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Why Should You Ask Your Doctor About Prostate Cancer Genetic Testing?

Why Should You Ask Your Doctor About Prostate Cancer Genetic Testing? from Patient Empowerment Network on Vimeo.

Why is it genetic testing important when it comes to prostate cancer care? Learn how test results could reveal more about YOUR prostate cancer and may indicate that one treatment may be more effective than another.

See More From INSIST! Prostate Cancer

Related Resources

How Does Genetic Testing Impact Prostate Cancer Care?

Treatment Options for Advanced Prostate Cancer

What Is a Prostate Cancer Genetic Mutation?


Transcript:

Why should you ask your doctor about genetic testing?

The test results may predict how your prostate cancer will behave and could indicate that one type of treatment may be more effective than another type.

Genetic testing identifies specific gene mutations, proteins, chromosomal abnormalities, and/or other molecular changes that are unique to YOU and YOUR prostate cancer.

There are two main types of genetic tests used in prostate cancer:

  • Germline or hereditary genetic testing, which is conducted via blood or saliva and identifies inherited gene mutations in the body. Germline mutations are present from birth and can be shared among family members and passed on to subsequent generations. Results can identify whether you could be at risk for another type of cancer or if your family members may need genetic counseling and testing to guide their own cancer risk.
  • The second is somatic or tumor genetic testing, which is performed through testing tumor tissue or by testing cancer cells/DNA extracted from blood to identify gene mutations that are unique to the cancer itself. It is also commonly referred to as genomic testing, biomarker testing, or molecular profiling. Somatic mutations are NOT inherited and are NOT passed on to subsequent generations or shared among family members.
  • Depending on your history, your doctor may order one–or both–of these types of tests.

So why do the test results matter?

Both germline and somatic mutation testing can identify the presence of certain genetic mutations that may help to guide your treatment plan, and germline testing specifically can inform cancer risk for you and, potentially, family members.

  • In some cases, mutations can indicate that a newer approach, such as targeted therapy or immunotherapy, may work better for you.
  • Results of these tests may also help you to find a clinical trial that may be appropriate for your particular cancer.
  • And, genetic testing results could also show that your cancer has a mutation or marker that may prevent a certain therapy from being effective, sparing you from getting a treatment that won’t work well for you.

How can make sure you have had essential biomarker testing?

  • First, always speak up and ask questions. Remember, you have a voice in YOUR prostate cancer care.
  • Ask your doctor if you have had or will receive genetic testing, including germline and somatic testing, and how the results may impact your care and treatment plan.
  • Ask whether your family members should meet with a genetic counselor or undergo testing to help gauge their risk of developing prostate cancer.
  • And, finally, bring a friend or a loved one to your appointments to help you process and recall information.

To learn more about your prostate cancer and to access tools for self-advocacy, visit powerfulpatients.org/prostatecancer

Which Metastatic Breast Cancer Treatment Is Right for You? What You Need to Know

Which Metastatic Breast Cancer Treatment Is Right for You? What You Need to Know from Patient Empowerment Network on Vimeo.

What do you need to know before deciding which treatment is best for YOUR metastatic breast cancer? Expert Dr. Jane Meisel reviews recent research news, discusses the role of key tests–including biomarker testing –in determining a treatment plan, and shares advice for self-advocacy.

Jane Lowe Meisel, MD is an Associate Professor of Hematology and Medical Oncology at Winship Cancer Institute at Emory University. Learn more about Dr. Meisel, here.

[Editor’s Note: On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older.]

Download Program Guide

See More From INSIST! Metastatic Breast Cancer

Related Resources:

 

What Could Advances in Breast Cancer Research Mean for You?

How Can You Advocate for the Best Breast Cancer Care?

Factors That Guide a Metastatic Breast Cancer Treatment Decision

 


Transcript:

Katherine:

Hello and welcome. I’m Katherine Banwell, your host for today’s program. In today’s webinar, we’ll discuss how you can access the most personalized metastatic breast cancer therapy for your individual disease and why it’s vital to insist on key testing. Before we meet our guest, let’s review a few more important details. The reminder email you received about this program contains a link to program materials.

If you haven’t already, click that link to access information to follow along during the webinar. At the end of this program, you’ll receive a link to a program survey. Please take a moment to provide feedback about your experience today, in order to help plan future webinars. And finally, before we get into the discussion, please remember, this program is not a substitute for seeking medical advice. Please refer to your healthcare team – Please refer to your healthcare team about what might be best for you.

All right, let’s meet our guest today. Joining us is Dr. Jane Meisel. Dr. Meisel, welcome. Would you please introduce yourself?

Dr. Meisel:

Absolutely and thank you so much for having me. My name is Jane Meisel and I’m a medical oncologist at the Winship Cancer Institute at Emory University. I’ve been here for about six years and before that, I did my training in Boston and at Memorial Sloan-Kettering in New York. And I specialize in breast cancer and have had a lot of great opportunities to treat amazing patients and participate in a lot of research.

And I’m looking forward to having this discussion with you today.

Katherine:

Thank you for joining us, we really appreciate it. So, let’s start by discussing the latest developments in treatment and research updates. Are there recent developments you feel breast cancer patients should know about?

Dr. Meisel:

Absolutely and I think it’s really been such a remarkable time because even during COVID, a pandemic, where I think a lot of people worried that research efforts would shut down or stall. We’ve still seen the approval of a number of drugs in the past year that’ve really already markedly changed lives. And a lot of important findings that’ve come out of other trials that they have opportunity to do that as well.

I think some of the biggest information that was presented at our most recent large meeting, which was the American Society of Clinical Oncology, or ASCO National Meeting in 2021, were a few things that pertain to the metastatic breast cancer population. One was two studies, the PALOMA-3 Trial and the MONALEESA-3 Trial, which looked at a class of drugs called CDK4-6 inhibitors along with anti-estrogen pills in metastatic estrogen-positive breast cancer.

And really confirm for patients that not only do these drugs improve the amount of time that people can stay on treatment before their cancer progresses, but actually improve how long people live. Even when they’re used very, very early on in treatment, they impact survival down the line for many, many years. So, it really confirms for physicians like me that this class of drugs should be used as the standard of care and first line for patients with estrogen-positive stage IV breast cancer, and I think that’s important for patients to know. Along those lines, there a drug called sacituzumab govitecan, or Trodelvy, which is a much easier to say name.

Katherine:

Yes.

Dr. Meisel:

A new antibody drug conjugate in triple-negative metastatic breast cancer. And we’ve also seen, since this drug was approved last year, it has markedly changed the lives of many patients with triple-negative disease. And the study called the ascent trial, which is what led to that drug’s approval was studied further and some of these additional results presented at ASCO this year.

And found that this drug not only improves again, how long people get before they have to move on to another treatment, but actually improves how long people live as well, even when given later on in the course of therapy. So again, really encouraging use especially in triple-negative metastatic disease, which is hard to treat. And I think another study that’s really worth patients and doctors taking a hard look at, was actually a study that looked at patient outcomes and patient experience. This is a study that actually talked with metastatic patients and gathered their views on treatment related adverse effects.

Talked to patients about what adverse effects they were experiencing from drugs. How they managed those adverse effects. And found that most patients, over 90%, will be willing to talk about reducing the dose of drugs or changing dosing schedules, in order to improve quality of life. And I think that’s really important because a lot of times, the doses of drugs that get approved are the doses that are the highest doses that don’t cause extreme toxicity. But sometimes people can have effective, really good outcomes on lower doses and have much better quality of life.

And in metastatic breast cancer where really the goal often times is to help people live as long as they can, but also as importantly, as well as they can, be able to have those open-ended conversations between patients and doctors about what’s really impacting your quality of life now and how can we make that better is important. And this study I think really highlighted that both for patients and physicians, how important that back and forth is to having a successful outcome. Both in terms of how life is lived, but in terms of quality of that life.

Katherine:

Right. Right. How can patients stay up to date on developing research?

Dr. Meisel:

It’s so interesting because there is so much coming out and I think it can be hard to figure out what Phase I study that looks exciting is really going to become something, versus what really could be important in my treatment today. And what I always tell people is actually, the NCI website. So, the National Cancer Institute, has a phenomenal page looking at advances in breast cancer research. So, if you Google “NCI advances in breast cancer research,” there’s a great page that comes up. And it’s impressively up to date and I think very patient-friendly.

Breaks things down into early stage and metastatic and then in the metastatic section, talks about estrogen-positive, HER2-positive, triple-negative, which we can talk about more today but are the three big subtype of metastatic disease that dictate how we treat them. And then have links to all the different research updates and talk about what these drugs are, what the classes are and what the settings are in which they’re studied.

And so, I think that’s a really great first stop and then the links can take you to all different stuff that’s on the page that you might want to look into more in depth. And then also, the Breast Cancer Research Foundation, which is a phenomenal organization. They have a great website, too and if you click around on the website, you can see not only who they’ve donated money to that’s doing promising research, they also have podcasts, they have a blog with science and research news. I think that’s a really great site for patients to use to stay updated.

