Mp16-08 Challenging the Paradigm of “Bcg Unresponsive” Bladder Cancer: Does Additional BCG Have an Effect?

You have accessJournal of UrologyBladder Cancer: Non-invasive I (MP16)1 May 2024MP16-08 CHALLENGING THE PARADIGM OF "BCG UNRESPONSIVE" BLADDER CANCER: DOES ADDITIONAL BCG HAVE AN EFFECT? Amanda A. Myers, Wei Shen Tan, Valentina Grajales, Hyunsoo Hwang, Kelly K. Bree, Neema Navai, Byron H. Lee, Colin P. N. Dinney, and Ashish M. Kamat Amanda A. MyersAmanda A. Myers , Wei Shen TanWei Shen Tan , Valentina GrajalesValentina Grajales , Hyunsoo HwangHyunsoo Hwang , Kelly K. BreeKelly K. Bree , Neema NavaiNeema Navai , Byron H. LeeByron H. Lee , Colin P. N. DinneyColin P. N. Dinney , and Ashish M. KamatAshish M. Kamat View All Author Informationhttps://doi.org/10.1097/01.JU.0001008640.01272.9d.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The category "BCG unresponsive disease", was formulated by experts and adopted by the United States Food and Drug Administration in 2018, mainly to facilitate single arm registration studies for novel agents. This paradigm has had tremendous success with 2 agents approved and additional trials ongoing. Over time, this term has become incorporated into clinical use with the implication that additional BCG should not be offered to these patients. We aim to report response rates to additional (rescue) BCG in patients meeting BCG unresponsive criteria. METHODS: We performed an IRB approved review of patients diagnosed with NMIBC between January 2000 and September 2021 to identify patients who met BCG unresponsive criteria. We analyzed the outcomes of patients who received rescue BCG as primary therapy. The primary outcome evaluated was event free survival (EFS): defined as any HG recurrence, progression, or death. The Kaplan-Meier (KM) method was used to estimate EFS, cystectomy free survival (CFS), progression to muscle-invasive or metastatic free survival (PFS) and overall survival (OS). RESULTS: We identified 163 patients with BCG unresponsive disease. Of these, 35 patients (T1: 19, Ta: 7, CIS only: 9 and concomitant CIS: 8) received rescue BCG as primary therapy. 26 (74%) patients showed no disease after rescue BCG; of these 25 (96%) received maintenance. Median follow-up was 5.9 years (IQR 2.8-8.5). KM estimates of EFS after rescue BCG were 68% at 12 months, 62% at 24 months and 48% at 36 months. Individual patient trajectories are displayed in Figure 1. In the 2 years after rescue BCG, 21 patients remained NED, 4 progressed to MIBC and 9 recurred without progression – of these, 2 had cystectomy and 7 had further bladder sparing therapies. This resulted in CFS at 12, 24 and 36 months (95% CI) of 88% (72-95), 79% (61-90) and 79% (61-90), respectively. PFS at 12, 24 and 36 months (95% CI) was 91% (82-100), 88% (77-100) and 76% (61-94), respectively. OS at 12, 24 and 36 months (95% CI) was 94% (86-100), 91% (82-100) and 85% (73-98), respectively. CONCLUSIONS: In selected patients who meet the "BCG unresponsive" definition, additional BCG therapy can demonstrate appreciable efficacy. This challenges current paradigms which recommend against using further BCG in these patients and emphasizes the need for randomized controlled trials. Download PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e242 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Amanda A. Myers More articles by this author Wei Shen Tan More articles by this author Valentina Grajales More articles by this author Hyunsoo Hwang More articles by this author Kelly K. Bree More articles by this author Neema Navai More articles by this author Byron H. Lee More articles by this author Colin P. N. Dinney More articles by this author Ashish M. Kamat More articles by this author Expand All Advertisement PDF downloadLoading ...