Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma

European Journal of Cancer

Volumn 47, Issue 14, 2011, Pages 2117-2127

  Kudo, Masatoshi ^a   Imanaka, Kazuho ^b   Chida, Nobuyuki ^c   Nakachi, Kohei ^d   Tak, Won Young ^e   Takayama, Tadatoshi ^f   Yoon, Jung Hwan ^g   Hori, Takeshi ^h   Kumada, Hiromitsu ⁱ   Hayashi, Norio ^j   Kaneko, Shuichi ^k   Tsubouchi, Hirohito ^l   Suh, Dong Jin ^m   Furuse, Junji ⁿ   Okusaka, Takuji ^o   Tanaka, Katsuaki ^p   Matsui, Osamu ^k   Wada, Michihiko ^q   Yamaguchi, Iku ^q   Ohya, Toshio ^q   Meinhardt, Gerold ^r   Okita, Kiwamu ^s   more..

^a KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

^c SENDAI CITY MEDICAL CENTER   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^e Kyungpook National University Hospital   (South Korea)

^f NIHON UNIVERSITY   (Japan)

^g Seoul National University Hospital   (South Korea)

^h Miyazaki Medical Center Hospital   (Japan)

ⁱ TORANOMON HOSPITAL   (Japan)

^j OSAKA UNIVERSITY HOSPITAL   (Japan)

^k KANAZAWA UNIVERSITY HOSPITAL   (Japan)

^l KAGOSHIMA UNIVERSITY HOSPITAL   (Japan)

^m University of Ulsan   (South Korea)

ⁿ KYORIN UNIVERSITY   (Japan)

^o NATIONAL CANCER CENTER HOSPITAL   (Japan)

^p YOKOHAMA CITY UNIVERSITY MEDICAL CENTER   (Japan)

^q BAYER YAKUHIN LTD   (Japan)

^r BAYER CORPORATION   (United States)

^s Shimonoseki Kohsei Hospital   (Japan)

more..

Author keywords

Controlled trial; Hepatocellular carcinoma; Randomised; Sorafenib; Transarterial chemoembolisation

Indexed keywords

PLACEBO; SORAFENIB;

ADULT; ALOPECIA; ARTICLE; CANCER GROWTH; CANCER RECURRENCE; CHEMOEMBOLIZATION; DESQUAMATION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOPHOSPHATEMIA; JAPANESE; LIVER CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PANCREATITIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SOUTH KOREA; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARCINOMA, HEPATOCELLULAR; CHEMOEMBOLIZATION, THERAPEUTIC; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; JAPAN; LIVER NEOPLASMS; MALE; MIDDLE AGED; PYRIDINES; REPUBLIC OF KOREA; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 79960805810     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.05.007     Document Type: Article

References (35)

