Transcript of Part 1 of Quality of Life After Bladder Removal Surgery with Dr. Bernard Bochner

March 21, 2022

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Voice over:

This is Bladder Cancer Matters, the podcast for bladder cancer patients, caregivers, advocates and medical and research professionals. It’s brought to you by the Bladder Cancer Advocacy Network, otherwise known as BCAN. BCAN works to increase public awareness about bladder cancer, advances bladder cancer research and provides educational and support services for bladder cancer patients and their loved ones. To learn more, please visit bcan.org.

Rick Bangs:

Hi, I’m Rick Bangs, the host of Bladder Cancer Matters, a podcast for, by and about the bladder cancer community. I’m also a survivor of muscle invasive bladder cancer, the proud owner of a 2006 model year neobladder and a patient advocate supporting cancer research at the Bladder Cancer Advocacy Network, or as many call it, BCAN. Producers of this podcast. This podcast is sponsored by Merck, Bristol Myers Squibb and Genentech. I’m pleased to bring you part one of a two part conversation with Dr. Bernie. Bochner, a urologic oncologist at Memorial Sloan Kettering Cancer Center, and a Professor in the Department of Urology at Weill Medical College of Cornell University.

Rick Bangs:

He has extensive experience with bladder cancer surgery, radical cystectomy, pelvic lymph adenectomy and the various urinary diversion options. Dr. Bochner is actively involved in research focusing on improving cancer diagnosis, patient treatment options and enhancing recovery after urologic surgery. His work is published in many high impact journals and he has over 275 publications to his credit. He is also an emeritus member of the BCAN Scientific Advisory Board. Dr. Bochner, congratulations on the article.

Dr. Bernard Bochner:

Rick, thank you so much. And thanks to BCAN for taking the time to do this.

Rick Bangs:

Oh, this is such a pleasure. This is an incredibly important study. So what I’d like to do is have you start talking about what this study is about and its goals.

Dr. Bernard Bochner:

Sure. So the main purpose of the article of the study, there was several goals that we had. First was really to try and better establish what exactly people are experiencing longer term after they undergo bladder removal surgery and urinary tract reconstruction. There’s lots of different people who undergo this procedure. It’s not just older men who have a history of smoking, it’s younger men who haven’t smoked. It’s older women, younger women, and they all have different needs. They’re at different points in their life. And what we really wanted to try to do was get a nice sampling of patient reported information so that we could number one, provide that information back to patients who are thinking about undergoing this treatment to provide that to clinicians, meaning surgeons as well so that they could have a better understanding as to what a contemporary quality of life should look like. And then longer term, we have some bigger goals that we can talk about later to really help establish new tools to be able to better understand on an individual basis how the quality of life changes for folks.

Rick Bangs:

So let’s put this in the context of some of the other similar healthcare quality of life research that’s been done. So what’s the rationale for this particular study? Why is this one so important? And I believe it is.

Dr. Bernard Bochner:

For bladder cancer patients undergoing bladder removal, there have been other studies that have been completed. Some of them are smaller. Some of them have used a decent size population of folks to look at. But the majority of these have been snapshot evaluation, so meaning that they sample people at a single time point. And what we really wanted to do was to establish what people are experiencing prior to surgery, what we would call a baseline measurement, and then really evaluate how people experience not just the immediate recovery after surgery, but how things evolve over the first two years after they’ve undergone the operation. And that really is what differentiates this study is the baseline measurement, the longitudinal nature of the study, the fact that it followed people in multiple time points out to two years and it’s a sizable group of folks as well.

Rick Bangs:

Yeah. So I want to come back to the baseline line and the time series because I absolutely agree with you. Those are really critical things here. So what, if anything, surprised you or might surprise your counterparts at other institutions and perhaps even would surprise patients?

