Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is particularly prevalent in men. Guidelines stratify patients into risk categories based on disease characteristics as patients often recur or progress to muscle-invasive disease. Most guidelines recommend transurethral resection of bladder tumor (TURBT) followed by up to 3 years of Bacillus Calmette-Guerin (BCG) therapy for high-risk (HR) patients. For very HR patients or those who recur after BCG, radical cystectomy (RC) is recommended. This study aimed to describe the profile of individuals with HR-NMIBC, alongside treatment patterns and outcomes across Europe, North America, and Japan.
Data were extracted from the Adelphi Disease Specific Program for 1,864 patients initially diagnosed with HR-NMIBC and 273 with very HR-NMIBC.
First-line treatment was mainly intravesical BCG, however, less than half of patients received the guideline recommended maintenance BCG and none received RC. Second-line treatment options were similar to first-line, with RC usage still rare.
While TURBT+BCG was shown to be the current standard of care, the underutilization of full guideline recommended treatment alongside the relatively high number of recurrences highlights the need for novel therapeutic approaches, either in combination with BCG therapy, or as alternative first-line treatments.
High-risk non-muscle-invasive bladder cancer (NMIBC) is a type of cancer that has not spread into the bladder wall’s muscle layer but is likely to spread or return after treatment. This study looked at characteristics of people with high-risk NMIBC in Europe, North America, and Japan. It also evaluated what treatments patients received. Researchers conducted a survey with doctors and patients with high-risk NMIBC to collect this information. Patient characteristics were similar across regions: 75% male with an average age of 71 years; two out of 10 patients were in full- or part-time employment, another eight out of 10 were current or ex-smokers. Disease characteristics, including symptoms and tumor stage of included patients were representative of the general high-risk NMIBC population. Typical care was similar across regions. Most patients underwent transurethral resection of bladder tumor (TURBT) followed by insertion of Bacillus Calmette-Guérin (BCG) into the bladder. TURBT is a procedure that removes cancer cells from the bladder’s inner layers to leave the rest of the bladder intact, BCG is a live vaccine that stimulates the immune system to attack cancer cells. Fewer than half of patients continued BCG treatment for the recommended one-year maintenance period. Few patients underwent radical cystectomy, a procedure that consists in removing the bladder and nearby tissue affected by cancer. Many patients’ cancer returned within 1 year despite receiving recommended treatments. There is therefore a need for new treatments that reduce the risk of cancer returning or growing and that improve quality of life for these patients.
Future oncology (London, England). 2026 Jul 27 [Epub ahead of print]
Jens Bedke, Anthony Eccleston, Mia Unsworth, Julia Brinkmann, Jane Chang, Abin Koshy, Laure Manuel, Jacob Skilling, Emilia Biondi, Elliott Brown, Caitlin Ford, Gary Steinberg, Yair Lotan, Yohann Loriot, Oscar Rodriguez Faba
Department of Urology and Transplantation Surgery, Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Stuttgart, Germany., Pfizer Inc, Surrey, UK., Adelphi Real World, Bollington, UK., Pfizer, Berlin, Germany., Pfizer, New York, NY, USA., Department of Urology, Rush University, Chicago, IL, USA., Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA., Department of Therapeutic Innovation and Early Phase Trials, Gustave Roussy, Villejuif, France., Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.