Title: A Prospective Study Comparing Oxaliplatin & 5-Fu with Gemcitabine & Cisplatin in Advanced Stage Carcinoma Gall Bladder
Authors: Roopali, S. Singh, S.Gupta, M.L.B. Bhatt, M. Jain, M. Saha, V. P. Raturi, J. Gaur, D. Kishan, R. Singh
DOI: http://dx.doi.org/10.18535/jmscr/v4i5.04
Background: Overall incidence of Gallbladder(GB) malignancy is rare but it is the most common primary hepatobiliary carcinoma. Its incidence is highest in India and median survival is less than 6 months. Different chemotherapy regimens have been tried. These days Gemcitabine with cisplatin is the most preferred therapeutic approach but still less number of patients are achieving the 1 year survival. But studies on oxaliplatin and fluropyrimidine combination shows appreciative results in term of overall survival .These evidences led us for current prospective study to compare these two regimens in locally advanced carcinoma GB. Aim: The primary objective was to compare the overall survival while secondary objectives were to assesss the response rate & toxicity. Method and Material: This single institution study included 50 cytopathologicaly proven advanced stage Carcinoma GB patients and randomizd into ARM A (gemcitabne and cisplatin) and ARM B( oxaliplatin and 5FU). 4 Result: OS for arm A was 5± 0.504(95%CI, 4.012-5.988) months and for arm B was 5.5 ±.542 (95%CI , 44.37-65.63)months. Most common side effects was nausea/vomiting and Anemia for arm A and arm B respectively. Conclusion: oxaliplatin and 5-FU regimen can be considered as first line chemotherapy or second line chemotherapy in patients with advanced stage carcinoma GB. To confirm these results , study on larger no. of patients population with advanced carcinoma GB needs to be undertaken with randomization. 1. Baillie J: Tumors of the gallbladder and bile ducts. J Clin Gastroenterol 1999;29:14-21 2. Lazcano-Ponce EC, Miquel JF, Munoz N, et al. Epidemiology and molecular pathology of gallbladder cancer. CA Cancer J Clin 2001;51:349 3. Perpetuo MD, Valdivieso M, Heilbrun LK, et al. Natural history study of gallbladder cancer: a review of 36 years experience at M. D. Anderson Hospital and Tumor Institute. Cancer 1978;42:330. 4. Hejna M, Pruckmayer M, Raderer M. The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer. 1998;34:977–986. [PubMed] 5. Penz M, Kornek GV, Raderer M, Ulrich-Pur H, Fiebiger W, Lenauer A, Depisch D, Krauss G, Schneeweiss B, Scheithauer W (2001) Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol 12: 183–186 6. 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 7. Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henß H (2006) Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer 95:848–852 8. Nehls O, Klump B, Arkenau HT, Hass HG, Gregor M, Porschen R (2001) A phase II trial of oxaliplatin, fluorouracil and leucovorin for advanced biliary system adenocarcinomas. Br J Cancer 87: 702 –704 9. 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 10. AD Wagner, P Buechner-Steudel, M Moehler, H Schmalenberg3, R Behrens4, J Fahlke5, A Wein6, S Behl, O Kuss, G Kleber and WE Fleig(2009) Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials.Br J Cancer 101, 1846 – 1852 11. Rachel P. Riechelmann, Carol A. Townsley, Sheray N. Chin, Gregory R. Pond,Jennifer J. Knox (2007). Expanded Phase II Trial of Gemcitabine and Capecitabine for Advanced Biliary Cancer. American cancer society September 15, 2007 / Volume 110 / Number 6: DOI 10.1002/cncr.22902 12. Andre´ 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 13. DC Doval, JS Sekhon, SK Gupta, J Fuloria, VK Shukla, S Gupta and BS Awasthy(2004). A Phase II study of gemcitabine and cisplatin in chemotherapy naive, unresectable gall bladder cancer. British Journal of Cancer (2004) 90, 1516 – 1520 14. Juan Valle, Harpreet Wasan, Daniel H. Palmer,David Cunningham, Alan Anthoney, Anthony Maraveyas, Srinivasan Madhusudan, Tim Iveson, Sharon Hughes,Stephen P. Pereira, Michael Roughton and John Bridgewater for the ABC-02 Trial Investigators(2010) Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. n engl j med 362;14Abstract
Keywords: Carcinoma Gall Bladder, Gemcitabine , Cisplatin,Oxaliplatin,5-FU.References