Dr. Bernard Bochner:

I think there’s a perception by many that undergoing this type of a procedure, which can affect a whole variety of bodily systems, not just the urinary system, but sexual function, potentially bowel function, and is perceived that it comes with a onerous type of recovery perhaps leading to a big drop-off in patients’ quality of life. And I think that that perception is what keeps people maybe from moving forward with surgery when it’s clearly the best treatment option. And I think that clinicians, some of them have that same perception as well. And that may alter even their decision-making as far as what it is that they offer people. And what we really wanted to do was to show what a coordinated team effort could provide patients in the contemporary setting.

Dr. Bernard Bochner:

This procedure’s been around for many years. The reconstructive options have evolved over time. As you mentioned in your introductions, such as being able to do complete internal reconstructions of folks. And what we see on a regular basis is how well folks do in general. And that was what we wanted to try and document. And we did this in a manner where it wasn’t just the doctors writing down their perceptions of what people’s quality of life was, but to use tools that have been designed and validated for people to tell us, for patients to tell us what they’re experiencing. And that’s what this is, all this data basically is patient reported outcomes.

Rick Bangs:

And I love that aspect of this, it’s so important to get that self-reported information and particularly across time. So let’s talk about the people who are doing the reporting, these 400 participants, who were they?

Dr. Bernard Bochner:

So this is a group of men and women who over about a six year period agreed to enter into this long-term quality of life study. When we ask folks to do this prior to their surgery, as I’m sure you remember, that’s a pretty stressful time for people to be thinking about joining studies or committing to years of follow up. But we really are indebted to a group of actually 550 patients who were entered onto the study and agreed to do this. Like all studies, sometimes time points are missed or people change their minds. And over time, some people will drop out of this study for various reasons. Ultimately, we needed 550 patients in order to get those roughly 400, it was 411 total, patients where we had their baseline information and the long-term follow up information as well. But they represent just people who are coming in for surgery here at Memorial Sloan Kettering.

Dr. Bernard Bochner:

This was a single institution study, but they were men and women undergoing all the various types of reconstructive options. Some of these folks received chemotherapy prior to their surgery. And there was a subset of folks that we did try to get information even prior to starting chemotherapy. Everybody got a baseline readout of how they’re doing immediately prior to their surgery. And then we followed folks out over time. Now, like most people who develop bladder cancer, the majority of folks in this study are men, about 80% or so are men, 20% roughly were women. And that makes up the basic demographics of the people undergoing the… Or who agreed to undergo the study. I guess one of the thing that I should add is that the majority of people underwent open surgery, so using standard surgical techniques.

Rick Bangs:

Mm-hmm (affirmative).

Dr. Bernard Bochner:

There was a small group of folks, about 12%, that underwent a minimally invasive approach, a robot-assisted procedure, but that really made up just a smaller group.

Rick Bangs:

Yeah, and that makes sense. So how do you and other researchers define quality of life? How would you view that [inaudible 00:09:55]?

Dr. Bernard Bochner:

Well I mean I think as I’ve learned over the years now participating in this study, that’s a very loaded question. And the reason is that there’s so many different aspects of quality of life that can be measured and it can range from physical functioning, how well their bowels are functioning or their urinary system is functioning, or how their sexual function has recovered or not. But there’s also psychosocial related issues, how much stress the people are experiencing, how much distress people are having. There’s issues obviously related to relationships that can also be affected. And so I think what we realize is that there’s an enormous number of variables that can affect people’s quality of life and people at different stages in their lives will have different aspects that are more important than others.

Dr. Bernard Bochner:

I think that was one of the frustrating things before we started the study was that the measures that are out there to measure quality of life were somewhat limited, especially the bladder cancer targeted ones. And we’re asking the same questions to some very different people, an 85-year-old widowed man who perhaps is no longer working, who has very different concerns than perhaps a 40-year-old woman with kids and a job and a spouse, and her quality of life obviously could depend on many different things. And so as we could talk about later, the development of tools that can really get to those responses I think are yet perhaps to be completely developed. But what we used for this study were standardized and validated tools to measure different aspects of quality life.

