A phase II study of cixutumumab (IMC-A12, NSC742460) in advanced hepatocellular carcinoma

Journal of Hepatology

Volumn 60, Issue 2, 2014, Pages 319-324

  Abou Alfa, Ghassan K ^a,b   Capanu, Marinela ^a   O'Reilly, Eileen M ^a,b   Ma, Jennifer ^a   Chou, Joanne F ^a   Gansukh, Bolorsukh ^a   Shia, Jinru ^a   Kalin, Marcia ^a   Katz, Seth ^a   Abad, Leslie ^c   Reidy Lagunes, Diane L ^a,b   Kelsen, David P ^a,b   Chen, Helen X ^d   Saltz, Leonard B ^a,b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Cixutumumab (IMC A12, NSC742460); Diabetes; Free IGF1; Hepatocellular Carcinoma; IGF IR; IGF2; IGFBP 1; IGFBP 3

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CIXUTUMUMAB; GLUCOSE; PHOSPHATE; SODIUM; TRIACYLGLYCEROL LIPASE;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALCOHOL LIVER CIRRHOSIS; ARTICLE; ASCITES; BLOOD LEVEL; BLURRED VISION; CANCER PROGNOSIS; CANCER STAGING; CANCER SURVIVAL; CONFUSION; DEHYDRATION; DIABETES MELLITUS; DIARRHEA; FEMALE; HEPATITIS B; HEPATITIS C; HUMAN; HYPERGLYCEMIA; HYPONATREMIA; KIDNEY FAILURE; LIVER CELL CARCINOMA; LIVER FUNCTION TEST; LYMPHOCYTOPENIA; MALE; MIDDLE AGED; MONOTHERAPY; NAUSEA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECTUM HEMORRHAGE; UNSPECIFIED SIDE EFFECT; VERY ELDERLY; VOMITING;

ADCC; AJCC; ALANINE AMINOTRANSFERASE; ALT; AMERICAN JOINT COMMITTEE ON CANCER; ANTIBODY-DEPENDENT COMPLEMENT-MEDIATED CYTOTOXICITY; ASPARTATE AMINOTRANSFERASE; AST; CALGB; CANCER LEUKEMIA GROUP B; CANCER THERAPY EVALUATION PROGRAM (CTEP)/NATIONAL CANCER INSTITUTE; CC1; CDC; CELL CONDITIONING 1; CELLS PER MICROLITER; CIXUTUMUMAB (IMC-A12, NSC742460); COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS; COMPLEMENT-DEPENDENT CYTOTOXICITY; CTCAE; CTEP/NCI; DIABETES; ELISA; ENZYME-LINKED IMMUNOSORBENT ASSAY; FREE IGF1; HAZARD RATIO; HCC; HEPATOCELLULAR CARCINOMA; HIV; HR; HUMAN IMMUNODEFICIENCY VIRUS; IGF-1; IGF-1R; IGF-2; IGF-2R; IGF-IR; IGF2; IGFBP 1; IGFBP 3; IGG1; IMMUNOGLOBULIN 1; INSTITUTIONAL REVIEW BOARD; INSULIN GROWTH FACTOR 1; INSULIN GROWTH FACTOR 1 RECEPTOR; INSULIN GROWTH FACTOR 2; INSULIN GROWTH FACTOR 2 RECEPTOR; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3; IRB; KARNOFSKY PERFORMANCE STATUS; KPS; LOH; LOSS OF HETEROZYGOSITY; MAP; MCL; MG/DL; MG/KG; MILLIGRAM/DECILITER; MILLIGRAM/KILOGRAM; MILLILITER PER MINUTE; MITOGEN ACTIVATED PROTEIN; ML/MIN; NASH; NON-ALCOHOLIC STEATOHEPATITIS; OS; OVERALL URVIVAL; PFS; PROGRESSION FREE SURVIVAL; PROTHROMBIN TIME/INTERNATIONAL NORMALIZED RATIO; PT/INR; RECIST; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; UNITS/L; UNITS/LITER;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; CARCINOMA, HEPATOCELLULAR; FEMALE; HUMANS; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3; INSULIN-LIKE GROWTH FACTOR I; INSULIN-LIKE GROWTH FACTOR II; KAPLAN-MEIER ESTIMATE; LIVER NEOPLASMS; MALE; MIDDLE AGED; RECEPTOR, IGF TYPE 1; TUMOR MARKERS, BIOLOGICAL;

EID: 84892493984     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jhep.2013.09.008     Document Type: Article

References (24)

