Improving Patient Outcomes: Optimal BCG Treatment Regimen to Prevent Progression in Superficial Bladder Cancer

Bacillus Calmette-Guérin (BCG) immunotherapy has been demonstrated in randomised clinical trials and meta-analyses to provide superior protection from tumour recurrence and, unlike chemotherapy, even reduce disease progression. Although the optimal maintenance schedule has not been defined by controlled comparison, review of controlled studies suggests that Dr. Lamm's 3-wk schedule with maintenance at 3, 6, 12, 18, 24, 30, and 36 mo may be best, but dose reduction and delay or suspension of treatments is frequently needed to reduce side-effects. Randomised comparison of this regimen using full-strength Connaught BCG versus one-third strength suggests the former is superior, but in some populations dose reduction may be superior. Moreover, long-term (15-yr) follow-up of BCG-treated patients demonstrates the need for continued protection from recurrence and progression. These considerations, plus the marginal improvement demonstrated with systemic BCG immunisation and the reduction in side-effects with dose reduction have led Dr. Lamm to use the following protocol. Induction consists of full-strength BCG given weekly for 6 wk with concomitant percutaneous administration. The dose is reduced to one third at the first sign of significant side-effects. Maintenance BCG in high-risk (G3, T1, or CIS) patients is given using one-third dose BCG at 3, 6, 12, 18, 24, 36, 48, 60, and 72 mo, and then every other year to the 12th year, with dose reductions to 1/10th, 1/30th, 1/100th as needed to prevent increasing side-effects.