Tag Archive for: immunotherapy
What Questions Should Patients Ask About Joining a Clinical Trial?
What Questions Should Patients Ask About Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.
Before participating in a clinical trial, what questions should you ask? Dr. Pauline Funchain of Cleveland Clinic shares critical questions patients should ask their healthcare team when considering a clinical trial.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Katherine Banwell:
If a trial is recommended, what questions should a patient ask about the trial itself?
Dr. Pauline Funchain:
Yeah. I mean, I think when it comes to that, I think that the important things to ask, really, are what are the drugs involved, and what your doc thinks about those drugs.
I think, what is the alternative? So, again, we were talking about option A, B, and C. Is this option A of A, B, and C, or option C of A, B, and C? Are there ones like Cindi mentioned, where if you don’t do it at this point, you’re going to lose the opportunity, because you started on something else. Because a lot of trials require either that a person has never gone through therapy, and so this is sort of first line trial. But some trials are you have to be at the second thing that you’ve been on.
So, these are the things that matter to know. Are you going to lose an opportunity if you didn’t do it now, or can you do it later, and what is the preference? And I think, practically speaking, a patient really wants to know what is the schedule? Can I handle this? How far away do I live from the place that is giving this trial?
What are the locations available? Because if there’s a trial and you have to come in every two weeks, or come in four times in two weeks, and then once every month after that, that makes a big difference depending on where you live, what season it is, weather, that kind of stuff.
And I think the question that you don’t really have to ask, but a lot of people ask, is about cost. So, medical care nowadays is complex, it costs money when you don’t expect it to, it doesn’t cost money when it’s – you just don’t know what will and what won’t. Financial toxicity is something that we really care about. Every center is really trying its best, but it’s hard to do in this type of environment. So, people then get concerned that clinical trials might be even more complex.
I think clinical trials are much less complex in that way, because a lot more of it is covered by the sponsor, whatever that sponsor is, whether that sponsor is the National Institutes of Health, as a grant, or a pharmaceutical company.
But, in general, a clinical trial really should cost the same or less than whatever the standard medical care is; that’s the way they’re built. So, many, many people ask us that question, but I think that is the question that probably is less important than what are the drugs, what does your doc think about this, are you going to lose an opportunity if there’s a different sequence, and does this fit into your life and your schedule, and people who can give you rides.
Katherine Banwell:
Yeah, right. Are there resources available to assist with the financial impact of a clinical trial?
Dr. Pauline Funchain:
There are not specific resources for clinical trials; there are specific resources for patients in general, though. There are things like helping with utility bills sometimes, sometimes with rides, I think a lot of clinical trials do pay for things like parking. In general, many trials themselves have extra financial support in them. There was a trial I remember that paid for airfare and lodging, because there were only five centers in the country, and so we had people fly in, and the whole thing was covered.
It depends on the trial. But in terms of outside of trials, there are always patient advocacy groups and things like that, where certain things can get covered. But often, the types of things that get covered by those groups are the same things that get covered with normal medical care.
How to Find a Clinical Trial That’s Right for You
How to Find a Clinical Trial That’s Right for You from Patient Empowerment Network on Vimeo.
If you are interested in participating in a clinical trial, where do you start? Dr. Pauline Funchain of Cleveland Clinic shares resources for patients on where to find and access a clinical trial that’s right for them.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Katherine Banwell:
So, if a patient is interested in joining a clinical trial, where should they start?
Dr. Pauline Funchain:
They can start anywhere. There are many places to start. I think their oncologist is a really, really good place to start. I would say an oncologist, depending on their specialties, will have a general grasp of trials, or a really specific grasp of trials.
I would say that the folks who have the most specific grasp on trials – what is available, what isn’t available, what’s at their center versus the next state over center – are the academic medical centers; the ones that are sort of university centers, places like the Cleveland Clinic where the docs are specialized by the type of cancer. That group of folks will have the best grasp on what’s current, what’s available.
And so, Cindi, your friend referred you. many people do say that. Just go to whatever your nearest university center is, just because there’s a lot more specialization in that sense. But I think it’s the age of the Internet, so people can look online. Clinicaltrials.gov is a fantastic place to look. It is not as up to date, I think, as something you can get directly from a person at a medical center, but it is a great place to start.
There are many advocacy groups and websites that will point people to trials. I mean, there are Facebook groups and things, where people will chat about trials. But I think the detail is better at a site like clinicaltrials.gov, and even better with a cancer-specific oncologist at a academic medical center.
Understanding Common Clinical Trial Terminology
Medical terminology can be confusing and is especially important to understand when reviewing information to learn about a clinical trial. Dr. Pauline Funchain of Cleveland Clinic explains common terms and phrases to help patients better understand the clinical trial process.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Katherine Banwell:
Dr. Funchain, are there common clinical trial terms that patients should know?
Dr. Pauline Funchain:
Yeah, there are trial terms that people hear all the time, and probably should know a little bit about. But I think the most common thing people will hear with trials are the type of trial it is, so Phase I, Phase II, Phase III. The important things to know about that are essentially, Phase I is it’s a brand-new drug, and all we’re trying to do is look for toxicity. Although we’ll always on the side be looking for efficacy for whether that drug actually works, we’re really looking to see if the drug is safe.
A Phase II trial is a trial where we’re starting to look at efficacy to some degree, and we are still looking at toxicity. And then in Phase III is, we totally understand the toxicity, and we are seeing promise, and what we really want to do is see if this should become a new standard. So, that would be the Phase I, II, and III.
Another couple of terms that people hear a lot about are eligibility criteria, or inclusion criteria. So, those are usually some set of 10 to 30 things that people can and can’t be. So, usually trials only allow certain types of cancer, and so that would be an inclusion criteria, but it will exclude other types of cancers. Most trials, unfortunately, exclude pregnant women. That would be an exclusion criteria.
So, these are things that, at the very beginning of a trial, will allow someone to enter, or say, “You’re not in the safe category, we should not put you on a trial.” Many trials are randomized, so people will hear this a lot. Randomization.