Dr. Bernard Bochner:

For this particular study, we used 14 different patient reported outcome measures. And again, they undergo a rigorous process of testing to be able to make sure that consistent data can be generated from these. And the paper is based upon those responses from those 14 patient-related outcome measures. Now, what we also did in this study, we didn’t report it in this paper we’re working on this data, is that we recognize there’s limitations in the forms themselves. The forms only ask specific questions and those questions may or may not be relevant to certain people. So we did another important evaluation that involved a open-ended interview technique for folks, where basically we let people tell us what they thought was important. We’re still analyzing that data so it’s not really pertinent to what we’re discussing today, but I suspect we’re going to also get some very useful information out of the interview data.

Rick Bangs:

Yeah, I think that’s fascinating because we’re all different and this is pointing out that there’s some commonalities and yet there’s also differences. So I think the follow-up interviews are really important. These measurements, I think you said there were 14 of them. So a lot of those measurements are done outside of bladder cancer also, correct? These tools have been used in other cancers and there’s been lots of extensive testing of these particular tools.

Dr. Bernard Bochner:

Yes, that’s absolutely right. And they’re measurements, again, that look at a variety of functions. So for instance, there’s a validated instrument that looks at male erectile function, the IIEF form. There’s a separate one for women, an International Index of Erectile Function for… I’m sorry, a Female Sexual Functioning Index, the FSFI tool. Then there’s Global Quality of Life measures and the ERTC QLQ-C30 for instance would represent that. We’ve included measurements of bowel function and there’s a validated bowel function questionnaire that was developed at Memorial Sloan Kettering. But we also look at things like fear of recurrence, a mental health inventory, a functional assessment of chronic illnesses related to therapy. And so we really did try to evaluate a whole variety of different aspects of quality of life. These are all domains that probably affect quality of life in people.

Rick Bangs:

So we talked earlier about baseline and I think your article raises this very important point about choosing a urinary diversion and the importance of understanding the starting point or the baseline for each patient before the bladder cancer diagnosis and treatment. Could you comment on that?

Dr. Bernard Bochner:

So there are in general three types of urinary tract reconstructions that are done after the bladders removed. One is the ileal conduit that requires the external appliance to collect the urine. And then there’s a couple of internal reconstructions, the neobladder, or some people refer to it as an orthotopic reconstruction where a new bladder is made out of part of the small intestine and hooked to the urethra so that people can void through the natural pathway, probably is the most common internal reconstruction. And then there’s a third internal reconstruction where reservoir is designed to keep the urine internal, but is connected to the abdominal wall through a channel that people catheterize. And there’s obviously a lot of selection that goes into who gets what type of reconstruction. And these are based on patients’ desires as well as clinicians, doctors, surgeons helping to guide patients through that.

Dr. Bernard Bochner:

The internal reconstructions use more intestine and there are some limitations with respect to underlying kidney function, liver function that allows us to either offer that or not to offer that. Sometimes there are tumor related factors that would prevent the reconstruction to the urethra. So for instance, if there’s a tumor within the urethra, or in a woman, if the tumor involves the bladder neck and the urethral junction, then it’s not necessarily safe from a cancer perspective to offer that. We also recognize that age and overall health can play a role in making that decision and that can vary from doctor to doctor sometimes as far as what those selection criteria are. So to your specific point, Rick, going back and looking at who received what type of reconstruction is not random and it’s really based on a carefully thought out part partnership between the patient and the doctor. And in general, people who receive the external bag tend to be older.

Dr. Bernard Bochner:

In our group, we could see there was a 10 year age difference between the ileal conduit group and the group that got the internal reconstructions. The younger group of patients also had fewer medical problems, fewer kidney issues. They were able to get more chemotherapy and several other differences, not just physical differences or differences with respect to treatment that they received, but when we looked at baseline measurements of various functions, again, it was comparing an older group to a younger, healthier group. And because of that, we saw some obvious differences in the baseline measurements. So the older men had more significant urinary function complaints, which goes along with larger prostates, longer period of time, maybe that bladder working against the big prostate so the bladder may not have functioned quite as well. They had more sexual dysfunction as well, which happens as an age-related event also.