Katherine:

Let’s shift gears for a moment and talk about another time sensitive topic, COVID. Now that vaccines are available, are they safe and effective for breast cancer patients?

Dr. Meisel:

Yeah, I think the short answer to that is yes, absolutely. I’m encouraging all my patients, no matter what their treatment status is to go ahead and get vaccinated. And we are seeing now this third surge in COVID with cases rising all over the country, and really among unvaccinated populations. And with the delta variant being more transmissible, I think it’s all the more time, even if you haven’t considered vaccination up until now, to really go ahead and strongly consider getting a vaccine.

I think some of the hesitations that some of the people have talked to me about is that there were not a lot of active cancer patients, if any, included in the initial trials. And whereas that is true, it’s still the case that now, so many cancer patients have been vaccinated. We haven’t really heard about adverse effects in vaccination being something that’s higher in patients who have cancer who are on active treatment. I think the one challenge is, if you have a compromised immune system because of cancer treatment, there’s the possibility that you might not mount the same immune response to the vaccine as someone who doesn’t have cancer or isn’t getting active treatment.

So, while I would say yes, definitely get vaccinated, I would also at the same time encourage caution in saying, because you might not mount the same, 95 percent or whatever immune response, it may still be a good idea to wear a mask when you go to the grocery store, taking those precautions because no one really knows what’s coming and it’s better to be safe than sorry. But I think we will get a lot of information as the months go on about, do we need boosters? Who might need boosters more soon than others and some of that will get clarified for us, but my short answer would be yes, vaccines for all.

Katherine:

Excellent, that’s very helpful.

Dr. Meisel:

Thank you.

Katherine:

Since this webinar is focused on metastatic disease, would you define metastatic breast cancer for us?

Dr. Meisel:

Absolutely. And I think metastatic breast cancer is one of those terms that as doctors, we throw around a lot and often times don’t stop to check understanding as to what that means.

And what metastatic breast cancer is and means, is breast cancer that is spread outside of the breast and surrounding lymph nodes to another organ system. So, metastatic breast cancer, some of the most common places where it spreads are to the bone, to the skin, to the lungs, to the liver, to the brain. There are other places it can spread to. I’ve seen it on the ovaries, in the GI tract. But basically, when breast cancer spreads outside of the breast and surrounding lymph nodes to another organ system, that’s when we consider it metastatic.

Katherine:

How can a patient ensure they are getting an accurate diagnosis?

Dr. Meisel:

Another good question. And I think the most important thing when you’re considering whether or not you have a diagnosis of metastatic breast cancer is to get a biopsy of that metastatic site. So, you wouldn’t want to assume, just based on a CT scan that shows something in the bone that you have metastatic disease. Ideally, we would biopsy that spot or some spot that was indicative of metastatic disease to actually prove that there is metastatic cancer in that distant site.

Because sometimes it’s nothing. Sometimes you get scans and a little bone abnormality, maybe a scar from a prior fall. And then also, sometimes if it is metastatic, sometimes the breast cancer, the hormone receptor status, for example, can change from the primary site to the metastatic site. And that might impact treatment. So, it’s important to both get a metastatic biopsy to confirm diagnosis. And also, to understand what the treatment plan might be. And I think also for patients, just to make sure that you understand what your stage is, ask your doctor.

Say, what is my stage? Because sometimes doctors think people understand and they don’t actually, so checking that understanding is important. But if your doctor or provider is not actively checking your understanding, you can check it with them to make sure that if you are metastatic or have Stage IV disease, which is another way we define metastatic or talk about metastatic cancer, that you make sure you have the definition right.

Katherine:

Right, right. So, once someone has been diagnosed with metastatic disease, are there key tests that’re used to help understand how their disease may behave and progress?

Dr. Meisel:

Absolutely. So, I think the first thing as I said is that metastatic biopsy. Another thing that’s very important is understanding the hormone receptor status and the HER2 status of the breast cancer. And probably for a lot of you listening, if you have listened to metastatic breast cancer webinars before or maybe know someone or have had a diagnosis yourself, you’re well versed in this. But for some who may not be, I think a quick overview is maybe helpful. Breast cancer can be divided into three different subtypes. So, triple-negative, estrogen-positive or HER2-positive. And estrogen-positive breast cancer is the most common kind.

That tends to be driven by hormones and often treated with what we call, endocrine therapy. So, anti-estrogen pills, things like Tamoxifen or aromatase inhibitors are examples of that. And that’s one kind. And then there’s HER2-positive breast cancer, which is a type of breast cancer that over expresses a marker called HER2. And we now, since we know about that marker, have been able to develop a lot of different treatments that target HER2 selectively.

And can be used to treat that subtype. And then triple-negative is basically estrogen-negative, progesterone-negative and HER2-negative. And that type of breast cancer traditionally was treated essentially only with chemotherapy. But now we’ve had some breakthroughs, which we’ll talk about I think later in this program talking about immunotherapy and more targeted therapy for that. But those subtypes help determine how we treat patients. And it also can sometimes predict behavior.

I would say one of the other things that helps us predict behavior of metastatic disease is, if a patient had early-stage disease before, how quickly they developed metastatic disease. So, for example, someone who develops estrogen-positive metastatic breast cancer 12 years out from their original diagnosis is statistically more likely to have a slower progressing course of disease than someone who develops triple-negative metastatic disease very soon after their initial treatment. So, I would say that’s the primary thing we look at in terms of determining treatment plan and then predicting overall course.

Katherine:

Right. Well, let’s talk about treatment options for advanced disease.

Can you review the types of treatments available for metastatic breast cancer?

Dr. Meisel:

Absolutely. And what I’ll do is, I’ll give you a broad overview and then because there’s so much and this is such a rich environment, I mean, I give hour long lectures just about the treatment of metastatic triple-negative breast cancer to our fellows. So, there is so much meaty information here. But I’ll give an overview with some key buzzwords so then people can go look up things that matter more to them or interest them more. So, as I said, we start with thinking about, is this hormone receptor-positive or estrogen-positive breast cancer? Is this HER2-positive or is this triple-negative? And those factors really send us down different paths.

So, if someone is estrogen-positive, I had mentioned before the PALOMA and MONALEESA studies showing that CDK4-6 inhibitors, which is a class of drugs that the first one was approved in 2015 and then two others have been approved subsequently. So, relatively new drugs. But those drugs, which are pills, added to traditional anti-estrogen therapy which would be aromatase inhibitors or fulvestrant.

Are often great first-line options for these patients. And people can do well for years on just that alone, with estrogen-positive metastatic breast cancer. On average, about two years before people progress and need something new. And then after that, there are lots of trials ongoing looking at different ways in which an estrogen-positive breast cancer might progress on that regiment and how do we target that. So that there are multiple other anti-estrogen options down the line that people can use in estrogen-positive breast cancer before they need to even think about going on to something like chemotherapy.

So, really lots and lots of options for those patients, but probably starting with a CDK4-6 inhibitor plus anti-estrogen combination. And then in HER2-positive breast cancer, typically the first-line treatment would be what we call monoclonal antibodies directed at HER2. So, something like Herceptin and Perjeta, which you may have heard of. And often combined with chemotherapy. But again, this is one of those areas that is also very, I think the art of medicine is very important and patient dependent.

Some of these regiments depend a little bit on patient’s age and other medical problems and desires, whether to include chemotherapy along with that frontline anti-HER2 regimen. Or whether to think about something like anti-estrogen therapy if the patient is HER2-positive and estrogen-positive. And then there are a lot of other different things we’re also using in HER2-positive disease after patients progress on that initial therapy, so there are what we call, antibody drug conjugates, where a chemotherapy like drug is attached to an antibody that then brings the chemo to the HER2-positive cell and allows for chemotherapy penetration more directly.

And then a class of drugs called tyrosine kinase inhibitors, which are oral drugs that get directed at HER2. So, another really exciting area to treat and a place where we’ve seen so many advances. And then in triple-negative breast cancer, I’d mentioned that chemotherapy has really been the mainstay of treatment historically because there weren’t great targets. But recently we’ve seen that immunotherapy, along with chemotherapy drugs like Keytruda, which you may have heard of.

Or atezolizumab, which is Mesenteric, can be used along with chemo and patients that overexpress a molecule called, PDL1. And that can actually include not just how long patients spend on the first treatment, but how long they live. So, we’re seeing a lot of triple-negative patients being great candidates for immune-based regimen now. And then for patients who have inherited a BRCA gene mutation, which many of you may have heard of. That gene mutation can actually predispose a triple-negative patient to be more receptive to a class of drugs called PARP inhibitors.

So, drugs like olaparib (Lynparza) or talazoparib (Talzenna) are new drugs that’ve been approved in the last couple of years in triple-negative metastatic breast cancer for patients who carry a BRCA1 mutation or BRCA2 mutation. And then there are also antibody drug conjugates in triple-negative breast cancer as well. The Trodelvy that’s been approved and then of course others that are in clinical trials currently. So, as you can see, it’s complex. I mean, the treatment of metastatic breast cancer is complicated. And so, it’s important I think to really be able to have a dialogue with your provider about what they’re recommending for you and why.

