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Ashish Kamat: Hello, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, Professor of Urologic Oncology and Cancer Research at MD Anderson Cancer Center. And it's a distinct pleasure, anytime I have the privilege of chatting with Dr. Bernard Bochner, Bernie needs no introduction but he's an attending surgeon at Memorial Sloan Kettering in New York, an expert in many things but especially in all things related to bladder cancer. And today he is going to talk to us about a recent publication from a study of his that talks about a very, very important thing for our patients, which is, their quality of life after surgery for bladder cancer, essentially, a radical cystectomy in this case. Bernie, the stage is yours.

Bernard Bochner: Ashish, thank you so much for the opportunity to present this. And again, it's always a pleasure and an honor to be able to do this with you. So, as you mentioned, this is an incredibly important area of surgery, which is the quality of life of our patients following the time that they spend with us in the operating room. And just real quick, my disclosures, none of which are relevant for today.

Radical cystectomy is a large operation, obviously, it's done on older patients and it affects lots of different systems. We remove the bladder and the prostate or the bladder and the gynecologic organs many times in women, do big node dissections and then have to reconstruct the urinary system.  So there are several important systems that are going to be affected potentially. And because this is done in older, comorbid patients who smoke, it's very important for us to try and understand what their quality of life is following surgery. There's been a variety of quality of life studies in people that have undergone radical cystectomy but many of the studies have used sort of snapshot approaches to look at specific time points following surgery. Or there have been studies that have taken baseline measurements and then followed them afterward but they've been rather small or they've been mixtures of different types of treatments.

And so what we wanted to do was just a large prospective, longitudinal study to really try to get a contemporary look at how patients do after radical cystectomy. And so this is a single-center study that we performed at Memorial on nonmetastatic bladder cancer patients. The type of diversion was per a shared decision-making discussion with patients and their surgeons. What we did was, we collected information using 14 validated quality of life, patient-reported outcome measures and we measured it at baseline. And then at 3, 6, 12, 18, and 24 months following radical cystectomy.

This is a look at the measures that we used. And we took a broad look at a variety of quality of life domains, including overall quality of life measures but also of various functional measurements, including sexual function, urinary function, bowel function. And then we took a real deep dive into a variety of psychosocial measures, including decisional conflict scale, the satisfaction of life, fear of recurrences, overall mental health inventories, things like that. So this really did give us, I think, a very deep and broad look at how patients do before and after surgery.

So we enrolled 550 patients onto the protocol and eventually, we had a little over 400 with valuable baseline information and then the follow-up information, as well. What we did was, we broke the groups up into those that received continent diversions, and non-continent diversions or ileal conduits. And we didn't do this to compare the two directly but because they are such different populations as you know, Ashish and the others that are listening too that do these procedures. In general, the people who are selected for conduits tend to be older, sicker patients.

And that's exactly what we found here, is that the patients receiving conduits were a decade older. They tended to be sicker with more comorbidities, which is why they received less neoadjuvant chemotherapy but they also received a lot more prior therapy to the pelvis such as prior pelvic radiation or pelvic surgery or even intravesical therapy, which we see in many older people who maybe are held on a little bit too long for the non-muscle invasive disease but a different group.

And we could see that when we looked at the baseline information that we collected as well here, this spider graph here, you can see that the outcomes in orange are the ileal conduit patients. The blue are the continent diversion patients.  But essentially what patients were telling us is that they were a bit older and had more urinary symptoms if they were selected for conduits. Whereas the younger, healthier, continent diversion patients tended to have a better overall sexual function and things like that. So the baseline information really did tell us that these were quite different groups.

And so what I want you to do as we look at the longitudinal data, is to look at them individually. And this is really, we put them side by side, just for you to follow the trajectory of what happens over time. And what we saw, what patients told us ... This wasn't our interpretation, this is what patients told us.  Was that, in general, they did quite well. Now we all know that the surgery itself comes with a significant early recovery and the perioperative morbidity associated with the surgery has been well documented. But what we were asking is, how do they recover beyond that? Because the perception is that patients take such a huge quality of life hit, that even some clinicians would suggest maybe a lesser effective treatment approach. And patients really begin to balk from this when they hear that maybe there is this huge hit in quality of life. But what we found here is that patients recovered.

