Toxicity assessment of a long-term BCG maintenance therapy
Article published in Urologia Polska 2004/57/2.

authors

Anna Kołodziej, Janusz Dembowski, Tomasz Szydełko, Tadeusz Niezgoda, Bartosz Małkiewicz, Michał Wróbel, Paweł Kowal, Romuald Zdrojowy, Jerzy Lorenz

Katedra i Klinika Urologii Akademii Medycznej we Wrocławiu
Kierownik kliniki: prof. dr hab. Jerzy Lorenz

keywords

bladder, urothelial cancer, immunotherapy BCG, toxicity

summary

introduction

After TURB we assessed the side effects (local and systemic) of weekly instillations with bacillus Calmette-Guerin (BCG) during a 6-week induction course followed by 3-weekly maintenance courses at 3, 6, 12, 18, 24, 30, and 36 months. We tried to determine the BCG toxicity and find out whether maintenance therapy is more toxic than induction course alone.

materials and methods

From March 1995 to March 2003, 134 patients with intermediate and high-risk superficial bladder cancer were treated with BCG maintenance therapy. Adverse reactions, observed during 2061 instillations, were classified in four categories using a scale based on WHO recommendations.

results

Of the patients in the maintenance group 30% (39 patients) have already completed the planned 3-year programmed treatment, while 19 (14,2%) patients discontinued the treatment due to local or systemic intolerance. Overall 41% patients received 18 planned BCG instillations to this moment. According to WHO based scale, grade IV toxicities were not noticed. Serious, grade III complications were present in 9 (6,7%) patients. 18 (13,4%) patients with grade II/III complications required antituberculous treatment. Of the 23 patients who stopped instillations due to local or systemic side effects, 13 (56%) stopped at induction course and during the first 6 months of therapy.

conclusions

Intravesical BCG therapy provokes both local and systemic side effects but according to our observations toxicity of maintenance therapy was relatively low only 6,7% of patients had grade III toxicity and required cessation of therapy and antituberculous drugs. Majority of adverse events were seen during the induction course and during the first two maintenance courses.