And I think there are often lots of options. And so, as much as you can make your doctor aware of what matters to you in terms of what side effects are you most afraid of or would you like most to avoid, what dosing schedules would be idea for your schedule for the rest of your life. So that you can deal with taking kids to school or the job that you’re currently working on or whatever, I think helps your doctor help you come up with the right regiment for you.

Katherine:

Yeah. Yeah. So, what factors are considered when deciding on the best treatment approach for an individual patient?

Dr. Meisel:

So, I think certainly the tumor type that we were talking about. Is it estrogen-positive or HER2-negative or HER2-positive? I think response to past treatments, both in terms of if someone has had metastatic disease for a long time and has had a few treatments already, how long did they respond to those treatments and how completely did they respond to those treatments. Did they have stable disease for a while or did their cancer actively shrink?

And then I think other than that, it would be some of the things I touched on. Side effect profiles. Do patients have pre-existing neuropathy from other chemotherapy? If so, maybe you want to avoid a regiment that causes more neuropathy. Schedule. Some patients, it’s really important to be on a certain schedule, as opposed to a different schedule. I think whether there are clinical trials available instead of whatever the standard of care regiment would be is also important.

Because for some patients who are interested in pushing the envelope or who might be a great candidate for a particular trial, if there is one that they’re a candidate for that’s not horribly inconvenient from a logistics standpoint, then trials I think are also a great option to consider. So, I think from an effectiveness standpoint, you want to think about the tumor type response to past treatments. And then potentially, if the patient has had, what we call genomic profiling, where the tumor has been sent for basically genomic analysis, to see what genes might be mutated in the tumor that could potentially drive a response to a newer, different therapy.

All those things can be taken into account as we think about the cancer. But then there is the patient specific factors, and I think those would be mainly side effects, schedule, clinical trials and desire or not to pursue those. And then, just what the patient’s perspective is on the plan that you’re offering them.

Katherine:

What is biomarker testing and how do results impact treatment options?

Dr. Meisel:

Great question. So, I think people often confuse germline mutations and somatic mutations. So, I’ll talk about that a little bit as we talk ab out biomarkers. So, I think biomarkers in general are factors within the tumor that allow us to make treatment decisions. So, if a biomarker in the tumor can predict response to a certain type of treatment, we want to know what that biomarker is so we can better treat the patient and more elegantly design a regimen. So, for example, having an estrogen-positive tumor, estrogen positivity is a biomarker suggestive of response to anti-estrogen treatments, which is why we give anti-estrogen therapy to ER-positive breast cancers.

But more recently, we’ve been able to move a little bit beyond estrogen, HER2- and triple-negative as our subtypes and think a little bit more in some patients about more sophisticated biomarkers. And that’s where somatic mutation testing comes in. So, there are germline mutations, which are inherited mutations that’re present in every cell in your body. So, for example, if your mother was a BRCA mutation carrier and based that BRCA mutation down to you, you would have a germline BRCA mutation. So, your cancer would carry a BRCA mutation, but so would every other cell you have.

And that’s a biomarker. That would make you a candidate for something like a PARP inhibitor. But in cancers, which the genes in the cancer have gone awry by definition, there are often other biomarkers within that tumor that may make you a candidate for certain treatments. And so, those mutations that arise in the cancer itself are called, somatic mutations. Those are mutations in the tumor, can’t be passed down to your offspring or anything like that and were not inherited by your parents. But mutations that’ve accumulated over time as these cancer cells have gone awry.

And so, genomic testing, or biomarker testing can be done often on a metastatic specimen. So, to be specific about it, say you had a metastatic breast cancer to the liver. You could have a liver biopsy done and that tissue from the liver biopsy could be sent for genomic testing. There are a lot of companies that do this and there are also some larger cancer centers that actually do in house testing for genomics. So, this testing can be done and what it does then is, it helps you determine, do you have a biomarker that predisposes you to a certain treatment.

So, if that metastatic liver tissues, for example contained high levels of PBL1 expression for example and you were triple-negative, that would say to your doctor, “Ooh, this is a great candidate for immunotherapy along with chemotherapy.” Or if you’re estrogen-positive, for example, and your tumor contains a mutation in the gene called PIK3CA and that might make you a candidate for a drug called, alpelisib (Piqray). So, these mutations could often be paired to a drug or treatment options, or sometimes to a clinical trial to allow patients to come take advantage of more targeted therapies.

That sometimes, because they’re targeted, have fewer side effects than drugs that are a little more discriminate.

Katherine:

Marie sent in this question prior to the program. Are there some genetic tests that’re more accurate than others?

Dr. Meisel:

That’s a good question. I would say most genetic testing platforms have been heavily vetted and approved by national organizations and laboratories that’ve been tested multiple times before they’re allowed to be marketed. So, I wouldn’t say that one genetic testing program is necessarily better than another. I think that any of the commercially available platforms that’re used are probably pretty accurate.

Katherine:

Okay. How does symptom management play into the treatment decision?

Dr. Meisel:

I was just going to add one thing to that, if that’s okay. I was going to say that I think it’s important when you’re using genetic testing platforms though to know what you’re testing for. So, there are some platforms that will just test for say, the three most common mutations in BRCA1 and BRCA2 that Ashkenazi Jews have.

And so, if you get that testing back and you’re negative, you might think oh, I don’t have a mutation in those genes. Well, we know from that testing, just as an example, is that you don’t have a mutation in those three alleles of that gene. But if you haven’t had full gene sequencing, you could have a mutation somewhere else in that gene. So, I would say all genetic testing that’s commercially available is probably pretty accurate. But it is important when you get testing done to know what you’re testing for and what you’re not testing for so you can interpret your results accurately. And genetic counselors, as well as your doctors can help you do that.

Katherine:

Right, right. Okay, I’m going to ask the question, this question again. How does symptom management play into the treatment decision?

Dr. Meisel:

I think symptom management is huge, because like I said and I tell this to all my patients at the outset of treatment that most of the time, metastatic breast cancer becomes a chronic diagnosis for a patient. You’re dealing with it, essentially like a chronic illness for the rest of your life. And you’re on some form of treatment for the most part, for the foreseeable future.

And so, making sure quality of life is as good as it can be is critically important. And I think symptom management is a huge part of that and we know that if we can treat and manage symptoms well, people can live better and often live longer because then they can stay on treatment for more extensive periods of time comfortably. And so, I always encourage patients, don’t be a martyr.

Don’t think you have to just bounce in here and tell me everything’s okay if it’s not okay. If you’re having symptoms and side effects from treatment, or from the cancer, I want to know about them so that we can really aggressively manage those symptoms just like we’re aggressively managing the cancer. A lot of times oncologists can do that on their own. We are pretty well versed in managing a lot of symptoms and side effects.

But a lot of times also, there are teams of doctors either who do palliative care or here at Emory, we call it supportive oncology where they are specially trained in things like pain management and managing more common side effects like nausea, constipation, diarrhea, appetite suppression, that can go along with cancer and with treatment.

And then they often will co-manage patients with us as well, just to make sure there’s that really strong focus on maintaining as much of a low symptom burden as possible.

Katherine:

So, you mentioned earlier, clinical trials. When should patients consider participating in a trial?

Dr. Meisel:

I think it’s a great question and I think the answer is really, almost any time. There are trials in every setting. So, I think one of the common misconceptions about clinical trials is that you really only should be in a clinical trial, or your doctor might only mention a clinical trial if they don’t have other options for you or if you’re really in stage. And I think that perception is changing. But I think the reality is that there are clinical trials in every setting.

So, we have clinical trails looking at prevention of breast cancer. Clinical trials looking to optimize early-stage treatment of breast cancer. Clinical trials looking at secondary prevention, so once you’ve had breast cancer, how can we reduce your risk of recurrence. And then lots of clinical trials in the metastatic setting both for patients who are initially diagnosed with metastatic breast cancer.

And then in second, third, fourth line and even for patients who have had tons and tons of additional therapy that we’re looking at new drugs for. So, I think at almost any juncture where you’re making a treatment change, it’s probably appropriate to say, would there be a clinical trail that you can think of that would be good for me in this setting? And it may be that there’s a one that’s 12 hours away, and it’s not convenient for you or feasible.

And it may be that your doctor doesn’t necessarily know of one but then that prompts them to ask a colleague who may be more involved in clinical trial design and development. Or it may be that there is one, but you ultimately choose not to pursue it because you have a different option. But I think it’s always appropriate to ask, would there be a trail for me? Because if there is, then maybe that opens up an option you hadn’t thought about before.

Katherine:

Sure. For patients who aren’t familiar with the stages of clinical trials, would you give us a brief overview of the stages?

Dr. Meisel:

Yeah. Absolutely. So, in terms of clinical trials that’re being done in humans, we talk about Phase I, Phase II and Phase III typically. So, a Phase II clinical trial is typically an earlier stage trial.