So, a lot of times, there is already a standard of care. When there’s already a standard of care, and you want to see if this drug is at least the same or better, then on that trial, there will be two different arms; a standard of care arm and experimental arm.
And then in order to be fair, a randomized trial is a flip of a coin. Based on a electronic flip of a coin – nobody gets to choose; not the doc, not the patient. On that type of trial, you’ll either get what you would normally get, standard of care, or something new. So, that’s a randomized trial. Not all trials are randomized, but some are. And those are the things that people will run into often.
You’ve Chosen to Participate In a Clinical Trial: What Are Next Steps?
You’ve Chosen to Participate in a Clinical Trial: What Are Next Steps? from Patient Empowerment Network on Vimeo.
What is it like to participate in a clinical trial? Dr. Pauline Funchain of Cleveland Clinic explains what to expect when joining a clinical trial and colorectal cancer survivor Cindi Terwoord shares her personal experience.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.
Katherine Banwell:
Dr. Funchain, once a patient like Cindi decides to participate in a trial, what happens next?
Dr. Pauline Funchain:
So, there is a lot, actually, that happens. So, there is a lead-in period to a trial. So, once you decide, it’s not like you can start tomorrow on a trial drug. What happens really, there’s a whole safety lead-in that we call an enrollment period, where there’s a long checklist of making sure that a person is healthy, and there’s nothing – no organ or anything in particular – where we would be worried about this particular drug.
So, there’s a checklist, that way there are usually – sometimes there’s a new scan if the last scan is a little bit too old, just so that we know exactly what somebody looks like right when they walk into the trial and start the drug. There are usually some blood tests and procedures that come before, and some of the stuff – half of the blood is for the trial, and half of the blood is for scientist usually, so that they can work on some of the science behind what’s happening to someone on a trial, which is pretty cool.
And sometimes there is a procedure – a biopsy or something like that – that’s involved.
But, in general, the lead-in is somewhere usually between two and four weeks from the time somebody decides they’re willing to be on a trial. And there are some extra safety measures, like if you hear about a trial, you can’t go on the trial right away, there’s got to be sort of a thinking period that’s usually about 24 hours before you can literally sign your name on the line.
But, yeah, I’d expect something about two to three weeks before going on a trial. And then once folks are on a trial, it’s kind of like treatment. It’s just getting the treatments when you get the treatments. Sometimes there’s extra checks, again for safety, on drug levels and things.
Katherine Banwell:
Would you review the safety protocols in place for clinical trials?
Pauline Funchain:
Yeah, sure. So, safety is number one when it comes to trials, really. There are guardrails on guardrails on guardrails. But in any clinical trial protocol, it actually starts even before the trial starts. So, whenever somebody wants to bring in a trial, or wants to start a trial – and this is true at any academic institution, or any institution that runs trials – the trial goes through something called an IRB, or an Institutional Review Board, and that board reviews it and says, “Look, is this safe, are we harming people, are we unnecessarily coercing people?”
And they read through the whole thing. And usually there’s a protocol data monitoring committee that also looks at it, there’s usually two. And there’s a lot of checks that a trial has to go through to make sure it’s safe, and fair, for all participants. So, that happens first.
And then once the trial opens, there is continual monitoring. Every visit, every number that’s drawn. Any visit, even if the visit isn’t at the hospital that’s running the trial, even if it’s at a local urgent care, all of those things end up getting reported back, and there’s a whole team of people besides.
So, a patient will see the doc, or the nurse, or maybe sometimes a research coordinator, research assistant. But then there are all these research coordinators that sit in offices that review everything, put it in the computers, and then record everything that happens to someone on the trial.
And all of that data actually goes to an external review organization, a clinical trial research organization. And what they do is, they look over all of the data also. So, it’s not just internal people checking, because internal people may be biased for the people that pay them, right?
Katherine Banwell:
Right.
Dr. Pauline Funchain:
All of that data goes to an external monitoring board also, to make sure that everything is going the way it’s supposed to go.
Katherine Banwell:
Yeah. Cindi, in your experience, did you feel like safety was a priority?
Cindi Terwoord:
Oh, definitely, definitely, yeah. They were very, very careful. Mine was a two-part; I had a vaccine along with this nivolumab (Opdivo).
And so, they would have to give me the vaccine, sit there and stare at me, to make sure I didn’t faint or something, and that was a good half-hour.
Then I got the immunotherapy, and I’d have to wait an hour after that before I started on the chemotherapy.
Katherine Banwell:
Oh.
Cindi Terwoord:
Yeah, they were in there watching me like a hawk, and I felt very safe, I really did.
Katherine Banwell:
Dr. Funchain, what are a patient’s rights when they participate in a trial?
Dr. Pauline Funchain:
So, the most important thing, I think, that Cindi mentioned before is, a patient can withdraw at any time. Any time. They can sign the paperwork, and the next second decide not to. They can be almost to the end of the trial and decide that they want to come off. The last word is always with the patient.
I think the other thing, in terms of safety, you can see – so every patient before starting a trial gets an informed consent. It is multiple pages, there’s a lot of legalese in it.
But they do try their best to make it as readable and understandable as possible, so that people can, even if they don’t have a medical background, kind of understand what they’ve gotten. The mechanism of what they’ve gotten, and what new drug they’re getting, and generally what are the risks and benefits.
For instance, let’s say there’s genetic testing involved, there’s always clauses that tell you what that means, and how protected your genetic information is, that kind of stuff.
So, it’s a very long thing. And again, once someone gets that, they have to have a certain amount of time before they can sign on the line. So, I think information education, and then the ability to come off if they find necessary.
Katherine Banwell:
Yeah. What happens after a trial is completed? Is a patient monitored? And if so, how?
Dr. Pauline Funchain:
So, that depends on the trial.
Most trials do monitor after either the drug is complete, or the course is complete for a certain amount of time, and it depends on the trial. For some trials, it’s six months after; for some trials, it’s years afterwards. So, in melanoma, we have a trial that just reported out their 7-1/2-year follow-up. But it was actually the first immunotherapy combination of its kind that involved the drug that you had to need nivolumab.
