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

Journal of Clinical Oncology

Volumn 31, Issue 28, 2013, Pages 3509-3516

  Llovet, Josep M ^a,b   Decaens, Thomas ^c   Raoul, Jean Luc ^d   Boucher, Eveline ^e   Kudo, Masatoshi ^k   Chang, Charissa ^a   Kang, Yoon Koo ^l   Assenat, Eric ^f   Lim, Ho Yeong ^m   Boige, Valerie ^g   Mathurin, Philippe ^h   Fartoux, Laetitia ⁱ   Lin, Deng Yn ^p   Bruix, Jordi ^b   Poon, Ronnie T ^r   Sherman, Morris ^s   Blanc, Jean Frédéric ^j   Finn, Richard S ^t   Tak, Won Young ⁿ   Chao, Yee ^q   Ezzeddine, Rana ^u   Liu, David ^u   Walters, Ian ^u   Park, Joong Won ^o   more..

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF BARCELONA   (Spain)

^c UNIVERSITÉ PARIS EST CRÉTEIL   (France)

^d INSTITUT PAOLI CALMETTES   (France)

^e Central Eugene Marquis   (France)

^f HÔPITAL SAINT ELOI   (France)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h LILLE UNIVERSITY HOSPITAL   (France)

ⁱ HÔPITAL SAINT ANTOINE   (France)

^j HÔPITAL SAINT ANDRÉ   (France)

^k KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^l Asan Medical Center   (South Korea)

^m Samsung Medical Center   (South Korea)

ⁿ Kyungpook National University Hospital   (South Korea)

^o National Cancer Center   (South Korea)

^p CHANG GUNG UNIVERSITY   (Taiwan)

^q TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^r UNIVERSITY OF HONG KONG   (Hong Kong)

^s TORONTO GENERAL HOSPITAL   (Canada)

^t UNIVERSITY OF CALIFORNIA   (United States)

^u BRISTOL MYERS SQUIBB   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BRIVANIB; SORAFENIB; ALANINE; CARBANILAMIDE DERIVATIVE; NICOTINAMIDE; PROTEIN KINASE INHIBITOR; TRIAZINE DERIVATIVE;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; ADVANCED CANCER; ADVERSE OUTCOME; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTERIAL EMBOLIZATION; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER MORTALITY; CANCER PATIENT; CANCER PROGNOSIS; CANCER SURGERY; CANCER SURVIVAL; CANCER THERAPY; CONFERENCE PAPER; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; DYSPHONIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPONATREMIA; HYPOTHYROIDISM; INTENTION TO TREAT ANALYSIS; LIVER CELL CARCINOMA; LIVER RESECTION; MAJOR CLINICAL STUDY; MALE; MEDIAN SURVIVAL TIME; MULTICENTER STUDY; NAUSEA; OVERALL SURVIVAL; PATIENT CARE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RADIOFREQUENCY ABLATION; RANDOMIZED CONTROLLED TRIAL; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; ANALOGS AND DERIVATIVES; CARCINOMA, HEPATOCELLULAR; CLINICAL TRIAL; DRUG EFFECTS; DRUG RESISTANCE; FOLLOW UP; LIVER NEOPLASMS; MIDDLE AGED; MORTALITY; PATHOLOGY; PROGNOSIS; SALVAGE THERAPY; SURVIVAL RATE; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ALANINE; CARCINOMA, HEPATOCELLULAR; DOUBLE-BLIND METHOD; DRUG RESISTANCE, NEOPLASM; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIVER NEOPLASMS; MALE; MIDDLE AGED; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROGNOSIS; PROTEIN KINASE INHIBITORS; SALVAGE THERAPY; SURVIVAL RATE; TRIAZINES; YOUNG ADULT;

EID: 84885587718     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.47.3009     Document Type: Conference Paper

References (35)

