<p><strong> </strong><strong>Clinicians should not prescribe additional BCG to a patient who is intolerant to BCG or has documented recurrence on TURBT with high-grade non-muscle-invasive disease and/or CIS within six months of two induction courses of BCG or induction BCG plus maintenance. (<em>Moderate Recommendation; Evidence Level: Grade C</em>)</strong></p>
Discussion
Discussion
<p>Clinicians should avoid prescribing additional BCG instillations to patients who are not likely to benefit from further BCG therapy. Various definitions have been put forth to more specifically classify patients in which disease continues or recurs quickly after BCG.<sup>249, 264, 266, 267</sup><sup> </sup>Historical evidence has demonstrated the lack of clinical benefit of additional BCG in patients who have continued disease after two prior BCG induction courses,<sup>247, 251</sup> while a short time interval between completion of BCG treatment and subsequent tumor detection has been identified as an adverse prognostic feature.<sup>86, 254, 264</sup> Recently, separate consensus panels have put forth similar defining characteristics of patients not likely to benefit from additional BCG.<sup>268-270</sup><sup> </sup>The FDA currently defines BCG-unresponsive disease as at least one of the following: persistent or recurrent CIS with or without recurrent Ta/T1 disease within one year of completing adequate BCG, recurrent high-grade Ta or T1 disease within six months of completing adequate BCG, or high-grade T1 disease at the first evaluation after completing induction BCG.<sup>270, 271</sup><sup> </sup>Adequate BCG in this context is defined as at least five of six doses of an induction round and at least two of three doses of at least one maintenance round of BCG therapy.<sup> </sup>The intention of such a definition as put forth in this statement is for patients to avoid receiving treatments from which they are unlikely to benefit, as well as to aid in future clinical trial design by establishing appropriate eligibility criteria for studies of novel therapies for those with a persistent or recurrent tumor despite BCG treatment.</p>