Gemcitabine in advanced biliary tract cancers

Critical Reviews in Oncology/Hematology

Volumn 61, Issue 3, 2007, Pages 230-242

  Pasetto, Lara Maria ^a   D'Andrea, Mario Rosario ^b   Falci, Cristina ^a   Monfardini, Silvio ^a  

^a VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^b SAN FILIPPO NERI HOSPITAL   (Italy)

Author keywords

Biliary tract cancer; Gemcitabine; Review

Indexed keywords

CAPECITABINE; CISPLATIN; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; MITOMYCIN C;

ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ASTHENIA; BILIARY TRACT CANCER; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTINUOUS INFUSION; DIARRHEA; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG FEVER; DRUG MEGADOSE; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; GRANULOCYTOPENIA; HAND FOOT SYNDROME; HEART PALPITATION; HUMAN; INSOMNIA; LEUKOPENIA; METASTASIS; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; PALLIATIVE THERAPY; REPEATED DRUG DOSE; REVIEW; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA;

ANTIMETABOLITES, ANTINEOPLASTIC; BILIARY TRACT NEOPLASMS; CLINICAL TRIALS; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; NEOPLASM STAGING; PALLIATIVE CARE; RADIOTHERAPY, ADJUVANT;

EID: 33847348389     PISSN: 10408428     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2006.04.006     Document Type: Review

References (62)

