(UroToday.com) The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA was host to a urothelial carcinoma poster session. Dr. Jens Bedke presented a study evaluating global real-world patient characteristics, treatment patterns, and the impact of BCG shortage in patients with high-risk, non-muscle invasive bladder cancer (NMIBC).
NMIBC accounts for around 75% of all bladder cancer cases. High-risk NMIBC is defined by any of the following criteria:
- Any T1 high grade tumor
- Any carcinoma in situ (CIS)
- Any multifocal tumors or any large (>3cm) high grade Ta tumors
Global guidelines recommend that HR-NMIBC patients receive induction BCG followed by 1-3 years of BCG maintenance. However, not all patients receive the recommended length of maintenance BCG, and some patients receive chemotherapy as an alternative.
Data were drawn from the Adelphi Real World HR-NMIBC Disease Specific Programme™, a cross-sectional survey, with retrospective data collection, of physicians (urologists and medical oncologists) and their consulting patients in France, Germany, Italy, Spain, the United Kingdom, United States, Canada, and Japan from June to December 2023. This methodology has been previously described, validated, and demonstrated to be representative and consistent over time. Physicians reported patient demographics, clinical characteristics, and treatment patterns for the next eight consecutively consulting patients. Physicians completed physician attitudinal surveys and patient record forms, based on medical chart data.
Overall, 364 physicians (55% urologists, and 45% medical oncologists) provided data for 1,930 patients with an initial diagnosis of HR-NMIBC. The patient demographics are summarized below:
The mean (SD) time between patient HR-NMIBC diagnosis and data collection was 8134
(564) days and the median (Interquartile range [IQR]) was 613 (505-896) days. At initial HR-NMIBC diagnosis, 73% of patients presented with high grade T1 tumors, 21% had carcinoma in situ, and 37% had multifocal tumors. The most common symptoms experienced by HR-NMIBC patients are reported below:
29% of patients experienced ≥1 recurrence. This was 35% when only BCG induction was administered, and 25% where patients went on to receive BCG maintenance. The median (IQR) time from initial diagnosis to first recurrence was 426 (224-580) days. After the first recurrence, 57 patients received partial or radical cystectomies.
Of the 1,395 patients who received intravesical therapy after the initial diagnosis of HR-NMIBC, 462 (33%) received induction treatment only, and 875 (63%) received induction followed by maintenance treatment.
Intravesical treatment patterns can be seen in the figure below:
BCG was received at induction by 1,151 (83%) patients, and 746 (53%) patients went on to receive BCG maintenance. Induction chemotherapy was received by 184 (13%) patients, and only 86 (6%) went on to receive maintenance chemotherapy.
Mitomycin C (70%, n=129) was the most commonly used chemotherapy at induction. BCG was not used at induction or maintenance following initial HR-NMIBC diagnosis for 751 (39%) patients. Of those who completed BCG maintenance treatment as intended by the physician (n=269), the median (IQR) duration was 336 (180-382) days, ranging from 1 to 60 months.
The BCG maintenance therapy duration distribution is shown in Figure 1.
What is the impact of BCG shortage on physician attitudes and physician-reported patient medical form data?
- Physician attitudinal data
- Physicians surveyed stated that a median (IQR) 20% (15-25%) of their overall NMIBC caseload was BCG unresponsive, and 50% (25-70%) were BCG naïve.
- Of the physicians surveyed, 45% reported having been affected by BCG shortage, ranging from 23% in Japan to 71% in Canada.
- Of those physicians affected, 61% stated that they reserved BCG for HR patients and 46% used intravesical chemotherapy as an alternative.
- Physician reported patient medical form data
- During initial treatment, physicians reported that BCG shortage affected 9% of HR-NMIBC patients. Only 1% of patients overall reported the shortage as a reason for not receiving BCG, whilst the other 8% affected had suboptimal BCG treatment.
- Amongst patients who received therapies other than BCG at induction and maintenance following initial HR-NMIBC diagnosis (n=125), the most common reason was because the patient refused to receive BCG (25%).
Dr. Bedke concluded as follows:
- Despite BCG being the standard of care treatment, most patients do not receive the recommended length of BCG maintenance, and many receive no BCG treatment at all.
- Where BCG is not received by patients, the top reported reasons by physicians are patient refusal and global shortages.
- BCG shortages affected 9% of patients' treatments, leading to fewer instillations, lower dosages, and different strains being used.
- Almost a third of all HR-NMIBC patients experienced at least one recurrence.
- New treatment options that could safely reduce the amount of BCG administered without compromising patients' outcomes are needed.
Presented by: Jens Bedke, MD, Vice Chairman at the Department of Urology, University of Tübingen, Germany
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.
Related content: Global BCG Shortage Impacts Treatment for High-Risk Bladder Cancer Patients - Jens Bedke