How to reduce bacillus Calmette-Guérin discontinuation in patients with severe functional impairment

Abstract

Background Severe functional impairment is often considered a contraindication to intravesical therapy for nonmuscle-invasive bladder cancer (NMIBC). A tailored intravesical bacillus Calmette-Guérin (BCG) procedure was evaluated in high-risk (HR)-NMIBC patients with severe functional impairment. Materials and methods Patients with a Katz Index score of 2 or less and an initial diagnosis of HR-NMIBC with atraumatic insertion of a Foley-type indwelling catheter, bladder emptying, and BCG instillation were prospectively treated; after 2 hours, the bladder was emptied and the catheter was removed (group A). After propensity score matching, 52 patients in group A were compared with that of 52 consecutive patients in group B using a retrospective database, with similar baseline/oncological characteristics and treated with standard intermittent catheterization. Moreover, groups A and B were compared with that of 130 consecutive patients (group C) retrospectively evaluated, with similar oncological characteristics but with a Katz Index score of 3 or greater and treated with standard intermittent catheterization. Results The discontinuation rates were 11.5%, 35%, and 9% in groups A, B, and C, respectively (A vs. B, log-rank score 42.52 [ p < 0.05]; B vs. C, 107.6 [ p < 0.05]; A vs. C, 3.45 [ p > 0.05]). The overall adverse event rates were 38.5%, 57.7%, and 39.2%, respectively (A vs. B, p = 0.04; B vs. C, 0.03; A vs. C, 0.92). The rates of severe adverse events were 1.9%, 1.9%, and 1.5%, respectively, without statistically significant differences. The cumulative HR disease-free survival rates were 63.4%, 48%, and 69.2%, respectively (A vs. B, log-rank score 154.9 [ p < 0.05]; B vs. C, 415 [ p < 0.05]; A vs. C, 244 [ p < 0.05]). Conclusions A tailored intravesical instillation procedure may reduce BCG discontinuation and adverse effects.

BCG and bladder cancer. Forty-eight years after Morales report

“…Di Gianfrancesco et al 50 showed that a tailored instillation procedure may reduce BCG discontinuation and side effects in patients with severe functional impairment. Serretta et al 51 out of 411 patients undergoing intravesical BCG with 1-year maintenance, reported that 215 (52.3%) only completed 1 year of treatment.…”