If you look at the overall quality of life, whether it's in the continent diversion or ileal conduit patients, they return to at least baseline usually by about a year but certainly by the two-year mark, they do quite well. Physical functioning does take a little bit of a hit in the early post-op period, meaning within the three to six month period, but again, return to baseline in both of the younger continent diversion and the older ileal conduit patients, and really we saw very little overall change in bowel function.

We saw that in most domains, but not all domains.  The two areas that stood out were sexual function in both groups and body image never really recovered in the ileal conduit patients.  Sexual function changes are largely related to the fact that overall sexual function at baseline in the group because of the older nature of the group and more comorbidities overall, was quite low and which makes nerve-sparing surgery sometimes less effective. And we know because of tumor factors, that we can't do nerve preservation on everybody. So this is not a surprise to see. And again, body image you can see does quite well in the continent diversion patients but the ileal conduit patients do take a bit of a long-term hit.

And so really what this told us was that at least, contemporarily now, we can see that patients tend to recover their overall quality of life and most domains are going to return to baseline.

This is really important for patients to recognize because these are the outcomes that they should expect. It's important for clinicians to know because as they are selecting therapies, they should know that their patients are going to recover. They are going to get back to their lives and be able to do the things that they want to do. And so I think that with the really outstanding local regional cancer control that radical cystectomy provides and this information showing that quality of life is maintained in our patients, that this is really the baseline that we need to go off of as we begin to move forward. And while we're always looking for safe ways to preserve bladders in patients, we should not be denying them this therapy because we're concerned that they are not going to recover their quality of life long term.

Ashish Kamat: Great. So Bernie, again, there has as you know, been a lot of discussion in the past between patients, between patients and physicians, and through various advocacy groups, and the data that we often see varies based on who's collecting and who's reporting the data. So that's why, as you alluded to in your succinct summary and in your paper, as well, these are patient-reported outcomes, right? I mean, just to make it clear for the audience, this is not your interpretation or your team's interpretation of how patients perceive their recovery. These are actual patient-reported outcomes.

Bernard Bochner: Yeah, that's correct. I mean, it's very important to recognize that this is not clinicians or researchers trying to interpret something that was written in the chart, on how a patient did. These are validated questionnaires, all 14 of them, that were used. And so these are the patient's words, basically, coming back at us. And I think that is really critically important to recognize.

And I think that, while this is a single-center evaluation, Ashish, I think that what we're doing at Memorial is similar to what a lot of referral centers do, which is, if you have people who are dedicated to the procedure and a team of people, a big team of people, nurses, stomal therapists, et cetera, that are there to support patients, this is how they can do. So I do not think that what we are doing is unique or not transportable to other areas. I think that this is exactly what a lot of major centers are able to produce. And honestly, this is kind of the outcome that our patients should expect.

Ashish Kamat: So it's interesting that you make that point, Bernie because I was thinking along those lines. But let me ask you, were you surprised by what you saw here? And let me rephrase that. I mean, our perception is that, when we counsel patients well, they do well, but at the same time you always wonder, right? Are they saying that because they're in that mutually beneficial relationship early on and trying to make sure that they do well and please their providers, us physicians, nurses, all of us? But when they report it in the way that is reported here, did this surprise you? Or were you like, "Okay, this is what I would expect."

Bernard Bochner: Well, as somebody like yourself, Ashish, that has spent now decades in doing these procedures and taking care of these patients, these outcomes didn't surprise me because this is what we see in the clinics. I think I was very gratified to know that this is exactly ... that our perceptions of what we see are exactly what patients are feeling. And so you're right, our clinic visits sometimes may not necessarily represent how they are doing at home or in other areas outside the clinic. So I was very gratified that, in fact, what we see in the clinic was validated by what patients told us on these forms. And so it was a very good feeling, but again, I think it just represented what we see, and this is what, I think, patients really need to be able to know as the reality of hopefully how they are going to do after surgery.