Looking at either a drug that has not been tested in humans before or a drug that has not been tested in a particular combination in humans before. And so, those trials are done only in select institutions, usually academic institutions as opposed to private hospitals. And they often have what’s called a dose finding phase and then a dose escalation phase. So, the earliest part of those trials is actually looking at, what is the safest dose to give to patients?

So, they start the first patients at a low dose of the compound. And if those patients do well, the next patients that’re enrolled get enrolled at a slightly higher dose. And then up until they reach the highest dose they can find where people are tolerating it and doing reasonably well. And in those Phase I trials, doctors and investigators are also evaluating efficacy, is this drug working. But the primary goal of the early phase trial is actually to find the right dose to then study in larger groups. And so, if they find the right dose and there’s good biological rationale for the compound, then the trial would go on to a Phase II.

Which might be just what we call single arm Phase II study, where every patient is getting that experimental drug. And we monitor them to see, is the drug effective, or is it less effective than the standard of care? Or sometimes they’re what we call, randomized Phase II trials where patients are randomized to either get the experimental drug, or to get what the standard of care would be in that situation. I think a lot of people get afraid about the idea of a randomized trial because they’re afraid they’re going to be randomized to a placebo. And that is really not done in the metastatic setting, because it wouldn’t be ethical to give a patient with active cancer a placebo.

So, usually the randomization would be either to the study compound or to a standard of care drug. And then if things look good in a Phase II trial, then a Phase III study is done which is usually what the FDA requires to allow a drug to go on and be administered outside of a study for approval. And those Phase III trials tend to be larger studies that’re done in larger groups of patients with more statistical validity because of their size, to determine, is this drug really better than the standard.

Katherine:

Right. We have another question we received earlier, this one from Eileen. She asks, how will I know whether my treatment is working?

Dr. Meisel:

That’s a really good question. So, I think for patients who have symptoms from their cancer, they often will know the drug is working because their symptoms improve. Say if you have lung metastases and you are short of breath and your shortness of breath gets better. That’s a really good sign that the treatment is working. I would say that often what we are doing, and it depends a little bit on the regimen and what the patient is getting and how often they’re coming in.

But we’re checking labs as well and sometimes there are lab abnormalities when a patient is diagnosed with metastatic cancer that can then improve over time. So, for example, if someone has a heavy burden of bone involvement with breast cancer, there’s a lab value called the alkaline phosphatases that will often be elevated. If that starts elevated and comes down, that’s a really good sign. And some of their liver function tests that we check and if a patient has liver metastases, we often will see those come down if a patient is responding.

There are also, what we call tumor markers that we can check in patients with metastatic breast cancer. Those would be proteins in the blood basically that can be made by the breast cancer in abundance. And those are called CA27-29 and CA15-3. Some doctors check both of them. Some will just check one depending on which one their laboratory at their institution is running. But typically, I will check those at diagnosis of metastatic disease. And then if it’s elevated, I know it’s a good marker to follow for my patient. And then I’ll follow that monthly or every three weeks, depending on when the patient is coming in to see me.

And if I see that marker start to go down, it’s not an absolute, but it can be a good early indicator of improvement with the treatment. And then I think it varies a little bit from practice to practice and based on patient preference. But often there will be scans done when a patient is initially diagnosed to determine the extent of the disease. So, usually a CT scan of the chest and the abdomen and the pelvis or a PET scan, which some of you may have heard of. Either one of those is good.

And that can be done about every 12 weeks usually in the beginning, to make sure a patient is responding and once you feel confident that they are, those can be done sell frequently. So, I would say the scans and the lab work and then the patient’s overall condition are usually the way that we look to see, are we having a response or not.

Katherine:

We’ve talked about several key tests. Some patients may be confused about whether they’ve received these tests. So, what questions should they ask their physician to make sure they’re getting appropriate testing?

Dr. Meisel:

I think it’s probably useful because not everybody needs every test, and I think there are often things you hear about online or from friends or even in a webinar like this, and there may be a good reason why you haven’t had that particular test. So, I wouldn’t assume that if you haven’t had everything that we’ve talked about today even, that someone’s made a mistake or that you need that and aren’t getting it. But I would ask. I think it’s always helpful to know more, knowledge is power. And so, if you have never had a CT scan or a CA27-29 level or a genomic testing.

I think it’s not a bad thing if you’re curious about it, to just ask your treating team, “Hey, I heard about genomic testing, is there a reason I haven’t had that? Or have I had that?” Maybe you have, and they called it something else. I think it is complicated, but I think it helps to understand what you’ve had done and what you haven’t had done. And sometimes, asking about something like that may prompt the team to do things that my benefit you.

Katherine:

Before we wrap up, Dr. Meisel, how do you feel about the future of breast cancer research and what would you like patients to know?

Dr. Meisel:

Yeah, I think one of the most important things and I actually said this to a family this morning where a loved one had received a new diagnosis of metastatic breast cancer is that the field has evolved so much over the past five years. I think often when people get a diagnosis of metastatic breast cancer, it’s the most dreadful feeling they ever had. They remember that day for the rest of their lives. But we are seeing so many people do so well for so long now and tolerate treatments well because the treatments are better tolerated.

And there’s I think more attention being paid now to symptom management. That people really can do so much better than they’ve been doing. And I would say really, every year, even every six months, when I go to give a lecture on a topic in metastatic breast cancer, I can’t just give the same talk. I’m always having to update my slides because there’s so many new things coming out, so much new research on the table.

And we’re seeing so many new drug approvals now that we’re starting to unlock some of these new mutations and reasons for progression and understanding new drug classes. So, really think it is a bright time to be in breast cancer research, and there’s never been a better time to be a patient if you have to fall into that category.

Katherine:

It all sounds so promising, Dr. Meisel. Thank you so much for joining us today.

Dr. Meisel:

You’re so welcome. Thank you for having me.

Katherine:

And thank you to all of our partners. If you would like to watch this webinar again, there will be a replay available soon. You’ll receive an email when it’s ready. Also, don’t forget to take the survey immediately following this webinar. It will help us as we plan future programs.

To learn more about breast cancer and to access tools to help you become a proactive patient, visit PowerfulPatients.org. I’m Katherine Banwell, thanks for joining us.

 

How Does Genetic Testing Impact Prostate Cancer Care?

How Does Genetic Testing Impact Prostate Cancer Care? from Patient Empowerment Network on Vimeo.

Genetic testing has taken on a vital role in prostate cancer care. Expert Dr. Maha Hussain provides insight about genetics and biomarker testing, how results are used in determining treatment options, and key questions to ask to ensure the best care.

Dr. Maha Hussain is the Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Learn more about this expert here.

See More From INSIST! Prostate Cancer

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Transcript:

Katherine:

Many patients are confused about the role of genetics and biomarker testing in prostate cancer care.

For people who haven’t heard of some of these terms before, let’s go into the definitions. So, what is genomic or biomarker testing, first of all?

Dr. Hussain:

So, I think there’s one thing. Maybe I can explain because the wording can be confusing. So, there is the genetics, and there is the genomics. The genetics would be what we inherit from our families. So, this would be present in our body. The genomics testing would be to look for what the structure of the genes of the cancer itself, cancer cells itself. Now, that doesn’t mean that this was inherited. It’s just that this is a renegade, and it evolved. And that is what is going to show up.

The reason these two are important, both of them have implications potentially for treatment or perhaps clinical trials. And again, with the PARP inhibitors, the BRCA-like genes will have implications for treatment sort of for resistance cancers.

With regard to the genetics, the implications are for, again, inheritance of family and potential risk for blood relatives. Now, there are panels that are FDA-approved for the purpose of genetic testing. And the requirement or the indications right now, anybody who presents with metastatic disease or an aggressive disease and diagnosis, the recommendation is to proceed with the genetic testing, certainly counseling and testing, because there are some people who prefer not to be tested. And that’s something else.

What I tell my patients is this, even if the testing is done and it was negative for inherited genes that might put the patient family at potential higher risk, the fact that a person has prostate cancer by default puts potential, adds risks to family, to blood relatives.

And the risks aren’t just for the males with regard to prostate cancer, but certainly breast cancer, ovarian cancer, pancreatic cancer potentially, and things of that sort. So, this is where I think a patient needs to be discussing with their doctors. And certainly, there are many centers that have genetics counselor, and so that’s where I generally refer my patients to. I counsel them myself, and then refer them also for more discussions with genetics counselor.

Katherine:

What exactly are genetic mutations? And how do they impact a treatment path?

Dr. Hussain:

Well, I think, again, it’s the changes that happens in specific genes that may promote the aggressiveness of a cancer. And so, the BRCA gene is one of the oldest genes that have been identified in breast cancer. And essentially, the body regulates itself.

