531 IS THERE A DIFFERENCE IN QUALITY OF LIFE BETWEEN BCG AND INTRAVESICAL CHEMOTHERAPY? RESULTS OF A RANDOMIZED PHASE II STUDY

You have accessJournal of UrologyUrothelial Cancer: Medical & Surgical Therapy1 Apr 2012531 IS THERE A DIFFERENCE IN QUALITY OF LIFE BETWEEN BCG AND INTRAVESICAL CHEMOTHERAPY? RESULTS OF A RANDOMIZED PHASE II STUDY Paolo Gontero, Alberto Gurioli, Marco Oderda, Anja Mehnert, Michael Rink, Marianne Schmid, Luis Kluth, Giovanni Pappagallo, Filippo Sogni, Sanguedolce Francesco, Giuseppe Martorana, and Felix Chun Paolo GonteroPaolo Gontero Turin, Italy More articles by this author , Alberto GurioliAlberto Gurioli Turin, Italy More articles by this author , Marco OderdaMarco Oderda Turin, Italy More articles by this author , Anja MehnertAnja Mehnert Hamburg, Germany More articles by this author , Michael RinkMichael Rink New York More articles by this author , Marianne SchmidMarianne Schmid Hamburg, Germany More articles by this author , Luis KluthLuis Kluth Hamburg, Germany More articles by this author , Giovanni PappagalloGiovanni Pappagallo Noale, Italy More articles by this author , Filippo SogniFilippo Sogni Novara, Italy More articles by this author , Sanguedolce FrancescoSanguedolce Francesco Bologna, Italy More articles by this author , Giuseppe MartoranaGiuseppe Martorana Bologna, Italy More articles by this author , and Felix ChunFelix Chun Hamburg, Germany More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.604AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES According to current evidence, BCG is perceived as less torelable than intravescial chemotherapy. Both these treatment options can be used as adjuvant treatment in intermediate-risk NMIBC. This is the first study to prospectively evaluate and compare the quality of life (QoL) of intermediate-risk NMIBC patients treated with chemotherapy or BCG. Gemcitabine, a promising intravesical agent for its efficacy and tolerability, was employed in the chemotherapy arm. METHODS We enrolled 120 intermediate-risk NMIBC patients. 61 were randomized to receive GEM 2000 mg/50 cc weekly for 6 weeks (maintenance monthly for one year), while 59 BCG Connaught 1/3 dose weekly for 6 weeks (maintenance 3 weekly instillations at 3, 6 and 12 months). QoL was measured by international validated EORTC QlQ-C30 and BLS-24 questionnaires at the following time intervals (T0 baseline, T1 after completion of induction cycle, T2 after 1 year). Adverse events were registered according to CTCAEv3. RESULTS 87 patients completed the study (40 in GEM arm and 47 in BCG arm). Mean age was 67.4 years. Multivariate analyses showed no significant differences between the BCG and GEM group in all QoL dimensions (EORTC-QlQ-C30) including bladder cancer-specific quality of life (P>.05). At T1, the GEM-group showed a significant better QoL in cognitive and emotional functioning (P