Pd48-09 a Quality-Adjusted Time Without Symptoms or Toxicity (Q-Twist) Analysis of Systemic Therapy Versus Standard of Care Intravesical Treatment (Bcg) in Non-Muscle Invasive Bladder Cancer Patients

You have accessJournal of UrologyBladder Cancer: Non-invasive III (PD48)1 May 2024PD48-09 A QUALITY-ADJUSTED TIME WITHOUT SYMPTOMS OR TOXICITY (Q-TWIST) ANALYSIS OF SYSTEMIC THERAPY VERSUS STANDARD OF CARE INTRAVESICAL TREATMENT (BCG) IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS Genesis Rivera-Marquez, Beatriz Walter, Rebecca Dolan, Sonia Belfield, and Vladimir A. Valera Genesis Rivera-MarquezGenesis Rivera-Marquez , Beatriz WalterBeatriz Walter , Rebecca DolanRebecca Dolan , Sonia BelfieldSonia Belfield , and Vladimir A. ValeraVladimir A. Valera View All Author Informationhttps://doi.org/10.1097/01.JU.0001008712.53259.7d.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Quality of life (QoL) is an important but underestimated indicator in clinical trials when comparing therapies for early, non-muscle invasive bladder cancer (NMIBC), especially if they potentially differ in toxicity. Moreover, time without symptoms or toxicity (TWiST) estimation as a surrogate of QoL can provide a better perspective for such patients. These evaluations are commonplace in clinical trials for metastatic disease but are rarely used for clinically localized disease. In this study, we aimed to use Q-TWiST methodology to assess the tolerability of systemic vs intravesical therapy for NMIBCa patients receiving treatment in the context of a clinical trial or standard of care (SoC) therapies. METHODS: This was a post-hoc analysis of combined patient-level data from two phase I trials in NMBIC that incorporated systemic therapy and a control BCG arm. From the adverse event data (CTCAE v 5.0), we estimated the duration of therapy related toxicity (TOX), time without symptoms and toxicity (TWiST), and time following recurrence (REL). The time period patients experienced TOX was defined as the total number of days spent with grade 3 or 4 adverse events. Time without symptoms or toxicity (TWiST) was defined as the period from treatment initiation to date of disease recurrence (assessed by mandatory biopsy) minus the number of days with grade 3 or 4 adverse events. The recurrence period (REL) was defined as the period after the date of recurrence diagnosis up to 12 months. Kaplan-Meir curves were calculated for each state and the area under the curve (AUC) compared between treatments. RESULTS: A total of 30 patients from two contemporary NMIBC trials (NCT02015104, NCT03258593) were included, 15 of which received a combination therapy that included systemic immunotherapy, and 15 that received intravesical (BCG) therapy alone. Baseline clinical or pathologic characteristics were non-significantly different between groups. Time to recurrence was 11.7 months (4-NA) for BCG SoC vs 13.9 months in the systemic therapy group (p>0.05). Four patients (27%) receiving systemic regimen had >grade 3 TrAES, compared to 20% (3/15) of patients with BCG only. Most significant AEs were mapped to the System-Organ-Class (SOC/MedDRA) group of genitourinary symptoms. Area under the curve comparison for TOX, TWiST, and REL times were not significantly different between treatments, but seemed to slightly favor SOC therapy for reduced systemic toxicity. CONCLUSIONS: QoL estimators including Time Without Symptoms or Toxicity (TWiST) should be incorporated more frequently into clinical trials for localized disease in bladder cancer, more so when using combination therapies that include potential systemic adverse events. Even though the data does not support a significantly increased risk of toxicities when using systemic therapies for NMIBC, larger studies in the post marketing/approval setting are needed to confirm our findings. Source of Funding: NIH Intramural Research Program © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e991 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Genesis Rivera-Marquez More articles by this author Beatriz Walter More articles by this author Rebecca Dolan More articles by this author Sonia Belfield More articles by this author Vladimir A. Valera More articles by this author Expand All Advertisement PDF downloadLoading ...