Single course of intravesical Bacillus Calmette-Guerin versus single course with maintenance therapy in the management of nonmuscle invasive bladder cancer: A prospective randomized study

Abstract

Objective: The objective of the study was to compare maintenance versus single course of intravesical Bacillus Calmette-Guerin (BCG) in the management of high-risk nonmuscle invasive bladder cancer (NMIBC) regarding recurrence, progression, survival, and complications. Patients and Methods: After transurethral resection of bladder tumor (TURBT), Group I patients (33) received weekly doses of 90 mg of live attenuated Pasteur strain of BCG. The course was started 14 days after the second TURBT for 6 consecutive weeks. In Group II: 35 patients, the induction schedule was followed by 3 weekly instillations at months 3, 6, and 12 as a maintenance course. Recurrence, progression rates, survival, and toxicity were assessed in both the groups. Results: Patients with induction therapy alone had significantly higher recurrence rate than those received maintenance therapy (55.6% vs. 19.2%, P = 0.01). The 5-year recurrence-free survival rate was 41% and 78% in both the groups, respectively. There was no significant difference regarding the progression rate for both the groups. The mean 5-year progression-free time was comparable between the two groups. The 5-year progression-free survival was 69.8% for patients who underwent induction therapy alone compared to 70.7% for maintenance therapy. Overall local adverse events were significantly higher in patients who underwent maintenance treatment protocol. Statistical Analysis Used: SPSS package version 20 and Kaplan-Meier curves were used to evaluate the survival rate. Conclusions: Maintenance doses of BCG significantly decrease and delay the recurrence of high-risk NMIBC. However, there is no significant favor as regards tumor progression. Maintenance doses of BCG are significantly associated with a higher incidence of local adverse effects than induction doses alone.