Most new bladder cancer cases are diagnosed as non-muscle invasive bladder cancer (NMIBC), a subclassification of urothelial carcinoma where the tumor has not invaded into or beyond the muscle wall of the bladder. For patients with high-risk NMIBC, intravesical Bacillus Calmette-Guérin (BCG) immunotherapy has been heralded as the gold standard of care for more than four decades.
But, what about the 30 to 40 percent of those patients who are unresponsive to BCG and experience recurrence or progression? The reality is that they have long gone underserved, facing limited salvage therapies that are typically ineffective in the long term. As a result, most patients are relegated to radical cystectomy, a bladder removal surgery that not only drastically impacts their quality of life but also has high morbidity and mortality rates, particularly for the elderly or those with multiple comorbidities.
Fortunately, the field has seen a wave of breakthroughs in recent years. In 2018, the US Food and Drug Administration released a new set of guidelines that define criteria for BCG-unresponsive disease and clinically meaningful endpoints in trial design. This has paved the way for the development and approval of novel therapies for this patient group.
In the wake of this transformational period for bladder cancer treatment, the time is right for healthcare professionals, clinical research institutions, hospital systems, and medical organizations to harness integrated care coordination and precision medicine in order to optimize patient outcomes across the disease continuum.
Building an Integrated Model for Treatment Decisions
Early diagnosis of bladder cancer is critical in helping prevent recurrence or progression and optimize patient outcomes. While there is no routine blood test for bladder cancer like there is for prostate cancer, it can often be detected early through urinalysis. This is a simple test that helps healthcare professionals screen for infection or microscopic hematuria, the presence of blood in the urine that can only be picked up under the microscope. However, microscopic hematuria is often misdiagnosed as a urinary infection, particularly among female patients, leading to the erroneous prescription of antibiotics.
This underscores the need to build a more collaborative ecosystem in urology. The first step is to bridge the gap between internists and gynecologists — who are often the first point of care for general urinary symptoms — and urologists, who can help advise on whether additional evaluation or care is needed. Following early diagnosis, healthcare professionals and hospital systems must continue to advance integrated care coordination during the risk stratification stage. In most cases, NMIBC is diagnosed and treated by a urologist, limiting the process to a singular disciplinary perspective. With recent advances in next-generation sequencing (NGS) testing for genetic alterations, there is immense value in bringing together urologists, oncologists, radiologists, and pathology specialists to collectively review sequencing results, stratify patients, and identify together the most appropriate treatment plan.
“From new diagnostics to precision medicine to genomics, the bladder cancer treatment landscape is more complex than ever before. We’re committed to listening to the evolving needs of urologists and their patients and helping them navigate through shared treatment decisions,” said bladder cancer expert and urologist Sam Spigelman, senior global medical affairs leader at Janssen Research & Development. “That’s why Janssen is currently developing programs that help improve the coordination of care between urologists, medical oncologists, radiologists, and pathologists. By merging these disciplines together earlier in the disease spectrum, we see a significant opportunity to help decrease rates of recurrence and progression, ultimately ensuring that no patients are left behind.”
Harnessing the Power of Precision Medicine
Beyond integrated care coordination, the advancement of novel therapies can usher bladder cancer care into a new era. An increasing number of newly approved targeted therapies are in oncology. As precision medicine continues to gain momentum, the field has an opportunity to accelerate the adoption of NGS testing and the development of more effective treatment alternatives.
“Janssen is currently developing drug delivery systems that can deliver medicine directly into the bladder. The goal is to enable intravesical treatment with a localized sustained drug delivery mechanism, which may be used in various stages of NMIBC and MIBC,” said Spigelman. “These advancements in clinical innovation may allow us to treat disease across the entire spectrum of bladder cancer.”
Current NGS testing typically relies on tissue samples, but Spigelman hopes that the field can develop routine urine testing capabilities for bladder cancer to facilitate broader adoption. In the interim, to help make NGS testing a more ubiquitous practice across all stages of NMIBC and MIBC, healthcare professionals, hospital systems, and academic medical centers should prioritize broader education around which genes are important to test for in which patients. Healthcare professionals can also proactively inform patients and their families about the role of genetic testing at the earliest stage of the disease to help them assess the most appropriate treatment options and improve patient outcomes.
As treatment options expand, the medical field must come together to recognize that precision medicine is paramount to unlocking potentially more effective and tolerable bladder-sparing alternatives. The more that healthcare professionals and industry take a personalized approach, the more they can partner with and empower patients with optimism — and better outcomes — in bladder cancer.