Regorafenib as second-line systemic therapy may change the treatment strategy and management paradigm for hepatocellular carcinoma

Liver Cancer

Volumn 5, Issue 4, 2016, Pages 235-244

  Kudo, M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; REGORAFENIB; SORAFENIB;

CANCER CHEMOTHERAPY; CHEMOEMBOLIZATION; DISEASE COURSE; DRUG EFFICACY; HUMAN; LIFE EXPECTANCY; LIVER CELL CARCINOMA; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RADIOFREQUENCY ABLATION; REVIEW; SURVIVAL RATE; SYSTEMIC THERAPY; TREATMENT FAILURE; TREATMENT INDICATION; TREATMENT RESPONSE;

EID: 85046240898     PISSN: 22351795     EISSN: 16645553     Source Type: Journal    
DOI: 10.1159/000449335     Document Type: Review

References (26)

1. Bruix J, Merle P, Granito A, Huang YH, Bodoky G, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross Paul J, Qin S, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Leberre M, Baumhauer A, Meinhardt G, Han G, on behalf of the RESORCE Investigators: Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma (HCC) progressing on sorafenib: Results of the international, randomized phase 3 RESORCE trial. Ann Oncol 2016; 27 (suppl 2): ii140-ii141. (abstr #LBA-03).
2. Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L: Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer 2013;49:3412-3419.
3. Wilhelm SM, Carter C, Tang L, Wilkie D, McNabola A, Rong H, Chen C, Zhang X, Vincent P, McHugh M, Cao Y, Shujath J, Gawlak S, Eveleigh D, Rowley B, Liu L, Adnane L, Lynch M, Auclair D, Taylor I, Gedrich R, Voznesensky A, Riedl B, Post LE, Bollag G, Trail PA: 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 2004;64:7099-7109.
4. Terashima T, Yamashita T, Takata N, Nakagawa H, Toyama T, Arai K, Kitamura K, Yamashita T, Sakai Y, Mizukoshi E, Honda M, Kaneko S: Post-progression survival and progression-free survival in patients with advanced hepatocellular carcinoma treated by sorafenib. Hepatol Res 2016;46:650-656.
5. Ueshima K, Kudo M, Tanaka M, Kumada T, Chung H, Hagiwara S, Inoue T, Yada N, Kitai S: Phase I/II study of sorafenib in combination with hepatic arterial infusion chemotherapy using low-dose cisplatin and 5-fluorouracil. Liver Cancer 2015;4:263-273.
6. Obi S, Sato S, Kawai T: Current status of hepatic arterial infusion chemotherapy. Liver Cancer 2015;4:188-199.
7. Lin CC, Hung CF, Chen WT, Lin SM: Hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma with portal vein thrombosis: Impact of early response to 4 weeks of treatment. Liver Cancer 2015;4:228-240.
8. Kudo M: Locoregional therapy for hepatocellular carcinoma. Liver Cancer 2015;4:163-164.
9. Tsurusaki M, Murakami T: Surgical and locoregional therapy of HCC: TACE. Liver Cancer 2015;4:165-175.
10. Kang TW, Rhim H: Recent advances in tumor ablation for hepatocellular carcinoma. Liver Cancer 2015;4:176-187.
11. Lencioni R, de Baere T, Martin RC, Nutting CW, Narayanan G: Image-guided ablation of malignant liver tumors: Recommendations for clinical validation of novel thermal and non-Thermal technologies a western perspective. Liver Cancer 2015;4:208-214.
12. Kudo M: Surveillance, diagnosis, treatment, and outcome of liver cancer in Japan. Liver Cancer 2015;4:39-50.
13. Reig M, Rimola J, Torres F, Darnell A, Rodriguez-Lope C, Forner A, Llarch N, Ríos J, Ayuso C, Bruix J: Postprogression survival of patients with advanced hepatocellular carcinoma: rationale for second-line trial design. Hepatology 2013;58:2023-2031.
