A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer

Annals of Oncology

Volumn 26, Issue 5, 2015, Pages 943-949

  Chen, J S ^a   Hsu, C ^b   Chiang, N J ^c,d,e   Tsai, C S ^f   Tsou, H H ^c   Huang, S F ^c   Bai, L Y ^g   Chang, I C ^c   Shiah, H S ^h   Ho, C L ⁱ   Yen, C J ^d   Lee, K D ^a   Chiu, C F ^g   Rau, K M ^a   Yu, M S ^j   Yang, Y ^k   Hsieh, R K ^l   Chang, J Y ^c,d   Shan, Y S ^d   Chao, Y ^m   Chen, Li Tzong ^c,d,e   Chin, Yung Hsin ⁿ   Chung, Tsai Rong ⁿ   Yu, Wei Lan ⁿ   Lee, Mei Hua ⁿ   Lin, Ling Fang ⁿ   Lin, Pei Chyi ⁿ   Wu, Ya Ling ⁿ   Wang, Hui Ling ⁿ   Lu, Li Ju ⁿ   Chen, Shiang Yi ⁿ   Wu, Chih Chu ⁿ   Wei, Te Chih ⁿ   more..

^a CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^c NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^d NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^e KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^f TAINAN MUNICIPAL HOSPITAL   (Taiwan)

^g CHINA MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^h TAIPEI MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

ⁱ TRI SERVICE GENERAL HOSPITAL   (Taiwan)

^j KAOHSIUNG VETERANS GENERAL HOSPITAL   (Taiwan)

^k TAICHUNG VETERANS GENERAL HOSPITAL   (Taiwan)

^l MACKAY MEMORIAL HOSPITAL   (Taiwan)

^m TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

ⁿ Taipei Veterans General Hospital ^*

more..

Author keywords

Biliary tract cancer; Cetuximab; Chemotherapy; KRAS mutation

Indexed keywords

CETUXIMAB; GEMCITABINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; KRAS PROTEIN, HUMAN; PLATINUM COMPLEX; PROTEIN P21;

ADULT; ADVANCED CANCER; AGED; ALLERGY; ANOREXIA; ARTICLE; BILIARY TRACT CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GENE MUTATION; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROPATHY; NEUTROPENIA; ONCOGENE K RAS; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT OUTCOME; TUMOR LOCALIZATION; VOMITING; ANALOGS AND DERIVATIVES; BILIARY TRACT NEOPLASMS; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; GENETIC PREDISPOSITION; GENETICS; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MUTATION; PATHOLOGY; PHENOTYPE; PROPORTIONAL HAZARDS MODEL; TAIWAN; TIME FACTOR; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BILIARY TRACT NEOPLASMS; CETUXIMAB; DEOXYCYTIDINE; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENETIC PREDISPOSITION TO DISEASE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MUTATION; ORGANOPLATINUM COMPOUNDS; PHENOTYPE; PROPORTIONAL HAZARDS MODELS; PROTO-ONCOGENE PROTEINS P21(RAS); TAIWAN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84929091392     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv035     Document Type: Article

References (29)

1. Randi G, Malvezzi M, Levi F et al. Epidemiology of biliary tract cancers: an update. Ann Oncol 2009; 20: 146-159.
2. 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.
3. Paule B, Herelle MO, Rage E et al. Cetuximab plus gemcitabine-oxaliplatin (GEMOX) in patients with refractory advanced intrahepatic cholangiocarcinomas. Oncology 2007; 72: 105-110.
4. Philip PA, Mahoney MR, Allmer C et al. Phase II study of erlotinib in patients with advanced biliary cancer. J Clin Oncol 2006; 24: 3069-3074.
5. Pirker R, Pereira JR, Szczesna A et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009; 373: 1525-1531.
6. Van Cutsem E, Kohne CH, Hitre E et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-1417.
7. Vermorken JB, Mesia R, Rivera F et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008; 359: 1116-1127.
8. Khambata-Ford S, Harbison CT, Hart LL et al. Analysis of potential predictive markers of cetuximab benefit in BMS099, a phase III study of cetuximab and firstline taxane/carboplatin in advanced non-small-cell lung cancer. J Clin Oncol 2010; 28: 918-927.
9. 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.
10. Malka D, Cervera P, Foulon SP et al. Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol 2014; 15: 819-828.
11. Jensen LH, Lindebjerg J, Ploen J et al. Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. Ann Oncol 2012; 23: 2341-2346.
12. De Roock W, Claes B, Bernasconi D et al. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol 2010; 11: 753-762.
13. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985; 69: 1375-1381.
14. Rubovszky G, Lang I, Ganofszky E et al. Cetuximab, gemcitabine and capecitabine in patients with inoperable biliary tract cancer: a phase 2 study. Eur J Cancer 2013; 49: 3806-3812.
15. Borbath I, Ceratti A, Verslype C et al. Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. Ann Oncol 2013; 24: 2824-2829.
16. 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.
17. Sohal DP, Mykulowycz K, Uehara T et al. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol 2013; 24: 3061-3065.
18. Hezel AF, Noel MS, Allen JN et al. Phase II study of gemcitabine, oxaliplatin in combination with panitumumab in KRAS wild-type unresectable or metastatic biliary tract and gallbladder cancer. Br J Cancer 2014; 111: 430-436.
19. Chen TC, Jan YY, Yeh TS. K-ras mutation is strongly associated with perineural invasion and represents an independent prognostic factor of intrahepatic cholangiocarcinoma after hepatectomy. Ann Surg Oncol 2012; 19: 675-681.
20. 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.
21. Tempero M, Plunkett W, Ruiz Van Haperen V et al. Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 2003; 21: 3402-3408.
22. Furuse J, Okusaka T, Bridgewater J et al. Lessons from the comparison of two randomized clinical trials using gemcitabine and cisplatin for advanced biliary tract cancer. Crit Rev Oncol Hematol 2011; 80: 31-39.
23. De Luca A, Gallo M, Aldinucci D et al. Role of the EGFR ligand/receptor system in the secretion of angiogenic factors in mesenchymal stem cells. J Cell Physiol 2011; 226: 2131-2138.
24. Sia D, Hoshida Y, Villanueva A et al. Integrative molecular analysis of intrahepatic cholangiocarcinoma reveals 2 classes that have different outcomes. Gastroenterology 2013; 144: 829-840.
25. Petrelli F, Borgonovo K, Barni S. The predictive role of skin rash with cetuximab and panitumumab in colorectal cancer patients: a systematic review and metaanalysis of published trials. Target Oncol 2013; 8: 173-181.
26. Petrelli F, Borgonovo K, Cabiddu M et al. Relationship between skin rash and outcome in non-small-cell lung cancer patients treated with anti-EGFR tyrosine kinase inhibitors: a literature-based meta-analysis of 24 trials. Lung Cancer 2012; 78: 8-15.
27. Miyamoto M, Ojima H, Iwasaki M et al. Prognostic significance of overexpression of c-Met oncoprotein in cholangiocarcinoma. Br J Cancer 2011; 105: 131-138.
28. Graham RP, Barr Fritcher EG, Pestova E et al. Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol 2014; 45: 1630-1638.
29. Gu TL, Deng X, Huang F et al. Survey of tyrosine kinase signaling reveals ROS kinase fusions in human cholangiocarcinoma. PLoS One 2011; 6: e15640.