINICAL ARTICLE; CLINICAL PROTOCOL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOXORUBICIN ELUTING BEAD; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART ATRIUM FLUTTER; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; LIVER CELL CARCINOMA; MALE; MULTIPLE CYCLE TREATMENT; NEEDLE BIOPSY; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; SIDE EFFECT; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARCINOMA, HEPATOCELLULAR; CHEMOEMBOLIZATION, THERAPEUTIC; DOXORUBICIN; FEMALE; HUMANS; LIVER NEOPLASMS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PYRIDINES;

EID: 80054722090     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.37.1021     Document Type: Article

References (24)

1. El-Serag HB, Rudolph KL: Hepatocellular carcinoma: Epidemiology and molecular carcinogenesis. Gastroenterology 132:2557-2576, 2007 (Pubitemid 46890874)
2. Llovet JM, Bustamante J, Castells A, et al.: Natural history of untreated nonsurgical hepatocellular carcinoma: Rationale for the design and evaluation of therapeutic trials. Hepatology 29:62-67, 1999 (Pubitemid 29023987)
3. Llovet JM, Ricci S, Mazzaferro V, et al.: Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359:378-390, 2008
4. 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 10:25-34, 2009
5. Llovet JM, Burroughs A, Bruix J: Hepatocellular carcinoma. Lancet 362:1907-1917, 2003 (Pubitemid 37518510)
6. Lo CM, Ngan H, Tso WK, et al.: Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology 35:1164-1171, 2002 (Pubitemid 34454013)
7. Hong K, Khwaja A, Liapi E, et al.: New intra-arterial drug delivery system for the treatment of liver cancer: Preclinical assessment in a rabbit model of liver cancer. Clin Cancer Res 12:2563-2567, 2006
8. Varela M, Real MI, Burrel M, et al.: Chemoembolization of hepatocellular carcinoma with drug eluting beads: Efficacy and doxorubicin pharmacokinetics. J Hepatol 46:474-481, 2007 (Pubitemid 46201723)
9. Lammer J, Malagari K, Vogl T, et al.: Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: Results of the PRECISION V study. Cardiovasc Intervent Radiol 33:41-52, 2010
10. Reyes DK, Vossen JA, Kamel IR, et al.: Singlecenter phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: Initial experience in the United States. Cancer J 15:526-532, 2009
11. Li X, Feng GS, Zheng CS, et al.: Expression of plasma vascular endothelial growth factor in patients with hepatocellular carcinoma and effect of transcatheter arterial chemoembolization therapy on plasma vascular endothelial growth factor level. World J Gastroenterol 10:2878-2882, 2004 (Pubitemid 39303010)
12. Wang B, Xu H, Gao ZQ, et al.: Increased expression of vascular endothelial growth factor in hepatocellular carcinoma after transcatheter arterial chemoembolization. Acta Radiol 49:523-529, 2008
13. Carmeliet P, Jain RK: Angiogenesis in cancer and other diseases. Nature 407:249-257, 2000
14. 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 (Pubitemid 40790169)
15. Kaseb AO, Hassan MM, Lin E, et al.: V-CLIP: Integrating plasma vascular endothelial growth factor into a new scoring system to stratify patients with advanced hepatocellular carcinoma for clinical trials. Cancer [epub ahead of print on December 14, 2010]
16. Tseng CS, Lo HW, Chen PH, et al.: Clinical significance of plasma D-dimer levels and serum VEGF levels in patients with hepatocellular carcinoma. Hepatogastroenterology 51:1454-1458, 2004
17. Jiang H, Meng Q, Tan H, et al.: Antiangiogenic therapy enhances the efficacy of transcatheter arterial embolization for hepatocellular carcinomas. Int J Cancer 121:416-424, 2007 (Pubitemid 46917712)
18. Kamel IR, Liapi E, Reyes DK, et al.: Unresectable hepatocellular carcinoma: Serial early vascular and cellular changes after transarterial chemoembolization as detected with MR imaging. Radiology 250:466-473, 2009
19. 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
20. Tsuchida Y, Therasse P: Response evaluation criteria in solid tumors (RECIST): New guidelines. Med Pediatr Oncol 37:1-3, 2001 (Pubitemid 32613627)
21. Bruix J, Sherman M: Management of hepatocellular carcinoma. Hepatology 42:1208-1236, 2005 (Pubitemid 43112690)
22. 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 with advanced hepatocellular carcinoma (HCC). Presented at the 5th Annual Gastrointestinal Cancers Symposium, Orlando, FL, January 25-27, 2008 (abstr 128)
23. Lencioni R, Zou J, Leberre M, et al.: Sorafenib (SOR) or placebo (PL) in combination with transarterial chemoembolization (TACE) for intermediatestage hepatocellular carcinoma (SPACE). J Clin Oncol 28:26s, 2010 (suppl; abstr TPS178)
24. Eastern Cooperative Oncology Group: Chemoembolization with or without sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery. http://clinicaltrials.gov/ct2/ show/NCT01004978?term= 01004978&rank=1