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Gemcitabine Alone or in Combination with Cisplatin for Advanced Biliary Tract Carcinomas: an Overview of Clinical Evidence

  • Sun, Tian-Tian (Shanghai Institute of Digestive Disease, Shanghai Jiaotong University School of Medicine Renji Hospital) ;
  • Wang, Ji-Lin (Shanghai Institute of Digestive Disease, Shanghai Jiaotong University School of Medicine Renji Hospital) ;
  • Fang, Jing-Yuan (Shanghai Institute of Digestive Disease, Shanghai Jiaotong University School of Medicine Renji Hospital)
  • Published : 2013.02.28

Abstract

Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Overall survival (OS), progression-free survival (PFS), overall response rates (ORR), tumor control rates (TCR), and toxicity were evaluated. Evidence levels of the results were evaluated with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Results of the eleven gemcitabine-cisplatin trials and ten gemcitabine trials showed both chemotherapy regimens had benefits with reference to mean OS (8.63 vs. 8.79 months), mean PFS (4.86 vs. 4.72 months), pooled ORR (25.3% vs. 19.6%) and TCR (55.2% vs. 53.1%). Two RCTs showed the gemcitabine-cisplatin combination to prolong the mean PFS (mean difference [MD] 2.57, 95%CI 1.69 3.45), substantially increasing the mean OS (MD 3.59, 95% CI 3.48 3.71), and producing a similar effect in ORR (risk ratio [RR] 1.59, 95%CI 1.04 2.43), increasing TCR (RR 1.15, 95%CI 1.02 1.31) compared with gemcitabine alone, with generally manageable grade 3 or 4 adverse events. The evidence level of OS was moderate, and other outcomes (ORR, PFS, TCR, anaemia, neutropenia) were at low evidence levels. Conclusion: Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