And when cancer cells come up and they sort of – the body no longer sustains that regulation, the genetic regulation in those cancer cells. Those cancer cells will behave the way they want to. That means that they’re going to grow faster. That means they could be resistant to treatment and things like that. And so, that’s what we check for, these alterations. And there are certain medications that would allow – and again, in prostate cancer, it’s not a lot. It’s just, as I said, right now the only things that are proven is the PARP inhibitors. This is essentially to kind of gang over the cancer cell, preventing from allowing it to repair itself so it can continue to grow.

Katherine:

Some patients may not know if they’ve received these important tests. So, for patients that aren’t all that sure, what key questions should they be asking their physician or their specialist?

Dr. Hussain:

So, I would say when it comes to the genetics testing, I believe a patient has to consent.

Because again, we live in the U.S., and this is a private matter for the patient. So, this generally has to be the case. Otherwise, depending on the institution, sometimes some tests will require for the overall testing for looking for any genetic alterations, general tumor alternation. Different centers have different things. But the patient should ask and say to their doctor, “Have my cancer genes been tested? Have my genes been tested? And if they have, what are the results?” Because we generally share with the patients once it’s been done.

The other things I should point out, some of the good things that have happened recently. Up until recently, when it comes to the tumor genomic testing, tissue was required. Nowadays, the FDA has approved blood tests that several companies now run that can actually collect blood sample and basically test it for circulating tumor cell genes there.

Now, no testing is 100 percent perfect. But in situations like patients with prostate cancer who may not have recent tissue or adequate tissue for testing, certainly doing the blood test to verify if there is anything reflective of the genes of the cancer, and that may allow for potential actionable-type treatments. Again, up until now, this is more going to apply for potential clinical trials or resistant metastatic disease.

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Is the COVID-19 Vaccine Safe and Effective for People With Colon Cancer?

Is the COVID-19 Vaccine Safe and Effective for People With Colon Cancer? from Patient Empowerment Network on Vimeo.

Dr. Smitha Krishnamurthi, a colon cancer specialist at Cleveland Clinic, provides vaccine safety information and discusses the effective immune response after COVID-19 vaccination in patients with colon cancer.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

See More From The Pro-Active Colon Cancer Patient Toolkit


Related Resources:

Should Your Family Members Be Screened for Colon Cancer?


Transcript:

Katherine Banwell:

Is the COVID vaccine safe and effective for people with colon cancer?

Dr. Krishnamurthi:

Yes. The COVID vaccine is safe. We have no data that patients with colorectal cancer or patients who are undergoing chemotherapy are at any increased risk of any side effects from the vaccine. People should be able to make a good immune response. Patients who are not able to make a good immune response are those who are getting very high-dose chemotherapy, like a bone marrow transplant or an organ transplant. But chemotherapy for colorectal cancer should not be problem. We basically advise – I ask all my patients to get the vaccine. They should just get it whenever they can. They don’t have to worry about timing in regards to their chemotherapy.

Katherine Banwell:

Okay. Dr. Krishnamurthi, thank you so much for joining us today.

Dr. Krishnamurthi:

Katherine, thank you so much for having me. It’s been such a pleasure.

Colon Cancer Treatment and Research News

Colon Cancer Treatment and Research News from Patient Empowerment Network on Vimeo.

What’s the latest colon cancer treatment and research news from the American Society of Clinical Oncology (ASCO) meeting? Dr. Smitha Krishnamurthi shares updates about research findings that were presented at the meeting along with exciting ongoing research in colon cancer.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

See More From The Pro-Active Colon Cancer Patient Toolkit


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Should Your Family Members Be Screened for Colon Cancer?


Transcript:

Should Your Family Members Be Screened for Colon Cancer?

Should Your Family Members Be Screened for Colon Cancer? from Patient Empowerment Network on Vimeo.

When should members of your family get colon cancer screening? Dr. Smitha Krishnamurthi from Cleveland Clinic shares screening guidelines for family members and discusses the necessity of genetic counseling.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

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How Is Colon Cancer Treated?


Transcript:

Katherine Banwell:

If you’ve been diagnosed with colon cancer, what is the guidance for screening family members, such as children and siblings?

Dr. Krishnamurthi:

Yes, this is an excellent question. We tell all our patients who have been diagnosed with colorectal cancer that their first-degree relatives should start screening by age 40, but also 10 years younger than the youngest affected member of the family. So, whichever is younger.

If my patient is 45, definitely that person needs to have genetic counseling because they’re young for colorectal cancer. Then we’d recommend at least start by age 35 for their children or siblings, even if no inherited cause is found.

Katherine Banwell:

Okay, all right.

What Should Be Considered When Choosing a Colon Cancer Treatment Approach?

What Should Be Considered When Choosing a Colon Cancer Treatment Approach? from Patient Empowerment Network on Vimeo.

Dr. Smitha Krishnamurthi, a colon cancer specialist from Cleveland Clinic, reviews considerations when choosing therapy, including staging and test results, as well as how clinical trials fit into treatment planning.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

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Transcript:

Katherine Banwell:

What are the main factors you take into consideration before a treatment approach is decided on?

Dr. Krishnamurthi:

For treatment of anyone with colorectal cancer, most important, of course, is the stage because stage determines whether it’s surgery alone or do we need to use chemotherapy or radiation? Or if it’s metastatic, is it systemic treatment only? We also look at the biologic features of the cancer, which we’re learning more and more are very important.

For example, we want every patient to know their DNA mismatch repair status. This is basically, is the cancer missing a gene that repairs damage to DNA? Then if that’s true, then we say they are DNA mismatch repair deficient. Or another term is “high microsatellite instability.” Mismatch repair deficient or microsatellite instability high, or you might hear MSI high.

That’s very important that we test that on all patients with colorectal cancer because in the early stage setting, it’s important because this is a way to identify patients who may have Lynch syndrome, the most common type of inherited colorectal cancer.

And also it impairs their prognosis. We know these patients tend to have a better prognosis. For example, for stage 2, we wouldn’t even have a conversation about chemotherapy if we know the patient has abnormal DNA mismatch repair or is MSI high. Then for patients of metastatic disease, it’s very important to know this upfront because those patients do better with immunotherapy as their first treatment.

So, we want to see those results for each patient. Then for our patients with metastatic cancer, we also need to see some other genetic mutations such as RAS, KRAS and NRAS gene mutations, because that affects what treatments we use.

Also, BRAF gene mutations are very important because of the particular regiment we use for treatment of that type of cancer.

We’re looking at the extent of the disease, what are the molecular features, and then also, of very importantly, what can the patient tolerate? What are the patient’s goals? We have a discussion about side effects and help them make the best choice for themselves.

Katherine Banwell:

Where do clinical trials fit in?

Dr. Krishnamurthi:

That’s an excellent question because clinical trials actually could be appropriate at any step along this pathway.

There are clinical trials that may be looking at tests to diagnose cancer better or detect it earlier.

There are treatment trials where they may be looking at standard treatment versus something investigational or standard plus investigational. Those sorts of treatment trials may be very interesting as the initial treatment or they could be used when a person has gone through all the standard treatments. Then there’s nothing left to do but try investigational. There are also studies that are looking at supportive care – a new treatment for nausea, for example. There are studies that are looking at the biologic factors of the cancer. Maybe asking a person to donate blood or give permission to use their tumor sample. By participation in these studies, people who volunteer for that are being so generous with their time and their lives.

But that’s how the field advances, especially for treatment trials. This is a way to access cutting edge treatments because the study is being done because the drug looks promising.

I think it’s very important to ask about clinical trials from the beginning and every time there’s a decision point made in the treatment.

How Is Colon Cancer Treated?

How Is Colon Cancer Treated? from Patient Empowerment Network on Vimeo.

Dr. Smitha Krishnamurthi, a colon cancer specialist from Cleveland Clinic, shares an overview of colon cancer treatment and which approaches are used for each stage for optimal patient outcomes.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

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Transcript:

Katherine Banwell:

Can you provide us with an overview of how colon cancer is treated?

Dr. Krishnamurthi:

Yes. Colon cancer is treated based on the stage. It’s a disease that, for the vast majority of patients, is only cured with surgery.

If it can be surgically resected, that’s how this disease is cured. So, it’s very important that we do all we can to maximize early detection because it’s a highly curable cancer when it’s caught early. For early-stage colon cancer, patients are treated with surgery. So, stages 1, 2, and 3.

If it’s rectal cancer, we do some treatment before surgery. We give some chemotherapy and radiation for stages 2 and 3 beforehand to maximally shrink down the tumor to enable the surgeon to take the tumor out of the pelvis with normal tissue all around, like negative margins. Rectal cancer tends to be more complicated surgery because of its location in the pelvis.

So, it’s a little bit different from colon cancer in that we do that chemo radiation and chemotherapy up front. Whereas, for colon cancer, patients who have early-stage disease have surgery. And then, if it’s just stage 1, and this is true for rectal also, they’re done.

Excellent prognosis and go on to surveillance.

But if it’s a stage 2, then in colon cancer we have a discussion about chemotherapy afterwards because that could increase the cure rate for some patients. But for stage 3, we absolutely want to offer chemotherapy to our patients with colon cancer because of this very long, proven track record that chemotherapy can increase the cure rate for stage 3 patients, so when it’s gone to lymph nodes. Then if the disease is metastatic, meaning it’s spread to other distant organs like liver or lung, chemotherapy is the mainstay of treatment, generally speaking.

