Tag Archive for: clinical trial

Charise Gleason: Why Is It Important for You to Empower Patients?

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Charise Gleason: Why Is It Important for You to Empower Patients? from Patient Empowerment Network on Vimeo.

How can patients and families be empowered? Advanced practice professional Charise Gleason from Winship Cancer Institute discusses her perspective and communication methods that have shown benefits for her myeloma patients.

See More from Empowering Providers to Empower Patients (EPEP)

Related Resources:

Dr. Jung Gong: Why Is It Important for You to Empower Patients?

 Beth Sandy: Why Is It Important for You to Empower Patients?

 Dr. Craig Cole: Why Is It Important for You to Empower Patients?

Dr. Craig Cole: Why Is It Important for You to Empower Patients?

Transcript:

Charise Gleason:

I think it’s important to empower our patients, and we do that from day one. Patient comes to us, we’re starting to develop that relationship. And the discussions that we have early on can be very different from later, but we have to continually reinforce, ask questions, give patients the opportunity to ask us questions. I know when I talk to a patient about a clinical trial, and I’m documenting, I put that back in, patient or family member or care partner was given the opportunity to ask questions.

Our clinics go very quickly, and you have to make the time for your patients. So you have that relationship, and they know that they can bring issues to you. Sometimes we don’t get it right either, and you’ve got to own that and move on to that next step. So you continue that relationship. Patients are going through losing control with having a cancer, and like myeloma and many times patients never even heard of multiple myeloma until they come into our world.

So it is an ongoing open communication, and we don’t make decisions for them. We give them options and upfront or early relapse, you may have far more options than you do in that relapsed/refractory setting. But you’ve got to know what’s important to your patient and what their goals are. And, are they still working? Our patients vary in age. But you want to think about where your patient is, what’s important to them, and you don’t know that unless you ask the questions and have that communication. Our patients are very savvy. We go to meetings. The first thing they want to know is what did you learn? Even when they’re doing well on their current treatment, they want to know what’s next. What’s out there for me if this stops working?

 When we’re in that biochemical relapse phase where we don’t have to change treatment, we’re already having those conversations about what are those options next for you? And so I think that having that team approach, that open communication is really important for our patients and empowers them to make good decisions. As an advanced practice provider, it’s important for me to explain my role, right?

Patients will come to a practice, and sometimes they’re surprised that I don’t see the physician every time I come. So I think it’s instead of ignoring that and not telling patients, I think it’s important that we describe our roles in that care as well. That, yes, I also specialize in multiple myeloma. I collaborate with your physician. We talk about you, even if you’re not seeing your physician. And so I think that patient and family understanding the rest of the team and what we bring to the table for them is essential as well. 

What Do You Need to Know When Considering CAR T-Cell Therapy?

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What Do You Need to Know When Considering CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

How does one access myeloma CAR T-cell therapy? This animated explainer video provides an overview of the steps involved in determining whether a patient qualifies to receive CAR T-cell therapy, what the process entails, common side effects, and why having a care partner is essential.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Understanding CAR T-Cell Therapy | How It Works and Who It’s Right For

Understanding CAR T-Cell Therapy | How It Works and Who It’s Right For 

 Understanding Possible Side Effects of CAR T-Cell Therapy

Understanding Possible Side Effects of CAR T-Cell Therapy 

 What You Need to Know About Accessing CAR T-Cell Therapy

What You Need to Know About Accessing CAR T-Cell Therapy 

Transcript:

The emergence of CAR T-cell therapy is revolutionizing treatment for some people with myeloma. But, who is it right for, and what is the process for people that qualify?  

  • The first step in accessing this treatment is to be referred by your physician to a center that specializes in CAR T-cell therapy. 
  • Then, a consultation will take place with the transplant team, and a health assessment is administered to ensure patients are healthy enough for CAR T-cell therapy. This includes testing to review the current status of your cancer and testing of your body’s major organ systems.
  • Next, the specialty center will evaluate the best type of CAR T-cell therapy for the patient, including clinical trial options.
  • After approval, financial coordinators will discuss insurance and therapy costs with the potential recipient. Logistics are also arranged at this time, which may include help with transportation and housing, if necessary.
  • Medical centers also require that patients have a care partner, such as a family member or friend, who can be with them at all times, particularly after leaving the hospital. 

So, what is the process once a patient is approved for CAR T-cell therapy? Once a patient is approved to move forward with the procedure, a date is set for collection of the patient’s T cells. T-cells are collected during a process called apheresis. During apheresis a specialized machine filters the patient’s blood to remove the T-cells for collection and the rest of the blood is returned to the patient.  

 After collection, the T cells are sent for manufacturing. During that time, the patient is given a “bridging therapy” to maintain the myeloma until the CAR T cells are infused.  

Once the CAR T cells are infused, the patient will be closely monitored by the CAR T center. This may or may not include hospitalization depending on the policies of the treatment center. Patients and their care partner should plan to stay close by the center for up to 30 days after the infusion.  

During this time, the patient is evaluated for their response to treatment and monitored for possible side effects so that they can be managed in a timely manner.  

The potential side effects of CAR T-cell therapy may include: 

  • Cytokine release syndrome, or CRS, which is an aggressive response to treatment by the immune system and may cause symptoms such as low blood pressure, high heart rate decreased oxygen saturation, fever, nausea, and body aches. 
  • Another possible side effect is neurotoxicity, which is an adverse event that may cause issues such as confusion, difficulty with communication, seizure, or tremors. 
  • And, another side effect may be low blood counts, which could impact the immune system and increase risk for infection. 

Every patient is different, so close monitoring is essential.  

So now that you know more about CAR T-cell therapy, you can work with your healthcare team to decide if this treatment option may be right for you. Be sure to speak up and ask questions. Remember, you have a voice in YOUR myeloma care. 

To learn more about myeloma and to access tools for self-advocacy, visit powerfulpatients.org/myeloma.  

Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia with IDH1 Mutation

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Introduction 

Once again a new drug that was recently FDA approved for some Acute Myeloid Leukemia (AML) patients. Olutasidenib (brand name: Rezlidhia) was approved in December 2022 for AML patients who have relapsed or are refractory to treatment (R/R) with a mutation in the Isocitrate Dehydrogenase 1 (IDH1) gene. There is a different gene called IDH2, which can also be mutated in patients with AML, but different medications are used for IDH2 mutations. 