So, it is pretty cool. I mean, that combination changed the face of what patients with melanoma could come to expect from their treatment, so we’re all very interested to know what that kind of follow-up is. But, yeah, it depends on the trial.
A Patient’s Perspective | Participating in a Clinical Trial
A Patient’s Perspective | Participating in a Clinical Trial from Patient Empowerment Network on Vimeo.
Colorectal cancer survivor Cindi Terwoord recounts her clinical trial experience and explains why she believes patients should consider trial participation.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.
See More from Clinical Trials 101
Related Resources:
|
|
|
Transcript:
Katherine Banwell:
Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?
Cindi Terwoord:
Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”
And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.
Katherine Banwell:
Mm-hmm. Had you had a colonoscopy before, or was that your first one?
Cindi Terwoord:
No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.
Katherine Banwell:
Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?
Cindi Terwoord:
Well, I have a friend – it was very interesting.
He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.
And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.
And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”
Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”
Katherine Banwell:
Mm-hmm. Did you have any hesitations?
Cindi Terwoord:
Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.
Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.
I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.
Katherine Banwell:
Oh, good for you.
Cindi Terwoord:
I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.
Katherine Banwell:
That’s a great idea.
Cindi Terwoord:
Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.
Katherine Banwell:
In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?
Cindi Terwoord:
Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.
I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”
I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.
Katherine Banwell:
Mm-hmm. So, how are you doing now, Cindi? How are you feeling?
Cindi Terwoord:
Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –
Katherine Banwell:
Cindi, what advice do you have for patients who may be considering participating in a trial?
Cindi Terwoord:
Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered.
And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.
And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.”
But that was all very helpful, and I did get free parking for a few weeks. I mean, sometimes I’d have to remind them. I’d say, “It’s costing me more to park than to get treated.” But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it.
Katherine Banwell:
Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with?
Dr. Pauline Funchain:
First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.
It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?
So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results.
And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible.
What Are the Risks and Benefits of Joining a Clinical Trial?
What Are the Risks and Benefits of Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.
Why should a cancer patient consider a clinical trial? Dr. Pauline Funchain of the Cleveland Clinic explains the advantages of clinical trial participation.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
See More from Clinical Trials 101
Related Resources:
|
|
|
Transcript:
Katherine Banwell:
Why would a cancer patient consider participating in a clinical trial? What are the benefits?
Dr. Pauline Funchain:
So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.
We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.
I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.
And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.
Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial.
Katherine Banwell:
Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them?
Dr. Pauline Funchain:
Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.
So, sort of getting all the subtleties of what those risks and benefits are, I think, are really important.
Katherine Banwell:
Mm-hmm. What are some key questions that patients should ask?
Dr. Pauline Funchain:
Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C.
What Do You Need To Know About Bladder Cancer?
What Do You Need To Know About Bladder Cancer? from Patient Empowerment Network on Vimeo.
What should you or your loved ones know following a bladder cancer diagnosis? This animated video reviews the diagnosis and types of bladder cancer, current treatment options, and key advice for taking an active role in your care.
See More From The Pro-Active Bladder Cancer Patient Toolkit
Related Programs:
|
|
|
Transcript:
What do you need to know if you or a loved one has been diagnosed with bladder cancer?
Bladder cancer occurs when cells in the urinary bladder grow out of control. As more cancer cells develop, they can form a tumor. And, over time, may spread to other parts of the body.
The most common type of bladder cancer is transitional cell carcinoma or T.C.C.. This may also be referred to as urothelial carcinoma. Other subtypes include: Squamous cell carcinoma, adenocarcinoma, small cell bladder cancer and, sarcomatoid carcinoma.
How bladder cancer is treated depends on the stage. The stages of bladder cancer include: Stage 1, which indicates that the cancer is growing in the inner lining layer of the bladder only. Stage 2 occurs when the cancer is growing into the inner or outer muscle layer of the bladder wall. Stage 3 means that the cancer has grown beyond the muscle layer and into fatty tissue that surrounds the bladder. And, Stage 4 indicates that the cancer is growing outside of the pelvic region and has spread to distant sites, such as the lung, liver, or bones. When cancer has spread to other organs in the body, it is considered metastatic cancer.
When making a treatment choice, your doctor may also consider age, any comorbidities, potential side effects, and the results of biomarker testing, as well as that patient’s preference.
So, what are the treatment options for bladder cancer? For early stage, or non-muscle-invasive, bladder cancer patients, doctors may use a form of immunotherapy instilled in the bladder called B.C.G. which stands for Bacillus Calmette-Guerin. B.C.G. is used to inhibit the cancer’s growth and prevent recurrence.
If patients do not respond or recur after B.C.G., a radical cystectomy – a surgical procedure to remove the bladder, is offered. In select patients, pembrolizumab, a form of immunotherapy, can be used as an alternative.
For localized bladder cancer invading the muscle, treatment is typically chemotherapy, followed by surgery. Tri-modality treatment using chemotherapy along with radiation is an option for patients who are not candidates for surgery – or refuse surgery – and who meet criteria for bladder preservation.
Surgery, including a urostomy where the bladder is removed and replaced with a stoma outside of their bodies, is a major procedure reserved for patients who are very fit with low comorbidities.
Now that you understand a little more about your bladder cancer and treatment options, how can you take an active role in your care?
First, continue to educate yourself about your condition. Ask your doctor for patient resources or visit powerfulpatients.org/bladdercancer for more information.
Understand the goals of your treatment and ask whether a clinical trial might be right for you.
You should also consider a second opinion or consult with a specialist following a diagnosis.
Try to write down your questions before and during your appointments. And bring a friend or loved one to your appointments to help you recall information and to keep track of important details.
Finally, remember that you have a voice in your care. Don’t hesitate to ask questions and to share your concerns. You are your own best advocate.
To learn more about bladder cancer and to access tools for self-advocacy, visit powerfulpatients.org/bladdercancer.
