Dr. Bukavina on the need to improve female representation in bladder cancer clinical trials

In this interview, Laura Bukavina, MD, MPH, MS, discusses the need to improve female representation in bladder cancer clinical trials, building on the recent Nature publication, “Why it’s essential to study sex and gender, even as tensions rise.” Bukavina is an assistant professor of urologic oncology at Cleveland Clinic Glickman Urologic Institute and the translational science lead in GU oncology at Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

Video Transcript:

This was an article published in Nature. They had a whole collection about sex and gender as being important within research. I found that article to be incredibly interesting because if we look at bladder cancer, for example, females represent only 1 in 4, [about] 20% to 30% of all our patients. So, if you look at all of the trials within immunotherapy [and] chemotherapy, females are particularly underrepresented; not on purpose, it's just part of the natural population –– less females. So, when we start looking at the hazard ratio to see if the drug is helping or not, we often find that immunotherapy particularly does not work very well in females. This is not unique to bladder cancer; this has been published over and over in lung, in melanoma, and in a lot of the gynecological malignancies. What we find that works really well in our male patients, either it's adjuvant or metastatic treatment with our immunotherapy, females just don't get the same benefit.
A lot of these drugs get approved based on the data for males because they represent the majority of patients, and it's showing good response and durable response. But when you actually start to dissect and look at the female population, we see that even in clinical practice, they just don't get the benefit. They get the side effects; they get the toxicity. The FDA approval is there because it's a great medication, but the females just don't get the same results. One way to think about it, and it becomes challenging in clinical trials, is to really make it a more balanced cohort of patients. So, while the natural epidemiological prevalence of disease is only 20% to 30%, we really should aim for studies where we can oversample the females to make sure that that medication truly is doing what it's doing in both males and females.

This transcription has been edited for clarity.