References

  1. Akl E, Muti P, Schunemann H (2008). Anticoagulation in patients with cancer: an overview of reviews. Pol Arch Med Wewn, 118, 183-93.
  2. Albores-Saavedra J, Henson D,Sobin L (1992). The WHO histological classification of tumors of the gallbladder and extrahepatic bile ducts. Cancer, 70, 410-4. https://doi.org/10.1002/1097-0142(19920715)70:2<410::AID-CNCR2820700207>3.0.CO;2-R
  3. Andrea C, Francesco C (2003). Squamous-cell and non-squamous-cell carcinomas of the gallbladder have different risk factors. Lancet Oncol, 4, 393.
  4. Bergman A, Ruiz van Haperen V, Veerman G, et al (1996). Synergistic interaction between cisplatin and gemcitabine in vitro. Clin Cancer Res, 2, 521.
  5. Charoentum C, Thongprasert S, Chewaskulyong B, et al (2007). Experience with gemcitabine and cisplatin in the therapy of inoperable and metastatic cholanglocarcinoma. World J Gastroenterol, 13, 2852-4.
  6. Comella P, Palmieri G, Lorusso V, et al (1996). Double biochemical modulation of 5-fluorouracil by methotrexate and levo-folinic acid in the treatment of advanced digestive tract malignancies. Eur J Cancer, 32, 1719-26. https://doi.org/10.1016/0959-8049(96)00155-4
  7. Crino L, Scagliotti G, Marangolo M, et al (1997). Cisplatin-gemcitabine combination in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol, 15, 297.
  8. Delbaldo C, Laurent A, Grenier J, et al (2009). Management of biliary bract carcinomas. Revue du Praticien, 59, 469-73.
  9. De Groen P, Gores G, LaRusso N, et al (1999). Biliary tract cancers. New Engl J Med, 341, 1368. https://doi.org/10.1056/NEJM199910283411807
  10. Doval D, Sekhon J, Gupta S, et al (2004). A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Brit J Cancer, 90, 1516-20. https://doi.org/10.1038/sj.bjc.6601736
  11. Ducreux M, Rougier P, Fandi A, et al (1998). Effective treatment of advanced biliary tract carcinoma using 5-fluorouracil continuous infusion with cisplatin. Ann Oncol, 9, 653. https://doi.org/10.1023/A:1008241008379
  12. Eng C, Ramanathan RK, Wong MK, et al (2004). A Phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. Am J Clin Oncol, 27, 565-9. https://doi.org/10.1097/01.coc.0000135924.94955.16
  13. Furuse J, Okusaka T, Bridgewater J, et al (2011). Lessons from the comparison of two randomized clinical trials using gemcitabine and cisplatin for advanced biliary tract cancer. Crit Rev Oncol Hematol, 80, 31-9. https://doi.org/10.1016/j.critrevonc.2010.10.009
  14. Gallardo J, Fodor M, Gamargo C, et al (1998). Efficacy of gemcitabine in the treatment of patients with gallbladder carcinoma. Cancer, 83, 2419-20. https://doi.org/10.1002/(SICI)1097-0142(19981201)83:11<2419::AID-CNCR23>3.0.CO;2-9
  15. Gallardo J, Rubio B, Fodor M, et al (2001). A phase II study of gemcitabine in gallbladder carcinoma. Ann Oncol, 12, 1403. https://doi.org/10.1023/A:1012543223020
  16. Gebbia V, Majello E, Testa A, et al (1996). Treatment of advanced adenocarcinomas of the exocrine pancreas and the gallbladder with 5-fluorouracil, high dose levofolinic acid and oral hydroxyurea on a weekly schedule: Results of a multicenter study of the Southern Italy Oncology Group (GOIM). Cancer, 78, 1300-7. https://doi.org/10.1002/(SICI)1097-0142(19960915)78:6<1300::AID-CNCR19>3.0.CO;2-4
  17. Giuliani F, Gebbia V, Maiello E, et al (2006). Gemcitabine and cisplatin for inoperable and/or metastatic biliary tree carcinomas: a multicenter phase II study of the Gruppo Oncologico dell'Italia Meridionale (GOIM). Ann Oncol, 17, vii73-7. https://doi.org/10.1093/annonc/mdl956
  18. Goldstein D, Gainford M, Brown C, et al (2011). Fixed-dose-rate gemcitabine combined with cisplatin in patients. with inoperable biliary tract carcinomas. Cancer Chemother Pharmacol, 67, 519-25. https://doi.org/10.1007/s00280-010-1351-8
  19. Heinrich S, Sch fer M, Weber A, et al (2008). Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg, 248, 1014. https://doi.org/10.1097/SLA.0b013e318190a6da
  20. Hitt R, Castellano D, Hidalgo M, et al (1998). Phase II trial of cisplatin and gemcitabine in advanced squamous-cell carcinoma of the head and neck. Ann Oncol, 9, 1347. https://doi.org/10.1023/A:1008413818569
  21. Higgins JP, Green S (2009). Cochrane Handbook for Systematic Reviews of Interventions 5.0.1 [updated September 2009]. http://www.cochrane-handbook.org/ (accessed 16 June 2010) edition. The Cochrane Collaboration.
  22. Kim S, Park J, Lee J, et al (2006). A phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. Cancer, 106, 1339-46. https://doi.org/10.1002/cncr.21741
  23. Levy AD, Murakata LA, Rohrmann CA Jr (2001). Gallbladder carcinoma: radiologic-pathologic correlation. Radiographics, 21, 295-314. https://doi.org/10.1148/radiographics.21.2.g01mr16295
  24. Lee G, Kang J, Kim H, et al (2006). Combination chemotherapy with gemcitabine and cisplatin as first-line treatment for immunohistochemically proven cholangiocarcinoma. Am J Clin Oncol, 29, 127. https://doi.org/10.1097/01.coc.0000203742.22828.bb
