Dr. Timothy D. Lyon, MD, an associate professor of urology at the Mayo Clinic, recently highlighted the significant logistical and clinical challenges faced by patients undergoing intravesical therapy for non-muscle-invasive bladder cancer (NMIBC), particularly with Bacillus Calmette-Guérin (BCG) treatment. The burdens imposed by the intensity and duration of therapy schedules are particularly impactful for an older patient demographic that often grapples with multiple health issues.
Lyon detailed that standard BCG therapy involves an induction phase requiring weekly intravesical instillations for six consecutive weeks, followed by maintenance therapy lasting between one to three years. In addition to this regimen, patients must also undergo quarterly cystoscopic evaluations and disease assessments to monitor their response and detect any recurrence or progression. According to Lyon, adherence to these stringent treatment schedules can be particularly challenging, with patients potentially facing as many as 19 clinic visits in the first year alone.
Such frequent visits can pose significant challenges, especially for patients with mobility limitations or transportation difficulties. Lyon pointed out that many individuals also juggle competing medical appointments and personal responsibilities, contributing to the high rates of non-adherence to BCG maintenance schedules. In randomized clinical trials, discontinuation rates have been reported as high as 35% for reasons not linked to toxicity or disease recurrence, suggesting that practical barriers often play a significant role.
Lyon stressed that these discontinuations are indicative of the need to re-evaluate the delivery methods of BCG therapy to improve adherence and long-term outcomes for patients. These insights have led to the inception of the phase 1/2 INVITE trial (NCT06704191), which seeks to explore strategies aimed at alleviating the logistical burdens associated with intravesical therapy.
Innovative Approaches to Treatment Delivery
The primary objective of the INVITE trial is to investigate whether treatment can be administered in a manner that “meets patients where they are.” This approach aims to reduce travel demands and enhance convenience for patients, potentially leading to improved adherence to recommended therapies. Lyon emphasized that enhancing the accessibility of intravesical treatments might significantly reduce early discontinuation rates, thereby optimizing therapeutic benefits.
As the patient population for NMIBC continues to age, addressing these logistical challenges becomes increasingly critical. Lyon’s research underscores the importance of aligning treatment delivery with the needs of these patients, ensuring that they can receive the care necessary for effective management of their condition.
By focusing on more patient-centered approaches, the medical community can better support those navigating the complexities of NMIBC treatment and ultimately improve outcomes for a population that faces considerable hurdles in their cancer care journey.
