Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: A phase II study of the belgian group of digestive oncology

Annals of Oncology

Volumn 24, Issue 11, 2013, Pages 2824-2829

  Borbath, I ^a   Ceratti, A ^a   Verslype, C ^b   Demols, A ^c   Delaunoit, T ^d   Laurent, S ^e   Deleporte, A ^f   Vergauwe, P ^g   Van Maanen, A ^a   Sempoux, C ^a   Van Cutsem, E ^b   Van Laethem, J L ^c  

^a CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c ERASME HOSPITAL   (Belgium)

^d Centre Hospitalier Jolimont Lobbes   (Belgium)

^e GHENT UNIVERSITY HOSPITAL   (Belgium)

^f JULES BORDET INSTITUTE   (Belgium)

^g AZ GROENINGE   (Belgium)

Author keywords

Cetuximab; Chemotherapy; Cholangiocarcinoma; Gemcitabine; KRAS

Indexed keywords

ANTIHISTAMINIC AGENT; CETUXIMAB; CORTICOSTEROID; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ANEMIA; ANOREXIA; ARTICLE; BELGIUM; BILE DUCT CARCINOMA; BILIARY TRACT INFECTION; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CLINICAL ARTICLE; DEEP VEIN THROMBOSIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEMALE; GENE MUTATION; HEMOLYTIC UREMIC SYNDROME; HUMAN; INFECTION; INOPERABLE CANCER; LIVER DYSFUNCTION; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTIC SYNDROME; NEUTROPENIA; ONCOGENE K RAS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT; VOMITING;

CETUXIMAB; CHEMOTHERAPY; CHOLANGIOCARCINOMA; GEMCITABINE; KRAS;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BILE DUCT NEOPLASMS; CHOLANGIOCARCINOMA; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PROTO-ONCOGENE PROTEINS; RAS PROTEINS;

EID: 84887105550     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt337     Document Type: Article

References (20)

1. Gores GJ. Cholangiocarcinoma: current concepts and insights. Hepatology 2003; 37: 961-969.
2. Nakeeb A, Pitt HA, Sohn TA et al. Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann Surg 1996; 224: 463-473; discussion 473-465.
3. Khan SA, Taylor-Robinson SD, Toledano MB et al. Changing international trends in mortality rates for liver, biliary and pancreatic tumours. J Hepatol 2002; 37: 806-813.
4. Shaib YH, Davila JA, McGlynn K et al. Rising incidence of intrahepatic cholangiocarcinoma in the United States: a true increase? J Hepatol 2004; 40: 472-477.
5. Jarnagin WR, Fong Y, DeMatteo RP et al. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg 2001; 234: 507-517; discussion 517-509.
6. Heimbach JK, Gores GJ, Haddock MG et al. Liver transplantation for unresectable perihilar cholangiocarcinoma. Semin Liver Dis 2004; 24: 201-207.
7. Andre T, Tournigand C, Rosmorduc O et al. Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study. Ann Oncol 2004; 15: 1339-1343.
8. Valle J, Wasan H, Palmer DH et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 2010; 362: 1273-1281.
9. Hezel AF, Deshpande V, Zhu AX. Genetics of biliary tract cancers and emerging targeted therapies. J Clin Oncol 2010; 28: 3531-3540.
10. Leone F, Cavalloni G, Pignochino Y et al. Somatic mutations of epidermal growth factor receptor in bile duct and gallbladder carcinoma. Clin Cancer Res 2006; 12: 1680-1685.
11. Gruenberger B, Schueller J, Heubrandtner U et al. Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Lancet Oncol 2010; 11: 1142-1148.
12. Malka D, Fartoux L, Rousseau V et al. Gemcitabine and oxaliplatin (GEMOX) alone or in combination with cetuximab as first-line treatment for advanced biliary cancer: final analysis of a randomized phase II trial (BINGO). J Clin Oncol 2012; 30: abs 4032.
13. Zhu AX, Meyerhardt JA, Blaszkowsky LS et al. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol 2010; 11: 48-54.
14. Lee J, Park SH, Chang HM et al. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2012; 13: 181-188.
15. Sharma A, Dwary AD, Mohanti BK et al. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol 2010; 28: 4581-4586.
16. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
17. Andersen JB, Spee B, Blechacz BR et al. Genomic and genetic characterization of cholangiocarcinoma identifies therapeutic targets for tyrosine kinase inhibitors. Gastroenterology 2012; 142: 1021-1031 e1015.
18. Tannapfel A, Benicke M, Katalinic A et al. Frequency of p16(INK4A) alterations and K-ras mutations in intrahepatic cholangiocarcinoma of the liver. Gut 2000; 47: 721-727.
19. Blake-Haskins JA, Lechleider RJ, Kreitman RJ. Thrombotic microangiopathy with targeted cancer agents. Clin Cancer Res 2011; 17: 5858-5866.
20. Borbath I, Verbrugghe L, Lai R et al. Human equilibrative nucleoside transporter 1 (hENT1) expression is a potential predictive tool for response to gemcitabine in patients with advanced cholangiocarcinoma. Eur J Cancer 2012; 48: 990-996.