Participating in a Clinical Trial: What You Need to Know
Participating in a Clinical Trial: What You Need to Know from Patient Empowerment Network on Vimeo.
Are you considering participating in a clinical trial? In this webinar, Dr. Pauline Funchain, cancer expert and researcher, discusses what to expect when joining a clinical trial, including patient safety and questions to ask your healthcare about trial participation. Patient advocate and colorectal cancer survivor Cindi Terwoord shares her experience and advice for other people with cancer considering joining a clinical trial.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.
Katherine Banwell:
Hello, and welcome. I’m Katherine Banwell, your host for today’s program. When faced with a cancer diagnosis, could a clinical trial be your best treatment option? Today, we’re going to learn all about clinical trial participation, what’s involved, and how you can work with your healthcare team to decide whether a trial is right for you.
Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. All right let’s meet our guest today. Joining me is Dr. Pauline Funchain.
Dr. Funchain, welcome, would you please introduce yourself?
Dr. Pauline Funchain:
Sure. Thank you for the invitation. So, I’m Pauline Funchain, I am a medical oncologist at the Cleveland Clinic. My specialty is melanoma and skin cancers. I also lead our genomics program here at Taussig Cancer Center.
Katherine Banwell:
Excellent. Thank you so much for joining us today.
Dr. Pauline Funchain:
Thank you.
Katherine Banwell:
And here to share the patient perspective is Cindi, who is a colorectal cancer survivor. Cindi, we’re so pleased to have you with us today.
Cindi Terwoord:
Thank you, nice to be here.
Katherine Banwell:
Before we learn more about Cindi’s experience, I’d like to start with a basic question for you, Dr. Funchain. Why would a cancer patient consider participating in a clinical trial? What are the benefits?
Dr. Pauline Funchain:
So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.
We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.
I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.
And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.
Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial.
Katherine Banwell:
Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them?
Dr. Pauline Funchain:
Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.
So, sort of getting all the subtilties of what those risks and benefits are, I think, are really important.
Katherine Banwell:
Mm-hmm. What are some key questions that patients should ask?
Dr. Pauline Funchain:
Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C.
Katherine Banwell:
Mm-hmm. Let’s learn more about Cindi’s story. Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?
Cindi Terwoord:
Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”
And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.
Katherine Banwell:
Mm-hmm. Had you had a colonoscopy before, or was that your first one?
Cindi Terwoord:
No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.
Katherine Banwell:
Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?
Cindi Terwoord:
Well, I have a friend – it was very interesting.
He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.
And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.
And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”
Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”
Katherine Banwell:
Mm-hmm. Did you have any hesitations?
Cindi Terwoord:
Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.
Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.
I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.
Katherine Banwell:
Oh, good for you.
Cindi Terwoord:
I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.
Katherine Banwell:
That’s a great idea.
Cindi Terwoord:
Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.
Katherine Banwell:
In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?
Cindi Terwoord:
Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.
I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”
I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.
Katherine Banwell:
Mm-hmm. So, how are you doing now, Cindi? How are you feeling?
Cindi Terwoord:
Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –
Katherine Banwell:
Oh, good for you.
Cindi Terwoord:
– as far as my strength. I like to lift weights, and I run, so I’m pretty much back to normal.
Katherine Banwell:
Good for you. Thanks so much for sharing your story with us.
Cindi Terwoord:
You’re welcome.
Katherine Banwell:
Dr. Funchain, once a patient like Cindi decides to participate in a trial, what happens next?
Dr. Pauline Funchain:
So, there is a lot, actually, that happens. So, there is a lead-in period to a trial. So, once you decide, it’s not like you can start tomorrow on a trial drug. What happens really, there’s a whole safety lead-in that we call an enrollment period, where there’s a long checklist of making sure that a person is healthy, and there’s nothing – no organ or anything in particular – where we would be worried about this particular drug.
So, there’s a check list, that way there are usually – sometimes there’s a new scan if the last scan is a little bit too old, just so that we know exactly what somebody looks like right when they walk into the trial and start the drug. There are usually some blood tests and procedures that come before, and some of the stuff – half of the blood is for the trial, and half of the blood is for scientist usually, so that they can work on some of the science behind what’s happening to someone on a trial, which is pretty cool.
And sometimes there is a procedure – a biopsy or something like that – that’s involved.
But in general, the lead-in is somewhere usually between two and four weeks from the time somebody decides they’re willing to be on a trial. And there are some extra safety measures, like if you hear about a trial, you can’t go on the trial right away, there’s got to be sort of a thinking period that’s usually about 24 hours before you can literally sign your name on the line.
But, yeah, I’d expect something about two to three weeks before going on a trial. And then once folks are on a trial, it’s kind of like treatment. It’s just getting the treatments when you get the treatments. Sometimes there’s extra checks, again for safety, on drug levels and things.
Katherine Banwell:
Would you review the safety protocols in place for clinical trials?
Dr. Pauline Funchain:
Yeah, sure. So, safety is number 1 when it comes to trials, really. There are guardrails on guardrails on guardrails. But in any clinical trial protocol, it actually starts even before the trial starts. So, whenever somebody wants to bring in a trial, or wants to start a trial – and this is true at any academic institution, or any institution that runs trials – the trial goes through something called an IRB, or an Institutional Review Board, and that board reviews it and says, “Look, is this safe, are we harming people, are we unnecessarily coercing people?”
And they read through the whole thing. And usually there’s a protocol data monitoring committee that also looks at it, there’s usually two. And there’s a lot of checks that a trial has to go through to make sure it’s safe, and fair, for all participants. So, that happens first.
And then once the trial opens, there is continual monitoring. Every visit, ever number that’s drawn. Any visit, even if the visit isn’t at the hospital that’s running the trial, even if it’s at a local urgent care, all of those things end up getting reported back, and there’s a whole team of people besides.
So, a patient will see the doc, or the nurse, or maybe sometimes a research coordinator, research assistant. But then there are all these research coordinators that sit in offices that review everything, put it in the computers, and then record everything that happens to someone on the trial.