Ashish Kamat: You know, one thing that I have noticed amongst my patients and, again, in the clinic and elsewhere is that those that have undergone the ERAS Pathway Care, which again is routine now, but it wasn't that routine 10, 15 years ago, seem to report a more rapid return to baseline function. And again, it's our perception, we haven't collected the way you have. Are you able to, based on your study, tease that out?

Bernard Bochner: Not specifically, largely because as you mentioned, everybody now is basically placed on an ERAS protocol and we are really taking our first postoperative measurement at the three-month mark. So I think that looking earlier on at the three-week, six-week, eight-week mark, you may be able to see some significant differences on and off an ERAS protocol. But again, I think that immediate perioperative recovery has been so well documented. And anybody who does these procedures would never minimize the recovery that is associated with the surgery.

We all know that it's significant. But I think that is what most people focus on and that they really haven't looked at the fact that beyond that first 90 days, what you see is that people really do bounce back and they do get back to their lives. They get back to their families, they get back to work if they are working and that is incredibly gratifying to see.

Ashish Kamat: Yeah, we recently had an FDA workshop. And one of the topics that we discussed is using cystectomy as a valid endpoint or cystectomy-free survival in patients that have BCG unresponsive disease. And as part of the discussion, we invited an expert from overseas, Maria Ribal to give the European perspective and also review the literature. Of course, your paper had just been released at that time and it was featured in that. And one of the questions that came up, not during the panel discussion, but in some of the chat from the attendees was, "Well, does this data now mean that the bar that people were using, saying patients don't want to have a radical cystectomy, does that need to be reevaluated?"  What do you think?

Bernard Bochner: I think it's a very valid question. Again, if the perspective and maybe this is not a correct perspective, is that we need to avoid cystectomy even at the cost of offering a less effective cancer therapy to avoid this perception of a significant loss in quality of life, I think that this data definitely needs to put that into question. My sense is that the cancer effectiveness of surgery and the fact that people do, in fact, recover the vast majority of domains measured in their quality of life, certainly should readjust the bar, I think, in people's thinking about how long do we try to push to spare a diseased bladder when it's not going in the right direction? And I don't think that it's appropriate to be thinking about decreases in cancer survival to basically spare surgery. That type of thinking, I do think, needs to be readjusted in light of this information.

Ashish Kamat: I couldn't agree with you more. I mean, obviously, we have new treatments and new therapies and each one of them appears to fall right in the range of about 20% CR rate at 12 months. And that's fine, so long as we don't miss the window of opportunity for a cure. What I fear and I'm sure you fear and all of us that take care of patients is that patients with non-muscle invasive bladder cancer should not start dying of their disease because the urologist or medical oncologist taking care of them is just afraid to have them go through a radical cystectomy because of misconceptions and misperceptions.

And I think papers, I mean, your paper will be very, very informative from that perspective or that aspect of things. So I really want to applaud you for the effort and for your succinct presentation today. Bernie, you know I could chat with you forever, but in the interest of time, let me hand the stage back to you. And in closing, any high-level thoughts you want to leave our audience with.

Bernard Bochner: I think that using this information and recognizing that patients are going to recover their quality of life following surgery really is, I think, the goal that we all need to aspire to when we perform this procedure. Developing the proper team to be able to support patients, I think, is the key to making these outcomes a reality. And I do think that we need to continue to recognize that the cancer control provided by radical cystectomy and this documented recovery of quality of life really solidifies it, I think, as the mainstay of treatment. Whether it's for muscle-invasive patients or for those high-risk non-muscle-invasive patients that simply are not responding to either intravesical or systemic therapy.

Ashish Kamat: Well said. Very well said. Well, thank you again for taking the time, Bernie. I look forward to actually seeing you and meeting in person in 2022.

Bernard Bochner: Likewise, thank you very much for this opportunity, Ashish.