Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study
| Autor: | Matt Simms, Samantha Conroy, Michelle Collinson, Richard W. Bell, Mark I. Johnson, Rohit Chahal, Kathryn Gordon, Phillip Koenig, Mohantha Dooldeniya, Heather Poad, Maureen Twiddy, Julie Croft, James W.F. Catto, Julia Brown, Louise Goodwin, Aidan P. Noon, Sunjay Jain |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Time Factors Urology medicine.medical_treatment Treatment outcome 030232 urology & nephrology MEDLINE Antineoplastic Agents Cystectomy law.invention Genitourinary Cancer 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Nitriles medicine Humans Neoplasm Invasiveness Prospective Studies Prospective cohort study Bladder cancer Extramural business.industry ORIGINAL REPORTS medicine.disease United Kingdom Administration Intravesical Treatment Outcome Oncology Urinary Bladder Neoplasms 030220 oncology & carcinogenesis BCG Vaccine Intravesical bcg Feasibility Studies Female Neoplasm Grading business |
| Zdroj: | Journal of Clinical Oncology |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL. |
| Databáze: | OpenAIRE |
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