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For patients with lower- to intermediate-risk non-muscle-invasive bladder cancer, bladder-conserving treatments may be a considerable option, an expert told CURE®.

Non-muscle-invasive bladder cancer is when the tumor has not grown into the muscle layer, which may indicate an earlier stage of cancer, the American Cancer Society defines. Bladder-conserving treatments are treatments that maintain the bladder without physical alterations, such as surgery.

So, receiving treatments, such as immunotherapies or chemotherapies can be helpful, said Dr. Bogdana Schmidt, urologic surgeon at the Huntsman Cancer Institute at the University of Utah.

CURE® spoke with Schmidt about bladder-conserving treatments, patients who would benefit from this treatment, its comparison to invasive treatment and more.

Differentiating Muscle-Invasive, Non-Muscle-Invasive Bladder Cancer

CURE®: What are the risk categories for bladder cancer and how might bladder-conserving treatments play a role?

 Non-muscle-invasive bladder cancer can be separated out into different risk categories. There's low risk, intermediate risk and high risk. For the lower-risk patients, I generally think of them as more nuisance tumors where there's a lot of effort on the part of the patient, where they have to come in get monitored often need additional tumor scrapings to treat the cancer, but very few of those patients progress to have deadly muscle-invasive disease.

The bulk of treatment in those patients is bladder-conserving … [and] lot of intravesical treatment (therapy administered directly into the bladder), so different immunotherapies or chemotherapies that are instilled in bladder to reduce tumor recurrence and progression (worsening or spreading).

Intermediate-risk [disease] is a mix with the higher-risk features. But [clinicians] still really want to focus on bladder-preserving treatments, so predominantly intravesical chemotherapy and sometimes intravesical immunotherapy. It’s a very exciting time right now with lots of clinical trials in the space, but those are the mainstays.

For high-risk, non-muscle-invasive cancers, those are the patients where we worry about them progressing to muscle-invasive disease or metastatic disease. For those patients, we often start by offering some intravesical bladder-preserving treatments. But know that if the first line of treatment doesn't work, the gold standard and the standard of care is usually radical cystectomy (surgical removal of the whole bladder) in those patients.

So right now, there are clinical trials in the space where we are moving past the front line of intravesical Bacillus Calmette-Guerin (BCG; an intravesical vaccine to treat early-stage bladder cancer), which is the mainstay of treatments in the high-risk non-muscle-invasive bladder cancer space. These are the patients where we have to be much more careful about because their risk of progressing to advanced disease is a lot higher. So, there are a lot of conversations and tradeoffs and how many rounds of additional treatment we’re willing to go through to try and salvage this bladder to allow the patient to keep their bladder, which of course is very important, but balancing that with not missing an opportunity to cure a cancer.

How do doctors identify who may be eligible for bladder-conserving treatment and who may not be?

There are a lot of individual cancer characteristics that we look at there. Patients with higher-risk tumors — so lots of larger tumors —are at higher risk for recurrence. Patients who have variant histology, meaning they do not have typical urothelial carcinoma, which is the most common type of bladder cancer, often end up showing progression much faster and more aggressively, and they end up not been the best candidates for bladder-preserving treatments.

In general, I think of younger, healthier patients. They have the most to lose if this cancer becomes deadly quickly. And so, on one hand, obviously younger patients really want to preserve their bladder because that's what they want. But on the other hand, when I have a young patient with a very aggressive tumor, that's when I'll often insist on earlier cystectomy and one round of intravesical treatments — I feel like everybody deserves that. But if they progress on that, then I'll usually encourage cystectomy earlier because I really worry about that patient dying from that disease and knowing that I have a window to cure them with surgery.

What’s the difference between bladder-conserving treatment versus invasive treatment?

When we talk about whole-bladder treatments, usually we're talking about muscle-invasive disease or patients who had a recurrence after intravesical treatments. The gold standard is a radical cystectomy and that's as invasive as it gets. It's basically removing the whole bladder and if the patient is a male, doctors usually remove the prostate with it. For female patients, we try to preserve organs. It's very uncommon for bladder cancer patients to have cancer extend to the uterus or ovaries. So, we try to preserve those for patients who have them. Occasionally, if the tumor is at the bottom of the bladder near the anterior vaginal wall, that'll be taken for some patients who can preserve the entire vagina, which is great for sexual function and just preservation of the pelvic musculature preventing prolapse or other things that can happen.

Also, urinary diversion, because once the bladder is removed, something has to be equipped to store the urine in the body. This could be an incontinent diversion (an artificial opening in the abdominal wall for urine to pass through), or a colon pouch.

