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Ruchika Talwar: Hi everyone, and welcome back to UroToday's Health Policy Center of Excellence. My name is Ruchika Talwar, and today I'm joined by Dr. Hiten Patel, who's an assistant professor of urology at Northwestern Medicine and the Chicago VA. He's joining us today to discuss his recent work published in Urology Practice entitled, "Neoadjuvant Chemotherapy Before Radical Cystectomy for Muscle Invasive Bladder Cancer: Elective and Eligibility Factors Impacting Utilization." Dr. Patel, we appreciate you joining us.

Hiten Patel: Yeah, thanks for inviting me and for being able to discuss some of this work. The impetus for this study was that we were seeing reports of how often neoadjuvant chemotherapy was being used before cystectomy, and the rates just seemed very low to me based on how I've seen practices at some places. And so during my fellowship at Loyola, this is something we dove a little bit more deeply into. And so that's what I wanted to discuss or just give a brief overview of what we found.

And so as we know, the standard of care for non-metastatic muscle invasive bladder cancer is to use in the U.S., usually neoadjuvant chemotherapy followed by a radical cystectomy, and that's going to be MVAC or Gem-Cis. And for patients who are cisplatin ineligible, usually they're going to get upfront cystectomy or consideration for a clinical trial. And what we've seen in the literature is that many patients don't receive neoadjuvant chemotherapy despite the evidence. And the rates were increasing over time, about 20% in 2009, 39% in 2015, and most patients were getting standard of care regimens by that time.

But of course, there's a little bit of a delay in both the administrative data and it's a little bit harder to tease out patient characteristics to say, well, we know all patients are being considered, but do we actually know that they were even eligible for neoadjuvant chemotherapy? So it made me think that we are missing some data here where is our target really supposed to be a hundred percent or is it that only 60% of patients were eligible and that's our target. And so it's kind of hard to set a quality metric or goal based on some of these data if we don't really tease that apart.

And so looking in the Loyola University Medical Center experience, we had almost 600 patients who had cystectomy, 380 who were muscle invasive. And in this subset we saw that about 154 patients or 40%, similar to the rates in some of the administrative data sets that have reported in the past, had actually received neoadjuvant chemotherapy. Now, what we found is that in those who didn't have neoadjuvant chemotherapy, the reasons for this were both potentially eligibility factors. Were they even eligible for neoadjuvant chemotherapy? And then about half were elective factors, that there's maybe patient preference, provider discretion, other factors that contributed to it that wasn't necessarily because they weren't eligible.

And so another way to look at it's to say, well, we know that of patients who are eligible, this 271, the rate of receiving neoadjuvant chemotherapy is actually higher, 57%, so higher than a lot of historical cohorts. But at the same time, a lot of patients still didn't get neoadjuvant chemotherapy. And then we looked at reasons for that. Patient preference and provider discretion often were among those.

And what happened is that when we look at more recent years and see these are recent years that administrative data sets don't capture as well, we saw that about 34% of patients in these early periods were receiving neoadjuvant chemotherapy, but it was up to 86% when we looked in the most recent few years potentially showing that adherence to guidelines has increased. And the question is why that happened. And what really we saw was that patients who were symptomatic that may need upfront cystectomy for those reasons, it really stayed stable. But provider discretion, patient refusal, either from education or interventions on what providers were, how they were counseling patients over time really helped decrease that pool of patients from foregoing neoadjuvant chemotherapy.

And our survival outcomes showed what we might expect: renal dysfunction was the most common reason for not receiving neoadjuvant chemotherapy, and those patients had worse survival. So that's why we sometimes think getting upfront cystectomy sooner makes a lot of sense. And obviously, elective factors were also associated with worse survival. So getting neoadjuvant chemotherapy was associated with better survival in general.

And so our conclusions were that basically our utilization rates increased among eligible patients, 30% of patients were not eligible at all. And we think previous reports really do underestimate utilization because a lot of these administrative data sets can't account for whether patients were eligible or not. And then it's hard to do a deep dive into what the reasons were why they didn't get neoadjuvant chemo. So really, we think that this 85%, at least in the Loyola experience, and I think similar in a lot of institutions I've worked or discussed with, that really is kind of a new modern-day benchmark compared to reports we've seen more in the 30-40% range.

And so I think those are kind of the takeaways of where the impetus came from to pursue the study, was more of I saw these rates and I didn't really understand what was happening. And I think taking a little bit deeper dive into patients' institutional side gives you a little bit of insight into what we're actually seeing in trends such as National Cancer Database and SEER and kind of help us target both internally but also across institutions what we can do or where we should be working with to get these rates higher.

Ruchika Talwar: Thanks, Dr. Patel, for that overview. A couple of interesting points I want to emphasize and then we'll take a deeper dive into what these results mean from a policy perspective. So first, I think you're right, a lot of the prior data reported exploring rates of neoadjuvant chemotherapy utilization in this population didn't have the ability due to limitations of data sets to really discern who was eligible versus who was not. So likely there was some degree of underestimation. I do think, however, we are long overdue for a more contemporary benchmark as you mentioned.