And all of that data actually goes to an external review organization, a clinical trial research organization. And what they do is, they look over all of the data also. So, it’s not just internal people checking, because internal people may be biased for the people that pay them, right?
Katherine Banwell:
Right.
Dr. Pauline Funchain:
All of that data goes to an external monitoring board also, to make sure that everything is going the way it’s supposed to go.
Katherine Banwell:
Yeah. Cindi, in your experience, did you feel like safety was a priority?
Cindi Terwoord:
Oh, definitely, definitely, yeah. They were very, very careful. Mine was a two-part; I had a vaccine along with this nivolumab.
And so, they would have to give me the vaccine, sit there and stare at me, to make sure I didn’t faint or something, and that was a good half-hour.
Then I got the immunotherapy, and I’d have to wait an hour after that before I started on the chemotherapy.
Katherine Banwell:
Oh.
Cindi Terwoord:
Yeah, they were in there watching me like a hawk, and I felt very safe, I really did.
Katherine Banwell:
Dr. Funchain, what are a patient’s rights when they participate in a trial?
Dr. Pauline Funchain:
So, the most important thing, I think, that Cindi mentioned before is, a patient can withdraw at any time. Any time. They can sign the paperwork, and the next second decide not to. They can be almost to the end of the trial and decide that they want to come off. The last word is always with the patient.
I think the other thing, in terms of safety, you can see – so every patient before starting a trial gets an informed consent. It is multiple pages, there’s a lot of legalees in it.
But they do try their best to make it as readable and understandable as possible, so that people can, even if they don’t have a medical background, kind of understand what they’ve gotten. The mechanism of what they’ve gotten, and what new drug they’re getting, and generally what are the risks and benefits.
For instance, let’s say there’s genetic testing involved, there’s always clauses that tell you what that means, and how protected your genetic information is, that kind of stuff.
So, it’s a very long thing. And again, once someone gets that, they have to have a certain amount of time before they can sign on the line. So, I think information education, and then the ability to come off if they find necessary.
Katherine Banwell:
Yeah. What happens after a trial is completed? Is a patient monitored? And if so, how?
Dr. Pauline Funchain:
So, that depends on the trial.
Most trials do monitor after either the drug is complete, or the course is complete for a certain amount of time, and it depends on the trial. For some trials, it’s six months after; for some trials, it’s years afterwards. So, in melanoma, we have a trial that just reported out their 7-1/2-year follow-up. But it was actually the first immunotherapy combination of its kind that involved the drug that you had Cindi, nivolumab.
So, it is pretty cool. I mean, that combination changed the face of what patients with melanoma could come to expect from their treatment, so we’re all very interested to know what that kind of follow-up is. But, yeah, it depends on the trial.
Katherine Banwell:
Dr. Funchain, are there common clinical trial terms that patients should know?
Dr. Pauline Funchain:
Yeah, there are trial terms that people hear all the time, and probably should know a little bit about. But I think the most common thing people will hear with trials are the type of trial it is, so Phase I, Phase II, Phase III. The important things to know about that are essentially, Phase I is it’s a brand-new drug, and all we’re trying to do is look for toxicity. Although we’ll always on the side be looking for efficacy for whether that drug actually works, we’re really looking to see if the drug is safe.
A Phase II trial is a trial where we’re starting to look at efficacy to some degree, and we are still looking at toxicity. And then in Phase III is, we totally understand the toxicity, and we are seeing promise, and what we really want to do is see if this should become a new standard. So, that would be the Phase I, II, and III.
Another couple of terms that people hear a lot about are eligibility criteria, or inclusion criteria. So, those are usually some set of 10 to 30 things that people can and can’t be. So, usually trials only allow certain types of cancer, and so that would be an inclusion criteria, but it will exclude other types of cancers. Most trials, unfortunately, exclude pregnant women. That would be an exclusion criteria.
So, these are things that, at the very beginning of a trial, will allow someone to enter, or say, “You’re not in the safe category, we should not put you on a trial.” Many trials are randomized, so people will hear this a lot. Randomization.
So, a lot of times, there is already a standard of care. When there’s already a standard of care, and you want to see if this drug is at least the same or better, then on that trial, there will be two different arms; a standard of care arm and experimental arm.
And then in order to be fair, a randomized trial is a flip of a coin. Based on a electronic flip of a coin – nobody gets to choose; not the doc, not the patient. On that type of trial, you’ll either get what you would normally get, standard of care, or something new. So, that’s a randomized trial. Not all trials are randomized, but some are. And those are the things that people will run into often.
Katherine Banwell:
So, if a patient is interested in joining a clinical trial, where should they start?
Dr. Pauline Funchain:
They can start anywhere. There are many places to start. I think their oncologist is a really, really good place to start. I would say a oncologist, depending on their specialties, will have a general grasp of trials, or a really specific grasp of trials.
I would say that the folks who have the most specific grasp on trials– what is available, what isn’t available, what’s at their center versus the next state over center – are the academic medical centers; the ones that are sort of university centers, places like the Cleveland Clinic where the docs are specialized by the type of cancer. That group of folks will have the best grasp on what’s current, what’s available.
And so, Cindi, your friend referred you. many people do say that. Just go to whatever your nearest university center is, just because there’s a lot more specialization in that sense. But I think it’s the age of the internet, so people can look online. Clinicaltrials.gov is a fantastic place to look. It is not as up to date, I think, as something you can get directly from a person at a medical center, but it is a great place to start.
There are many advocacy groups and websites that will point people to trials. I mean, there are Facebook groups and things, where people will chat about trials. But I think the detail is better at a site like clinicaltrials.gov, and even better with a cancer-specific oncologist at a academic medical center.
Katherine Banwell:
If a trial is recommended, what questions should a patient ask about the trial itself?
Dr. Pauline Funchain:
I mean, there’s so many questions to ask.
Katherine Banwell:
Safety is definitely one of them, right?
Dr. Pauline Funchain:
Yeah. I mean, I think when it comes to that, I think that the important things to ask, really, are what are the drugs involved, and what your doc thinks about those drugs.