1. Jemal A, Bray F, Center MM, et al: Global cancer statistics. CA Cancer J Clin 61:69-90, 2011
2. 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 56:908-943, 2012
3. Forner A, Llovet JM, Bruix J: Hepatocellular carcinoma. Lancet 379:1245-1255, 2012
4. Llovet JM, Di Bisceglie AM, Bruix J, et al: Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 100:698-711, 2008
5. Llovet JM, Ricci S, Mazzaferro V, et al: Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359:378-390, 2008
6. 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
7. Presta M, Dell'Era P, Mitola S, et al: Fibroblast growth factor/fibroblast growth factor receptor system in angiogenesis. Cytokine Growth Factor Rev 16:159-178, 2005
8. Grose R, Dickson C: Fibroblast growth factor signaling in tumorigenesis. Cytokine Growth Factor Rev 16:179-186, 2005
9. Mise M, Arii S, Higashituji H, et al: Clinical significance of vascular endothelial growth factor and basic fibroblast growth factor gene expression in liver tumor. Hepatology 23:455-464, 1996
10. Ogasawara S, Yano H, Iemura A, et al: Expressions of basic fibroblast growth factor and its receptors and their relationship to proliferation of human hepatocellular carcinoma cell lines. Hepatology 24: 198-205, 1996
11. El-Assal ON, Yamanoi A, Ono T, et al: The clinicopathological significance of heparanase and basic fibroblast growth factor expressions in hepatocellular carcinoma. Clin Cancer Res 7:1299-1305, 2001
12. Uematsu S, Higashi T, Nouso K, et al: Altered expression of vascular endothelial growth factor, fibroblast growth factor-2 and endostatin in patients with hepatocellular carcinoma. J Gastroenterol Hepatol 20:583-588, 2005
13. Poon RT, Ng IO, Lau C, et al: Correlation of serum basic fibroblast growth factor levels with clinicopathologic features and postoperative recurrence in hepatocellular carcinoma. Am J Surg 182: 298-304, 2001
14. Bergers G, Hanahan D: Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer 8:592-603, 2008
15. Casanovas O, Hicklin DJ, Bergers G, et al: Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 8:299-309, 2005
16. Villanueva A, Llovet JM: Second-line therapies in hepatocellular carcinoma: Emergence of resistance to sorafenib. Clin Cancer Res 18:1824- 1826, 2012
17. Cai ZW, Zhang Y, Borzilleri RM, et al: Discovery of brivanib alaninate ((S)-((R)-1-(4-(4-fluoro-2-methyl-1H-indol- 5-yloxy)-5-methylpyrrolo[2,1-f][1,2,4] triazin-6- yloxy)propan-2-yl)2-aminopropanoate), a novel prodrug of dual vascular endothelial growth factor receptor-2 and fibroblast growth factor receptor-1 kinase inhibitor (BMS- 540215). J Med Chem 51:1976-1980, 2008
18. Bhide RS, Lombardo LJ, Hunt JT, et al: The antiangiogenic activity in xenograft models of brivanib, a dual inhibitor of vascular endothelial growth factor receptor-2 and fibroblast growth factor receptor-1 kinases. Mol Cancer Ther 9:369-378, 2010
19. Huynh H, Ngo VC, Fargnoli J, et al: Brivanib alaninate, a dual inhibitor of vascular endothelial growth factor receptor and fibroblast growth factor receptor tyrosine kinases, induces growth inhibition in mouse models of human hepatocellular carcinoma. Clin Cancer Res 14:6146-6153, 2008
20. Allen E, Walters IB, Hanahan D: Brivanib, a dual FGF/VEGF inhibitor, is active both first and second line against mouse pancreatic neuroendocrine tumors developing adaptive/evasive resistance to VEGF inhibition. Clin Cancer Res 17:5299-5310, 2011
21. Tovar V, Cornella, Villanueva A: FGF signaling is involved in acquired resistance to sorafenib in an in vivo model of hepatocellular carcinoma. International Liver Cancer Association, 2011 (abstr 0-006)
22. Lencioni R, Llovet JM: Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis 30:52-60, 2010
23. Edeline J, Boucher E, Rolland Y, et al: Comparison of tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST in patients treated with sorafenib for hepatocellular carcinoma. Cancer 118:147-156, 2012
24. Park JW, Finn RS, Kim JS, et al: Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res 17:1973-1983, 2011
25. Finn RS, Kang YK, Mulcahy M, et al: Phase II, open-label study of brivanib as second-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res 18:2090-2098, 2012
26. Pocock SJ, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:103-115, 1975
27. Santoro A, Rimassa L, Borbath I, et al: Tivantinib for second-line treatment of advanced hepatocellular carcinoma: A randomised, placebo-controlled phase 2 study. Lancet Oncol 14:55-63, 2013
28. Johnson PJ, Qin S, Park J-W, et al: Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: Results from the randomized phase III BRISK-FL study. J Clin Oncol 31:3517-3524, 2013
29. Izzedine H, Ederhy S, Goldwasser F, et al: Management of hypertension in angiogenesis inhibitor-treated patients. Ann Oncol 20:807-815, 2009
30. Izzedine H, Massard C, Spano JP, et al: VEGF signalling inhibition-induced proteinuria: Mechanisms, significance and management. Eur J Cancer 46:439-448, 2010
31. Launay-Vacher V, Deray G: Hypertension and proteinuria: A class-effect of antiangiogenic therapies. Anticancer Drugs 20:81-82, 2009
32. Feldt S, Schussel K, Quinzler R, et al: Incidence of thyroid hormone therapy in patients treated with sunitinib or sorafenib: A cohort study. Eur J Cancer 48:974-981, 2012
33. Schwartz GK, Maki RG, Ratain MJ, et al: Brivanib (BMS-582664) in advanced soft-tissue sarcoma (STS): Biomarker and subset results of a phase II randomized discontinuation trial (RDT). J Clin Oncol 29:605s, 2011 (suppl; abstr 10000)
34. Ratain MJ, Schwartz GK, Oza AM, et al: Brivanib (BMS-582664) in advanced solid tumors (AST): Results of a phase II randomized discontinuation trial (RDT). J Clin Oncol 29:213s, 2011 (suppl; abstr 3079)
35. Garrett CR, Siu LL, El-Khoueiry A, et al: Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy. Br J Cancer 105:44-52, 2011