Opinion
Video
Expert Discussion on BCG-Unresponsive NMIBC
Panelists discuss the evolving definition of BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), emphasizing its critical role in identifying patients who fail adequate BCG therapy, guiding next-line treatment decisions, and determining eligibility for clinical trials exploring novel therapeutic options.
The concept of BCG-unresponsive non–muscle-invasive bladder cancer has evolved significantly since its introduction in 2015. This designation is crucial for identifying patients who have received an adequate amount of BCG therapy but continue to show high-grade disease. Importantly, adequacy is not defined by receiving a full, half, or quarter dose; rather, it requires completion of at least 5 of 6 BCG induction doses and 2 of 3 maintenance doses. Patients are considered BCG unresponsive if they present with high-grade T1 disease at their first 3-month evaluation, or if they relapse within 12 months with high-grade disease such as carcinoma in situ (CIS) or high-grade Ta.
This classification is supported by a combination of expert consensus statements and FDA guidance, which aim to standardize criteria for clinical decision-making and research eligibility. Recognizing a patient as BCG unresponsive is not only clinically significant but also necessary for determining the next steps in treatment, including eligibility for emerging therapies and clinical trials.
The BCG-unresponsive label plays a central role in the design and execution of clinical trials for new treatment approaches. It serves as a key inclusion criterion in studies investigating alternative therapies for patients with persistent or recurrent high-grade disease despite treatment with BCG. These trials often target patients with CIS, with or without accompanying papillary tumors, to test novel agents aimed at improving outcomes where traditional therapies have failed. This evolving definition continues to shape both clinical practice and the research landscape in bladder cancer treatment.