I think, what is the alternative? So, again, we were talking about option A, B, and C. Is this option A of A, B, and C, or option C of A, B, and C? Are there ones like Cindi mentioned, where if you don’t do it at this point, you’re going to lose the opportunity, because you started on something else. Because a lot of trials require either that a person has never gone through therapy, and so this is sort of first line trial. But some trials are you have to be at the second thing that you’ve been on.
So, these are the things that matter to know. Are you going to lose an opportunity if you didn’t do it now, or can you do it later, and what is the preference? And I think, practically speaking, a patient really wants to know what is the schedule? Can I handle this? How far away do I live from the place that is giving this trial?
What are the locations available? Because if there’s a trial and you have to come in every two weeks, or come in four times in two weeks, and then once every month after that, that makes a big difference depending on where you live, what season it is, weather, that kind of stuff.
And I think the question that you don’t really have to ask, but a lot of people ask, is about cost. So, medical care nowadays is complex, it costs money when you don’t expect it to, it doesn’t cost money when it’s – you just don’t know what will and what won’t. Financial toxicity is something that we really care about. Every center is really trying its best, but it’s hard to do in this type of environment. So, people then get concerned that clinical trials might be even more complex.
I think clinical trials are much less complex in that way, because a lot more of it is covered by the sponsor, whatever that sponsor is, whether that sponsor is the National Institutes of Health, as a grant, or a pharmaceutical company.
But, in general, a clinical trial really should cost the same or less than whatever the standard medical care is; that’s the way they’re built. So, many, many people ask us that question, but I think that is the question that probably is less important than what are the drugs, what does your doc think about this, are you going to lose an opportunity if there’s a different sequence, and does this fit into your life and your schedule, and people who can give you rides.
Katherine Banwell:
Yeah, right. Are there resources available to assist with the financial impact of a clinical trial?
Dr. Pauline Funchain:
There are not specific resources for clinical trials; there are specific resources for patients in general, though. There are things like helping with utility bills sometimes, sometimes with rides, I think a lot of clinical trials do pay for things like parking. In general, many trials themselves have extra financial support in them. There was a trial I remember that paid for airfare and lodging, because there were only five centers in the country, and so we had people fly in, and the whole thing was covered.
It depends on the trial. But in terms of outside of trials, there are always patient advocacy groups and things like that, where certain things can get covered. But often, the types of things that get covered by those groups are the same things that get covered with normal medical care.
Katherine Banwell:
Okay. Before we wrap up the program, Cindi, what advice do you have for patients who may be considering participating in a trial?
Cindi Terwoord:
Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered.
And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.
And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.”
But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it.
Katherine Banwell:
Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with?
Dr. Pauline Funchain:
First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.
It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?
So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results.
And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible.
Katherine Banwell:
Yeah. Dr. Funchain and Cindi, thank you both so much for joining us today.
Cindi Terwoord:
You’re welcome, thanks for having me.
Dr. Pauline Funchain:
Thank you.
Katherine Banwell:
And thank you to all of our collaborators. To access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell, thanks for being with us today.
Expert Update: Bladder Cancer Treatment & Research News
Expert Update: Bladder Cancer Treatment & Research News from Patient Empowerment Network on Vimeo.
Dr. Fern Anari reviews highlights from the ASCO 2022 meeting and shares her expert perspective on the future of bladder cancer treatment.
Dr. Fern M. Anari is a genitourinary medical oncologist and assistant professor in the department of hematology/oncology at Fox Chase Cancer Center. Learn more about Dr. Anari, here.
See More From The Pro-Active Bladder Cancer Patient Toolkit
Related Programs:
|
|
|
Transcript:
Katherine Banwell:
Dr. Anari, cancer researchers recently came together for the 2022 ASCO meeting. Were there any highlights from that meeting that bladder cancer patients should know about?
Dr. Anari:
Yes. So, our annual meetings are always a really exciting time to learn about and share the results of really cutting-edge research that’s been going on. And this year at ASCO 2022, I think there were several standout studies for various stages of bladder cancer.
So, in patients with localized bladder cancer, again, similarly to what we discussed with immunotherapy and what we call BCG unresponsive bladder cancer, they looked at combining BCG with another new drug. And what they found is that the cancer shrunk down completely in over two-thirds of cases.
And those responses tend to last over two years of follow-up. The drug was shown to be safe and tolerable. So, I think that’s a really exciting potential future treatment for people. There was another study that looked at a targeted treatment called enfortumab vedotin, which is typically used in the metastatic setting after someone’s received chemotherapy and/or immunotherapy. They looked at using that before surgery in localized muscle-invasive bladder cancer.
The reason it’s important to look at drugs like this is because the standard of care right now is to give cisplatin-based chemotherapy before surgery to remove the bladder.
But not everyone is eligible to get that cisplatin drug for various reasons. So, the current standard of care is to just go straight to surgery. But we know that by giving some form of a chemotherapy before, that helps increase cure rates.
And what they actually found in this study looking at enfortumab vedotin is that they were able to shrink down cancer completely, meaning at the time of surgery there was no cancer left in the bladder 36% of the time, which is actually on par with our standard of care treatment that we use today.
So, I think this also shows a lot of promise in patients who historically would need to go straight to surgery without any preoperative treatment. And then, lastly, HER2 is a type of targeted therapy as well that’s most commonly known in the breast cancer treatment world. But it’s also been looked at in bladder cancer.
And there’s a new drug that’s being studied that really strongly targets HER2, which is expressed on some bladder cancer cells. So, they’re looking at this new drug in combination with immunotherapy, which is already approved in bladder cancer. And, again, I think this is another really promising combination for patients who’ve already received other treatments for their bladder cancer.
Katherine Banwell:
It sounds like a lot of progress is being made in the field. What are you excited about when it comes to bladder cancer research?
Dr. Anari:
I think what excites me the most is being able to offer patients both the standard treatment options where, really, the clinical trials of yesterday are our standard treatments today. So, I’m excited to be able to offer them the standard treatment but also give them the background of why that’s approved and why we use it but also give them the hope that we have these really promising drugs.
