There is currently insufficient evidence to supportthe efficacy of bacillus Calmette-Guérin (BCG) maintenance therapy forbladder cancer. This Japanese study examined the efficacy and safety of18 months BCG maintenance therapy for the prevention of recurrence inpatients following transurethral resection of bladder tumour fornon-muscle-invasive bladder cancer (stage Ta or T1).
The study involved 116 patients randomised to one of the following three treatment groups:
1. Maintenancegroup (BCG, 81mg, intravesically instilled once weekly for 6 weeks asinduction therapy, followed by three once-weekly instillations at 3, 6,12 and 18 months after initiation of the induction therapy)
2. Non-maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks)
3. Epirubicin group (epirubicin, 40mg, intravesically instilled nine times).
Theprimary endpoint was recurrence-free survival (RFS). The efficacyanalysis for 115 patients (41 maintenance, 42 non-maintenance and 32epirubicin) found that at the 2-year median point of the overall actualfollow-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 statistically significantlyprolonged in the maintenance group compared with the non-maintenancegroup (p = 0.0190).
The researchers conclude from thesefinding that BCG maintenance therapy prolonged the post-TURBT RFScompared with BCG induction therapy alone or epirubicin intravesicaltherapy.
https://www.nelm.nhs.uk/en/NeLM-Area/News/2011---January/06/Bacillus-Calmette-Guerin-BCG-maintenance-therapy-for-non-muscle-invasive-bladder-cancer-prolongs-recurrence-free-survival/