An existing drug, called ivosidenib (brand name: Tibsovo) was already approved for patients with AML and a mutation in IDH1. It was initially approved in July 2018 as a single agent for patients with R? AML with a IDH1 mutation. Later it was approved for use in combination with azacytidine for newly diagnosed AML patients with an IDH1 mutation. There was also a specific test (the Abbott RealTime IDH1 Assay) approved along with the initial approval of ivosidenib. This test was also approved to select patients to be treated with olutasicdenib.

Results of the Current Study 

The study used to support the approval was a non-randomized trial (all patients received olutasidenib). The study included patients with AML and ones with Myelodysplastic Syndrome (MDS) who had a mutation in the IDH1 gene. Patients were treated with olutasidenib as a single agent (monotherapy) as well as combined with azacytidine. The approval was based on the results of the 147 patients who received olutasidenib monotherapy (the results are described in detail here). 

In the study, about 35% of patients achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) – the latter means that they appear to be in remission, but their blood counts are not normal. In addition, about one third of patients who were platelet and/or red blood transfusion dependent at the start of the trial eventually did not require transfusions for 8 or more consecutive weeks (transfusion independent). All patients experienced 1 or more adverse events (AEs) and almost all experience a serious (Grade III or IV) AE. These AEs are expected in patients with AML, particularly older patients, as most of the patients were. 

Comparison with Ivosidenib 

Now that there are 2 drugs approved for AML patients with an IDH1 mutation, the question becomes which drug should be used and in which circumstances. There have been no studies (at least ones that are published) that directly compare the drugs. According to the paper from Bload Advances on the responses to olutasidenib and ivosidenib as single agents was about the same, however the length of remission in the patients receiving olutasidenib (a median of 25.9 months) compared to ivosidenib (8.2 months0. The big caveat is that, since the comparison was not randomized, it is difficult to determine if there were differences in risks in each group. My guess is that there will not be a randomized comparison of these two groups.

It will be more interesting to look at these drugs in combination with azacytadine and also as a 3 drug combination of azacytidine and venetoclax. In addition, these drugs could be combined with existing intensive chemotherapy regimens (for instance, so-called 7+3 induction with cytarabine and daunorubicin). Likely the combinations would produce more remissions but might have significantly more side effects. 

In summary, the good news is that there is another drug that can help some patients with AML, the bad news is that the determination of the best therapy is yet more complicated. 

Further reading 

Olutasidenib: 

Ivosidenib: 

Advances in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (AML)

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Advances in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (AML) from Patient Empowerment Network on Vimeo.

AML expert Dr. Omer Jamy discusses his approach when considering treatment for patients with relapsed or refractory AML, including transplant eligibility, molecular markers, and whether clinical trials may be an appropriate option.

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

See More From INSIST! AML

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What Is the AGILE Study? Research for AML Patients With the IDH1 Mutation

What Is the AGILE Study? Research for AML Patients With the IDH1 Mutation

 What Is the Purpose of AML Genetic Testing

What is the Purpose of AML Genetic Testing?

 Essential Testing | Optimizing AML Care With Personalized Medicine

Essential Testing Optimizing AML Care with Personalized Medicine

Transcript:

Katherine Banwell:

Dr. Jamy, are there any recent advances that may affect the care of patients with relapsed or refractory AML? 

Dr. Omer Jamy:

Yeah, that’s a good question. So, patients with relapse refractory AML, of course, carry a poor prognosis. That means that chemotherapy was working and has stopped working or chemotherapy didn’t work from the get-go, right?  

So, in my practice I try to divide patients into two different buckets. One is that I need to get them into remission, and they’re fit for a transplant, so I take them to transplant.  

So, then my treatment approach is a little different for those patients. As opposed to someone who’s elderly or too frail, that they may go into remission, but they may not be able to proceed to stem cell transplantation after that.  

So, what happened in the relapsed/refractory setting also depends on what the patient received in the upfront setting. Ideally, I would recommend a clinical trial enrollment for patients with relapse refractory AML if they have access to it. At the time of relapsed/refractory AML, it is very important to again profile the leukemia to see if there are any mutations that were present at diagnosis or if there are any new mutations for which there may be targeted therapy. Some of those mutations for which we have targeted therapy include FLT3-ITD for which there is a drug called gilteritnib (Xospata), which is FDA-approved in the relapsed/refractory setting. 

We spoke about IDH 1 which is ivosidenib, IDH 2 which is enasidenib (Idhifa) is also approved for patients with relapsed/refractory AML. And then more recently the FDA approved another IDH1 compound called olutasidenib (Rezlidhia) which is also for patients with relapse refractory acute myeloid leukemia with an IDH1 mutation. I think these are target therapies which have shown to get people into a second remission and beyond. And these have been approved in the last few years. And I think it is very important to basically test whether the person harbors these mutations so that we can target them accordingly.  

For patients who don’t have any mutations we would generally, outside of a clinical trial, probably use the combination of some of the approved agents that may be venetoclax (Venclexta) with azacitidine (Vidaza) or decitabine (Dacogen). Patients who may have received this venetoclax or a hypomethylating agents frontline and may still be eligible for intensive chemotherapy.  

You could offer them intensive chemotherapy in the relapsed/refractory setting, but I would say that at this point being at a center where there’s opportunities to enroll in a clinical trial would be really helpful as well. 

When Should AML Patients Consider Joining a Clinical Trial?

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When Should AML Patients Consider Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.

With AML research advancing quickly, clinical trials are an important consideration when making a treatment decision. AML expert and researcher Dr. Omer Jamy discusses when joining a clinical trial may be appropriate. 

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

See More from Thrive AML

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Expert Perspective | Key Advice for AML Patients

Expert Perspective | Key Advice for AML Patients

 Updates in AML Treatment and Research From ASCO 2023

 What Are the Phases of AML Therapy

Transcript:

Katherine Banwell:

Dr. Jamy, when should AML patients consider joining a clinical trial? 

Dr. Omer Jamy:

Yeah, that’s a very interesting question. No, I have my personal thoughts on that which I share. So, I feel like clinical trials are of different flavors. They range from early phase to late phase trials. I think being at a center where there’s opportunities to enroll in clinical trials is really helpful. Now if you have a newly diagnosed patient with AML, there is good standard of care treatment. Of course, they can be improved upon.  

I would probably improve upon them in the setting of a Phase III where they get standard of care plus an additional agent versus placebo where at minimum, they’re getting standard of care, right? So, it will be very challenging unless it’s a very novel concept to enroll someone who has not seen any standard therapy on an earlier phase study. Let’s put it this way. Whereas it changes completely when they’ve relapsed meaning they’ve gone through options which are pretty standard. At that point, enrolling in the clinical trial is most likely in their best interest. I think because once leukemia relapses, we have limited options.  