And, luckily, at our cancer center, we have access to a lot of these before they’re approved by the FDA. So, it’s really exciting to be able to offer this cutting-edge research in the form of treatments to our patients.
How Does Immunotherapy Treat Bladder Cancer?
How Does Immunotherapy Treat Bladder Cancer? from Patient Empowerment Network on Vimeo.
Dr. Fern Anari from Fox Chase Cancer Center explains immunotherapy and how this therapy works to treat bladder cancer. Dr. Anari also discusses the importance of communicating how you’re feeling with your healthcare team.
Dr. Fern M. Anari is a genitourinary medical oncologist and assistant professor in the Department of Hematology/Oncology at Fox Chase Cancer Center. Learn more about Dr. Anari, here.
See More From The Pro-Active Bladder Cancer Patient Toolkit
Related Programs:
|
|
|
|
Transcript:
Katherine Banwell:
What is immunotherapy and how does it work to treat bladder cancer?
Dr. Anari:
So, immunotherapy, the analogy that I often use when I see patients is immunotherapy goes in by IV, and it acts as the drill sergeant. And it trains your own body’s immune system or the soldiers to find and fight the cancer cells. So, that’s really how it really works. The drug itself is training your own body to do the work.
Most people will have no side effects from this. And they tolerate it really well. However, because the immune system is getting a little bit activated, sometimes those soldiers or your immune cells can go rogue. And they can start attacking normal healthy tissue in the body, almost like an autoimmune disease.
So, when on these drugs, it’s really important if anything is new or different to let your doctors know, because it’s often easy to troubleshoot over the phone or at a quick office visit if it’s related to immunotherapy or not. So, it’s really important that you keep that in mind whenever a new symptom or anything may pop up.
Katherine Banwell:
That’s great information – it’s really important to communicate any issues you may be having. So, who is immunotherapy right for? Is it right for every bladder cancer patient?
Dr. Anari:
So, immunotherapy is used in several different settings for bladder cancer treatment. It’s used in the metastatic bladder cancer treatment world mostly. Often, we use it as either a second-line treatment after chemotherapy or in a maintenance-type approach after someone’s completed their chemotherapy, meaning we plan for about two years of treatment. And patients that can’t get chemotherapy for whatever reason we can use immunotherapy as a first-line treatment.
And it’s also used in localized bladder cancer meaning cancer that’s contained only to the lining of the bladder in patients who’ve gotten treatments that go inside the bladder called BCG. When their cancer isn’t responding, immunotherapy is also an option there.
Katherine Banwell:
And what might be some of those side effects that patients should look out for?
Dr. Anari:
So, what I tell everyone is they can get inflammation or an “itis” of anything. So, some examples of that: If someone has a rash, that’s called dermatitis. That can be mild, or it can be severe. If someone has inflammation of the bowels or colitis, they can have diarrhea that starts all of a sudden.
Another example is pneumonitis or inflammation of the lungs. People may have cough, trouble breathing, low oxygen levels. It really can affect any organ system that you have. So, that’s why it’s really important if something feels different to let your doctors know.
It’s also really important if you’re not near your doctor for whatever reason and you end up seeing a local doctor, let’s say, at an emergency room that you let them know that you’ve received immunotherapy because they’ll think about the problems that you’re having a little bit differently.
How Does Targeted Therapy Treat Bladder Cancer?
How Does Targeted Therapy Treat Bladder Cancer? from Patient Empowerment Network on Vimeo.
Dr. Fern Anari, a bladder cancer specialist from Fox Chase Cancer Center, explains how targeted therapy works and which type of patient this therapy is most appropriate for.
Dr. Fern M. Anari is a genitourinary medical oncologist and assistant professor in the Department of Hematology/Oncology at Fox Chase Cancer Center. Learn more about Dr. Anari, here.
See More From The Pro-Active Bladder Cancer Patient Toolkit
Related Programs:
|
|
|
Transcript:
Katherine Banwell:
What is targeted therapy, and how does it work to treat bladder cancer?
Dr. Anari:
So, targeted therapy is really a newer, more tailored approach to treating certain types of bladder cancer. Targeted treatments because they’re targeted have most of their effect on the cancer cells. Although, obviously, there’s other potential side effects. But the way it works to treat bladder cancer really depends on the different types. There are several different targeted treatments out there.
Often, targeted treatments are approved for people after they’ve gotten chemotherapy and/or immunotherapy for their bladder cancer treatments. There are several different ones out there. Erdafitinib is one of them. It’s a pill. It’s approved for patients who have an FGFR alteration.
Well, what is that? It’s something that your doctor finds by getting the DNA or genetic makeup of your cancer cells. So, those pills are available to people with that certain alteration that’s found on special testing.
With these pills, potential side effects – we talked about how the effects are mostly on the cancer cells. But there are other side effects that we have to keep in mind. This drug in particular can have different eye disorders. So, we work closely with ophthalmologists.
And then we check blood work because people can have high phosphate levels in the blood. Phosphate levels can be controlled often with diet, sometimes with medications, and sometimes with just adjusting the dose of the pill itself.
Katherine Banwell:
You mentioned the FGFR genetic alteration. Should bladder cancer patients undergo molecular testing?
Dr. Anari:
So, the most common place where we do that is when people have metastatic bladder cancer. It’s a good idea to test the biopsy sample or bladder cancer sample that’s already been removed.
That way we get this information. While it doesn’t always change the up-front treatment for bladder cancer, it is really important to know really what tools in our toolbox we have for the treatment of bladder cancer.
Key Advice for Newly Diagnosed Bladder Cancer Patients
Key Advice for Newly Diagnosed Bladder Cancer Patients from Patient Empowerment Network on Vimeo.
When you or a loved one has been diagnosed with bladder cancer, it can feel overwhelming. Where do you start? Bladder cancer expert Dr. Fern Anari shares key advice for newly diagnosed patients.
Dr. Fern M. Anari is a genitourinary medical oncologist and assistant professor in the Department of Hematology/Oncology at Fox Chase Cancer Center. Learn more about Dr. Anari, here.
