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.

Abstract

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.