Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: Two parallel, multicentre phase-II trials

British Journal of Cancer

Volumn 101, Issue 11, 2009, Pages 1846-1852

  Wagner, A D ^a,h   Buechner Steudel, P ^a   Moehler, M ^b   Schmalenberg, H ^c   Behrens, R ^d   Fahlke, J ^e   Wein, A ^f   Behl, S ^a   Kuss, O ^g   Kleber, G ^a,i   Fleig, W E ^a,j  

^a MARTIN LUTHER UNIVERSITÄT HALLE WITTENBERG   (Germany)

^b UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^c JENA UNIVERSITY HOSPITAL   (Germany)

^d Gastroenterology Practice   (Germany)

^e UNIVERSITY HOSPITAL MAGDEBURG   (Germany)

^f UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^g MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^h Multidisciplinary Oncology Centre (CePO)   (Switzerland)

ⁱ Ostalb Klinikum   (Germany)

^j UNIVERSITY OF LEIPZIG   (Germany)

more..

Author keywords

5 FU; Bile duct cancer; Gallbladder cancer; Gemcitabine; Oxaliplatin

Indexed keywords

FLUOROURACIL; GEMCITABINE; OXALIPLATIN;

ADULT; ADVANCED CANCER; ADVERSE OUTCOME; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILE DUCT CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CHOLANGITIS; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; DYSPHAGIA; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GALLBLADDER CARCINOMA; HUMAN; INFECTION; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OBSTRUCTIVE JAUNDICE; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SIDE EFFECT; SUDDEN DEATH; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; BILE DUCT NEOPLASMS; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; GALLBLADDER NEOPLASMS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; SURVIVAL RATE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 70649088777     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605377     Document Type: Article

References (35)

