<p><strong> </strong><strong>In patients fit for surgery with high-grade T1 disease after a single course of induction intravesical BCG, clinicians should offer radical cystectomy. (<em>Moderate Recommendation; Evidence Level: Grade B</em>)</strong></p>
Discussion
Discussion
<p>The Panel recognizes the adverse prognostic significance of high-grade T1 disease in patients treated with induction BCG.<sup>257</sup><sup> </sup>Data have demonstrated adverse CSS among patients with NMIBC recurrence after BCG who undergo delayed versus early cystectomy.<sup>258</sup><sup> </sup>Patients initially with NMIBC who progress to muscle invasion have been found to have a worse prognosis than patients initially presenting with muscle-invasive disease.<sup>259-261</sup> Further, in a retrospective comparative analysis, patients with T1 recurrence after BCG treated with radical cystectomy were noted to have a decreased 5-year cumulative incidence of death from disease (31%) compared to patients with T1 recurrence after BCG treated with repeat resection and BCG (48%).<sup>262</sup> In addition, there is evidence from the pragmatic CISTO trial that there is clear benefit in numerous quality of life domains for performing a radical cystectomy rather than bladder-sparing therapy.<sup>263</sup> Thus, the Panel recommends that patients with high-grade T1 disease after a single course of induction BCG who are fit for surgery be offered radical cystectomy. The timing of tumor recurrence following BCG may be incorporated into the decision process for treatment as well as the time between BCG treatment and tumor detection and has been identified as an additional prognostic feature.<sup>86, 254, 264</sup> A small prospective phase 2 trial, NRG Oncology/RTOG 0926, suggested a potential role for trimodal therapy combining radiotherapy with systemic radiosensitizing therapy for the treatment of high-grade T1 disease after BCG-unresponsiveness.<sup>265</sup> While these results are promising, additional prospective studies are required before this approach can be recommended routinely.</p>