Bacillus Calmette-Guérin Without Maintenance Therapy for High-Risk Non–Muscle-Invasive Bladder Cancer

• Published in: European urology 2011-07, Vol.60 (1), p.32-36
• Main Authors: Herr, Harry W, Dalbagni, Guido, Donat, Sherri M
• Format: Article
• Language: English
• Subjects: Adjuvants, Immunologic - therapeutic use; Adult; Aged; Aged, 80 and over; Bacterial diseases; BCG; BCG Vaccine - therapeutic use; Biological and medical sciences; Bladder cancer; Female; Human bacterial diseases; Humans; Infectious diseases; Mainetenance; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Prospective Studies; Risk Factors; Tuberculosis and atypical mycobacterial infections; Tumors of the urinary system; Urinary Bladder Neoplasms - drug therapy; Urinary tract. Prostate gland; Urology; Young Adult
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2011.03.051

Abstract Background Bacillus Calmette-Guérin (BCG) is the standard intravesical treatment of high-risk noninvasive (Ta, T1, Tis) bladder cancer. Maintenance BCG is recommended for maximum efficacy. Objective We compared our results in a large cohort of high-risk bladder cancer patients who received BCG without maintenance with published results from randomized maintenance BCG trials. Design, setting, and participants A cohort of 1021 patients underwent restaging transurethral resection for high-risk (Ta, T1, Tis) bladder cancer. Intervention Patients received a 6-wk induction course of BCG therapy. Responding patients did not receive maintenance BCG. Relapsing patients were eligible for retreatment with BCG. All patients were followed for a minimum of 5 yr. Measurements End points were 5-yr tumor- and progression-free survival rates. Results and limitations Of 816 complete responders to induction BCG, 2- and 5-yr recurrence-free survival rates were 73% and 46%, respectively. The progression-free survival rate was 89%. Progression-free survival time was 56 mo (95% confidence interval, 55–58 mo). Thirty-two percent of the patients required another course of BCG therapy. We cannot exclude that maintenance BCG may benefit patients beyond 5 yr over induction BCG alone and selective BCG retreatments. Conclusions Our results with BCG treatment without maintenance of patients with high-risk non–muscle-invasive bladder cancer compare favorably with trials in which comparable patients received maintenance BCG.