We thank Dr Passarelli and colleagues for their insightful comments,1 and we agree that UGN-102 is a valuable potential treatment of patients with low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG-IR-NMIBC).2 We disagree that comparison with agents used in the postsurgery adjuvant setting is relevant to consideration of the clinical benefits of UGN-102, which has been developed as primary medical therapy for patients with LG-IR-NMIBC. UGN-102 produces durable recurrence-free survival exceeding that achieved by primary transurethral resection of bladder tumor with an acceptable safety profile.3 Patients enrolled in the ENVISION trial had biopsy confirmation of low-grade histology before the initiation of treatment with UGN-102. Debulking to reduce tumor burden to a prespecified limit was not performed as part of the ENVISION protocol. This is in contrast to the OLYMPUS trial that led to the approval of UGN-101 for the treatment of low-grade upper tract urothelial carcinoma, in which debulking was performed in many study participants before drug treatment to reduce total tumor burden to a prespecified 5 to 15 mm.4 Although we appreciate the concern that pretreatment biopsy could have affected the complete response rate observed in the ENVISION trial, it is important to note that a representative biopsy was required before treatment, not a biopsy of each tumor noted during screening. Eighty-three percent of patients enrolled in the ENVISION trial had multifocal disease at baseline, which is typical for patients with recurrent LG-IR-NMIBC. It would therefore not be plausible that pretreatment biopsy would have significantly altered total tumor burden at the outset of treatment with UGN-102 in most of the enrolled patients.
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