1. D. Burtrum, Z. Zhu, D. Lu, D.M. Anderson, M. Prewett, and D.S. Pereira et al. A fully human monoclonal antibody to the insulin-like growth factor I receptor blocks ligand-dependent signaling and inhibits human tumor growth in vivo Cancer Res 63 2003 8912 8921
2. T.E. Adams, V.C. Epa, T.P. Garrett, and C.W. Ward Structure and function of the type 1 insulin-like growth factor receptor Cell Mol Life Sci 57 2000 1050 1093
3. Y. Wang, and Y. Sun Insulin-like growth factor receptor-1 as an anti-cancer target: blocking transformation and inducing apoptosis Curr Cancer Drug Targets 2 2002 191 207
4. J.D. Wu, A. Odman, L.M. Higgins, K. Haugk, R. Vessella, and D.L. Ludwig et al. In vivo effects of the human type I insulin-like growth factor receptor antibody A12 on androgen-dependent and androgen-independent xenograft human prostate tumors Clin Cancer Res 11 2005 3065 3074
5. A.T. De Souza, G.R. Hankins, M.K. Washington, R.L. Fine, T.C. Orton, and R.L. Jirtle Frequent loss of heterozygosity on 6q at the mannose 6-phosphate/insulin-like growth factor II receptor locus in human hepatocellular tumors Oncogene 10 1995 1725 1729
6. H. Huynh, P.K. Chow, L.L. Ooi, and K.C. Soo A possible role for insulin-like growth factor-binding protein-3 autocrine/paracrine loops in controlling hepatocellular carcinoma cell proliferation Cell Growth Differ 13 2002 115 122
7. Y.I. Lee, Y.J. Han, S.Y. Lee, Y.I. Lee, S.K. Park, and Y.J. Park et al. Activation of insulin-like growth factor II signaling by mutant type p53: physiological implications for potentiation of IGF-II signaling by p53 mutant 249 Mol Cell Endocrinol 203 2003 51 63
8. N. Sedlaczek, A. Hasilik, P. Neuhaus, D. Schuppan, and H. Herbst Focal overexpression of insulin-like growth factor 2 by hepatocytes and cholangiocytes in viral liver cirrhosis Br J Cancer 88 2003 733 739
9. V. Tovar, C. Alsinet, A. Villanueva, Y. Hoshida, D.Y. Chiang, and M. Solé et al. IGF activation in a molecular subclass of hepatocellular carcinoma and pre-clinical efficacy of IGF-1R blockage J Hepatol 52 2010 550 559
10. M. Höpfner, A. Huether, A.P. Sutter, V. Baradari, D. Schuppan, and H. Scherübl Blockade of IGF-1 receptor tyrosine kinase has antineoplastic effects in hepatocellular carcinoma cells Biochem Pharmacol 71 2006 1435 1448
11. R.X. Lin, Z.Y. Wang, N. Zhang, C.W. Tuo, Q.D. Liang, and Y.N. Sun et al. Inhibition of hepatocellular carcinoma growth by antisense oligonucleotides to type I insulin-like growth factor receptor in vitro and in an orthotopic model Hepatol Res 37 2007 366 375
12. Y.C. Zhang, X.P. Wang, L.Y. Zhang, A.L. Song, Z.M. Kou, and X.S. Li Effect of blocking IGF-I receptor on growth of human hepatocellular carcinoma cells World J Gastroenterol 12 2006 3977 3982
13. G.K. Abou-Alfa, and A.P. Venook The impact of new data in the treatment of advanced hepatocellular carcinoma Curr Oncol Rep 10 2008 199 205
14. J.M. Llovet, S. Ricci, V. Mazzaferro, P. Hilgard, E. Gane, and J.F. Blanc et al. Sorafenib in advanced hepatocellular carcinoma N Engl J Med 359 2008 378 390
15. P. Therasse, S.G. Arbuck, E.A. Eisenhauer, J. Wanders, R.S. Kaplan, and L. Rubinstein 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 2000 205 216
16. M. Daher, M.E. Lacouture, D. Rathkopf, R.G. Maki, M.L. Keohan, and B. Gansukh et al. Case series of dermatologic events associated with the insulin-like growth factor receptor 1 inhibitor cixutumumab J Clin Oncol 29 2011 e638 e640
17. M. Conchillo, R.J. de Knegt, M. Payeras, J. Quiroga, B. Sangro, and J.I. Herrero et al. Insulin-like growth factor I (IGF-I) replacement therapy increases albumin concentration in liver cirrhosis: results of a pilot randomized controlled clinical trial J Hepatol 43 2005 630 636
18. C.M. Fernández-Rodriguez, I. Prada, A. Andrade, M. Moreiras, R. Guitián, and R. Aller et al. Disturbed synthesis of insulinlike growth factor I and its binding proteins may influence renal function changes in liver cirrhosis Dig Dis Sci 46 2001 1313
19. A. Gualberto, M.L. Hixon, D.D. Karp, D. Li, S. Green, and M. Dolled-Filhart et al. Pre-treatment levels of circulating free IGF-1 identify NSCLC patients who derive clinical benefit from figitumumab Br J Cancer 104 2011 68 74
20. A. Cheng, Y. Kang, D. Lin, J. Park, M. Kudo, and S. Qin et al. Phase III trial of sunitinib (Su) vs. sorafenib (So) in advanced hepatocellular carcinoma (HCC) J Clin Oncol 29 2011
21. P.J. Johnson, S. Qin, J.W. Park, R.T. Poon, J.L. Raoul, and P.A. Philip et al. Brivanib vs. 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 2013 3517 3524
22. < http://news.bms.com/press-release/rd-news/brisk-fl-study- investigational-compound-brivanib-hepatocellular-carcinoma-does >. Accessed March 20, 2013.
23. A.X. Zhu, O. Rosmorduc, J. Evans, P. Ross, A. Santoro, and F. Carrilho et al. SEARCH: a phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with hepatocellular carcinoma (HCC) Ann Oncol 23 2012 LBA2
24. R. O'Donnell, A.B. El-Khoueiry, H. Lenz, and D.R. Gandara A phase I trial of escalating doses of the anti-IGF-1R monoclonal antibody (mAb) cixutumumab (IMC-A12) and sorafenib for treatment of advanced hepatocellular carcinoma (HCC) J Clin Oncol 28 2010 [suppl; abstr TPS212]