6533b860fe1ef96bd12c35c4

RESEARCH PRODUCT

COMPLIANCE WITH ONE YEAR MAINTENANCE INTRAVESICAL BCG IN PATIENTS AFFECTED BY T1G3 BLADDER CANCER

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Introduction: BCG maintenance for at least one year is the best regimen for prevention of recurrence and progression in high risk non muscle invasive bladder cancer (NMIBC), undergoing conservative approach. Noteworthy, a relevant number of patients do not complete the planned treatment interruption. Study aim was to analyze retrospectively the reasons of treatment. Patients and Methods: Consecutive patients affected by T1G3 BC, undergoing BCG maintenance for one year, according to the SWOG schedule (3 weekly instillations at 3, 6, 12 months) were included in this study. Connaught BCG (81 mg/50 ml) was given starting 1430 days after TUR. If toxicity occurred, treatment was postponed up to two weeks. No dose reduction was considered. The patients’ compliance with the treatment was analyzed. Results: Out of 160 patients, 148 (92.5%) completed the induction cycle. In 10 (6.3%) more patients a recurrence was detected. In 15 (9.4%) patients induction only was planned due to personal difficulties. In 123 patients (76.8%) maintenance for one year was planned. However, 8 patients never started and 67 (54.4%) completed only one year maintenance: 6 (4.8%) interrupted for toxicity and 9 (7,3%) for recurrence. Compliance decreased from 84.5% at 3 to 57,7% at 12 months, 56 (45.6%) patients not completing one-year. In particular 109 patients (83.8%) completed the maintenance at 3 and 88 (67.2%) at 6 months. Noteworthy, mild grade I BCG toxicity, not requiring therapy on urologists’ opinion, was recorded in 91 (74%) out of 123 patients in whom maintenance was planned. Main limit was the retrospective nature of the study. Conclusion: Maintenance interruption was due to moderate-severe toxicity in only 5% of the patients. The poor patient’s compliance was probably multifactorial, partially related to grade I toxicity, not taken into appropriate account by the urologists. A correct and periodical counselling with the patients undergoing BCG maintenance regimen could ameliorate the compliance to BCG.