Dr. Bernard Bochner:

And so these were very important for us to be able to document. And so the way that we put this paper together was to separate the groups, not to provide a direct comparison between the two groups because we’re really talking about apples and oranges with respect to who gets these diversions. So we’re not saying this is a comparison of patients with ileal conduits versus a comparison to patients getting internally reconstructed, that’s really not valid for this particular paper. What we are trying to show is what the baseline is for the two different groups and their pattern of recovery of quality of life afterwards, more just to show you exactly what’s happening within the groups, but because they’re so different and the way that they start is different, their age, the whole thing, we’re not really saying that you can tell one is better than the other here, that’s not the comparison that this paper is able to do.

Rick Bangs:

Yeah. So the top line summary is that baselines are really important and then comparisons are really not valid, right? So between the diversion choices, comparisons aren’t valid. But the baseline for each group is really critical.

Dr. Bernard Bochner:

Yeah, exactly. And so I think the way people can look at this data is to say, “Okay, well after my discussion with my doctor, it was determined that the best thing for me is a neobladder. Okay, well what is the quality of life changes after a cystectomy and a neobladder?” Those are the outcomes then that you should take a look and focus on. Just like if you were selected for an ileal conduit, you would look at the data on ileal conduits. And that’s what this data I think is able to provide people.

Rick Bangs:

Yeah. So there was another point that you made and you’ve hinted at this or made some comments about it, but that if you’re measuring quality of life in patients with cancer, you really ought to adjust your questions with age. But that isn’t the norm in terms of the way these quality of life measures work today, is that right?

Dr. Bernard Bochner:

Yeah. I think that that’s exactly right. These are validated forms, but they’re a single instrument for instance, right? So if we use this bowel function related scoring, or if we use the male sexual function tool, you’re going to give that same tool to somebody who’s older or younger, but the overall quality of life evaluation will be given to everybody as well. And so I think what we’re both hinting at here is that maybe those questions are not necessarily all equally as important, depending upon where you are in your stage of life and the challenges that you may be facing as you’re moving into a surgery like this. And so right now, this is what’s available. It’s why we use such a broad range. But we’re hoping that in the future to use this data perhaps to develop a more bladder cancer specific and maybe even a patient centric type of tool. We’re hoping that the mountain of data that was developed from this particular study will allow those types of modeling to be done. And then obviously, if a tool’s developed, we’ll need to go out and validate that as well.

Rick Bangs:

Sure. So the first data point you mentioned after the baseline, the first data point was at three months, and I can fairly vividly remember my own challenges in those first eight to 12 weeks. So talk about the challenges in that window between the baseline and the first three months. And I think it’s going to relate to the answer to why you chose three months.

Dr. Bernard Bochner:

Sure. Well listen, we know that the perioperative recovery, the time to just recover from the surgery itself, is going to take several months, right? And for some it’s three months and for some it could be six months, but that initial big hit where you might even validate this, it’s not probably too much different than being hit by a bus. It’s a big challenge. It’s a big operation and it takes time to get over just the initial surgery, to get your sea legs back and feel like your energy’s improving and your appetite’s getting back to normal and your weight stabilizes. And we know that at a minimum, I tell people at a minimum it’s three months before you really feel like you’re getting 100% back to be able to do your full day’s activities.

Dr. Bernard Bochner:

But we know that that’s not the end of the recovery phase. So that first 90 days after surgery has been pretty well documented with respect to the complications that people have and how that initial period affects people. And what we wanted to do was step beyond that initial I’ve just been hit by a bus phase. What comes after that? Now that I can see straight and I can stand straight and it feels like my energy’s coming back, what now is ahead? And that really is what this study was trying to answer at least out to the two year period.

