Adverse events following intravesical Bacillus Calmette-Guérin therapy in Mater Dei Hospital, Malta

Abstract

Introduction: Intravesical administration of Bacillus Calmette-Guerin (BCG), following transurethral resection of bladder tumour, has been shown to reduce recurrence and progression in appropriately selected patients with non-muscle invasive bladder cancer. The aim of the study was to report the local incidence and range of adverse events experienced by patients managed with intravesical BCG. Methods: All patients who received at least one dose of intravesical BCG treatment at Mater Dei Hospital in 2014 were included in the study. A database including demographic, histological and chronological data, together with complication type, degree and treatment required was created. Patient medical files were reviewed and the patients were invited to take part in this audit via a telephone survey. Results: 55 patients satisfied inclusion criteria and were included in the study. 54 patients were documented to have had induction BCG, with maintenance BCG in 32 patients. 22 of these experienced at least 1 adverse event with BCG, whilst 33 had no complications. 1 patient had 3 adverse events, 7 patients had 2 adverse events and 14 patients had 1 complication. Most adverse events were considered to be mild or moderate in severity. Storage bladder symptoms accounted for most of these adverse events. No death as a consequence of intravesical BCG therapy was recorded. Conclusion: Intravesical BCG therapy remains one of the mainstay therapies in the management of bladder cancer. The majority of adverse effects recorded were self-limiting or easily treatable with oral analgesics or antibiotics.