Trimodality therapy — or radiation therapy — is another possible treatment for bladder cancer, usually for muscle-invasive bladder cancer, and that involves a surgical removal of the bladder tumor, coupled with chemotherapy and radiation. There’s not a lot of data using trimodality therapy and non-muscle-invasive disease. So, we try to stay away from whole-bladder treatments for non-muscle-invasive disease.

How do bladder conserving treatments affect quality of life? Does it typically make it better or worse?

That’s a really tough question, but a very important one. On one hand, a lot of people’s concepts of quality of life is really tied to having their native bladder, so they feel like losing their bladder is a really huge adjustment for their quality of life. When it comes to non-muscle-invasive treatments, obviously the goal is to preserve the bladder. With that, the bladder often suffers because whatever treatments we put in the bladder can be quite irritating. And so, people can have dysuria, or burning with urination, painful urination, urgency, urinary frequency, some blood in the urine — all of those symptoms can be quite bothersome and certainly can impact the quality of life.

When we compare some of the newer treatments to our older treatments like BCG, we're seeing some favorable profiles, meaning that a lot of the newer drugs are not worse than what we're used to. With BCG, some are actually better-performing with less irritation on the bladder, but they all cause some amount of bladder discomfort based on the way they work. These drugs try to irritate the bladder, they're trying to activate the immune system to basically attack cancer cells on the bladder. So, all of that comes with some amount of quality of life.

That becomes a trade off, because I have had patients who have been through BCG, whose bladder has been causing them so much pain with painful urination, frequency, urgency, where they are ready to move on to having their bladder removed. They’re done with the quality of life, and they can move on to having their bladder removed and have less pain, less discomfort, less thought about their bladder on a day-to-day basis.

Then, you have patients on the opposite end of the spectrum who say, “Well, you just can't take my bladder. I will get up and pee every hour. I will wear a pad I will do everything, but don't take my bladder out,” and I think that's very personal and certainly depends on patients’ activities, their lifestyle and what's important to them as part of their identity and their standard of life. That's where shared decision making comes in. Every patient should be able to make those treatment decisions for themselves.

Transcription was edited for clarity and conciseness.

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Bladder-conserving treatment may be beneficial for certain patients with non-muscle-invasive bladder cancer, and may not be for those with high-risk disease. 

Knowing Benefits, Risks of Bladder-Conserving Therapies in Bladder Cancer

Getting second opinions is highly encouraged for patients recently diagnosed with bladder cancer because “it’s not one size fits all,” experts told CURE®.

How to Self-Advocate During Bladder Cancer Awareness Month

With bladder cancer awareness month in May, it’s important for patients and survivors to know how to advocate for themselves, two experts told CURE®.

Patients who have received a diagnosis of bladder cancer should “go seek out a second opinion,” said Dr. Jonathan Wright.

Wright is an associate professor at Fred Hutchinson Cancer Center and medical director, University of Washington Center Urology Clinic.

Because bladder cancer is not “one size fits all,” he said, it’s important to seek different types of providers. Some may include a urologist, radiation oncologist or another medical oncologist, Wright suggested.

He noted that “It’s not one size fits all,” so it’s important for patients to ask if they would benefit from speaking with another doctor about their cancer.

4 Questions to Ask After a Bladder Cancer Diagnosis

Participating in annual bladder cancer walks hosted by the Bladder Cancer Advocacy Network during May is another way to spread awareness, said Dr. Petros Grivas.

“We’re doing a walk every year and it happens in May,” he said. “We have the privilege and opportunity to work with amazing people, our patients, patient advocates and the Bladder Cancer Advocacy Network here at Fred Hutch and UW.”

Grivas is a board-certified medical oncologist and the clinical director of the genitourinary cancers program at Fred Hutchinson Cancer Center and the University of Washington.

Wright and Grivas sat down with CURE® to discuss bladder cancer awareness month and ways patients and survivors can advocate for themselves.

 It's always intimidating when you go to see the doctor, I go see my doctor too, and it's intimidating for me as well. You're nervous, you're scared, so one of the things we really work on is building that relationship with the patients because if you feel comfortable with your physician, then you're going to share more information.

What is great is if you can try to bring somebody with you to the doctor's office, not everybody can. Maybe it's just a neighbor or friend too. But if you don't have anybody, then [make sure] you're still going to come and we're going to take care of you. It is one thing we can do to help make sure that we're hearing everything and asking some of the questions that we might be afraid to ask and realize the doctor can only help you if you give them the information. So that's what I mean by self-advocating, speak up for yourself. Especially now with so much of the medical records where you get to have your own records on your smartphone or your computer. I encourage patients to go over that and ask questions: “What [and] why this?” and “What does this mean?” So, it’s different ways to empower them to then help us take better care of them too.