I think we’ve been lucky over the past five years that we’ve had several drugs approved. But there’s still probably less than 10. And out of those, not everybody is a candidate for each of those drugs. They’re targeting specific mutations. So, the relapse refractory setting I think enrolling in a clinical trial is really helpful. Up front I just take more interest in the clinical trial design and the consent form before agreeing to participate. 

Expert Perspective | Key Advice for AML Patients

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Expert Perspective | Key Advice for AML Patients from Patient Empowerment Network on Vimeo.

Facing an AML diagnosis can feel overwhelming. Dr. Omer Jamy shares tips for newly diagnosed AML patients, emphasizing the importance of a consultation with a specialist.

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

See More from Thrive AML

Related Resources:

Updates in AML Treatment and Research From ASCO 2023

What Are the Phases of AML Therapy

Transcript:

Katherine Banwell:

Dr. Jamy, for patients who have been diagnosed with AML, could you share three key pieces of advice for them. How can they be proactive in their care? 

Dr. Omer Jamy:

Sure. So, I feel like as a leukemia physician I would like to see, just to give you an example, I’d like to see all the leukemia patients in Alabama. But that’s not feasible, right? But what I would recommend to patients and caregivers is that wherever they are diagnosed, I do feel that they would benefit from a consultation with a leukemia physician at a tertiary care center or an academic center. And they would benefit due to various reasons, right? So, the first reason would be that as a leukemia physician my job is to just keep myself upgraded with leukemia care, leukemia management.  

So, one aspect of leukemia is therapeutics, right? So, drugs that are approved, easy to give. But the other aspect is understanding the biology of the disease, understanding how leukemia is going to behave. To get a better profile for AML for a patient. So, in a way saying that not all AML cases are the same. So, to be seen at a center would help the physician understand the unique cytogenetic or molecular profile of that patient’s AML which may be different from the next patient’s AML which could mean that the treatment algorithm for one person might be slightly different from the second person. So, I mean the academic and the people working at academic centers cannot survive without people working in the community, so it goes hand in hand. So, I feel like co-management of a patient with AML is extremely important. I feel like things will not get missed that way.  

I feel like the treatment plan, no matter where it is implemented, would really benefit the patient. It can be implemented closer to home as long as it’s been co-managed with someone closer to home as well as someone at the center where they have access to more information. What this would also help is get the person and the family plugged into a system where, let’s say if therapy wasn’t working, they’d have access to enroll on clinical trials down the line as well. Which unfortunately are only present at academic centers and not very widely available, especially for blood cancers. There may be trials for solid tumors easily conducted outside of academic centers, but unfortunately that’s not the case for blood cancers, specifically AML. So, the opportunity to enroll in clinical trials will also help.  

And then lastly, I feel like it’s our ability to offer bone marrow transplant to older patients has improved over the past 10 to 15 years.  

We’ve become better in identifying donors and in identifying patients, getting them ready for transplant that I feel that a person and the caregiver should inquire from their physician about the opportunity – oh, of No. 1 the need for transplant for the leukemia is because not all the AML patients may benefit from our transplant, but most of them do. And definitely anyone who relapses would benefit from a stem cell transplant.  

So, I feel like inquiring about that is very important because to get plugged in at a transplant center early on is important because you don’t want to waste time early on. You may not need the transplant, but just having the consultation and just having a preliminary donor search ongoing in the background is really helpful because when the time comes that a person needs the transplant, then you’ve already got some of that information ready, and you can proceed quickly. So, I feel like a few of those things might be helpful which I try to educate in the community as well and do outreach.  

Because I feel like it’s important to let people know that AML is an aggressive disease. Transplant is pretty intense, but we are now making it more and more tolerable for older patients. 

Updates in AML Treatment and Research From ASCO 2023

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Updates in AML Treatment and Research From ASCO 2023 from Patient Empowerment Network on Vimeo.

AML expert Dr. Omer Jamy shares highlights from the recent American Society of Clinical Oncology (ASCO) annual meeting, including an update on an immunotherapy agent showing promise as well as a vaccine therapy being studied for patients in a second remission.

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

See More from Thrive AML

Related Resources:

Expert Perspective | Key Advice for AML Patients

Expert Perspective | Key Advice for AML Patients

What Are the Phases of AML Therapy

Transcript:

Dr. Omer Jamy:

My name is Omer Jamy, and I’m a leukemia and bone marrow transplant physician at the University of Alabama at Birmingham. And I’m really happy to be here today.  

Katherine Banwell:

Well, thank you. Dr. Jamy, the ASCO 2023 meeting just wrapped up recently. What were the highlights in AML research from that meeting? 

Dr. Omer Jamy:

Thank you. Yeah. There were several interesting studies in AML presented at ASCO this year. I’d like to highlight a couple of them in particular mainly because the focus on a novel mechanism of action, at least for patients with acute myeloid leukemia. And that mechanism of action being immunotherapy. So, we’re all aware that immunotherapy has had tremendous results in solid tumors.   

It’s making its way into hematological malignancies mainly lymphomas as well as B-cell ALL which is acute lymphoblastic leukemia. And we are trying to investigate it in patients with AML as well.  

And I think in that context there were a couple of abstracts which I thought were really interesting. The first one was actually presented by Dr. Anthony Stein and colleagues. Looking at a drug which is basically CD123 NK-cell engager.  

And I spent a little bit trying to explain what that is, but basically, it’s a drug which it harnesses the person’s immune system to fight the cancer basically. So, it targets an antigen which is expressed on leukemia cells called CD123. And it binds it to natural killer cells or NK cells. So, this drug is taking the host which is the patient’s natural killer cells and the leukemia cells and binding them together and then leads to the activation of the NK cells which causes killing of the leukemia cells.  

So, I think that mechanistically speaking that’s a very interesting concept to fine tune the person’s own immune system to fight the leukemia. This is obviously very early in development, so it’s a Phase I study, Phase I/Phase II. And they have presented results in 23 patients with relapsed/refractory AML.  

And just to give you some background, CD123 is expressed in the majority of patients with acute myeloid leukemia. It’s also expressed in patients with myelodysplastic syndrome as well as ALL. So, the study had all three diseases, but we’re going to focus on AML today. So, there were 23 patients with acute myeloid leukemia in the study. And because it’s a Phase I study, they have to test it at the lowest dose, and then assess for safety, and then keep on going up on the dose. So, they actually looked at six dose levels. And luckily because it’s a Phase I, the primary objective is to make sure it’s a safe drug to administer.  