Rick Bangs:

Right. Yeah, because I can remember coming home from the hospital and taking a shower and being exhausted after. And after the first month, I was back working part-time and by three months, I was back working full-time, which not to say I was completely back to the baseline, but it was substantially improved and certainly I felt less like I’d been hit by the bus at three months than I did seven days out or whatever.

Dr. Bernard Bochner:

Well listen, it’s critical that people who are staring into the tunnel getting ready to make the decision about surgery understand that, right? Because I think that if your expectations are appropriately set and you’re eight weeks into your recovery and you still feel tired, oh yeah. I remember that’s exactly where I should be at this point. So you don’t feel like you’re falling behind. And that’s what this data we’re hoping will also be able to provide people is that look, here’s what hundreds of people who have undergone this procedure are telling us about the different aspects of quality life that we measured, here’s what the recovery looks like. And it provides what we hope is some very hopeful information for people.

Rick Bangs:

Yeah. So let’s talk about that. So you started with this baseline and you didn’t do just a point in time, you did the time series, you did three months, six months, 12 months, 18 and 24. So why is that important and how did things change for patients between where they started, which is the baseline before they had the surgery, and where they were after two years?

Dr. Bernard Bochner:

So what we found is that for many of the measures as expected, that first measurement at three months or so would take a drop, meaning that if we looked at things like a measure of physical functioning, just like you mentioned, you’re not able to do the same things that you were prior to surgery.

Rick Bangs:

Right.

Dr. Bernard Bochner:

And even at three months, even though you’re feeling better, it’s still not quite the same. So measurements like that would see a bit of a drop off. Bowel function for instance, sometimes the bowels just take a little while to settle back into a normal rhythm. And it was interesting, by about three months, we really didn’t see a lot of differences beyond the baseline in both the internally reconstructed folks or the ileal conduit. But as we began to follow folks out and we looked at a multitude of different measures and specific domains, what we found is that pretty much across the board, except for a couple of very specific standouts, people were reporting getting back to their baseline measurements by usually a year.

Dr. Bernard Bochner:

But certainly by that second year, in many of the measures, it looked like people had recovered. And to me, that was what we’ve been seeing for years. But it was so gratifying to see this now in patients reporting this out onto validated measures. And I think that that really provides a lot of hope for people and that’s really what a contemporary outcome ought to look like. I mean based on these 400 people, it really does provide a lot of hope that you’re going to get back to life.

Rick Bangs:

Yeah. And it’ll be reassuring for the patients in our audience to hear this in terms of patient data, because it’s one thing when you hear from your doctor, even though it may have some accuracy, but it’s another thing to be able to say, “Hey, there’s real data. We’ve talked to patients and we’ve got their input and we’ve measured it across time.” So really important.

Dr. Bernard Bochner:

That’s exactly right. And Rick, the way that the data’s measured, the way that it’s analyzed is these forms don’t go to the doctors per se, right? We use some very smart biostatisticians who they’re screened out from patient name and all patient identification and information, and what they see are the numbers. They basically then just are able to use their statistical methodology to develop these curves. And so we go into the study hoping that we find what we see, but the reality is we really don’t know until the data is generated and presented and it was really gratifying for us to be able to see this.

Rick Bangs:

That’s all the time we have today for part one of my two part conversation with Dr. Bernie Bochner about the Memorial Sloan Kettering quality of life survey of bladder cancer patients who have undergone a radical cystectomy. Be sure to tune in for part two.

Voice over:

Thank you for listening to Bladder Cancer Matters, a podcast by the Bladder Cancer Advocacy Network, or BCAN. BCAN works to increase public awareness about bladder cancer, advanced bladder cancer research and provide educational and support services for bladder cancer patients. For more information about this podcast and additional information about bladder cancer, please visit bcan.org.