Kamat - Figure 28
Recurrent CIS
FIG. 28: In this Figure, also from the Steinberg study,[25] there is some useful information that can help clinicians and investigators counsel their patients. The data in the upper red frame in the Figure shows that any patient with CIS with prior BCG failure <12 months who had received ≥2 courses of BCG, at 12 months had only a 21% chance of responding to BCG plus interferon α-2B and only 14% at 24 months. The data in the lower red frame in the Figure, in pure papillary patients, show that if their prior BCG failure interval was <6 months, if they had ≥2 courses of BCG, these patients had a 41% chance of responding to subsequent therapy with BCG plus interferon α-2B, and 25% at 24 months. If they had multiple tumors, their chance of being disease-free at 24 months was only 20%. Numbers such as these are important, because this is a category of patient in whom the US Food and Drug Administration (FDA) and other regulatory authorities have approved single-arm studies.
References
Steinberg RL, Thomas LJ, Mott SL, O'Donnell MA. Bacillus Calmette-Guérin (BCG) treatment failures with non-muscle invasive bladder cancer: a data-driven definition for BCG unresponsive disease. Bladder Cancer. 2016;2:215−24 https://dx.doi.org/10.3233%2FBLC-150039