And then second your objectives are basically if it’s efficacious or not. So, there were no dose limiting toxicities in the 21 evaluable patients out of the 23. So, that’s good. I think the lowest dose was 100 micrograms per kilograms per day. And the highest dose was 3,000 micrograms per kilogram per dose. The doses IV once or twice a week for the first couple of weeks, and then followed by weekly administration. In 23 patients the drug was thought to be safe. Again, no dose limiting toxicities.  

With immunotherapy you worry about side effects such as cytokine release syndrome because you are basically putting your immune system in overdrive. So, you don’t want to make sure your immune system doesn’t wreak havoc on the body itself. So, cytokine release syndrome or CRS as well as associated neurotoxicity are two common side effects of most of these novel immunotherapies.  

Which for the general audience, if they’ve heard about CAR T therapy or antibody drug conjugates or bispecifics, these are all under the same umbrella of immunotherapy. So, their side effect profile is pretty overlapping and different from what would be seen with conventional chemotherapy. So, they saw no neurotoxicity. And they saw CRS which was very manageable, right? Grade 1 or Grade 2 in a couple of patients. And as far as efficacy was concerned, out of the 23 patients they saw a response in three patients. Now that doesn’t sound very appealing, but you have to realize these are starting at a very low dose level and going up. So, when they looked at patients who were getting a dose of 1f,000 micrograms per kilograms per day, so a pretty hefty dose. Three out of eight patients, which roughly translates to 40% of the patients, achieved a remission. So, which to me for relapse refractory population is attractive. And it makes me want to investigate this molecule further.  

And that is exactly what’s going on currently with the study. And I think again CD123 is an interesting target. The other companies targeting as well either as NK-cell engagers or antibody drug conjugates with other payloads. So, this is an area of active investigation. So, that’s where – 

Katherine Banwell:

You said – 

Dr. Omer Jamy:

Yeah.  

Katherine Banwell:

Yeah, you said there was another study. Could you briefly tell us about that.  

Dr. Omer Jamy:

Exactly. So, the other study is also harnessing the person’s immune system to fight leukemia in a very different way. And this is a randomized Phase III study, ongoing. It’s international. And it’s a trials in progress meaning that it’s accruing across the country, or actually across the globe. And I wanted to highlight this in case people want to reach out to centers where this study is ongoing and want to participate in it. This is a trials in progress poster of a compound called GPS which is basically a vaccine against a protein called Wilm’s tumor 1 or WT1 which is vitally expressed on leukemia cells as well.  

Now this is a tumor vaccine actually which is a novel concept of an AML. So, vaccines as you know, are better at prevention than treatment. So, this is a maintenance drug for people in second remission or beyond who are unable to proceed to stem cell transplantation.  

So, they get the opportunity to enroll in this Phase III which is a randomized study of either GPS versus a physician’s choice which includes a wide variety of agents to choose from making it a pretty reasonable control arm and follows patients to see if the primary end point being overall survival. So, I think again for patients who achieve second remission or beyond ideally, they should proceed to stem cell transplantation. But there are several barriers to that including advanced age, comorbidities, socioeconomic barriers. So not everyone can proceed. So, for patients in that situation, there is no standardized maintenance therapy.   

And in that context I feel like an immunotherapy agent basically this vaccine which has shown very promising results in single-arm Phase I, Phase II studies is now being investigated in a Phase III study. And because it’s a trials in progress I cannot share any results with you because we don’t have any results. But I feel like people should know about this because it is open at 20 to 30 centers in the US.  

And it’s an option out there for patients who would like to participate in such a clinical trial. 

PODCAST: Clinical Trials as a Prostate Cancer Treatment Option | What You Should Know

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Should you consider participating in a prostate cancer clinical trial? Dr. Sumit Subudhi explains the clinical trial process, addresses common trial patient concerns, and provides key advice for trial participation. Dr. Subudhi also shares an update on promising prostate cancer research.

Dr. Sumit Subudhi is an Associate Professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

See More from the Empowered! Podcast

Transcript:

Katherine Banwell:

Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today we’re going to discuss prostate cancer research advances and the role of clinical trials and moving treatment developments forward. Before we meet our guest, let’s review a few important details.   

The reminder email you received about this program contains a link to a program resource guide. 

If you haven’t already, click that link to access information to follow along during the webinar. At the end of this program, you will receive a link to a program survey. This will allow you to provide feedback about your experience today, and it will 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. 

Well, let’s meet our guest today. Joining me is Dr. Sumit Subudhi. Dr. Subudhi, thanks for being with us. Would you introduce yourself? 

Dr. Subudhi:

Hi. I’m Sumit Subudhi. I’m an associate professor in the GU Medical Oncology department at MD Anderson Cancer Center. And I exclusively treat patients with advanced prostate cancer. And I’ve been doing it for about a decade. 

Katherine:

Thank you. I’d like to begin with an update on prostate cancer research. Would you walk us through the newer classes of treatments that are showing promise? 

Dr. Subudhi:

Yeah, in clinical trials, there are classes of drugs known as androgen receptor degraders. And so, the androgen receptor is a protein that basically is the mouth of the prostate cancer. That’s how I like to describe it. And it actually allows testosterone, which is the food, to be eaten by the mouth, and it actually helps the cancer grow. 

And what these drugs do is they actually degrade or break down the mouth of the cancer. And, therefore, it starves the cancer to death, and that’s actually the concept. And they seem to be showing some exciting activity in clinical trials, especially in those patients who are resistant to the second-generation hormonal drug that you may have heard of already, such as enzalutamide (Xtandi), apalutamide (Erleada), and darolutamide (Nubeqa). So, I think is something that we’re looking forward to seeing more data on. 

Another class of drugs are antibody drug conjugates or ADCs.  

And these are what I think of as heat-seeking missiles. So, one part of the drug actually recognizes the cancer, and the other part of the drug actually has a payload that sort of releases a bomb or sort of like chemotherapy-type agent right where the cancer’s located and kills the cancer in that way. And we’re seeing some great clinical activity in prostate cancer with this class of drugs. 

And then the final one is bispecifics, and in particular T-cell bispecifics. So, T cells are part of the immune system that actually help kill the cancer.  

And, unfortunately, prostate cancer, like some other cancers like pancreatic and glioblastoma, have few T cells inside it. And, therefore, a lot of the immunotherapies that many people have heard about, such as ipilimumab (Yervoy) and pembrolizumab (Keytruda), they’re not very responsive in patients with prostate cancer. And it’s because there’s few T cells in prostate cancer.  

