Pd30-08 Elucidating the Response Rates to Continued Bacillus Calmette-Guerin (Bcg) in Patients With BCG Exposed Bladder Cancer: Implications for Clinical Trial Design

You have accessJournal of UrologyBladder Cancer: Non-invasive II (PD30)1 May 2024PD30-08 ELUCIDATING THE RESPONSE RATES TO CONTINUED BACILLUS CALMETTE-GUERIN (BCG) IN PATIENTS WITH BCG EXPOSED BLADDER CANCER: IMPLICATIONS FOR CLINICAL TRIAL DESIGN 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.0001008848.77629.6f.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: BCG-exposed NMIBC includes patients who are not BCG naïve yet do not meet criteria to be considered BCG unresponsive. The standard treatment for these patients is additional BCG, yet response rates in this patient group are not well elucidated. Clinical trials evaluating novel agents are often powered based on historical response rates in BCG naïve patients, leading to delays in readout. To fill the lack of data, herein, we report the response rate to continued BCG in patients classified as BCG-exposed. METHODS: We performed an IRB approved review of consecutive patients diagnosed with NMIBC between January 2000 and September 2021 to identify patients who met BCG exposed criteria i.e., having high grade recurrence within two years after BCG exposure but not meeting criteria for being 'BCG unresponsive'. We analyzed the outcomes of patients who received additional BCG as primary therapy. The primary outcome was event free survival (EFS) defined as any high grade recurrence, progression, or death. The Kaplan Meier (KM) method was used to estimate EFS, cystectomy free survival (CysFS), progression to muscle-invasive or metastatic free survival (PFS) and overall survival (OS). RESULTS: From the total dataset of 858 patients treated with BCG at our institution, we identified 50 patients who met the criteria for BCG exposed. Tumor stage at initiation of additional BCG was T1 (1), Ta (37), CIS only (12), and concomitant CIS (6). After additional BCG, 39 (78%) patients showed no disease; of these 37 (95%) received ongoing maintenance BCG. Median follow-up was 4.9 years (IQR 2.8-8). At a prespecified analysis at three years of follow-up; 20 (40%) recurred, of which 6 (12%) progressed. The response rates after additional BCG are summarized in Table 1. Major points to emphasize are 1) EFS at 12 months was 67% and at 24 months was 60% and 2) CysFS at 12, 24 and 36 months of 86%, 82% and 82%, respectively. CONCLUSIONS: Given the demonstrable durable response with additional BCG in patients classified as BCG exposed, it is essential that clinical trials in this population compare against BCG as a control arm. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e627 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 ...