Can we treat bladder cancer with intravesical Bacillus Calmette-Guerin in patients with prior tuberculosis infection? A population-based cohort study

BACKGROUND: Intravesical bacillus Calmette-Guerin (BCG) therapy is the treatment of choice for patients with T1 or high-grade superficial bladder cancer or those with carcinoma in situ after transurethral resection. A personal history of tuberculosis infection has been viewed as a relative contraindication for BCG therapy, because it may increase the risk of complications or decrease the treatment effectiveness. We determined the safety and efficacy of intravesical BCG treatment for patients with prior tuberculosis infection by analyzing the data obtained from the National Health Insurance Research Database in Taiwan. METHODS: We included patients who were newly diagnosed with bladder cancer from 2000 to 2009 and who received adjuvant intravesical BCG therapy within 3 months after the surgery. We excluded those who developed upper urinary tract cancer during the study period. Disease recurrence, disease progression, and major adverse effects were compared between patients with and without a prior diagnosis of tuberculosis infection until December 31, 2011. RESULTS: Among the 3915 patients included, 187 (4.8%) had been previously diagnosed with tuberculosis infection. The proportion of men (84.0% versus 76.9%) and older patients was higher in the group with a prior tuberculosis infection than in those without a prior tuberculosis infection. Significant differences in disease recurrence (20.3% versus 22.8%; hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.63–1.21, p = 0.404) or disease progression (10.2% versus 12.8%, HR, 0.74; 95% CI, 0.46–1.17, p = 0.191) were not observed between the two groups. None of the patients with a prior tuberculosis infection had severe urinary tract infections, whereas four (0.1%) patients without such an infection developed severe urinary tract infections. CONCLUSION: A prior tuberculosis infection did not affect the treatment efficacy or safety of intravesical BCG treatment. The efficacy and safety of intravesical BCG therapy are comparable between bladder cancer patients with and without prior tuberculosis infections.