Can Early Single Dose Instillation of Epirubicin Improve Bacillus Calmette-Guerin Efficacy in Patients With Nonmuscle Invasive High Risk Bladder Cancer? Results From a Prospective, Randomized, Double-Blind Controlled Study
- 31 July 2008
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Journal of Urology
- Vol. 180 (1), 110-115
- https://doi.org/10.1016/j.juro.2008.03.038
Abstract
We evaluated the impact of epirubicin perioperative instillation in improving subsequent bacillus Calmette-Guerin instillation efficacy in high risk patients with nonmuscle invasive bladder cancer. Between January 2005 and June 2007, 161 patients affected by high risk nonmuscle invasive bladder cancer were enrolled in this prospective, randomized, controlled, double-blind study. A total of 80 patients were assigned to group A (perioperative epirubicin 80 mg/50 ml normal saline) plus delayed bacillus Calmette-Guerin instillations (5 x 108 colony-forming units in 50 ml saline) and 81 to group B (delayed bacillus Calmette-Guerin alone). The main outcome measures were time to first recurrence and recurrence rate. All data obtained from a median followup of 15.3 months in group A and 14.8 months in group B, were analyzed. At the end of followup 46 of 80 patients in group A (57.5%) had no evidence of disease, just like 41 of 81 in group B (50.6%). No statistical difference was observed between the 2 groups in terms of recurrence rate (p = 0.82) or time to first recurrence (p = 0.095). Kaplan-Meier analysis of recurrence showed no significant differences between group A and group B (p = 0.0952). On multivariate analysis the early single dose instillation of epirubicin was not indicated as an independent prognostic factor (HR 0.50, 95% CI 0.32-1.18). The present study showed no statistically significant differences in terms of disease-free time and recurrence rate between high risk patients with nonmuscle invasive bladder cancer who had undergone perioperative epirubicin instillation plus delayed bacillus Calmette-Guerin and those who had undergone delayed bacillus Calmette-Guerin alone.Keywords
This publication has 18 references indexed in Scilit:
- Cancer Statistics, 2007CA: A Cancer Journal for Clinicians, 2007
- The management of superficial transitional cell carcinoma of the bladderUrology, 2006
- Predicting Recurrence and Progression in Individual Patients with Stage Ta T1 Bladder Cancer Using EORTC Risk Tables: A Combined Analysis of 2596 Patients from Seven EORTC TrialsEuropean Urology, 2006
- A SINGLE IMMEDIATE POSTOPERATIVE INSTILLATION OF CHEMOTHERAPY DECREASES THE RISK OF RECURRENCE IN PATIENTS WITH STAGE Ta T1 BLADDER CANCER: A META-ANALYSIS OF PUBLISHED RESULTS OF RANDOMIZED CLINICAL TRIALSJournal of Urology, 2004
- Alternating Mitomycin C and BCG Instillations versus BCG Alone in Treatment of Carcinoma in Situ of the Urinary Bladder: A Nordic StudyEuropean Urology, 2003
- Factors Explaining Recurrence in Patients Undergoing Chemoimmunotherapy Regimens for Frequently Recurring Superficial Bladder CarcinomaEuropean Urology, 2002
- Guidelines on Bladder CancerEuropean Urology, 2002
- A systematic review of intravesical bacillus Calmette‐Guérin plus transurethral resection vs transurethral resection alone in Ta and T1 bladder cancerBJU International, 2001
- INTRAVESICAL INSTILLATION OF EPIRUBICIN, BACILLUS CALMETTE-GUERIN AND BACILLUS CALMETTE-GUERIN PLUS ISONIAZID FOR INTERMEDIATE AND HIGH RISK TA, T1 PAPILLARY CARCINOMA OF THE BLADDER: A EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER GENITO-URINARY GROUP RANDOMIZED PHASE III TRIALJournal of Urology, 2001
- EFFECTIVENESS OF A SINGLE IMMEDIATE MITOMYCIN C INSTILLATION IN PATIENTS WITH LOW RISK SUPERFICIAL BLADDER CANCER: SHORT AND LONG-TERM FOLLOWUPJournal of Urology, 1999