What the T-cell bispecifics do is they actually have one part of the drug that actually recognizes the cancer and the other part that recognizes T cells. So, like a bulldozer, it brings T cells right into the prostate cancer and helps kill the cancer that way.  

Katherine:

Now there are some inhibitors as well. Is that correct? 

Dr. Subudhi:

Yeah. So, the immune checkpoint inhibitors have been around for a while. And, basically, in combination, they seem to be more effective in prostate cancer. But when given alone as monotherapy, they’re less effective. 

Katherine:

Are these treatments specifically for patients with advanced prostate cancer? 

Dr. Subudhi:

All of them are actually in trials in patients with advanced prostate cancer. And I define advanced prostate cancer as either having metastatic disease, meaning the cancer has spread to other parts of the body outside of the prostate.  

Examples include lymph node, the bone, the lung, the liver. But there are so few trials in patients with locally advanced prostate cancer. What I mean by that is they have high-grade prostate cancer, but it’s local, or it’s just in regional lymph nodes. And some of these classes of drugs are being evaluated in that setting as well. 

Katherine:

Let’s shift to talk about your research. What are you excited about right now? 

Dr. Subudhi:

So, my research focuses on immune checkpoint therapies, which are the inhibitors that you were referring to and understanding how to make them work better in prostate cancer. 

And we’re finding out that in prostate cancer there’s about 20 to 25 percent of patients that appear to respond to this type of treatment. But these are patients that don’t have a lot of bone metastases. And these immune checkpoint inhibitors are given in combination. So, they’re not given alone. They’re given with either a combination of anti-CD34 and anti-PD-1 or some other form of that. 

Katherine:

Prostate cancer research really can only move forward through clinical trials and patient participation in those trials. Can you briefly explain what a trial is for people who may not be familiar with the term? 

Dr. Subudhi:

That’s a great question. My own father has prostate cancer. And he had the same exact question when he started his journey in that. 

And so, what I explained to him is that clinical trials are experiments. They’re experiments that are done in our patients.  

So, they’re drugs that are thought to mechanistically kill the cancer cell or at least change the environment around the cancer cell to help people live longer. But these drugs were actually tested in mouse models or in tissue models. And we don’t know if they actually work in patients. 

And so, in clinical trials, we’re actually testing whether these drugs are safe and whether they’re efficacious or beneficial to our patients. So, I want to be very clear. When patients go on clinical trials, we don’t know if it’s going to work on them. And that’s something that they should know that they’re showing a lot of courage and risk in joining these trials.  

But the other point I want to make is that every standard of care drug that is out there actually went through the clinical trial process, and they were approved because they showed benefit in a group of patients. 

Katherine:

Well, how can a prostate cancer patient benefit from participating in a trial? 

Dr. Subudhi:

One of the key benefits is that you get access to drugs that may actually prolong your life or even cure you and that you wouldn’t have access to in trials.  

And so, some of my patients, unfortunately, they’ve exhausted all the standard of care choices that are out there. And the trial’s the only option left versus leaving it up to natural causes of demise from prostate cancer. And so, clinical trials give other opportunities to potentially live longer and have a great quality of life. 

Katherine:

So, they could offer some hope. 

Dr. Subudhi:

Definitely. As far as I’m concerned, yes. And, actually, with my patients, I try to not wait while they’ve exhausted all the treatments to start them on clinical trials, because I feel like we may be able to save some of these treatments in our back pocket for when they’re too exhausted to be coming to our clinic so often. And so, I like to actually try to get them enrolled in clinical trials early on in their journey with prostate cancer. 

Katherine:

I’d like to define some clinical trial terminology to help patients further understand the process. Let’s start with the phases. What occurs during each phase?  

Dr. Subudhi:

So, great question. Phase I is the safety phase. So, all we’re trying to do is find the right dose of the drug that is actually safe to give in the patients. And we’re looking for the maximum tolerated dose. And once we find that dose, then we use that dose to go to Phase II of the trial. And Phase II trials are looking at efficacy. So, looking to see whether the trial is giving you any clinical benefit, meaning the cancer’s shrinking or even disappearing. 

Katherine:

Go on.  

Dr. Subudhi:

And then the third phase is Phase III where you’re testing the current drug, experimental drug, to either standard of care or to a placebo to see whether or not you get a benefit, either a progression-free survival benefit or overall survival benefit. And so, those are the three phases of clinical trials.   

Katherine:

What are the different types of clinical trials? 

Dr. Subudhi:

So, they’re controlled trials. Actually, I should back up. So, there’s open-label trials where everyone that enrolls in the trial will get the experimental drug. So, there is no control arms in these trials. Then there is the control trials where you can either get the drug, or you may get a placebo or standard of care drug.  

There are some trials that allow for crossover, meaning that if you’re in the placebo or standard of care arm, if your cancer progresses, you can actually cross over and get the experimental drug. But I just want to be clear that not all clinical trials have crossover. And if you’re in a control trial, I think that’s an important question to ask your doctors about that. 

But the reason why we do the control trials is that we’ve learned that using historical controls – for example, we’re doing a lot of combination studies with chemotherapy, such as docetaxel (Taxotere), which was FDA-approved in 2004. So, if we’re using historical data from almost 20 years ago, it’s not the same thing as our patients that are being treated with docetaxel now, because their treatment landscape has changed so much, and our patients have changed so much. 

And so, for that reason, control trials give us a better sense of how effective this experimental drug is doing as opposed to comparing it to a historical perspective. 

Katherine:

What other types of clinical trials are available? 

Dr. Subudhi:

So, there are a few other options. So, we talked about open-label where everyone’s guaranteed to get the drug. We talked about a controlled study where you will either get one drug or another. And another type is a randomized trial where a computer decides whether or not you’re going to actually get one drug versus another. It’s not your doctor because a lot of people think that I’m making that decision, and I’m not. It’s actually a random computer. 

And some trials have 1:1 ratio, meaning a 50 percent chance that you’ll get the experimental drug versus the control drug. But other trials have 1:2 ratio or 1:3 ratio. So, that’s something that, again, you have to ask your physician of how these trials are being randomized. 

Katherine:

Well, in a randomized clinical trial, the patient isn’t going to know what drug they’re being given. 

Dr. Subudhi:

Actually, that’s not true. 

Katherine:

Oh, it’s not. 