1. Leonard G.D., and O'Reilly E.M. Biliary tract cancers: current concepts and controversies. Expert Opin Pharmacother 6 (2005) 211-223
2. Pollera C.F., Ceribelli A., Crecco M., et al. Weekly gemcitabine in advanced bladder cancer: a preliminary report from a phase I study. Ann Oncol 5 (1994) 182-184
3. Venook A.P., Egorin M.J., Rosner G.L., et al. Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol 18 (2000) 2780-2787
4. Eckel F., Lersch C., Assmann G., and Schulte-Frohlinde E. Toxicity of a 24-hour infusion of gemcitabine in biliary tract and pancreatic cancer: a pilot study. Cancer Invest 20 (2002) 180-185
5. Fossella F.V., Lippman S.M., Shin D.M., et al. Maximum-tolerated dose defined for single-agent gemcitabine: a phase I dose-escalation study in chemotherapy-naive patients with advanced non-small-cell lung cancer. J Clin Oncol 15 (1997) 310-316
6. Morganti A.G., Trodella L., Valentini V., et al. Concomitant gemcitabine (Gemzar) and extended nodes irradiation in the treatment of pancreatic and biliary carcinoma: a phase I study. Onkologie 26 (2003) 325-329
7. Noble S., and Goa K.L. Gemcitabine. A review of its pharmacology and clinical potential in non-small cell lung cancer and pancreatic cancer. Drugs 54 (1997) 447-472
8. Heinemann V., Hertel L.W., Grindey G.B., and Plunkett W. Comparison of the cellular pharmacokinetics and toxicity of 2′,2′-difluorodeoxycytidine and 1-β-d-arabinofuranosylcytosine. Cancer Res 48 (1988) 4024-4031
9. Plunkett W., Huang P., Xu Y.-Z., et al. Metabolism, mechanisms of action, and self-potentiation. Semin Oncol 22 Suppl. 11 (1995) 3-9
10. Hughes T.L., Hahn T.M., Reynolds K.K., et al. Kinetic analysis of human deoxycytidine kinase with the true phosphate donor uridine triphosphate. Biochemistry 36 (1997) 7540-7547
11. Von Hoff D.D. Activity of gemcitabine in a human tumour cloning assay as a basis for clinical trials with gemcitabine. San Antonio Drug Development Team. Invest New Drugs 14 (1996) 265-270
12. Tempero M., Plunkett W., van Haperen V.R., et al. Randomised phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed-dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 21 (2003) 3402-3408
13. Brand R., Capadano M., and Tempero M. A phase I trial of weekly gemcitabine administered as a prolonged infusion in patients with pancreatic cancer and other solid tumors. Invest New Drugs 15 (1997) 331-341
14. Touroutoglou N., Gravel D., Raber M.N., et al. Clinical results of a pharmacokinetically-based strategy for higher dosing of gemcitabine in patients with solid tumors. Ann Oncol 9 (1998) 1003-1008
15. Eng C., Ramathan R.K., Wong M.K., et al. A phase II trial of fixed-dose rate gemcitabine in patients with advanced biliary tree carcinoma. Am J Clin Oncol 27 (2004) 565-569
16. Castro M.P. Efficacy of gemcitabine in the treatment of patients with gall bladder carcinoma. Cancer 15 (2000) 639-912
17. Teufel A., Lehnert T., Stemmel W., et al. Chemotherapy with gemcitabine in patients with advanced carcinoma. Z Gastroenterol 38 (2000) 909-912
18. Verderame F., Mandina P., Abbruzzo F., et al. Biliary tract cancer: our experience with gemcitabine treatment. Anticancer Drugs 11 (2000) 707-708
19. Mezger J., Sauerbruch T., Ko Y., Wolter H., Funk C., and Glasmacher A. Phase II study with gemcitabine in gallbladder and biliary tract carcinomas. Onkologie 21 (1998) 232-234
20. Burris III H.A., Moore M.J., Andersen J., et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomised trial. J Clin Oncol 15 (1997) 2403-2413
21. World Health Organization. The WHO handbook for reporting results of cancer treatment vol. 48 (1979), World Health Organization, WHO Offset Publication, Geneva
22. Gallardo J.O., Rubio B., Fodor M., et al. A phase II study of gemcitabine in gallbladder carcinoma. Ann Oncol 12 (2001) 1403-1406
23. Kubicka S., Rudolph K.L., Tietze M.K., Lorenz M., and Manns M. Phase II study of systemic gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas. Hepatogastroenterology 48 (2001) 783-789
24. Lin M.H., Chen J.S., Chen H.H., and Su W.C. A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas. Chemotherapy 49 (2003) 154-158
25. Tsavaris N., Kosmas C., Gouveris P., et al. Weekly gemcitabine for the treatment of biliary tract and gallbladder cancer. Invest New Drugs 22 (2004) 193-198
26. Valencak J., Kornek G.V., Raderer M., et al. Gemcitabine for the treatment of advanced biliary tract carcinomas: evaluation of two different dose regimens. Onkologie 22 (1999) 498-501
27. Penz M., Kornek G.V., Raderer M., et al. Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol 12 (2001) 183-186
28. Braakhuis B.J.M., Ruiz van Haperen V.W.T., Boven E., et al. Schedule-dependent antitumor effect of gemcitabine in in vivo model systems. Semin Oncol 22 (1995) 42-46
29. Schulz L., Schalhorn A., Wilmanns W., et al. Synergistic interaction of gemcitabine and 5-fluorouracil in colon cancer cells. Proc Am Soc Clin Oncol (1998) [abstract 965]
30. Ren Q., Kao V., and Grem J.L. Cytotoxicity and DNA fragmentation associated with sequential gemcitabine and 5-fluoro-2′-deoxyuridine in HAT-29 colon cancer cells. Clin Cancer Res 4 (1998) 2811-2818
31. Louvet C., Andrè T., Hammel P., et al. Phase II trial of bimonthly LV, 5-fluorouracil and gemcitabine for advanced pancreatic adenocarcinoma (FOLFUGEM). Ann Oncol 12 (2001) 675-679
32. Gebbia V., Giuliani F., Maiello E., et al. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol 19 (2001) 4089-4091
33. Polyzos A., Nikou G., Giannopoulos A., et al. Chemotherapy of biliary tract cancer with mitomycin C and 5-fluorouracil biochemically modulated by folinic acid: a phase II study. Ann Oncol 7 (1996) 644-645
