Treatment options for BCG failures

Abstract

Herr and Dalbagni aptly noted that comparisons between therapies for BCG failure patients have been hampered by the lack of standard definitions for BCG failure and BCG-refractory transitional cell carcinoma (TCC) [2]. Some series have defined BCG failure after a single induction course of BCG [3, 4], others after two courses [5]. In addition, the methods of reporting the results have been inconsistent. Most studies have included all patients who received one or more courses of BCG [6, 7, 8]. Investigators have often combined patients with persistent disease (non-responders) and patients with recurrent disease after an initial response [3, 4, 5] and a few studies have combined patients who were non-responders to BCG and patients who could not complete BCG therapy because of toxicity (BCG intolerant) [5, 6]. Finally, most studies did not indicate the disease-free interval after the last BCG course. These inconsistencies have led to comparisons of outcome in a very heterogeneous population. In the most general sense any recurrent disease after initiation of BCG therapy can be referred to as “BCG failure.” However, to provide more uniformity in reporting, the following alternative descriptive terms for specific types of BCG failure should be used whenever possible: BCG refractory Failure to achieve a disease-free state by 6 months after initial BCG therapy with either maintenance or re-treatment at 3 months due to either persistent or rapidly recurrent disease. Also includes any progression in stage, grade, or disease extent by 3 months after first cycle of BCG, i.e., non-improving or worsening disease despite BCG. BCG resistant Recurrence or persistence of disease at 3 months after induction cycle but of lesser degree, stage or grade which subsequently is no longer present at 6 months from BCG re-treatment ± TUR, i.e., disease improves then resolves with further BCG. BCG relapsing Recurrence of disease after achieving a disease-free status by 6 months, i.e., disease resolves after BCG then returns. Relapse is further defined by time of recurrence: early (within 12 months); intermediate (12–24 months); late (>24 months). Caution: relapsing disease while on active maintenance (within 3 months) may qualify as BCG refractory. BCG intolerant Disease recurrence after a less than adequate course of therapy is applied due to a serious adverse event or symptomatic intolerance that mandates discontinuation of further BCG, i.e., recurrent disease in setting of inadequate BCG treatment from drug toxicity.