Dr Lyon on Logistical and Clinical Challenges Associated With Intravesical Therapy for NMIBC

“In the randomized studies of BCG maintenance, up to 35% of patients discontinued their recommended maintenance therapy when they were randomly assigned to the maintenance therapy for reasons other than toxicity and disease recurrence.”

Timothy D. Lyon, MD, an associate professor of urology and the director of the Urology Residency Program at Mayo Clinic, discussed the substantial logistical and clinical challenges faced by patients with non–muscle-invasive bladder cancer (NMIBC) who undergo intravesical therapy, particularly BCG.

He emphasized that the intensity and duration of treatment schedules place significant burdens on a patient population that is often older and managing multiple comorbidities. Lyon outlined that standard BCG therapy requires an induction phase consisting of weekly intravesical instillations for 6 consecutive weeks, followed by maintenance therapy for 1 to 3 years. In addition, patients must undergo quarterly cystoscopic evaluations and disease assessments to monitor response and detect recurrence or progression, according to Lyon. When considering the full SWOG induction and maintenance protocol, patients may be required to attend approximately 19 clinic visits in the first year alone, he explained. This frequency of visits is demanding for patients who may have limitations in mobility, transportation challenges, or competing medical and personal responsibilities, he said.

Given these factors, Lyon noted that it is unsurprising that adherence to prolonged BCG maintenance schedules is often suboptimal. Importantly, discontinuation rates in randomized clinical trials reflect this burden: up to 35% of patients discontinued BCG maintenance for reasons unrelated to toxicity or disease recurrence, he reported. He emphasized that these discontinuations likely reflect practical barriers rather than treatment intolerance, highlighting the need to reconsider how BCG is delivered to improve adherence and long-term outcomes.

Lyon explained that these challenges formed the foundation for the development of the phase 1/2 INVITE trial (NCT06704191), which aims to examine strategies that reduce the logistical burden associated with intravesical therapy. The overarching objective is to explore whether treatment can be delivered in a way that “meets patients where they are,” thereby reducing travel demands, improving convenience, and potentially enhancing adherence to guideline-recommended therapy, Lyon said. He concluded that improving the accessibility of intravesical treatments may help mitigate early discontinuation, optimize therapeutic benefit, and better align treatment delivery with the needs of an aging NMIBC population.