Dr. Subudhi:

So, you bring up a great question. So, there’s a double-blind randomized clinical trial where not only the patient doesn’t know, but even the physicians and the nurses. No one except for the pharmaceutical company that’s running the trial actually knows who’s actually getting which drug. And it’s only towards the end of the trial that we unblind, and then we share that information. Well, the pharmaceutical company first shares it with the medical team who then shares it with the patient. 

Katherine:

I see. Are there other common clinical trial terms that you think patients should know about and understand? 

Dr. Subudhi:

I think for now those are… 

Katherine:

…they’re the most important?  

Dr. Subudhi:

I think to me those are the most important. And I think that sometimes too much information can bog us down.  

Katherine:

Well, speaking of information, there is a lot out there, some of which may not be very reliable. And that could lead many patients to having misconceptions about clinical trials. Let’s walk through a few common concerns we’ve heard from our community about trials. 

One frequent question is – will I receive a placebo instead of a real treatment? And, first, I’d like you to define placebo. And should this be a concern for patients? 

Dr. Subudhi:

Right. So, placebo is a drug that looks similar to the experimental drug. For example, if the experimental drug is a blue pill, then the placebo will be a blue pill. But it will be a pill that should have no known biological activity.  

If the experimental drug is given intravenously and you get it in a liquid bag, then the placebo will also come in a liquid bag. So, it will look the same. And that’s why both the medical team as well as the patients or their families will not know which drug the patients have received, meaning the experimental drug or the placebo. But the placebos are meant to not have any biological activity. 

Katherine:

So, it shouldn’t be a concern to patients then.   

Dr. Subudhi:

Well, the concern that most of my patients share with me when they hear about placebo-controlled trials is, “Well, if I’m not going to get the experimental drug, why should I do this? I mean what benefit does it have for me?” And so, I tell them that one of the benefits is that we are watching you very carefully. 

Because we don’t know sometimes which drug you’re getting. But in some control trials, like a randomized control trial, we will know because I’m not blinded.  

If you’re in the arm that’s only getting chemotherapy, well, you know you’re not getting an oral pill. So, it’s very clear to the patient what they’re getting. But if they’re getting an oral pill that’s a placebo, we’re watching them very carefully.  

So, we’re watching the patients very carefully in these placebo-controlled trials. And they’re coming in often so that we’re not going to miss any devastating things happening from the cancer. In fact, we’ll pick it up earlier than if they were just getting a standard of care outside of a trial. And for that reason I tell that my patients, “Don’t be worried.” And I always make sure that I have a backup plan. 

So, the backup plan is either they’re going to cross over, meaning the trial allows for them to cross over to get the experimental drug. Or I have another trial that I know that they will qualify for. Or the third alternative is that I actually have a standard of care drug that I’m ready to give them the second I have it so that they don’t have to have those concerns. 

Katherine:

That’s really great information to have. Patients also often have questions about safety. So, what are the risks of clinical trial participation? 

Dr. Subudhi:

So, safety is a major issue, especially more into the Phase I. The Phase I trial, if you remember, are the trials where we’re dose escalating, meaning we start off with a small cohort of patients, maybe three to five patients. And we give one dose of the drug. We see if it’s safe. If it’s safe, then we go to the next dosing level. And we just keep going until we find a dose that may be too toxic or too unsafe for our patient. 

So, in the Phase I, we have less information, especially in the first-in-human drugs. But in those cases, we are watching you carefully to make sure that nothing bad happens to you. 

But the problem with those trials is it requires a lot of time at the institution or with your doctor. For example, I’m doing a bispecific trial where we have to keep the patients inside the hospital for eight days, purely for safety reasons. They’re not getting the drug for all eight days. But we’re just keeping them under observation so in case anything bad happens we’re ready to react because we know that if something bad happens at their home in that first eight days, it could actually risk their lives. 

So, in those cases, some trials, if we’re concerned about safety, you’ll be spending more time in the doctor’s office or in a hospital being evaluated. So, that’s the one negative. But sometimes, the trials that can be more exhausting as far as the amount of time it takes you away from your home and family are the ones that have the most reward. 

Katherine:

Well, what protocols are in place to protect patients? 

Dr. Subudhi:

So, when they sign up for a protocol, we are instructed to give them our best information. So, let’s say it’s a first-in-human drug. Well, usually, first-in-human drugs are tested in other mammals, such as monkeys, and we look for toxicities there. And we have signs of what’s going to happen. Sometimes, a first-in-human drug is part of a class of drugs, like I talked to you about T-cell bispecifics. 

Well, there’s several T-cell bispecifics out there. And we’ve learned that this class of drugs has a unique set of side effects that they all tend to have. Some have it more, and some have it less. 

But when we’re discussing this with you or the patient, we are actually going to go through each and all of these side effects. Now, me personally, my patients that go on my trials, they all get my cellphone number so they have 24/7 access to me because I know they’re taking a risk. And it’s a lot of courage to go on these trials. And it’s scary. And I want to make sure they don’t feel like they’re ever alone. 

Katherine:

Another common concern we hear is that a clinical trial is only considered when there are no other treatment options available for a patient. What are your thoughts on this? 

Dr. Subudhi:

There’s a lot of my colleagues in the field that feel that way. And I know a lot of patients’ misconceptions are also that way. And that’s partly because of Hollywood and movies and TV shows that we watch. But I think that many people, especially in the medical field, think of clinical trials as the last resort. 

And I actually disagree with that. I think that I like to actually start my patients with one or two standard of care treatments. But after that, really start putting clinical trials in between. And we have to remember that there’s not always a clinical trial available that the patient actually meets the criteria for.  

So, it’s always disheartening in clinic when I meet someone for the very first time who was referred to me because they exhausted everything. And we just don’t have any clinical trials available, or they’re so weak from the cancer and all the prior treatments that they don’t qualify for a clinical trial. And then I really don’t have anything else to give them.  

So, my personal approach is to try to put clinical trials in between and always have something in my back pocket so that if they get a bit exhausted or they want to spend more time with friends and family, they can get the standard of care treatment. 

Katherine:

If a patient is interested in participating in a trial, what’s the best way to find out which trials might be available for them and right for them? 

Dr. Subudhi:

So, that’s a great question. I think number one is always ask your oncologist, and they’re a great resource. But also, there’s websites. So, for different types of cancer – so, example, I do prostate cancer. So, the Prostate Cancer Foundation or PCF.org is a wonderful resource that will give you a list of cutting-edge trials. 