1. Alberts SR, Al Khatib H, Mahoney MR, Burgart L, Cera PJ, Flynn PJ, Finch TR, Levitt R, Windschitl HE, Knost JA, Tschetter LK (2005) Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma:a North Central Cancer Treatment Group phase II trial. Cancer 103:111-118
2. André T, Reyes-Vidal JM, Fartoux L, Ross P, Leslie M, Rosmorduc O, Clemens MR, Louvet C, Perez N, Mehmud F, Scheithauer W (2008) Gemcitabine and oxaliplatin in advanced biliary tract carcinoma:a phase II study. Br J Cancer 99:862-867
3. André T, Tournigand C, Rosmorduc O, Provent S, Maindrault-Goebel F, Avenin D, Selle F, Paye F, Hannoun L, Houry S, Gayet B, Lotz JP, de Gramont A, Louvet C (2004) Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma:a GERCOR study. Ann Oncol 15:1339-1343
4. Chatni SS, Sainani RS, Mehta SA, Mohandas KM (2008) Infusion chemotherapy with cisplatinum and fluorouracil in the treatment of locally-advanced and metastatic gallbladder cancer. J Cancer Res Ther 4:151-155
5. Ciuleanu T, Diculescu M, Hoepffner NM, Trojan J, Sailer V, Zalupski M, Herrmann T, Roth A, Chick J, Brock K, Albert D, Philip PA (2007) A randomised phase II study of OSI-7904L vs 5-fluorouracil (FU)/leucovorin (LV) as first-line treatment in patients with advanced biliary cancers. Invest New Drugs 25:385-390
6. Cunningham D, Chau I, Stocken C, Davies C, Dunn J, Valle J, Smith D, steward W, Harper P, Neoptolemos J (2005) Phase III randomized comparison of gemcitabine (gem) vs gemcitabine plus capecitabine (Gem-CAP) in patients with advanced pancreatic cancer. Eur J Cancer 3(suppl 4); abstract no. PS 11
7. Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B (2005) A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma:results of the 40955 EORTC trial. Eur J Cancer 41:398-403
8. Eckel F, Schmid RM (2007) Chemotherapy in advanced biliary tract carcinoma:a pooled analysis of clinical trials. Br J Cancer 96:896-902
9. Faivre S, Raymond E, Woynarowski JM, Cvitkovic E (1999) Supraadditive effect of 20,20-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol 44:117-123
10. Gallardo J, Rubio B, Ahumada M, Barajas O, Villanueva L, Diaz J, De Aretxabala X, Reyes J (2008) Therapy for advanced gallbladder cancer:improving survival. ASCO Annu Meet Proc 26; abstract no. 15566
11. Gallardo J, Rubio B, Villanueva L, Barajas O (2005) Gallbladder cancer, a different disease that needs individual trials. J Clin Oncol 23:7753-7754
12. Glimelius B, Hoffman K, Sjoden PO, Jacobsson G, Sellstrom H, Enander LK, Linne T, Svensson C (1996) Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7:593-600
13. Gores GJ, Baskin-Bey ES, Baron TH, Alberts SR (2004) Treatment endpoints for advanced cholangiocarcinoma. Nat Clin Pract Gastro-enterol Hepatol 1:4-5
14. Heffernan N, Cella D, Webster K, Odom L, Martone M, Passik S, Bookbinder M, Fong Y, Jarnagin W, Blumgart L (2002) Measuring health-related quality of life in patients with hepatobiliary cancers:the functional assessment of cancer therapy-hepatobiliary questionnaire. J Clin Oncol 20:2229-2239
15. Hezel AF, Zhu AX (2008) Systemic therapy for biliary tract cancers. Oncologist 13:415-423
16. Jarnagin WR, Klimstra DS, Hezel M, Gonen M, Fong Y, Roggin K, Cymes K, DeMatteo RP, D'Angelica M, Blumgart LH, Singh B (2006) Differential cell cycle-regulatory protein expression in biliary tract adenocarcinoma:correlation with anatomic site, pathologic variables, and clinical outcome. J Clin Oncol 24:1152-1160
17. Kaplan EL, Meier P (1958) Nonparametric-estimation from incomplete observations. J Am Stat Assoc 53:457-481
18. Kim ST, Park JO, Lee J, Lee KT, Lee JK, Choi SH, Heo JS, Park YS, Kang WK, Park K (2006) A phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. Cancer 106:1339-1346
19. Knox JJ, Hedley D, Oza A, Feld R, Siu LL, Chen E, Nematollahi M, Pond GR, Zhang J, Moore MJ (2005) Combining gemcitabine and capecitabine in patients with advanced biliary cancer:a phase II trial. J Clin Oncol 23:2332-2338
20. Kobayashi K, Tsuji A, Morita S, Horimi T, Shirasaka T, Kanematsu T (2006) A phase II study of LFP therapy (5-FU (5-fluorouracil) continuous infusion (CVI) and low-dose consecutive (Cisplatin) CDDP) in advanced biliary tract carcinoma. BMC Cancer 6:121
21. Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W (2004) Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer:a randomised phase II trial. Ann Oncol 15:478-483
22. Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47:207-214
23. Misra S, Chaturvedi A, Misra NC (2005) Gemcitabine(G) plus cisplatin (C) in advanced carcinoma gallbladder-a large single center experience. ASCO Annu Meet Proc 23; abstract no. 4136
24. Nehls O, Oettle H, Hartmann JT, Hofheinz RD, Hass HG, Horger MS, Koppenhofer U, Hochhaus A, Stieler J, Trojan J, Gregor M, Klump B (2008) Capecitabine plus oxaliplatin as first-line treatment in patients with advanced biliary system adenocarcinoma:a prospective multicentre phase II trial. Br J Cancer 98:309-315
25. Patt YZ, Hassan MM, Lozano RD, Waugh KA, Hoque AM, Frome AI, Lahoti S, Ellis L, Vauthey JN, Curley SA, Schnirer II, Raijman I (2001) Phase II trial of cisplatin, interferon alpha-2b, doxorubicin, and 5-fluorouracil for biliary tract cancer. Clin Cancer Res 7:3375-3380
26. Peters GJ, Bergman AM, Ruiz van Haperen VW, Veerman G, Kuiper CM, Braakhuis BJ (1995) Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol 22:72-79
27. Randi G, Malvezzi M, Levi F, Ferlay J, Negri E, Francesci S, La Veccia C (2009) Epidemiology of biliary tract cancers:an update. Ann Oncol 20:146-159
28. Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR (2005) Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer 92:1650-1654
29. Reyes-Vidal J, Gallardo J, Yanez E, Rosas J, Palma M, Cerda B, Loredo E, Del Castillo C, Arriagada R, Quijada I (2003) Gemcitabine (G) and cisplatin (C) in the treatment of patients (pts) with unresectable or metastatic gallbladder cancer:results of the phase II GOCCHI study 2000-2013 Proc Am Soc Clin Oncol 22; abstract no. 1095
30. Riess H, Helm A, Niedergethmann M, Schmidt-Wolf J, Moik M, Hammer C, Zippel K, Weigang-Köhler K, Stauch M, Oettle H (2005) A randomized, prospective, multicenter phase III trial of gemcitabine, 5-fluorouracil (5-FU), folinic acid vs gemcitabine alone in patients with advanced pancreatic cancer. Proc Am Soc Clin Oncol 23; abstract no. 4009
31. Sanz-Altamira PM, Ferrante K, Jenkins RL, Lewis WD, Huberman MS, Stuart KE (1998) A phase II trial of 5-fluorouracil, leucovorin, and carboplatin in patients with unresectable biliary tree carcinoma. Cancer 82:2321-2325
32. Valle JW, Wasan H, Palmer DD, Cunningham D, Anthoney A, Maraveyas A, Hughes SK, Roughton M, Bridgewater J (2009) Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC):Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). ASCO Annu Meet Proc 27; abstract no. 4503
33. Wagner AD, Buechner-Steudel P, Wein A, Schmalenberg H, Lindig U, Moehler M, Behrens R, Kleber G, Kuss O, Fleig WE (2007) Gemcitabine, oxaliplatin and weekly high-dose 5-FU as 24-h infusion in chemonaive patients with advanced or metastatic pancreatic adenocarcinoma:a multicenter phase II trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Ann Oncol 18:82-87
34. Yonemoto N, Furuse J, Okusaka T, Yamao K, Funakoshi A, Ohkawa S, Boku N, Tanaka K, Nagase M, Saisho H, Sato T (2007) A multi-center retrospective analysis of survival benefits of chemotherapy for unresect-able biliary tract cancer. Jpn J Clin Oncol 37:843-851
35. Yoshikawa D, Ojima H, Iwasaki M, Hiraoka N, Kosuge T, Kasai S, Hirohashi S, Shibata T (2008) Clinicopathological and prognostic significance of EGFR, VEGF, and HER2 expression in cholangiocarcinoma. Br J Cancer 98:418-425