 These are great points, a very important point to highlight what Wright just said, and in the same line, speaking about what other people have gone through [and their] same experiences. Can we learn from people who have had the cystectomy? Meaning the removal of the bladder, which Jonathan is an expert on. Can we think about other therapies, medical therapies and sometimes connecting with other patients? The Bladder Cancer Advocacy Network is a good example of that because it can connect the patient to peers who are survivors, and that will be a great opportunity for them.

Also, ask about clinical trials and research. I think there will be an important opportunity so they can ask how they can help themselves through innovative treatments, but also help Jonathan, myself and others to generate important no less to help future patients.

Transcript was edited for clarity and conciseness.

For patients with bladder cancer, being prescribed certain drugs may “take a village,” particularly for medications recently approved by the Food and Drug Administration (FDA), two experts told CURE®.

 for patients with metastatic bladder cancer with susceptible FGFR3 or FGFR2 alterations was an instance of the “village” it takes to prescribe the medication to eligible patients.

“There are a couple of additional steps with medications like [Balversa], compared to say a blood pressure medication or some of the more routine medications that patients might be on,” explained Kelli Rourke, a pharmacist with specialized clinical training in oncology at Johns Hopkins University School of Medicine, during an interview with CURE®.

“There is typically an insurance authorization step for these medications. And then once authorization is obtained from insurance, sometimes we run into issues with the cost,” she said. “Even when they're covered, we can still see really high copays for patients and out-of-pocket costs on these medications. So, these additional steps can cause some barriers or delays and getting the patient started on that medication.”

These additional steps taken before patients receive their prescribed drugs cause a whole team to become involved in the process, said Dr. Jean Hoffman-Censits, a doctor and associate professor of medical oncology and urology at Johns Hopkins Medicine, in the same interview.

“The first [step] is getting some additional information about the tumor to determine whether or not a patient really is eligible for this medication,” she explained. “One of the steps is that information has to be gotten and there's a few different ways that oncologists in general are getting this information. But that's either a send-out or we interface with the pathology team at the local hospital to get that information. It can take a few weeks to get back, so in the meantime, we're using other therapies.”

But the village also goes beyond just the doctors on the care team. Other specialists may be involved, depending on patient needs and the side effects they experience from the related drug.

Specifically with Balversa, Hoffman-Censits noted that a common side effect patients experience was higher levels of phosphorous. She said this would often lead to engaging with a dietician or nutritionist to help patients select the necessary food in their diets to balance and manage their side effects.

Balversa Fills a ‘Critical Need’ for Metastatic Bladder Cancer

When drugs are FDA-approved, it’s very common for doctors and pharmacists to want to get eligible patients started on the drug, Hoffman-Censits and Rouke agreed, but more steps are involved before the drug is even shipped.

“When a drug has a lot of promise, and you find out it's FDA approved, we as clinicians are eager to get that drug started. But the manufacturer may not have shipped it yet, or the insurer and the manufacturer may not even have a billing code for that drug yet,” said Hoffman-Censits. “Each institution has a pharmacy and therapeutics committee that has to approve that that drug is being used. So multiple different steps really have to come to pass.”

Additionally, Hoffman-Censits and Rourke noted that the timing of when patients can receive these drugs depends on whether the drug was ever approved before in a different indication.

“It can take some time if the drug has never been FDA approved, that's somewhat different than if a drug was approved for a different indication,” Hoffman-Censits said. “So for instance, in the past couple of years, [bladder] cancer has started using a drug that was previously FDA-approved for breast cancer. So all of those previous issues with the shipment and having the drug available and on a formulary (list of prescription drugs) were fine. And it's almost like you just opened a new door, and now a new group of doctors can use the medication.”

“Sometimes we want to just snap our fingers and be able to do the new things and kind of offer these new options to patients. But [also] recognizing that there can be a lot of steps when it is truly a new [drug],” Rourke added. “But [we recognize that] it can be a little bit more of a slow process when it's a truly new approval and a new indication kind of across the board.

Prescribing newly FDA-approved drugs may take a long time before patients can start taking them, so experts told CURE® why. 

Getting Newly Approved Cancer Drugs May ‘Take a Village,’ Experts Say

For patients who have received a diagnosis of bladder cancer, the conversations they have with their care team can be incredibly important, as one expert explained.

“Bladder cancer is really a heterogeneous disease. On one hand, you have a mild type of cancer, one you have a very aggressive life-threatening cancer. So, the conversations will be very different from each of these patients. What usually happens is that when the patient is initially diagnosed, they are usually managed by local urologist or a community urologist. But if they are diagnosed with aggressive cancers, that's when the conversations on other things become very important,” said Dr. Murugesan Manoharan.