  25. Lee J, Kim T, Lee M, et al (2008). Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas. Cancer Chemoth Pharmacol, 61, 47-52.
  26. Lin MH, Chen JS, Chen HH, et al (2003). A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas. Chemotherapy, 49, 154-8. https://doi.org/10.1159/000070622
  27. Meyerhardt J, Zhu A, Stuart K, et al (2008). Phase-II study of gemcitabine and cisplatin in patients with metastatic biliary and gallbladder cancer. Digest Dis Sci, 53, 564-70. https://doi.org/10.1007/s10620-007-9885-2
  28. Metzger J, Sauerbruch T, Ko Y, et al (1998). Phase II study with gemcitabine in gallbladder and biliary tract carcinomas. Onkologie, 21, 232-4. https://doi.org/10.1159/000026821
  29. Okusaka T, Ishii H, Funakoshi A, et al (2006). Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer. Cancer Chemoth Pharmacol, 57, 647-6. https://doi.org/10.1007/s00280-005-0095-3
  30. Okusaka T, Nakachi K, Fukutomi A, et al (2010). Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Brit J Cancer, 103, 469-74. https://doi.org/10.1038/sj.bjc.6605779
  31. Pasetto L, D'Andrea M, Falci C, et al (2007). Gemcitabine in advanced biliary tract cancers. Crit Rev Oncol/Hematol, 61, 230-42. https://doi.org/10.1016/j.critrevonc.2006.04.006
  32. Patel T (2002). Worldwide trends in mortality from biliary tract malignancies. BMC Cancer, 2, 10. https://doi.org/10.1186/1471-2407-2-10
  33. Patt Y, Hassan M, Lozano R, et al (2001). Phase II trial of cisplatin, interferon alpha-2b, doxorubicin, and 5-fluorouracil for biliary tree cancer. Clin Cancer Res, 7, 3375-80.
  34. Park B, Kim Y, Park J, et al (2006). Phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. J Gastroenterol Hepatol, 21, 999-1003. https://doi.org/10.1111/j.1440-1746.2006.04230.x
  35. Park J, Oh S, Kim S, et al (2005). Single-agent gemcitabine in the treatment of advanced biliary tract cancers: a phase II study. Japn J Clin Oncol, 35, 68. https://doi.org/10.1093/jjco/hyi021
  36. Penz C, Kornek G, Raderer M, et al (2001). Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol, 12, 183. https://doi.org/10.1023/A:1008352123009
  37. Rau S, Autschbach F, Riedel HD, et al (2008). Expression of the multidrug resistance proteins MRP2 and MRP3 in human cholangiocellular carcinomas. Eur J Clin Invest, 38, 134-42. https://doi.org/10.1111/j.1365-2362.2007.01916.x
  38. Schunemann H, Jaeschke R, Cook D, et al (2006). An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. Am J Respir Crit Care Med, 174, 605-14 https://doi.org/10.1164/rccm.200602-197ST
  39. Sasaki T, Isayama H, Nakai Y, et al (2011). Feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with refractory biliary tract cancer. Investigational New Drugs, 29,1488-93. https://doi.org/10.1007/s10637-010-9485-4
  40. Smith G, Bukowski R, Hewlett J, et al (1984). Hepatic artery infusion of 5-fluorouracil and mitomycin C in cholangiocarcinoma and gallbladder carcinoma. Cancer, 54, 1513-6. https://doi.org/10.1002/1097-0142(19841015)54:8<1513::AID-CNCR2820540806>3.0.CO;2-9
  41. Thongprasert S, Napapan S, Charoentum C, et al (2005). Phase II study of gemcitabine and cisplatin as first-line chemotherapy in inoperable biliary tract carcinoma. Ann Oncol, 16, 279. https://doi.org/10.1093/annonc/mdi046
  42. Tsavaris N, Kosmas C, Gouveris P, et al (2004). Weekly gemcitabine for the treatment of biliary tract and gallbladder cancer. Invest New Drugs, 22, 193-8. https://doi.org/10.1023/B:DRUG.0000011797.09549.53
  43. Valencak J, Kornek G, Raderer M, et al (2000). Gemcitabine for the treatment of advanced biliary tract carcinomas: evaluation of two different dose regimens. Onkologie, 22, 498-501.
  44. Valle J, Wasan H, Palmer DH, et al (2010). Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. New Engl J Med, 362, 1273-81. https://doi.org/10.1056/NEJMoa0908721
  45. Von der Maase H, Sengelov L, Roberts J, et al (2005). Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol, 23, 4602. https://doi.org/10.1200/JCO.2005.07.757
  46. Von Delius S, Lersch C, Schulte-Frohlinde E, et al (2005). Phase II trial of weekly 24-hour infusion of gemcitabine in patients with advanced gallbladder and biliary tract carcinoma. BMC Cancer, 5, 61. https://doi.org/10.1186/1471-2407-5-61
  47. Wang LR, Zhang GB, Chen J, et al (2011). RRM1 gene expression in peripheral blood is predictive of shorter survival in Chinese patients with advanced non-small-cell lung cancer treated by gemcitabine and platinum. J Zhejiang Univ Sci B, 12, 174-9. https://doi.org/10.1631/jzus.B1000197
  48. Won HS, Lee MA, Chung ES, et al (2010). Comparison of thymidine phosphorylase expression and prognostic factors in gallbladder and bile duct cancer. BMC Cancer, 19, 564.

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