Aim of the study
BCG maintenance for at least one year is advocated by urological guidelines as the best intravesical regimen
in high-risk non muscle invasive bladder cancer (NMIBC), conservatively treated. Noteworthy, a relevant
percentage of patients does not complete the planned treatment even if toxicity accounted for less that 10%
of drop outs in recent multi-institutional trials. The aim of this study was to analyze the reasons for treatment
interruption in everyday clinical practice.
Materials and methods
Consecutive patients affected by T1HG NMIBC undergoing conservative management with adjuvant BCG
entered the study. The Connaught BCG strain was administered intravesically, at the dose of 81mg diluted in
50 ml of saline solution, according to the South West Oncology Group schedule for one year, starting 21-30
days after TUR. Toxicity and causes of treatment interruption were recorded.
Results
Between 2000 and 2012, intravesical BCG with 1-year maintenance regimen was proposed to 411 patients.
Out of them, 380 (92,5%) completed the induction cycle and 308 (81%) started the maintenance. A total
of 215 (52.3%) completed one year of treatment. Patients\u2019 compliance decreased from 81% at 3 months to
56.6% at 12 months. Toxicity requiring treatment interruption was recorded in 25 (6.1%) patients only. In
60 patients (14.6%) a delay of one or more instillations was necessary. Noteworthy, grade-I toxicity, not
requiring therapy interruption or delay on urologists\u2019 judgment, was recorded in 193 (46.9%) cases. The
retrospective nature of the study represents its major limit.
Discussion
Although one year BCG maintenance is recommended by both European Association of Urology (EAU)
and National Comprehensive Cancer Network (NCCN), and indicated as the elective intravesical adjuvant
regimen in intermediate- and high- risk NMIBC, conservatively treated, patients who complete the planned
schedule doesn\u2019t exceed 50%. According to recent literature BCG-related toxicity shouldn\u2019t represent
the major limiting fact. In the present experience, the high drop-out rate from treatment could be meanly
attributable to grade-I toxicity underestimated by the urologists and to inadequate counselling.
Conclusions
Severe toxicity caused BCG interruption in a limited amount of cases. Almost 60% of treatment
interruptions could be attributable to lack of patient\u2019s counseling and low grade toxicity