See More From The Pro-Active Bladder Cancer Patient Toolkit
Related Programs:
|
|
|
Transcript:
Katherine Banwell:
Dr. Anari, what are three key pieces of advice that you have for a patient who has just been diagnosed with bladder cancer?
Dr. Anari:
I think probably my number one piece of advice is come to the first oncology appointment with an open mind and an extra set of ears. I think there’s always a lot of information to digest and cover at that first visit. So, it’s always great to have a loved one there to support you and also absorb the information as well.
Probably another piece of advice is to go somewhere where they can provide you with multidisciplinary care. There’s not just one specialist who treats bladder cancer. Often, we work collaboratively between medical oncology, radiation oncology, and urologic oncology.
So, it’s important that the whole team really works together to formulate the right plan for you. And then lastly, it’s really difficult, but stay positive because I think it’s important to know that no matter what you encounter along the way, your doctor is always going to have a plan for you. So, that’s probably the three most important pieces of advice.
Why Lung Cancer Patient Advocacy Is Essential
Why Lung Cancer Patient Advocacy Is Essential from Patient Empowerment Network on Vimeo.
Dr. Estelamari Rodriguez, a lung cancer specialist, discusses the importance of patient advocacy in lung cancer care. Dr. Rodriguez shares how self-advocacy can impact cancer care and how being vocal as a patient advocate can help others in the lung cancer community.
Dr. Estelamari Rodriguez is Associate Director of Community Outreach – Thoracic Oncology at the Sylvester Comprehensive Cancer Center, University of Miami Health System. Learn more about Dr. Rodriguez, here.
See More from Thrive Lung Cancer
Related Resources:
|
|
|
Transcript:
Katherine Banwell:
Why is it so important for patients to share their symptoms and side effects that they’re having with their healthcare team?
Dr. Estelamari Rodriguez:
So, there are two types of advocacy. There’s the advocacy that you do at your personal level, so if the patient is not telling us that they’re having side effects, weeks can go by and these things don’t get addressed. So, you have to be your own advocate, your family can be a great advocate. It doesn’t matter who you are, if we don’t know your side effects, and you’re not communicating that, we’re not able to impact, and intervene early. But there’s a bigger message of advocacy that is extremely important, specifically in lung cancer for decades.
I mean, I think for a long time we didn’t have a lot of lung cancer advocates because people were not surviving lung cancer. And now, that we have people live years with lung cancer, metastatic cancer, and really are coming off treatment, now we have patients that can be the guiding light.
They can tell other patients about how they did, their side effects, can tell their story about how targeted treatment impacted their prognosis. So, advocacy is critical, we don’t have a lot of advocacy in lung cancer. We need advocates in every community, rural communities, urban communities, African Americans, Hispanics, Native Americans. In every community there is someone who’s impacted by lung cancer.
I think that you get something out of it, you feel like you’re helping other people, you’re definitely making people aware. And hopefully, if a legislator hears your story, because last night I was at an advocacy summit, and we had a legislator, and we were asking what really moves legislators to invest in research. And he’s like, “It’s not letter, it’s not emails, it’s these personal stories from patients, and patient advocates.” And we don’t have those stories unless people come out and say and tell them. But they really make people invest, and they really prioritize the importance of research. And that would help you also because if there’s more research, then your next treatment will be funded faster.
Expert Advice for Recently Diagnosed Lung Cancer Patients
Expert Advice for Recently Diagnosed Lung Cancer Patients from Patient Empowerment Network on Vimeo.
A lung cancer diagnosis can be overwhelming. Lung cancer specialist Dr. Estelamari Rodriguez shares key advice for recently diagnosed patients, including tips related to essential testing and preparing for appointments.
Dr. Estelamari Rodriguez is Associate Director of Community Outreach – Thoracic Oncology at the Sylvester Comprehensive Cancer Center, University of Miami Health System. Learn more about Dr. Rodriguez, here.
See More from Thrive Lung Cancer
Related Resources:
|
|
|
Transcript:
Katherine Banwell:
What key advice do you have for recently diagnosed lung cancer patients?
Dr. Estelamari Rodriguez:
I think that a couple of things. When it’s a diagnosis of lung cancer, it’s very overwhelming, and fortunately now there’s a lot of resources online, but at the beginning there’s a lot of information that you don’t know. So, sometimes if you go online all you do is get scared. I think that you need to answer some very specific questions from your doctor. What is your stage? And then, after your stage, my next question is; what is a molecular driver of my tumor, the sequencing of my tumor?
In the past, we thought all the lung cancers were the same, but now we know they’re many, many different types of lung cancer. And they’re the EGFR-driven cancers, the ALK, the ROS, they’re all different, they all have different treatment options. And when you go and look online, there’s organized advocacy groups around each of these mutations, and then you can get better information, and valuable kind of insight from the information that is out there. So, I think the first thing is to before you go in the internet, talk to your doctor about your stage and require, not ask lightly.
Require that your genetic mutation, your sequencing is done at the time of diagnosis of advanced lung cancer. Because that would really determine your treatment.
So, I think that is very important for patients that get diagnosed. And then also, understand that there are a lot of resources out there, so that you need to ask for questions, bring someone with you. During COVID a lot of the clinics were closed, but we were able to have family members join virtually the visits, and now patients can come in with their family members.
I find that having someone else in the room who wrote answers and wrote notes, will really help you kind of get the most out of your consultation. And also ask questions for the next time you come, or we have a portal where patients ask questions online. So, the first visit where you get the most questions answered, and sometimes it’s part B and part C. So, you have to keep until you feel satisfied that you understand the plan. We also tell patients that doctors don’t know everything, sometimes the doctor that you have is not the one that you feel you have a connection with. So, know that you have rights, and there are other doctors out there, and you can get second opinions.
So, you are the best advocate, it’s your life, and you can rely on your doctor, and their physician extenders, physician assistants, nurses, to get as much as you can from that. But also, look outside of your institution, maybe there’s a better option for you.