In addition, the government has clinicaltrials.gov. And that’s where you can actually type in your cancer type and different criteria, and you’ll get a list of trials. 

Katherine:

That’s good to know. What questions should patients ask their healthcare team when considering joining a trial? 

Dr. Subudhi:

I would ask them, “Would you do it yourself if you were in my situation?”  

Katherine:

Very good. 

Dr. Subudhi:

I think that’s a very important thing to ask.  

Katherine:

Are there barriers that interfere with patients’ access to clinical trials? I think you touched on this but maybe if you have anything to add.

Dr. Subudhi:

Yeah. So, travel can be a major barrier. And that’s something that the pharmaceutical industry understands. And, therefore, some of the trials, especially the multicenter trials, actually allow for travel cost. That sometimes includes flights, driving, hotels, food.  

So, that’s something that’s important to ask because sometimes when we’re thinking about clinical trials, we’re so anxious in the doctor’s office. And then it’s not until we go back home when we’re trying to figure out how do we get the resources to come so frequently. You’ll find out that’s sometimes travel costs. 

The other thing is underrepresented minorities are something that we’ve been doing a relatively poor job recruiting to our clinical trials. Part of that is just from history that we didn’t have the safety rules in place that we do now. And underrepresented minorities were affected negatively in some of the earlier trials.  

And the other thing is just the resources of getting to and from their homes to our cancer site as often as they need to because they may be the sole breadwinner in their homes and things like that. So, there are resources to try to help do this. But I still think we have to do a better job. 

Katherine:

Can trials be coordinated between a local doc and the institution? 

Dr. Subudhi:

So, most trials cannot. Most. But there are some that can. So, if it’s a standard of care treatment, sometimes we can have the safety visits done with the local doctors. But every time they’re going to get the treatment they have to come see us at the institution that is actually running the trial.   

But most of the time, what I tell all my patients is, “I want them to have a local doctor.” Because if there’s something that happens in the middle of the night, I want to be able to say, “You’re going to go to this emergency room where this doctor works.” And then when they go there, as soon as they get admitted into the emergency room center, I talk to the ER doctor, and I say, “This is what I want to be done. These are how these drugs work.” 

Because they’re not going to know what these experimental drugs are. They’re not available in the community. So, I just think it’s important to have communication, especially for our patients that are out of state. MD Anderson is in Houston, Texas. And Texas is so big that a lot of my patients live six to eight hours away, and they’re still in Texas. 

Katherine:

Oh, wow. So, what are your thoughts on what could be done to overcome the barriers that some patients are experiencing? And are there resources available?  

Dr. Subudhi:

So, the pharmaceutical companies are putting in more financial resources as well as a diversity resource. And when I say diversity resources, those outreach programs just to make sure that the communities that are underserved are hearing about the clinical trials because if you don’t hear about it you’re never going to join it. So, one thing is just knowledge. 

And then, number two, we’re trying to create financial resources. For example, there’s Angel Flight as one example where they will pay for the flight for you. And they’ll put you on maybe a chartered plane or something or a smaller plane to defray the cost of traveling by air. So, there are things out there, but we still need a lot more. 

Katherine:

But one thing patients could do is talk to their healthcare team about what resources are available for them.  

Dr. Subudhi:

Absolutely. Absolutely. 

Katherine:

Before we end the program, Dr. Subudhi, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation? 

Dr. Subudhi:

First of all, thank you for even thinking about it. That’s the one big step. And for those of you who actually take the next step and actually join a clinical trial, again, thank you for being so brave. 

I think it’s a gift that you’re giving to other fellow patients with cancer. And it’s also a gift that you’re giving to the scientific and medical community, because we are learning by your participation in the trial. And I want you to know whether the trial worked for you or does not work for you, regardless, we’re going to learn something that’s going to help change outcomes in your cancer. 

Katherine:

Dr. Subudhi, thank you so much for taking the time to join us today. 

Dr. Subudhi:

Well, thank you. I really appreciate it.  

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. 

And don’t forget to take the survey immediately following this webinar. It will help us as we plan programs in the future. To learn more about prostate cancer and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thank you for being with us. 

AML Treatment Approaches | Factors That Impact Options

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AML Treatment Approaches | Factors That Impact Options from Patient Empowerment Network on Vimeo.

What factors are considered when choosing an AML treatment approach? Dr. Ann-Kathrin Eisfeld explains how shared decision-making comes into play when deciding on a therapy and reviews the options available to treat AML.

Dr. Ann-Kathrin Eisfeld is Director of the Clara D. Bloomfield Center for Leukemia Outcomes Research at The Ohio State University and a member of the Leukemia Research Program at the OSUCCC – James. Learn more about Dr. Eisfeld.

See More From INSIST! AML

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Essential Testing | Optimizing AML Care With Personalized Medicine

 How Have Advances in Testing Impacted AML Care

 AML Targeted Therapy: How Molecular Test Results Impact Treatment Options

Transcript:

Katherine Banwell:

With all the new tools that are available, what other factors do you consider when working with an AML patient to choose a treatment approach for them?  

Dr. Eisfeld:

The most important aspects are what we call – and this is – I’m glad that you bring this question up because I feel you have to think of – and that was what we’ve been talking about – called disease-associated factors. This is everything in the leukemic cell. They – how does a leukemia looks like? How does the blast look like? What changes are there?  

That’s the biggest part of what I would call patient-associated factors: the patient age, the patient performance status, actually the patient. In every – because I think, sometimes, we forget about it. But we just look at all the molecular testing.  

But even if – for example, there would be a patient with a very good risk leukemia, where I think, “Oh, this leukemia should respond very well to an intensive chemotherapy.” 

If the patient cannot tolerate chemotherapy or – and I see it more often than I would wish for patients who are young who have a great performance status, but they just cannot – they – their family reasons. Small children sometimes – they just cannot be away for so long. This all comes into consideration. So, it’s really important because we all work together as a team. And the right treatment for the leukemia might not be the right treatment for the patient.  

And for most cases, however, I think, it will only work if one stands with a whole heart with both physicians, and patients, and family. Because it’s a long journey behind the care that’s being given. And so, this is a joint decision-making, and there are different options that can be done. Of course, I would not advise something where I would think there are no chances of success.  

And so, this has to be an open discussion. But this is – it’s very often a very tough treatment to communicate that and see what are the goals of each patient? That will be most important for treatment and decision-making.     

Katherine Banwell:

What types of AML treatment classes are currently available?  

