| ORIGINAL ARTICLE |
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| Year : 2020 | Volume
: 12
| Issue : 4 | Page : 360-365 |
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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
Mohamed Bakr Mohamed1, Mohamed Hassan Ali2, Mostafa A Shamaa2, Sami M Shaaban2
1 Department of Urology, Faculty of Medicine, Port Said University, Port Said, Egypt
2 Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt
Correspondence Address:
Dr. Mohamed Hassan Ali
Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia
Egypt
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DOI: 10.4103/UA.UA_137_19 
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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.
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