Increasing age is not associated with toxicity leading to discontinuation of treatment in patients with urothelial non-muscle-invasive bladder cancer randomised to receive 3 years of maintenance bacille Calmette–Guérin

Objective: To determine the relationship of age to side-effects leading to discontinuation of treatment in patients with stage Ta–T1 non-muscle-invasive bladder cancer (NMIBC) treated with maintenance bacille Calmette–Guérin (BCG).
Patients and Methods: We evaluated toxicity for 487 eligible patients with intermediate- or high-risk Ta–T1 (without carcinoma in situ) NMIBC randomised to receive 3 years of maintenance BCG therapy (247 BCG alone and 240 BCG + isoniazid) in European Organisation for Research and Treatment of Cancer Genito-Urinary Group trial 30911. The percentage of patients who stopped for toxicity and the number of treatment cycles that they received were compared in four age groups, ≤60, 61–70, 71–75 and >75 years, using the Mantel–Haenszel chi-square test for trend.
Results: The percentage of patients stopping BCG for toxicity was 17.9% in patients aged ≤60 years, 21.9% in patients aged 61–70 years, 22.9% in patients aged 71–75 years, and 16.4% in patients aged >75 years (P = 0.90). For both systemic and local side-effects, there was likewise no significant difference.
Conclusion: In patients with intermediate- and high-risk Ta–T1 NMIBC treated with BCG, no differences in toxicity as a reason for stopping treatment were detected based on patient age.