Abstract
ONCOLOGIC OUTCOMES OF GEMCITABINE-DOCETAXEL COMBINATION INTRAVESICAL BLADDER SPARING THERAPY COMPARED TO UPFRONT RADICAL CYSTECTOMY IN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER
Urologic oncology, Vol.42(Supplement), pp.S52-S53
03/2024
DOI: 10.1016/j.urolonc.2024.01.160
Abstract
The recommended treatment per guidelines for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) is radical cystectomy (RC). Yet;many patients are ineligible for RC based on comorbid/performance status or refuse RC based on preference to avoid radical surgery. Recently, gemcitabine and docetaxel (Gem/Doce) combination intravesical therapy has gained popularity in both BCG-naïve and BCG-unresponsive NMIBC disease states. However, there is limited data on the efficacy of Gem/Doce as bladder-sparing therapy (BST) compared to patients who get upfront RC, as prior single and multi-institutional data focused only on patients who received Gem/Doce without including upfront RC as a comparator. The purpose of this study was to compare oncologic outcomes in patients undergoing salvage BST with Gem/Doce compared to patients who receive upfront RC in a large multinational cohort of patients with BCG-unresponsive NMIBC.
Patients from a larger multinational cohort of patients with BCG-unresponsive NMIBC from 10 academic medical centers were retrospectively collected. This analysis included only patients who underwent upfront RC or BST with Gem/Doce specifically. Patients were included if they had BCG-unresponsive disease after adequate BCG therapy according to FDA criteria, defined as 1) >1 T1 HG disease on the first assessment following adequate BCG, 2) ≥ Ta within 6 months of adequate induction and maintenance BCG therapy, 3) any component of CIS within 12 months of adequate induction and maintenance BCG. Adequate BCG was defined as 5/6 doses for induction and 2/3 doses for maintenance. Patients who were pathologic ≥ T2, node-positive, or metastatic at time of BCG-unresponsiveness were excluded. Demographic data, recurrence and progression, and oncologic outcomes are reported. Survival outcomes were calculated using Kaplan-Meier method.
172 patients underwent upfront RC and 95 received BST with Gem/Doce at diagnosis of BCG-unresponsive disease. Median age was 70 and 73 for upfront RC and Gem/Doce, respectively. 44/95 (46%) patients undergoing Gem/Doce as first line BST recurred intravesically at a median of 21m, and 42% underwent a 2nd separate line of BST. At 2 years after BCG-unresponsive diagnosis, 9% of patients undergoing upfront RC developed metastases compared to 8% Gem/Doce arm (p=0.38). At median follow-up of 39m, patients treated with Gem/Doce had higher cancer specific survival than patients undergoing upfront RC (HR=0.27, p=0.036) (Figure 1). Overall survival was not statistically different. At a median f/u of 32m, 17 patients (18%) in Gem/Doce arm underwent RC. The node positivity rate was higher in Gem/Doce group (5/17 (29%)) compared to in the upfront RC group (9/172 (5.3%)) (p=0.004). Overall pathologic T-stage was not statistically different.
In a large multi-center cohort of BCG-unresponsive NMIBC patients, BST treatment with Gem/Doce does not appear to significantly compromise oncologic outcomes. Furthermore, cancer specific survival appeared non-inferior in patients undergoing Gem/Doce BST compared to upfront RC. A large percentage of patients receiving Gem/Doce recurred and underwent additional salvage therapy, suggesting close to half of these patients will require additional measures at 2 years be it further effective BST or eventual radical cystectomy. These data suggest;that in the carefully selected patient, oncologic outcomes are likely not compromised in the near term over the first two years, and a trial of intravesical Gem/Doce salvage therapy can be appropriate for patients that decline RC as upfront therapy after diagnosis of BCG-unresponsive disease.
Details
- Title: Subtitle
- ONCOLOGIC OUTCOMES OF GEMCITABINE-DOCETAXEL COMBINATION INTRAVESICAL BLADDER SPARING THERAPY COMPARED TO UPFRONT RADICAL CYSTECTOMY IN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER
- Creators
- Drupad Annapureddy - The University of Texas Southwestern Medical CenterJacob Taylor - The University of Texas Southwestern Medical CenterJeffrey Howard - The University of Texas Southwestern Medical CenterSolomon L. Woldu - The University of Texas Southwestern Medical CenterYair Lotan - The University of Texas Southwestern Medical CenterWei Shen Tan - The University of Texas MD Anderson Cancer CenterAshish Kamat - The University of Texas MD Anderson Cancer CenterIan M. McElree - University of IowaVignesh T. Packiam - University of IowaMichael O'Donnell - University of IowaDavaro Facundo - Moffitt Cancer CenterRoger Li - Moffitt Cancer CenterKendrick Yim - Brigham and Women's HospitalMark A. Preston - Brigham and Women's HospitalStephen Harrington - Pennsylvania State UniversityElizabeth Dyer - Pennsylvania State UniversityJay Raman - Pennsylvania State UniversityAnna Black - University of British ColumbiaPeter Black - University of British ColumbiaPratik Kanabur - Baylor College of MedicineSeth Lerner - Baylor College of MedicineMathieu Roumiguié - Centre Hospitalier Universitaire de ToulouseGary Steinberg - Rush UniversityWilliam Huang - NYU Langone Health
- Resource Type
- Abstract
- Publication Details
- Urologic oncology, Vol.42(Supplement), pp.S52-S53
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.urolonc.2024.01.160
- ISSN
- 1078-1439
- eISSN
- 1873-2496
- Language
- English
- Date published
- 03/2024
- Academic Unit
- Urology
- Record Identifier
- 9984573831002771
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