<p><strong> </strong><strong>In</strong><strong> high-risk patients with persistent or recurrent Ta or CIS disease after a single course of induction intravesical BCG, clinicians should offer a second course of BCG. (<em>Moderate Recommendation; Evidence Level: Grade C</em>)</strong></p>
Discussion
Discussion
<p>Approximately 50% of patients who have persistent or recurrent NMIBC following a single induction course of BCG respond to a second induction course of BCG.<sup>245-248</sup><sup> </sup>Patients, particularly those with Ta or CIS after a single induction course of BCG, should be offered retreatment with BCG, provided that the patient tolerated the initial induction course of BCG. Retreatment may consist of a second six-week induction course or, particularly for patients with CIS, three weekly treatments which would effectively represent the first of the patient’s maintenance therapy.<sup>249, 250</sup></p>
<p>While the use of interferon alpha-2b (IFN-α2B) in combination with BCG has been reported in patients previously treated with BCG,<sup>251-254</sup> this regimen has not been directly compared with a second course of BCG alone, and therefore, the incremental additive value of BCG with IFN-α2B over BCG alone in this setting remains unknown. In addition, when compared to BCG induction and maintenance in a BCG-naïve population, the group that received combination BCG and IFN-α2B had no improvement in tumor recurrence rates and had more side effects.<sup>255</sup> The Panel believes that this combination should not be used as a primary initial therapy. In addition, one phase 2 randomized trial demonstrated that intravesical gemcitabine was associated with a superior two-year recurrence-free survival compared to BCG (19% versus 3%; p<0.008) among patients with high-risk non-muscle invasive recurrence after a single course of BCG, albeit with no significant difference in progression.<sup>256</sup><sup> </sup>However, the small sample size of the study (n=80), the high rate of disease recurrence noted in the BCG group, and lack of robust subsequent validation raises questions about the study’s generalizability.</p>