1655 INTRAVESICAL GEMCITABINE VERSUS BACILLUS CALMETTE-GUERIN ( BCG) IN TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER: SHORT TERM COMPARATIVE STUDY

Abstract

You have accessJournal of UrologyBladder Cancer: Superficial1 Apr 20111655 INTRAVESICAL GEMCITABINE VERSUS BACILLUS CALMETTE-GUERIN ( BCG) IN TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER: SHORT TERM COMPARATIVE STUDY Lotfy Bendary, Salem Khalil, Ashraf Shahin, and Nashwa Nawar Lotfy BendaryLotfy Bendary Zagazig, Egypt More articles by this author , Salem KhalilSalem Khalil Zagazig, Egypt More articles by this author , Ashraf ShahinAshraf Shahin Zagazig, Egypt More articles by this author , and Nashwa NawarNashwa Nawar Zagazig, Egypt More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1765AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There is still some controversy about the best agent to be used for intravesical therapy after TURBT.So the aim of this study is to compare the efficacy and safety of intravesical instillation of the new drug (Gemcitabine) versus (BCG) in treatment of non-muscle invasive TCC of the bladder. METHODS During the period from January 2006 to June 2008, 80 patients with primary Ta-T1 TCC of the bladder without CIS were the subject of the study. Their mean age was (56.2 ± 11.18 years). After complete TURBT patients were randomized to receive Gemcitabine or BCG (40 patients for each group). Both groups received 6 weekly intravesical instillation after 2 weeks from resection. BCG dose was 6×108 colony forming units in 50 ml of normal saline. Gemcitabine dose was 2000 mg dissolved in 50 ml normal saline. The follow up period ranged from 3-18 months (mean 10.8 ±2.7 months). The end point of the study for any patient was either completing a period of 18 months of follow up without recurrence or progression , or appearance of recurrence and / or progression at any time during the period of follow up. RESULTS Ta group showed recurrence in 26.31% of the BCG group and in 22.22% of the Gemcitabine group, with no statistically significant difference between both groups (P =0.92), progression occurred in one patient of either group. T1 tumors showed recurrence in 33.33% of patients in the BCG group and in 27.27% patients of the Gemcitabine group with insignificant statistical difference(P =0.66), progression occurred in 9.5%,9.1% respectively with no statistically significant difference (P=1.0). The overall recurrence for the BCG group was 30% compared to 25% for the gemcitabine group with insignificant statistical difference (p=0.61) while the overall progression for the BCG group and the Gemcitabine group was equal(p=1.0). As regard safety, Gemcitabine was better tolerated than BCG with better safety profile. Dysuria was present in 35% in the BCG group compared to 12.5% in the gemcitabine group with statistically significant difference (P< 0.05) and urinary frequency was present in 45% of the BCG group compared to 10% in the gemcitabine group with highly significant statistical difference (P <0.001). CONCLUSIONS After complete TUR-BT, at short term follow up, intravesical Gemcitabine was as effective as BCG in prevention of recurrence and progression of non-muscle invasive TCC of the bladder, even with a better safety profile and minimal toxicity. Further studies are needed to confirm these findings in a large number of patients with a longer follow up period. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byGontero P, Oderda M, Mehnert A, Gurioli A, Marson F, Lucca I, Rink M, Schmid M, Kluth L, Pappagallo G, Sogni F, Sanguedolce F, Schiavina R, Martorana G, Shariat S and Chun F (2018) The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guérin Instillation Therapy on the Quality of Life in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Prospective, Randomized, Phase II TrialJournal of Urology, VOL. 190, NO. 3, (857-862), Online publication date: 1-Sep-2013. Volume 185Issue 4SApril 2011Page: e664-e665 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lotfy Bendary Zagazig, Egypt More articles by this author Salem Khalil Zagazig, Egypt More articles by this author Ashraf Shahin Zagazig, Egypt More articles by this author Nashwa Nawar Zagazig, Egypt More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...