title: Final results of the phase III URO-BCG 4 multicenter study: efficacy and tolerance of one-third dose BCG maintenance in nonmuscle invasive bladder cancer.
abstract: The objective of this study was to assess at 3 years bacillus Calmette-Guerin (BCG) maintenance treatment for NMIBC using one-third dose schedule and fewer instillations every 3 or 6 months. This was a phase III randomized study including patients with intermediate-risk or high-risk NMIBC, who received, after a full-dose induction schedule, three-weekly instillations of one-third dose BCG every 6 months (group I) and two-weekly instillations every 3 months (group II) during 3 years. We assessed oncological efficacy, BCG side effects, leukocyturia, and prostate-specific antigen. No tumor recurrence was reported at 36 months for 55 (82.09%) patients in group I versus 64 (90.14%) patients in group II (P=0.241). Muscle invasion was observed in six patients at 36 months (P=0.942). In terms of BCG toxicity, grade II and III local or systemic side effects were, respectively, reported in 8.7 and 23.9% of patients during the first year. Nevertheless, the adverse events (AEs) score at 36 months underlined a lower median value of 0.8 in group I versus 1.1 in group II (P=0.037). Furthermore, 9.9% major AEs occurred in group II versus 3% in group I (P=0.031). Leukocyturia and prostate-specific antigen level were not associated significantly with either tumor recurrence or muscle progression. We observed a significant difference in the AEs score at 36 months, suggesting less toxicity in patients who were treated with one-third dose of BCG for 3 consecutive weeks every 6 months.
authors.affiliation: aUrology Department, Charles Nicolle University Hospital bInserm 1404, Onco-Urology Group, Clinical Investigation Center, Rouen cUrology Department, Nantes University Hospital, Nantes dUrology Department, Amiens University Hospital, Amiens eUrology Department, Lyon University Hospital, Lyon fUrology Department, Kremlin Bicêtre University Hospital, Paris gUrology Department, Toulouse University Hospital, Toulouse, France.
authors.forename: François X
authors.initials: FX
authors.lastname: Nouhaud
authors.forename: Jérome
authors.initials: J
authors.lastname: Rigaud
authors.forename: Fabien
authors.initials: F
authors.lastname: Saint
authors.forename: Marc
authors.initials: M
authors.lastname: Colombel
authors.forename: Jacques
authors.initials: J
authors.lastname: Irani
authors.forename: Michel
authors.initials: M
authors.lastname: Soulie
authors.forename: Christian
authors.initials: C
authors.lastname: Pfister
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D001500:BCG Vaccine