Roman Tomaškin, Boris Eliáš, Pavol Slávik, Katarína Macháleková, Ján Kliment
Objective: The maintenance intravesical BCG therapy continuing at least 1 year is necessary to achieve the best results in patients with high risk non-muscle invasive bladder cancer. With the number of instillations the incidence of adverse events increases. Our experience with longterm intravesical BCG therapy, its tolerability, the incidence of complications and their treatment is reported. Material and methods: Between 1997 and 2007 132 patients with high risk Ta-T1-CIS bladder cancer were indicated for intravesical BCG therapy (strain Connaught) at our department. There were following indications for BCG treatment: any G3 tumour, CIS, multifocal T1G1 - 2, at least two recurrences within the most recent year. The treatment started with 6-week induction therapy and continued with minimum 1-year maintenance therapy with BCG instillations each week for 3 weeks given 3, 6, 12 months and then every 6 months after initial treatment. In this retrospective study we evaluated medical records from 83 patients who achieved 1-year maintenance therapy or interrupted therapy due to its intolerability or significant complications. Patients who interrupted treatment due to other reasons (e.g. treatment failure) were not included in this study. Treatment tolerability was evaluated from clinical view as incidence and relevance of side effects, necessity to postpone instillations, to reduce BCG dose (27 mg) or to interrupt treatment definitely. Results: 52 from 83 evaluated patients (63 %) treated with intravesical BCG completed at least 1-year lasting regimen (6 + 3 + 3 + 3 instillations) according to schedule with acceptable tolerability (according to WHO scale for side effects grade 0 or 1, lasting < 48 hours). Other 20 patients (24 %) completed 1-year treatment regimen with temporary deferred instillations (9 pts), reduced dose to 27 mg (5 pts) or combination of both (6 pts) (grade 2 side effects lasting > 48 hours). 6 pts (7 %) refused maintenance therapy during first year due to intolerability (urgency, bladder pain, recurrent infection), but without serious side effects. Only 5 pts (6 %) discontinued initial or maintenance therapy due to serious side effects grade 3 or 4 (1 for BCG hepatitis + pneumonitis, 1 for BK+ cystitis, 1 for granulomatous epididymitis and perianal abscess, 1 for reactive arthritis, 1 for granulomatous penis lesions). All side effects were successfully treated according to published recommendations without persistent medical consequences. Conclusions: In our study cohort 72 patients (86 %) were able to complete at least 1-year maintenance intravesical BCG therapy with good tolerability, 6 patients refused maintenance therapy due to poor tolerability and only 5 patients discontinued therapy due to serious complications. Intravesical BCG therapy is safe, well-tolerated treatment modality with acceptable quality of life and reasonable risk/benefit ratio.