But there are subsets of patients who benefit from surgery. So, if the cancer is metastasized to just the liver or the lung or both organs, but in limited fashion, there is a track record for patients being cured with surgery.

We always are considering that when we have patients with metastatic disease. My first thought is, is this cancer potentially curable? Then we go from there. In some cases, it’s clear that it’s not curable; it’s widely metastatic. Then there’s no point in subjecting a person to surgery and we know that chemotherapy or drug therapy would be the mainstay of treatment.

What Are the Stages of Colon Cancer

What Are the Stages of Colon Cancer from Patient Empowerment Network on Vimeo.

Colon cancer specialist, Dr. Smitha Krishnamurthi of Cleveland Clinic, provides an overview of the stages of colon cancer and how these stages are determined.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

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Transcript:

Katherine Banwell:

Let’s start with a basic question. What are the stages of colon cancer?

Dr. Krishnamurthi:

Colon cancer is categorized in four stages – stage 1, 2, 3, 4. This takes into account the tumor itself, how thick it is. These tumors start on the inside of the colon, like as a polyp. Then they can grow through the colon wall. The tumor thickness and has it spread to any of the lymph nodes? and has it spread further to a distant organ like liver or lungs?

That’s a tumor node metastasis. Considerations that go into the staging. Stage 1 colon cancer or colorectal cancer would be a very shallow tumor, maybe just in a polyp and hasn’t spread to any nodes or anywhere else. Stage 2 is when the tumor is thicker. It may be involving the full thickness of the colon or rectum but has not spread to any nearby lymph nodes. Stage 3 is when the cancer has spread to regional or nearby lymph nodes. Stage 4 is when it’s metastatic or it’s spread to another organ.

Katherine:

Okay. Thank you.

Which Prostate Cancer Treatment Is Right for You? What You Need to Know

Which Prostate Cancer Treatment Is Right for You? What You Need to Know from Patient Empowerment Network on Vimeo

What do you need to know before deciding which treatment is best for YOUR prostate cancer? Dr. Maha Hussain discusses the role of key tests in choosing therapy, including biomarker testing, provides tips for partnering with your care team and reviews recent research news.

Dr. Maha Hussain is the Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Learn more about this expert here.

Download Guide

See More From INSIST! Prostate Cancer

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What Is a Prostate Cancer Genetic Mutation?

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Transcript:

Katherine:

Hello, and welcome. I’m Katherine Banwell, your host for today’s program. Today, we’re going to discuss how to access the most personalized prostate cancer therapy for your individual disease and why it’s essential to insist on key testing. Before we meet our guest, let’s review a few important details. 

The reminder email you received about this program contains a link to program materials. If you haven’t already, click on that link to access information to follow along during this webinar. At the end of this program, you’ll receive a link to a program survey. Please take a moment to provide feedback about your experience today in order to help us plan future webinars.  

Finally, 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. Maha Hussain. Dr. Hussain, would you please introduce yourself? 

Dr. Hussain:

Sure. Thank you, Katherine. 

It’s my pleasure to join you. And to the audience, nice to meet you all virtually. My name is Maha Hussain. I am a genitourinary medical oncologist with a focus on prostate cancer and bladder cancer. And I am a professor at Northwestern University Feinberg School of Medicine, Department of Medicine, and endowed professor there. And I also serve as the deputy director for the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. 

Katherine:

Wonderful. Thank you so much for taking time out of your busy schedule to join us today. 

Dr. Hussain:

My pleasure. 

Katherine:

I’d like to start by asking about developments in prostate cancer research and treatment. Experts recently gathered at the annual American Society of Clinical Oncology meeting, also known as ASCO, to share their research. 

So, what were the highlights from that meeting that you feel patients should know about? 

Dr. Hussain:

I think probably perhaps I can focus on two major – what I would consider major highlights, and those were the results from two randomized Phase III clinical trials. 

One of the trials is called the VISION trial. And the VISION trial was a Phase III randomized trial evaluating lutetium-PSMA-617 treatment in patients with metastatic castration-resistant prostate cancer. And the delightful thing about this study is that that study was positive. The PSMA story has been really going on for a few years now. And there’s the PSMA for purposes of scans, imaging, to assess the cancer. And the FDA just approved a PSMA PET imaging this year. 

I think it was in May when it was approved. And that would help better define if the cancer is spread or not, and it help with the decision regarding treatment. But the second part is treatment purposes, so identifying the cancer location and trying to attack it with a specific sort of targeted attack to the tumor is really important. 

And so, the FDA is currently looking at this particular agent. And I am hopeful that we will hear soon from the FDA, hopefully before the end of the year, and maybe – who knows? – maybe by summer, middle summer or end of summer. Because I do think that would be a major benchmark in there. And so, that’s one thing. 

The other clinical trial that I thought was interesting from a data perspective – and for disclosure, I am one of the investigators on this study. And this was an intergroup Southwest Oncology, or SWOG, sponsored clinical trial. So, it’s a federal study that Dr. Aggarwal presented. And this was a study that was aiming at maximizing, again, the anti-tumor therapy with the use of a drug which I call is the younger brother of abiraterone. 

So, abiraterone is a drug that is FDA-approved and has been around for several years right now for both castration-resistant prostate cancer and certainly hormone-sensitive metastatic disease. And so, TAK 700 (Orteronel) is a younger brother, I call it, of abiraterone. And one of the potential advantageous when this trial was designed was the fact that you don’t need to use prednisone. And the trial was completed. It was a national clinical trial. And what was interesting is that there is certainly what appears to be a potential benefit, but not in terms of the conclusive based on the way the study was designed.

Having said that, what I thought was remarkable is that patients who basically were only on the control arm was LHRH therapy, so this could’ve been like Lupron, Zoladex, or something like that plus bicalutamide, which is what we call combined androgen deprivation. And that was sort of like the strongest control arm we could do at the time when the trial was designed. 

Remarkably, the patients who were on that arm had a median survival of basically 70 months. That’s the median. That’s the bell-shaped curve with the number in the middle. Seventy months is probably the longest ever in any other randomized trials in this disease space, in the hormone sensitive space. So, that tells us is that men are living longer with prostate cancer, even though it’s metastatic disease; and, yes, it’s not necessarily curable, but men are living longer. And it’s a function of all of the better treatments that are supportive care and everything that was going on.  

And so, the control arm, as I mentioned, was the 70.2 months. The actual experimental arm was about 81.1 months. And again, I don’t know where things will go from this. Obviously, I’m not the sponsor not the FDA. But the point here is that men are living longer, and so wellness and health become even more so important than we ever did. And as I tell my patients, every day you’ll live longer. The odds of living longer is there because of better treatments coming on. 

So, to me – not to take too much time from the interview – to me, these were the two highlights: new, approved – I’m sorry, new treatment that I’m hoping will be FDA-approved and, obviously, the fact that men are living longer.  

Katherine:

How can patients keep up to date on the research that’s going on? 

Dr. Hussain:

I’m a bit biased, obviously. I’m a member of ASCO. 

And what I would recommend to my patients is to look at the cancer.net website. The cancer.net is a website that is an ASCO-generated website specifically for patients and families to review. It is vetted. The committees are not run just by physicians, oncologists, a multidisciplinary team, but also patient representative. So, the lingo and the presentation are lay-friendly, I call it, there. 

The other part I would say, the NCI website, and the American Cancer Society, the American Urological Association. I would say there’s a lot of stuff on the media. The difficulty is vetting what is sort of fake, what is not so accurate, or bias versus there. I also think that the NCCN has also some resources for patients. 

And one thing I always tell patients: explore, look, but make sure that you talk to your doctor about the meanings of everything because sometimes it can be not – it could be misleading, I should say, or maybe not very clear on what the implications are. 

Katherine:

Right. One thing that’s a topic on the mind of many people right now is COVID. 

Dr. Hussain:

Yeah. 

Katherine:

Is the COVID vaccination safe and effective for prostate cancer patients? 

Dr. Hussain:

The answer is yes and yes. So, I have to say, by default, I deal mostly with older men. Age brings in other comorbidities. And certainly, while I see all kinds of shades of gray in terms of the disease extent, going all the way from newly diagnosed all the way to end-stage disease, the bulk of the patients I end up seeing tend to have more systemic disease and have other issues going on. And I have to say, surprisingly, less than a handful of my patients had the infection. 

Only one required hospitalization with supportive measure, but not even needed incubation; however, he needed a lot of CPAP and other respiratory support. I’m not aware of any of my patients or my colleague’s patients who deal with prostate cancer that have died from COVID. So, I would say that’s the good news and that we have not seen a big hit in the population that I deal with. 

I also know that I would say 99.9 percent of my patients have opted to be vaccinated, and they have tolerated the vaccine just fine. There’s only one case, which I actually even saw just this week, who had been vaccinated but have a very, very severe end-stage disease with significantly compromised bone morrow, who got infected but hospitalized for a few days and is recovering. 