So I think your data is really important in that regard because as the healthcare system sort of swings more towards rewarding high-quality outcomes, receipt of neoadjuvant chemotherapy prior to cystectomy, given that we know it improves outcomes so much, that certainly could be a reasonable quality measure and a performance indicator. So I think as highlighted by the reasons you saw that shift in earlier years to contemporary years, patient refusal went down. That's a reflection on the counseling that physicians are now giving as well as the fact that physician discretion patterns change there. Share a little bit about your thoughts on how institutions should be auditing this data and how we can have these discussions with providers to make sure we have aligned behavior.

Hiten Patel: Yeah, I think a lot of these things start sometimes with our GU oncology tumor boards and I think discussion, they're bringing up patients to say, well, and you saw there's definitely a percentage of patients where they're symptomatic, they've clot retention, whatever the reasons are, that sometimes offering cystectomy makes sense. And so bringing up some of these cases, I think in that discussion and acceptability, I think bringing our medical oncology providers is important because having someone, a system where you can refer to your colleagues or to somewhere in the community where you trust. The patient may not be getting systemic therapy close to an institution where they were referred for a surgery. And so just because of that is not a reason to not recommend it or try to work with local providers. So I think patients having networks of these referral centers to say, Hey, we need to work with our community providers or have a resource in the clinic.

And some of that is having your support in the clinic yourself to be able to discuss and educate outside providers. And they're not seeing sometimes medical oncologists who are GU focused or specific to help assess both eligibility but then also provide it in a timely fashion. I think some providers are worried, oh, this patient may not get treatment for a few months. I'll see them back and then they've come back and they still haven't had neoadjuvant chemotherapy. And at that point, I don't want to delay things another three to six months. And so I think that's part of where I think the improvements can happen is just one, discussion within the institution, but then also your referral network of where are patients coming from that you see and have they seen a medical oncology provider? So getting them to established care.

And then, like you were talking about the metric, I do think it's an important metric that internally we sometimes see for prostate cancer, we say, well, surgeons sometimes get feedback on, well, what are your margin rates? Or how many patients with grade group one prostate cancer are you putting on surveillance versus operating on? So that percentage, I think, is similar for muscle-invasive bladder cancer where this could be similarly utilized or kind of provide feedback. It's hard; maybe there aren't a lot of providers who are doing as much volume of cystectomies, but there should be a couple that a lot of places that are doing a little bit more. But I think the community practices where there's not as many of these going on, it's more of the education I think and involvement. But sometimes it's just kind of availability of medical oncologists to talk to and who's making that assessment? Are we deciding, hey, they have a little bit of tinnitus, they're not eligible, versus them actually seeing medical oncology and saying, Hey, we can do split dose, or we can do some other ways to get therapy?

Ruchika Talwar: And I think you bring up some important points about care coordination, particularly for rural patients who may not have access to a specialized GU medical oncologist near home. They often will travel the distances for surgery and preoperative appointments, but the onus often has to be on the urologist to ensure that a medical oncologist at the center of excellence has at least commented on the ability to get chemotherapy locally. That's definitely an important point. I think bladder cancer is certainly not as common as prostate cancer. And so we haven't seen a lot of these big quality initiatives like through MUSIC or the PERC or other quality consortiums focus here. However, bladder cancer is a very expensive disease. And so certainly when the healthcare system is looking on how to improve costs overall, I think this particular area could be a potential quality improvement target. So I think a lot of this data is going to be really relevant. What are your main takeaways for urologists who see muscle-invasive bladder cancer patients and perhaps maybe counseling them on their recommendation regarding neoadjuvant chemotherapy?

Hiten Patel: Yeah, I think firstly just being direct about what is the standard of care and what are options, and then doing a good job trying to assess their eligibility. I think trying to be objective and providing even in your referral to the medical oncologists, what your perception is of their risk status as sometimes how much of their disease risk you have. So I think being able to judge the disease and then their eligibility, and that something I've learned over time, I don't see as many bladder cancer patients now, but I know over time that figuring out what are the actual factors and then if they're borderline in their GFR, would they be potentially eligible or do medical oncologists, could they do split dose Gem-Cis or something else for them?

And so I think the main takeaway is just make a good recommendation. Patients should be informed. And then again, if they're counseled well, just like these data shows, that I think they will often make the decision that's going to benefit them in the long term. And secondly, obviously having your support structure set up so that the fear is that there's going to be a delay in treatment or delay in surgery, so I think trying to minimize that is kind of part of the local resources.

Ruchika Talwar: Yeah, absolutely. Well, thank you so much for doing a deep dive into your data. We really appreciate you spending time with us today.

Hiten Patel: Yeah, thanks for having me.

Ruchika Talwar: And to our UroToday audience, thank you so much for joining us for this important discussion. We'll see you next time.