34. Rougier P., Zarba J.J., Ducreaux M., et al. Phase II study of cisplatin and 120 h infusion 5-fluorouracil in patients with advanced pancreatic adenocarcinoma. Ann Oncol 4 (2000) 333-336
35. Sanz-Altamira P.M., Ferrante K., Jenkins R.L., et al. A phase II trial of 5-fluorouracil, leucovorin, and carboplatin with unresectable biliary tree carcinoma. Cancer 15 (1998) 2321-2325
36. Castellano D., Paz-Ares L., Pronk L., et al. A phase I/II clinical and pharmacological study of dose-escalating and dose sequencing of administration of gemcitabine and folinic acid/fluorouracil in advanced pancreatic cancer. Proc Am Soc Clin Oncol 19 (2000) [abstract 290]
37. Knox J.J., Hedley D., Oza A., Siu L.L., Pond G.R., and Moore M.J. Gemcitabine concurrent with continuous infusional 5-fluorouracil in advanced biliary cancers: a review of the Princess Margaret. Ann Oncol 15 (2004) 770-774
38. Murad A.M., Guimaraes R.C., Aragao B.C., et al. Phase II trial of the use of gemcitabine and 5-fluorouracil in the treatment of advanced pancreatic and biliary tract cancer. Am J Clin Oncol 26 (2003) 151-154
39. Alberts S.R., Al-Khatib H., Mahoney M.R., et al. Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma: a North Central Cancer Treatment Group phase II trial. Cancer 103 (2005) 111-118
40. Chang H., Ryu M., Lee J., et al. Phase II trial of gemcitabine plus capecitabine in patients with advanced biliary tract cancer. Proc Am Soc Clin Oncol (2005) [abstract 4173]
41. Knox J.J., Hedley D., Oza A., et al. Combining gemcitabine and capecitabine in patients with advanced biliary cancer: a phase II trial. J Clin Oncol 23 (2005) 2332-2338
42. Iyer R.V., Gibbs J., Lawrence D., Soehnlein N., Kuvshinoff B., and Javle M.M. A phase II study of gemcitabine (G) and capecitabine (C) in advanced cholangiocarcinoma (CC) and gall bladder carcinoma (GBC). Proc Am Soc Clin Oncol (2005) [abstract 4230]
43. Carraro S., Servienti P.J., Bruno M.F., et al. Gemcitabine and cisplatin in locally advanced or metastatic gallbladder and bile duct adenocarcinomas. Proc Am Soc Clin Oncol (2001) [abstract 2333]
44. Doval D.C., Sekhon J.S., Gupta S.K., Gupta S., and Awasthy B.S. Chemotherapy in biliary tract carcinomas: results in India. Semin Oncol 29 6 Suppl. 20 (2002) 46-50
45. Lee M.A., Woo I.S., Kang J.H., Hong Y.S., and Lee K.S. Gemcitabine and cisplatin combination chemotherapy in intrahepatic cholangiocarcinoma as second-line treatment: report of four cases. Jpn J Clin Oncol 34 (2004) 547-550
46. Thongprasert S., Napapan S., Charoentum C., and Moonprakan S. Phase II study of gemcitabine and cisplatin as first-line chemotherapy in inoperable biliary tract carcinoma. Ann Oncol 16 (2005) 279-281
47. Malik I.A., Aziz Z., Zaidi S.H., and Sethuraman G. Gemcitabine and cisplatin is a highly effective combination chemotherapy in patients with advanced cancer of the gallbladder. Am J Clin Oncol 26 (2003) 174-177
48. Doval D.C., Sekhon J.S., Gupta S.K., et al. A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Br J Cancer 90 (2004) 1516-1520
49. Park J.O., Kang W.K., Kim T., et al. A phase II trial of gemcitabine plus cisplatin (GP) in patients with inoperable biliary tract cancer (BTC). Proc Am Soc Clin Oncol (2005) [abstract 4133]
50. Misra S., Chaturvedi A., and Misra N.C. Gemcitabine (G) plus cisplatin (C) in advanced carcinoma gallbladder - a large single centre experience. Proc Am Soc Clin Oncol (2005) [abstract 4136]
51. André T., Tournigand C., Rosmorduc O., et al. Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study. Ann Oncol 15 (2004) 1339-1343
52. Gebbia N., Verderame F., Di Leo R., et al. A phase II study of oxaliplatin (O) and gemcitabine (G) first line chemotherapy in patients with advanced biliary tract cancers. Proc Am Soc Clin Oncol (2005) [abstract 4132]
53. Wagner A.D., Buechner-Steudel P., Wein A., et al. Gemcitabine, oxaliplatin and weekly high-dose 5FU as a 24-hr-infusion in chemonaive patients with advanced or metastatic biliary tree adenocarcinoma: preliminary results of a multicenter phase II-study. Proc Am Soc Clin Oncol (2005) [abstract 4147]
54. Kirchhoff T., Zender L., Merkesdal S., et al. Initial experience from a combination of systemic and regional chemotherapy in the treatment of patients with nonresectable cholangiocellular carcinoma in the liver. World J Gastroenterol 28 (2005) 1091-1095
55. Kuhn R., Hribaschek A., Eichelmann K., Rudolph S., Fahlke J., and Ridwelski K. Outpatient therapy with gemcitabine and docetaxel for gallbladder, biliary, and cholangiocarcinomas. Invest New Drugs 20 (2002) 351-356
56. Raderer M., Hejna M.H., Valencak J.B., et al. Two consecutive phase II studies of 5-fluorouracil/leucovorin/mitomycin C and of gemcitabine in patients with advanced biliary cancer. Oncology 56 (1999) 177-180
57. Kornek G.V., Schuell B., Laengle F., et al. 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 (2004) 478-483
58. Sun W., and Haller D. Irinotecan and fixed-dose-rate gemcitabine in advanced pancreatic and biliary cancer: phase I study. Oncology (Williston Park) 17 9 Suppl. 8 (2003) 16-19
59. Bhargava P., Jani C.R., Savarese D.M., O'Donnell J.L., Stuart K.E., and Rocha Lima C.M. Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report. Oncology (Williston Park) 17 9 Suppl. 8 (2003) 23-26
60. Shimonishi T., Miyazaki K., and Nakanuma Y. Cytokeratin profile relates to histological subtypes and intrahepatic location of intrahepatic cholangiocarcinoma and primary sites of metastatic adenocarcinoma of liver. Histopathology 37 (2000) 55-63
61. Rudi J. Chemotherapy with gemcitabine in patients with gall-bladder carcinoma. Ann Oncol 13 (2002) 807
62. Scheithauer W. Review of gemcitabine in biliary tract carcinoma. Semin Oncol 29 6 Suppl. 20 (2002) 40-45