And so, I would say just by the pool of patients I see, my answers are yes and yes. 

Katherine:

Very good. Thank you. 

Dr. Hussain:

And I would encourage all the audience to go get vaccinated. I myself am vaccinated. And I’ve advised all my family members to be vaccinated, just to clarify that too. 

Katherine:

Good. Good to know. Dr. Hussain, we’re going to spend most of this conversation talking about advanced prostate cancer. But before we move on, would you give us a brief overview of the stages of prostate cancer? 

Dr. Hussain:

Absolutely. So, with any cancer, we count sort of like four stages. But I would say in prostate cancer the biggest thing is when the cancer is newly diagnosed, which could be confined to the prostate or locally advanced, meaning the cancer has gotten outside the capsule of the prostate but still within that pelvic region. 

There is the group of patients who have pelvic lymph nodes at time of diagnosis. And of course, that is the patients who have systemic disease, which would be technically stage four. Now, the systemic disease implies any abnormality that is found on scans that is beyond the public region. So, that could be lymph nodes in the back of the belly. That could be thoracic lymph nodes. That could be neck nodes. That could be lung lesions, of course, or bone, or liver. 

Now, the most common area where the cancer goes to is really – when we talk about metastatic disease – is the bone. And then lymph is another area where the cancer goes to. Prostate cancer that is confined to the prostate is curable in the vast majority of patients. There is a category of men who undergo surgery or radiation, and then their PSA begins to go up afterwards. 

And this is what we call biochemical relapse. And this is a situation where we know that, in all likelihood obviously, especially of the patients who have had their prostate out, that the cancer has spread. With the current imagine, a good chunk of times, we do not find anything because we’re able to pick up PSA that goes from undetectable to 0.2 to 0.3, but there’s not enough cancer to show up on the scans. We’re hoping, obviously, the better scans, the PET Axumin scan, the PSMA scans are going to help us to identify sites of metastases. 

But this is a group of men where if there is no cancer visible and the only thing we’re dealing with is PSA that’s going up, if they’ve had surgery, then there’s room for what we call salvage therapy with radiation and hormonal treatment. The case is a bit different if there’s only just the prostate – if radiation was given previously. And of course, we talked about metastatic disease. 

Katherine:

Yeah. Once someone has been diagnosed, what tests are used to help understand the aggressiveness of their disease and their overall prognosis? 

Dr. Hussain:

Well, I think there is different basic things, as in, what was the extent of the cancer? How did it look under the microscope? And what is the PSA levels? So, these are the general things. There are different sort of genomic panels that the urologist will use to kind of decipher and other things to kind of help with figuring out aggressiveness and things like that. What I would say is this, is a patient who is diagnosed and has a cancer, and at a minimum has what we consider a Gleason 7 prostate cancer – so, that’s the scoring system that is done with the original Gleason score, or the new patterns where it’s talking about intermediate risk to high risk – to me, this is a cancer that needs to be treated. 

And again, that’s all to do with if a person has other comorbidities, they have some other terminal condition that’s a separate story. But talking generically, that would be when we would recommend. And these are the patients that are generally not seen by the medical oncologist. They’re seen by the urologist, and then they can refer them to radiation oncology also for consultation. 

Katherine:

Now that we understand how test results can help inform a patient’s cancer and how it may behave. Let’s discuss how they can affect treatment options for men with advanced disease. First, let’s do a brief review of the treatment types currently available. There’s hormone therapy, right. What else? 

Dr. Hussain:

Perhaps, it’s simpler if we focus on advanced disease, specifically metastatic disease. 

So, if that’s the deal, then the backbone of treatment is hormone treatment. And it really is. We call it hormone, but technically it’s an anti-hormone. What we’re trying to do is shut down the hormonal pathway that stimulate the testes, which is the factory that makes testosterone. So, we are looking at shutting down testosterone production from the testes in order to starve the cancer. 

Now, the male hormone is produced predominantly – somewhere about 95 percent of it is made by the testes, and then there are about 5 percent-ish that comes from other sources. These are, again, male hormones like the adrenal gland and so on. And there was a while ago some research – I want to say from the MD Anderson crowd, but this is two years ago – that suggested also that the tumor may start to make sort of in-house production of male hormone to support itself. 

Now, having said that, again, testes continue to be the source of the majority of the male hormone. And so, historically, the first data that showed benefit was actually by surgically removing the testes, which is what we call orchiectomy or bilateral orchiectomy. And then medications began hitting the market and were evaluated in the late ’80s and then 1990s, beginning with Lupron – which by the way, in the ’80s, it was an injection that the patient had to give themselves every day, which is remarkable. 

But even then, there is a personal preference by patients to go and take injections as opposed to go through surgery with orchiectomy. But still, I would say for some patients it may be an option until it ought to be discussed as an option. Then what we know is this, is because of the potential other sources for the male hormone, the concept of what we call combined androgen depravation was being evaluated. 

And again, this goes back to the ’80s when the first drug was flutamide and then bicalutamide, and there are other drugs that became. And they kind of added a sprinkle, I call it, to survival. But it wasn’t dramatic, huge differences in survival. And so, generally, while we used it, everybody believed in using it. Moving forward, the drugs like abiraterone, enzalutamide, apalutamide are the three hormonal drugs that have demonstrated conclusively really an advantage in terms of prolonging life when added to the Lupron. 

So, what I tell my patients is that, when it comes to hormone treatment there is really no way around it. You can delay it. Some people are exploring for some patients who don’t have a lot of cancer, maybe a couple of areas, maybe just do targeted radiation and then leave the person alone to buy them some treatment-free time. 

And, to me, this is where the discussion that has to happen with the patient. What is the objective? Is the objective to kind of be ahead of the game and maximally treat the cancer with the hope of prolonging life? Or is the objective to delay treatment? And I would tell you that, with these types of conversation, nine out of 10 or 9.5 out of 10 men opt for moving aggressively up front with management. So, that’s that. 

Now, the one thing I should point out, one of the trials that also was a landmark trial in this disease was the study CHAARTED, which was an intergroup clinical trial at the time it was designed, led by ECOG, and the PI was Dr. Chris Sweeney. I was part of the team that worked on the design also of the study. 

And that was a trial that looked at adding docetaxel to hormone therapy, versus hormone therapy alone, to try to see if it adds something. Historically, all the chemotherapies prior to that that were added to hormone treatment for patients with newly diagnosed metastatic disease had not delivered. And docetaxel did. 

However, one thing I should point out, based on that trial – and I don’t want to go into too much details for the sake of time – the patients that seemed to be benefiting were the patients that had more aggressive, more disease in their system. And so, liver metastases, lung metastases spread in the bone at different areas, not like few isolated areas in the spine or the pelvis, but much more than that. 

And so, for the patients who have what we call high-volume prostate cancer based on scans – and I’m happy to explain what that means if it’s needed – these are the patients that I would offer either the docetaxel plus hormone treatment, which is the injection, or the injection plus the hormonal pills that I mentioned earlier. 

Katherine:

What about targeted therapy? How is that used? 

Dr. Hussain:

Okay. So, let’s begin with the molecularly targeted therapy. So, as we speak right now, for patients who have newly diagnosed metastatic disease that we call hormone sensitive, molecularly targeted therapy is not standard of care. So, I would encourage patients who may qualify for clinical trial to be involved in those. The flipside is – we can talk about it – is that molecularly targeted therapies, specifically with PARP inhibitors have pretty much entered in the space of prostate cancer with a couple of drugs that were FDA-approved. 

The other way of targeted treatment, which would be what we refer to targeted radiation, this would be a different story. This is not systemic treatment. This is a local treatment. And what is done is basically if patients do not have a lot of cancer in their body based on scans, and only certain areas, and they are starting systemic therapy, they can certainly consult with a radiation oncologist to target radiation to areas that are visible on scan. So, if somebody has a couple of, let’s say, pelvic bone lesions, maybe a lymph node, and they are already starting systemic therapy, they can consult with a radiation oncologist focal radiation. And so, that would be the general scheme. 

Katherine:

Many patients are confused about the role of genetics and biomarker testing in prostate cancer care. 

For people who haven’t heard of some of these terms before, let’s go into the definitions. So, what is genomic or biomarker testing, first of all?  

Dr. Hussain: So, I think there’s one thing. Maybe I can explain because the wording can be confusing. So, there is the genetics, and there is the genomics. The genetics would be what we inherit from our families. So, this would be present in our body. The genomics testing would be to look for what the structure of the genes of the cancer itself, cancer cells itself. Now, that doesn’t mean that this was inherited. It’s just that this is a renegade, and it evolved. And that is what is going to show up. 

The reason these two are important, both of them have implications potentially for treatment or perhaps clinical trials. And again, with the PARP inhibitors, the BRCA-like genes will have implications for treatment sort of for resistance cancers. 

