Opinion
Video
Author(s):
"Real-world data has a real place in demonstrating some of these findings and allowing us to ask better questions," says Bogdana Schmidt, MD, MPH.
In this video, Bogdana Schmidt, MD, MPH, and Devon Langston, MD, discuss the recent Photocure white paper "Addressing inequality in bladder cancer care."
Schmidt: Hi, my name is Bogdana Schmidt. I'm a urologic oncologist at the University of Utah Huntsman Cancer Institute and the Salt Lake City VA. With me today is Devon Langston, a second-year urology resident here at the University of Utah, to discuss the recent white paper from Photocure. Photocure is the maker of hexaminolevulinate HCI, or Cysview, used for blue light cystoscopy during transurethral resection of bladder cancer, and it's been shown to improve detection of non–muscle-invasive bladder cancer and reduce recurrence rates. This paper highlighted that there is a role for real-world evidence in bladder cancer, as it can often point out disparities in health care outcomes not immediately visible in clinical trial data. Even though gold standards are based on clinical trials, unfortunately, many patients don't have a care experience that replicates those outcomes in the community. Specifically, they emphasize different outcomes with respect to race, gender, and socioeconomic status. Devon, do you want to highlight any of those findings?
Langston: Certainly. They highlighted 2 critical findings. Firstly, they highlighted that some ethnic groups were found to have poorer bladder cancer outcomes than others. Specifically, Black patients were less likely to undergo diagnostic evaluations for bladder cancer such as cystoscopy, as highlighted through work with the National Cancer Database. There's also great work from Case Western underscoring the impact of race and sex on metastatic bladder cancer survival, which concluded that Black females experience excess mortality and overall and cancer oncologic outcomes in metastatic disease. It was also highlighted in the white paper that minority patients who are less likely to receive optimal treatment, have higher risk of 90-day mortality, and have a higher specific poor, 5-year cancer-specific survival, suggesting that Black race was an independent prognostic factor for poor disease-specific survival. Secondly, they discussed the socioeconomic factors, specifically income, insurance status, and educational level have all been associated with worse overall survival. They highlighted that these patients are less likely to receive optimal, appropriate cancer care. One example they provided was a delay from time between urologic referral and transurethral resection of bladder tumor or TURBT, for a patient with muscle-invasive disease. This actually resembled work from UT San Antonio, that identified several socioeconomic factors and sociodemographic factors such as income and insurance status, all of which predict the likelihood of receiving standard of care, surgical management for non metastatic muscle-invasive disease, all of which highlights the importance of exploring demographic and clinical factors that impact bladder cancer care.
Schmidt: Exactly, and this is unfortunately reflected in what we see in our patients. So with this in mind, Photocure is trying to raise awareness of bladder cancer inequalities, things that we see in clinical practice every day. And the first steps toward greater understanding—ultimately, improved outcomes—is getting the information that comes from clinical trials. If we can't get it out of clinical trials, real-world data has a real place in demonstrating some of these findings and allowing us to ask better questions. So in this spirit, they're sponsoring several of their own real-world streams of data, including the US Blue Light and Cysview Registry. This now has over 4400 patients. They have a Nordic Flexible Blue Light Registry that has about 500 patients at 5 sites. They are partnering with the VA Health Care System near and dear to my heart, which at this point has evaluated nearly 400 patients in an equal-access setting with non–muscle-invasive bladder cancer. Through some of the VA papers, they actually were able to show that access really makes a big difference, meaning in the VA Health Care System, with patients having equal access to physicians, regardless of other private insurance status, or being able to get into see a provider at a more reasonable time frame, having physicians who are adhering to evidence-based practices, etc, things we know from VA health care data, patients actually have better outcomes or less disparities than are seen in other series. And also the RESECT study, that was an interesting trial that we should be seeing more data from. It's over 19,000 surgeries globally, of surgeons getting randomized feedback on their TURBT quality, and we'll be hearing more about the findings from that study soon. In addition to the Photocure efforts, there are several hospital-based retrospective outcome series that Dr. Langston has highlighted, NCDB and SEER studies, numerous other efforts aimed at improving bladder cancer care. In this vein, the FDA is actually trying to bridge this gap too, with its push to make clinical trials more inclusive as well with enrichment programs to attract high-risk populations and enroll patients from a more diverse population of sites.
Langston: Even in a recent Society of Urologic Oncology presentation, Dr. Cheryl Lee from The Ohio State University, my alma mater, highlighted ways to address this paucity through study design via expanding access or adopting inclusive enrollment and retention practices via social media or direct community outreach for patient recruitment and reducing the burden on the participant not only through financial incentives, but also through study protocol that are amenable to the working research participant. Ultimately, a better understanding of sociodemographic factors and their impact on bladder cancer care, will empower patients and build better partnerships with research organizations to create the real-world evidence that you mentioned, Dr. Schmidt, that provides critical insights and leads to more equitable bladder cancer care.
Schmidt: And that's ultimately our goal.
This transcription was edited for clarity.