1. M. Kudo The 2008 Okuda lecture management of hepatocellular carcinoma: from surveillance to molecular targeted therapy J Gastroenterol Hepatol 25 2010 439 452
2. M.F. Yuen, J.L. Hou, and A. Chutaputti Hepatocellular carcinoma in the Asia-Pacific region J Gastroenterol Hepatol 24 2009 346 353
3. Asia-Pacific working party on prevention of hepatocellular carcinoma. Prevention of hepatocellular carcinoma in the Asia-Pacific region: consensus statements. J Gastroenterol Hepatol 2010;25:657-63.
4. J.M. Llovet, A. Burroughs, and J. Bruix Hepatocellular carcinoma Lancet 362 2003 1907 1917 (Pubitemid 37518510)
5. M. Makuuchi, and N. Kokudo Clinical practice guidelines for hepatocellular carcinoma: the first evidence based guidelines from Japan World J Gastroenterol 12 2006 828 829 (Pubitemid 43380776)
6. J. Bruix, and M. Sherman Management of hepatocellular carcinoma: an update Hepatology 53 2011 1020 1022
7. F. Trevisani, S. De Notariis, C. Rossi, and M. Bernardi Randomized control trials on chemoembolization for hepatocellular carcinoma: is there room for new studies? J Clin Gastroenterol 32 2001 383 389 (Pubitemid 32378268)
8. C.M. Lo, H. Ngan, and W.K. Tso Randomized control trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma Hepatology 35 2002 1164 1171 (Pubitemid 34454013)
9. J.M. Llovet, M.I. Real, and X. Montaña Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial Lancet 359 2002 1734 1739 (Pubitemid 34607087)
10. J.M. Llovet, and J. Bruix Systematic review of randomized trials for unresectable hepatocellular carcinoma: chemoembolization improves survival Hepatology 37 2003 429 442 (Pubitemid 36152543)
11. L. Marelli, R. Stigliano, and C. Triantos Transarterial therapy for hepatocellular carcinoma: which technique is more effective? A systematic review of cohort and randomized studies Cardiovasc Intervent Radiol 30 2007 6 25 (Pubitemid 44900485)
12. H.-Y. Cheng, X. Wang, D. Chen, A.-M. Xu, and Y.-C. Jia The value and limitation of transcatheter arterial chemoembolization in preventing recurrence of resected hepatocellular carcinoma World J Gastroenterol 11 2005 3644 3646 (Pubitemid 40903532)
13. J.M. Llovet Updated treatment approach to hepatocellular carcinoma J Gastroenterol 40 2005 225 235 (Pubitemid 40613379)
14. K. Kasai, A. Ushio, and K. Sawara Transcatheter arterial embolizaiton with a fine-powder formulation of cisplatin for hepatocellular carcinoma World J Gastroenterol 16 2010 3437 3444
15. A. Seki, S. Hori, K. Kobayashi, and S. Narumiya Transcatheter arterial embolization with epirubicin-loaded superabsorbent polymer microspheres for 135 hepatocellular carcinoma patients: single-center experience Cardiovasc Intervent 34 2011 557 565
16. K. Takayasu, S. Arii, and I. Ikai Prospective cohort study of transarterial chemoembolization for unresectable hepatocellular carcinoma in 8510 patients Gastroenterology 131 2006 461 469 (Pubitemid 44142456)
17. Groupe d'Etude et de Traitement du Carcinome Hépatocellulaire. A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. N Engl J Med 1995;332:1256-61.
18. M. Fernández, D. Semela, and J. Bruix Angiogenesis in liver disease J Hepatol 50 2009 604 620
19. B. Wang, H. Xu, and Z.Q. Gao Increased expression of vascular endothelial growth factor in hepatocellular carcinoma after transcatheter arterial chemoembolization Acta Radiol 49 2008 523 529
20. X. Li, G.-S. Feng, C.-S. Zheng, C.-K. Zhuo, and X. Liu 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 2004 2878 2882 (Pubitemid 39303010)
21. S. Wilhelm, and D.S. Chien BAY 43-9006: preclinical data Curr Pharm Des 8 2002 2255 2257 (Pubitemid 35189898)
22. S.M. Wilhelm, C. Carter, and L. Tang 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 (Pubitemid 39331023)
23. F. Carlomagno, S. Anaganti, and T. Guida BAY 43-9006 inhibition of oncogenic RET mutants J Natl Cancer Inst 98 2006 326 334 (Pubitemid 43338212)
24. J.M. Llovet, S. Ricci, and V. Mazzaferro Sorafenib in advanced hepatocellular carcinoma N Engl J Med 359 2008 378 390
25. A.-L. Cheng, Y.-K. Kang, and Z. Chen 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 2009 25 34
26. Liver Cancer Study Group of Japan Criteria for the evaluation of direct efficacy in treatment of liver cancer Kanzo 45 2004 380 385
27. K. Takayasu, S. Arii, and N. Matsuo Comparison of CT findings with resected specimens after chemoembolization with iodized oil for hepatocellular carcinoma AJR Am J Roentgenol 175 2000 699 704
28. R. Yamada, H. Nakatsuka, and K. Nakamura Hepatic artery embolization in 32 patients with unresectable hepatoma Osaka City Med J 26 1980 81 96 (Pubitemid 11009683)
29. R. Yamada, M. Sato, and M. Kawabata Hepatic artery embolization in 120 patients with unresectable hepatoma Radiology 148 1983 397 401 (Pubitemid 13073577)
30. J.H. Shim, J.-W. Park, and J.H. Kim Association between increment of serum VEGF level and prognosis after transcatheter arterial chemoembolization in hepatocellular carcinoma patients Cancer Sci 99 2008 2037 2044
31. S.J. Schoenleber, D.M. Kurtz, J.A. Talwalkar, L.R. Roberts, and G.J. Gores Prognostic role of vascular endothelial growth factor in hepatocellular carcinoma: systematic review and meta-analysis Br J Cancer 100 2009 1385 1392
32. R. Lencioni, J. Zou, and M. Leberre Sorafenib (SOR) or placebo (PL) in combination with transarterial chemoembolization (TACE) for intermediate-stage hepatocellular carcinoma (SPACE) J Clin Oncol 28 15 Suppl. 2010 [Abstract TPS178]
33. M.B. Thomas, D. Jaffe, and M.M. Choti Hepatocellular carcinoma: consensus recommendations of the National Cancer Institute Clinical Trials Planning Meeting J Clin Oncol 28 2010 3994 4005
34. Park J-W, Kim HY, Shim JH, et al. Interim analysis of a phase II study of the combination of TACE and sorafenib for unresectable hepatocellular carcinoma in National Cancer Center Korea (COTSUN Korea Trial). In: Proceedings of the fourth annual conference of the International Liver Cancer Association (ILCA), Montreal, Quebéc, Canada; 10-12 September 2010. p. 26 [Abstract O-027].
35. US national institutes of health. Transcatheter arterial chemoembolization therapy in combination with sorafenib (TACTICS), NCT01217034. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01217034?term= sorafenib±AND±tactics&rank=1 [accessed 07.12.10].