Manoharan, surgical urologic oncologist and the chief of urologic oncology surgery at Miami Cancer Institute, as well as the chairman of the Department of Urology and Abbhi Family Endowed Chair in Urologic Oncology at Baptist Health South Florida and a professor of urology at Herbert Wertheim College of Medicine, Florida International University, explained four key questions patients should as their care team following a diagnosis of bladder cancer.

Does the facility have a multidisciplinary team and a tumor board?

“First of all, does that hospital or that center have what is called a multidisciplinary team, meaning the patient will be treated not alone by the surgeon, they will be treated with a medical oncologist, radiation oncologist, psychologist, many other support people”? said Manoharan. “So, [asking] ‘Do you have a team-based approach to deal with a bladder cancer?’ is the most important thing. Or, [is there] a single person who is making a decision?

“And along with those things, you need to know whether they have something called a tumor board, where the individual patient will be presented to a group of doctors from different specialties and they make a joint decision. That's the first question to ask, ‘Hey, do you have a multidisciplinary team and a tumor board or review system?’”

Learn More: Moving Into an Era of Targeted Bladder Cancer Treatments

Does the facility have access to clinical trials?

“Sometimes you have the long-standing old treatments, but the new treatments come through the clinical trials, [where] both the patient gets benefited and the patient also benefits the future generations to come,” said Manoharan. “So, whether that center has clinical trials or whether any clinical trials are available for that particular patient is a second important question I'd ask.”

Does the provider have access to the latest technological advancements?

“[With] scientific advances many things, [such as] CT scans, PET scans, have changed and the treatment has changed. So, we need to know whether that particular doctor or the center has access to new technological advances,” said Manoharan.

Learn More: Answering the Call for Bladder Cancer Support

Is there a patient support group available?

“Doctors like us, we do not know how to be a patient,” Manoharan said. “We can understand, but we have never been a patient, whereas in a support group, a patient who underwent chemotherapy and even surgery, they all will be there. If there is a patient support group there, this particular patient can join them and [patients can] speak to each other and get to know more about the disease and how to cope with things.”

Dr. Murugesan Manoharan of Miami Cancer Institute and Baptist Health South Florida shares key questions patients who have received a diagnosis of bladder cancer should ask their care team.

Dr. Andrea Apolo at the 2024 Genitourinary Cancers Symposium, discussing Keytruda (pembrolizumab) side effects in bladder cancer

Keytruda Side Effects: 'If Something Doesn't Feel Right ... Call'

Patients with bladder cancer who are being treated with the immunotherapy agent, Keytruda (pembrolizumab) should always reach out to their oncology team if they are experiencing side effects, explained Dr. Andrea Apolo.

In a recent interview at the 2024 Genitourinary Cancers Symposium, Apolo, who is the head of the Bladder Cancer Section of the Genitourinary Malignancies Branch and Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic in the Center for Cancer Research of the National Cancer Institute, discussed findings from the phase 3 AMBASSADOR Alliance A031501 trial, which investigated Keytruda in patients with muscle-invasive, locally advanced bladder cancer.

Findings showed that Keytruda outperformed observation when it came to disease-free survival. While the study determined that the immunotherapy agent was safe and tolerable, immunotherapy drugs such as Keytruda can come with side effects that patients should speak up about, according to Apolo.

Keytruda works by inhibiting a certain protein — also called a checkpoint — that helps cancer cells hide from the immune system. Once that checkpoint is blocked, the immune system can better find and destroy tumor cells.

Keytruda Has Received Nearly 40 FDA Approvals. How Does It Work?

In sparking an immune response, the drug can also cause immune-related side effects that can affect any part of the body, and are crucial to bring up to the care team.

Anytime something doesn't feel right, patients should call their oncologist just to be evaluated, be seen (and) have labs drawn, because the toxicity of (Keytruda) and other checkpoint inhibitors are very nonspecific. They affect the immune system, and the immune system is all over our body so it can affect any organ in the body.

So if something doesn't feel right, it's time to call the if you're on treatment with (Keytruda) it's time to call the medical oncologist or go in, get a full exam, be assessed and get some labs.

Patients with bladder cancer being treated with the immunotherapy agent, Keytruda, should not hesitate to call their oncology team if something does not feel right, an expert said. 

Keytruda Side Effects: ‘If Something Doesn’t Feel Right … Call’

There are so many types of treatment for bladder cancer, which can make it a challenge to understand what is available and most effective for you. So, CURE® spoke with two bladder cancer experts to discuss different types of treatments for bladder cancer.

Bladder cancer, according to the American Cancer Society, is when cells that form the urinary bladder begin to grow uncontrollably. When these cells continue to grow, it can turn into a tumor that may eventually spread to other parts of the body.

It’s important to know what kinds of treatments are available for bladder cancer and understand that having a “tailored” treatment is important for patients, experts said.

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