120 days ago
90 days ago
30 days ago
7 days ago
Clinical trial, phase 1
Clinical trial, phase 2
Clinical trial, phase 3
Clinical trial, phase 4
Consensus development conference
Consensus development conference, NIH
Controlled clinical trial
Corrected republished article
Randomized controlled trial
All infant: 0-23 mos
All child: 0-18 yrs
All adult: 19+ yrs
Newborn: birth-1 mo
Preschooler: 2-5 yrs
Adolescent: 13-18 yrs
Young adult: 19-24 yrs
Middle-aged: 45-64 yrs
Aged: 65+ yrs
Elderly: 80+ yrs
Maintenance therapy with bacillus Calmette-Guérin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscle-invasive bladder cancer.
BJU Int (2011)
108(2):187-95 PMID 21176079
• To confirm the recurrence-preventing efficacy and safety of 18-month bacillus Calmette-Guérin (BCG) maintenance therapy for non-muscle-invasive bladder cancer.
• The enrolled patients had been diagnosed with recurrent or multiple non-muscle-invasive bladder cancer (stage Ta or T1) after complete transurethral resection of bladder tumours (TURBT). • The patients were randomized into three treatment groups: a maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks as induction therapy, followed by three once-weekly instillations at 3, 6, 12 and 18 months after initiation of the induction therapy), a non-maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks) and an epirubicin group (epirubicin, 40 mg, intravesically instilled nine times). The primary endpoint was recurrence-free survival (RFS).
• Efficacy analysis was performed for 115 of the full-analysis-set population of 116 eligible patients, including 41 maintenance group patients, 42 non-maintenance group patients and 32 epirubicin group patients. • At the 2-year median point of the overall actual follow-up period, the final cumulative RFS rates in the maintenance, non-maintenance and epirubicin groups were 84.6%, 65.4% and 27.7%, respectively. • The RFS following TURBT was significantly prolonged in the maintenance group compared with the non-maintenance group (generalized Wilcoxon test, P= 0.0190).
• BCG maintenance therapy significantly prolonged the post-TURBT RFS compared with BCG induction therapy alone or epirubicin intravesical therapy.
© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.
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