14. Kudo M, Ueshima K, Minami Y, Nishida N: Molecular targeted therapy for hepatocellular carcinoma: Impact of regorafenib and consideration on trial designs of novel investigational agents. Liver Cancer 2016 (in press).
15. Kudo M, Park JW, Obi S, Qin S, Assenat E, Umeyama Y, Chakrabarti D, Valota O, Fujii Y, Martini JF, Williams JA, Kang YK: Regional differences in efficacy/safety/biomarkers in a randomised study of axitinib in 2nd line patients (pts) with advanced hepatocellular carcinoma (HCC). J Clin Oncol 34, 2016 (suppl 4S; 2016 Gastrointestinal Cancers Symposium; abstr 329).
16. Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M: Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol 2015;26:2457-2463.
17. Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW: Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol 2013;31:3509-3516.
18. Llovet JM, Ducreux M, et al European Association For The Study Of The Liver European Organisation For Research And Treatment Of Cancer: EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol 2012;56:908-943.
19. Kudo M, Matsui O, Izumi N, Iijima H, Kadoya M, Imai Y, Okusaka T, Miyayama S, Tsuchiya K, Ueshima K, Hiraoka A, Ikeda M, Ogasawara S, Yamashita T, Minami T, Yamakado K, Liver Cancer Study Group of Japan: JSH consensus-based clinical practice guidelines for the management of hepatocellular carcinoma: 2014 update by the Liver Cancer Study Group of Japan. Liver Cancer 2014;3:458-468.
20. Arizumi T, Ueshima K, Chishina H, Kono M, Takita M, Kitai S, Inoue T, Yada N, Hagiwara S, Minami Y, Sakurai T, Nishida N, Kudo M: Validation of the criteria of transcatheter arterial chemoembolization failure or refractoriness in patients with advanced hepatocellular carcinoma proposed by the LCSGJ. Oncology 2014;87(Suppl 1):32-36.
21. Ogasawara S, Chiba T, Ooka Y, Kanogawa N, Motoyama T, Suzuki E, Tawada A, Kanai F, Yoshikawa M, Yokosuka O: Efficacy of sorafenib in intermediate-stage hepatocellular carcinoma patients refractory to transarterial chemoembolization. Oncology 2014;87:330-341.
22. Arizumi T, Ueshima K, Minami T, Kono M, Chishina H, Takita M, Kitai S, Inoue T, Yada N, Hagiwara S, Minami Y, Sakurai T, Nishida N, Kudo M: Effectiveness of sorafenib in patients with transcatheter arterial chemoembolization (TACE) refractory and intermediate-stage hepatocellular carcinoma. Liver Cancer 2015;4:253-262.
23. Kudo M, Matsui O, Izumi N, Kadoya M, Okusaka T, Miyayama S, et al: Transarterial Chemoembolization Failure/Refractoriness: JSH-LCSGJ Criteria 2014 Update. Oncology 2014;87(Suppl 1):22-31.
24. Arizumi T, Ueshima K, Iwanishi M, Minami T, Chishina H, Kono M, Takita M, Kitai S, Inoue T, Yada N, Hagiwara S, Ida H, Minami Y, Sakurai T, Kitano M, Nishida N, Kudo M: Validation of a modified substaging system (Kinki criteria) for patients with intermediate-stage hepatocellular carcinoma. Oncology 2015;89(Suppl 2):47-52.
25. Kudo M, Arizumi T, Ueshima K, Sakurai T, Kitano M, Nishida N: Subclassification of BCLC B stage hepatocellular carcinoma and treatment strategies: Proposal of modified Bolondi?s subclassification (Kinki criteria). Dig Dis 2015;33:751-758.
26. El-Khoueiry AB, Sangro B, Yau TC, Crocenzi TS, Welling TH, Yeo W, et al: Phase I/II safety and antitumor activity of nivolumab (nivo) in patients (pts) with advanced hepatocellular carcinoma (HCC): Interim analysis of the CheckMate-040 dose escalation study. J Clin Oncol 34, 2016 (suppl; 2016 ASCO Annual Meeting; abstr 4012) .