With regard to the genetics, the implications are for, again, inheritance of family and potential risk for blood relatives. Now, there are panels that are FDA-approved for the purpose of genetic testing. And the requirement or the indications right now, anybody who presents with metastatic disease or an aggressive disease and diagnosis, the recommendation is to proceed with the genetic testing, certainly counseling and testing, because there are some people who prefer not to be tested. And that’s something else. 

What I tell my patients is this, even if the testing is done and it was negative for inherited genes that might put the patient family at potential higher risk, the fact that a person has prostate cancer by default puts potential, adds risks to family, to blood relatives. 

And the risks aren’t just for the males with regard to prostate cancer, but certainly breast cancer, ovarian cancer, pancreatic cancer potentially, and things of that sort. So, this is where I think a patient needs to be discussing with their doctors. And certainly, there are many centers that have genetics counselor, and so that’s where I generally refer my patients to. I counsel them myself, and then refer them also for more discussions with genetics counselor. 

Katherine:

What exactly are genetic mutations? And how do they impact a treatment path? 

Dr. Hussain:

Well, I think, again, it’s the changes that happens in specific genes that may promote the aggressiveness of a cancer. And so, the BRCA gene is one of the oldest genes that have been identified in breast cancer. And essentially, the body regulates itself. 

And when cancer cells come up and they sort of – the body no longer sustains that regulation, the genetic regulation in those cancer cells. Those cancer cells will behave the way they want to. That means that they’re going to grow faster. That means they could be resistant to treatment and things like that. And so, that’s what we check for, these alterations. And there are certain medications that would allow – and again, in prostate cancer, it’s not a lot. It’s just, as I said, right now the only things that are proven is the PARP inhibitors. This is essentially to kinda gang over the cancer cell, preventing from allowing it to repair itself so it can continue to grow. 

Katherine:

Some patients may not know if they’ve received these important tests. So, for patients that aren’t all that sure, what key questions should they be asking their physician or their specialist? 

Dr. Hussain:

So, I would say when it comes to the genetics testing, I believe a patient has to consent. 

Because again, we live in the U.S., and this is a private matter for the patient. So, this generally has to be the case. Otherwise, depending on the institution, sometimes some tests will require for the overall testing for looking for any genetic alterations, general tumor alternation. Different centers have different things. But the patient should ask and say to their doctor, “Have my cancer genes been tested? Have my genes been tested? And if they have, what are the results?” Because we generally share with the patients once it’s been done. 

The other things I should point out, some of the good things that have happened recently. Up until recently, when it comes to the tumor genomic testing, tissue was required. Nowadays, the FDA has approved blood tests that several companies now run that can actually collect blood sample and basically test it for circulating tumor cell genes there. 

Now, no testing is 100 percent perfect. But in situations like patients with prostate cancer who may not have recent tissue or adequate tissue for testing, certainly doing the blood test to verify if there is anything reflective of the genes of the cancer, and that may allow for potential actionable-type treatments. Again, up until now, this is more going to apply for potential clinical trials or resistant metastatic disease. 

Katherine:

Are there other important factors to consider, like a patient’s age, that can help them access the best treatment for their prostate cancer? 

Dr. Hussain:

Yes. And I think that age is one factor. What I say and what I tell my fellows, age is to be respected, but used to discriminate in terms of management. 

 We all age. And certainly, the body reserve is not the same. And so, that’s why I would say that has to be respected. But it doesn’t mean that we cannot treat patients. 

And I’ll tell you, it’s interesting. There are times where you have – I have a gentleman who used to run seven miles a day. He was 87 years old. This was in my days when I used to be in Ann Arbor at University of Michigan. And the gentleman came to me, and he said, “Dr. Hussain, I don’t feel good.” And I said, “Sir, why? What has happened?” “I can’t run like I did before.” And I said, “You’re not running?” “No, I am running. I’m just not able to do seven miles a day. I can do only four miles a day.” I’m like, whoa, that’s about 100% more than I do. 

Now, again, I’m bringing this as an extreme example. But for some of the oral agents, like the Olaparib trial, there were men in there literally late-’80s, early-’90s that were included in the clinical trials. Same thing goes for several of the other trials. 

I do think that functionality is important. So, if somebody comes to you so sick they are in a wheelchair, you really have to be very careful. And again, I’m just using kind of extremes. And so, you have to be careful by what you are able to do. And any time the doctor thinks the odds are going to be more harm than good, this is really where absolutely a situation where the physician needs to be careful about it, and the patient needs to understand it also. At the end of the day, it’s a shared decision. 

Katherine:

Before we close, Dr. Hussain, how do you feel about the future or prostate cancer research, and what would you like patients to know? 

Dr. Hussain:

First, let me say that I would love for the patients to know that they are a partner, a most critical partner in the process.  

That we need to continue the research and investment in research. It is research that will end up curing cancer. Wishful thinking will not do it. And patient volunteering, which I think is remarkable across all cancers. The business I’m in, the way that drug discovery and evolution often happen because patients volunteered. And without testing these new treatments and combinations, we will not be able to get better results.  

And I will tell you that, when I started my training, the median survival for patients with resistant prostate cancer was on the magnitude of about nine months. Now it is three years-plus. Now, you could argue, well, that’s not huge. But that is a huge change because, again, we’re picking up the cancers much earlier. And the patients who had, as I mentioned, metastatic disease, again, the longevity then at the time I was in training, but even afterwards, was give and take in the three years. And now we’re talking six-plus years. 

And so, there’s been tremendous progress. And really partnership with the patients and their families and supportive others is very critical, and investment in research. So, yes, advocate constantly for more investment in research. 

Katherine:

All sounds very promising, Dr. Hussain. Thank you so much for taking the time to join us today. 

Dr. Hussain:

My pleasure. And be well, all of you.  

Katherine:

Thank you. And thank you to all of our partners. If you would like to watch this webinar again, there will be a replay available soon. You’ll receive an email when it’s ready. And don’t forget to take the survey immediately following this webinar. It will help us as we plan future programs. To learn more about prostate cancer and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us. 

What Are Some Hereditary Factors Impacting Prostate Cancer Patients?

What Are Some Hereditary Factors Impacting Prostate Cancer Patients? from Patient Empowerment Network on Vimeo.

Along with aging, hereditary factors also contribute to prostate cancer incidence. Expert Dr. Leanne Burnham details some of the hereditary factors, their mechanism of action, and some treatments under study in prostate cancer clinical trials for African American men.

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Transcript:

Dr. Leanne Burnham

So, cancer is a disease of aging, and cancer is a hereditary disease for a lot of different kinds of cancers, not all, but for a lot of them. And so prostate cancer is one of those that we know for sure that there are some genetic variations that are passed down from our parents that would make men either predisposed or not to get prostate cancer and also would predispose them to get aggressive prostate cancer.

And so, for example, if you have a father, an uncle, grandfather, if you have family members that have had prostate cancer, and beyond that, if you had women in your family that have had breast cancer, then that increases your chance as a man to get prostate cancer and to get it even younger than other races would. And so certain things that we look at in the lab and in the clinic at City of Hope are really trying to understand what those hereditary factors are, and then how you can target them with drug treatments specifically.

So, for example, we have a clinical trial that a team of us developed, and we are looking at the ability of something called PARP inhibitor not to get too technical with you, but PARP inhibitors, if you want to Google it, they are at the forefront of prostate cancer treatments right now, and especially a few running in clinical trials. And so there is a hereditary disposition, there is a mutation on the BRCA gene that leads to PARP inhibitors benefiting any person that would have that BRCA mutation.

What we’re doing in our clinical trial is we are using a PARP inhibitor called talazoparib (Talzenna), and we are not only providing that to patients that have the spark commutation, but we are extending it to patients that may not have that mutation, and the reason for is because, and I definitely don’t want to get crazy technical, but the reason for it in a nutshell, as we know in cancer there is an interaction between PARP inhibition and androgen receptor function and reaction to treatments. And so, you may have heard of androgen and androgen receptor when it comes to prostate cancer, it’s really the fancy way of saying testosterone, and prostate cancer needs testosterone, or it needs androgen and androgen receptor to function and to grow. And so, what we want to see in this clinical trial is if we target, if we use PARP inhibitors in combination with hormone therapy that’s targeting androgen production androgen receptor, will we see better treatment and better response to the drugs in those patients. And the extra cool part to me is we know that there are variations in DNA segments that affect androgen receptor function in African American men. And so, for a specific mechanism that I won’t dive into, it involves trinucleotide repeats and link, segments links and all this, but because of these variations and androgen receptor in African American men that we know was associated with their ancestry and what they’ve inherited in their own DNA, this drug should work better in African American men. And we will be able to tease that out in this clinical trial. So, it’s an opportunity for African American men who have prostate cancer who have not developed castration resistance yet, but who do have metastatic prostate cancer so, at that point, there is not a cure, right, and so you can go to your physician, and you can get a standard of care therapy, or you may want to consider this clinical trial where you would receive standard care therapy. And then also, as I said before this VIP access to this new drug, this PARP inhibitor that we think may improve outcomes in men.