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.

Abstract

PURPOSE:

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.

MATERIALS AND METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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.

• Authors: Tommaso Cai, Gabriella Nesi, Galliano Tinacci, Enzo Zini, Nicola Mondaini, Vieri Boddi, Sandra Mazzoli, Riccardo Bartoletti
• Journal: The Journal of urology (J Urol) Vol. 180 Issue 1 Pg. 110-5 (Jul 2008) ISSN: 1527-3792 [Electronic] United States
• PMID: 18485394 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Adjuvants, Immunologic
• Antibiotics, Antineoplastic
• BCG Vaccine
• Epirubicin

Topics

• Adjuvants, Immunologic (therapeutic use)
• Administration, Intravesical
• Aged
• Aged, 80 and over
• Antibiotics, Antineoplastic (administration & dosage)
• BCG Vaccine (therapeutic use)
• Double-Blind Method
• Drug Synergism
• Epirubicin (administration & dosage)
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Invasiveness
• Prospective Studies
• Risk Factors
• Time Factors
• Urinary Bladder Neoplasms (drug therapy, pathology)