MP13-05 A RANDOMIZED TRIAL COMPARING TWO DIFFERENT RETENTION PERIODS OF INTRAVESICAL PIRARUBICIN INSTILLATION FOR INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) AFTER TRANSURETHRAL RESECTION.

Aim of this study was to evaluate HRQoL of patients affected by NMIBC underwent intravesical instillations of Bacillus Calmette-Gu erin (BCG) or Mytomicin C (MMC) with a short-term follow-up.METHODS: From December 2011 to December 2014 we recruited 108 consecutive patients in a single academic center with a first-time diagnosis of NMIBC at intermediate or high risk.The median age was 73 years (38-94) and 55.3% (N 57) patients underwent BCG and 44.7% (N 46) patients underwent MMC after TURBT respectively.The assessment of HRQoL was performed using two questionnaires from EORTC: QLQ-C30 and QLQ-BLS24 specific for NMIBC.Patients self-completed the questionnaires in three different times: T0 (before intravesical instillation), T1 (after intravesical instillation), T2 (at three months after last instillation).The above analysis was stratified by gender, age (?70 years and >70 years), tumour degree risk (intermediate and high risk) and type of intravesical therapy (MMC and BCG).Wilcoxon two sample test was used to verify differences.Statistical significance was achieved if pvalue was ¼0.05 (two-sides).RESULTS: Treatment was well tolerated in both groups of patients underwent intravesical instillations of BCG and MMC respectively.Grade I and II side effects, as CTCAE classification, were reported by 46.6% of patients at T1 and 47.5% at T2. 5 patients dropped out of the study (3 lost in follow-up and 2 developed side effects of BCG).At T1 we founded a drop in QoL, with reference to Physical, Role, Emotional and Social functioning domains and a worsening of urinary bladder symptoms with a generally decrease of Global Quality of Life Score.The sexual sphere was affected by adjuvant therapy with persistence or worsening of sexual disorders.At T2 patients showed a progressive return to baseline QoL, in particular in the Social and clinical symptoms domains.Male gender, age >70 years, high-risk tumours and BCG seem to be the factors that worsening HRQoL of these patients.CONCLUSIONS: Intravesical instillations seem to modify the HRQoL of these patients with a return at 3 months to baseline conditions.