Dr. Eisfeld:

This is a very good question. The most classic treatment class is intensive chemotherapy. This is just because people might have heard the names. It is called 3 + 7 or 7 + 3, which refers to one weeklong impatient chemotherapy treatment. But you get one chemotherapy for seven days. And the first three days, you get a second treatment as well.  

That’s why it’s called three in seven in here, but it’s a total of seven days. So, we have intensive chemotherapy. And there are different flavors of it. But this is usually the backbone. The second class is what I would call a targeted inhibitor. And here we can look at two different aspects. We have targeted inhibitors for a specific DNA mutation that are found. And specifically, one are called IDH or FLT3 mutations.  

And these are pill forms that I usually by now combined with a third drop class which is called hypomethylating agents. And I will go through in a moment.  

But these are pills that really only work in patients and carry that genetic change. They have very, very low toxicity and very high chances of working. So, that’s why this testing is so important to see if one is one of the 15 percent of AML patients carrying an IDH mutation – 15 percent isn’t low. And a similar rate carries a FLT3 mutation.  

And then there is also going to target inhibitors. That is targeted because it is against what I would call a pathway. The gene that is commonly activated in acute leukemia – and this is called BCL-2 and the drug is called venetoclax (Venclexta).  

This is now stormed through the acute myeloid leukemia world in just a few years ago and has been approved as a front-line treatment option for several patients, especially for those who are older. And we know that even patients who respond usually favorably to chemotherapy, some of those also respond well to venetoclax the Bcl-2 inhibitor. The benefit is that this treatment in many cases if it works, can be done as an outpatient in here and has very often lower complications.  

It is actually has so good results that I – sometimes it seems too easy. So, we actually advise patients to still try to get – the first time they get the treatment, do it at a center where it’s done more commonly. Because it sometimes – don’t underestimated the power of a pill. And it’s still a very, very powerful drug. So, doing it in a controlled setting – because if cancer cells break down, they break down and can create all sorts of trouble.  

So, that is really something – for several leukemias, it can be concerning. And again, now the treatment group would be called hypomethylating agents. The names are azacitidine (Vidaza) and decitabine (Dacogen). And they act in a very different way. They try to change the epigenetics like methylation patterns. And often, if it is an untargeted way of the tumor cells and they can be used alone.  

Or very often by now in combination with the targeted inhibitors that I was just mentioning. These are infusions that can be done either over five, seven, or 10 days depending on the combination treatment. And for patients, as I mentioned before, that don’t respond well to many other options to those patients with a complex karyotype. This is, for example, a scenario where patients can just receive this as their only therapy.          

Katherine Banwell:

What about stem cell transplant? You didn’t mention that.   

Dr. Eisfeld:

Yes. That would be the next one. So, stem cell transplant always comes as an option, which I would call as a maintenance therapy. Again, two aspects. We have two different end goals.  

First is get rid of some leukemia. Second is to make sure it stays away. And as soon as the leukemia is in complete remission, depending on the performance status – the agent. Again, in multiple different things. It’s not an easy decision. 

At that time, there has to be a conversation. And that always involves a leukemia physician and a transplant physician very often. These are different providers that goes for the risks and benefits. Where the question is if I only continue to do chemotherapy – because it’s never only once. You would always have to repeat your chemotherapy. What is the likelihood that the leukemia comes back, and does it outweigh the risks that comes with the stem cell or bone marrow transplant that comes in here. But for many leukemias, especially for young patients and for patients with higher risks, this is the only chance of a cure. That is the most curative and only curative attempt for many leukemia attempts.  

Katherine Banwell:

Where do clinical trials fit into the treatment plan? 

Dr. Eisfeld:

That is the absolute backbone. We always have to think about that. 

Everything – all the treatment options that I mentioned – have been clinical trials, just very, very short time – very few years ago. So, every patient that comes to a leukemia or a cancer center, clinical trials will be discussed if they’re available. Because they will provide a special opportunity to have even more fine-tuned treatments – either newer agents. And I think what is very important to mention is that all clinical trials that are available would give the option of the best standard of care.  

And then the hope that a patient wouldn’t be getting any of the best standard of care options that are approved. The hope is that the new agent or added agent in many cases would even do better.  

It’s also important that there’s a lot of additional monitoring during the trial. I think it can be seen in two ways as two parts of a coin. In one way, it may be additional visits to the hospital or additional blood draws that are necessary to be sure that the medications are safe, and that researchers and conditions can learn about it. But on the other hand, it also gives you this extra bit of being looked after and really getting checked in and out, making sure that all organs are functioning that everything is just going fine. And many patients appreciate this a lot. And they have this pair of extra eyes on them all the time.  

Katherine Banwell:

Dr. Eisfeld, what therapies are available for AML patients who relapse or don’t respond to initial therapy? And is this treatment approach different from those who are newly diagnosed?  

Dr. Eisfeld:

Most of the time, the treatments available at relapse are the same available at the first diagnosis. Just because we know now that, for example, if you have a molecular marker that, for example, is available, it would act with also relatively high chance of relapse upset. However, at relapse, the most important thing I personally would do is consider a clinical trial even stronger than in the first mindset. 

 Because it means that the leukemia outsmarted current treatments very often. So, usually what we would be doing is see if there is a targeted inhibitor or a cell mutation FLT3 or IDH, which I would personally always prefer to go in MLL rearrangement now for the new menin inhibitors where one would go with the same option as if it would have been their diagnosis. But if not to really consider clinical trials is a strong urge. 

Katherine Banwell:

Should patients or should relapsed patients undergo genetic testing again? Is it necessary?  

Dr. Eisfeld:

Yes. At any time. Yes. Because we know that the leukemia changes. And you just can think about it in the way is that the cells that are surviving treatment, they’ve become smart. There was so much poison. There was so much treatment put on them. 

And the ones that survive might have a quiet additional chromosome change as additional gene changes. And even if a genetic change has not been present at time of diagnosis, the reason the cell has survived might have been that it has now one of these changes that came up on a later time during treatment or while the cell is hiding somewhere to come back. 

What Biomarkers Affect Lung Cancer Care and Treatment?

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What Biomarkers Affect Lung Cancer Care and Treatment? from Patient Empowerment Network on Vimeo.

Lung cancer driver mutations can have an impact on therapy choices for patients. Dr. Grace Dy discusses the various lung cancer driver mutations and how treatment options may target specific markers.

Dr. Grace Dy is Chief of Thoracic Oncology and Professor of Oncology in the Department of Medicine at Roswell Park Comprehensive Cancer Center in Buffalo, New York. Learn more about Dr. Grace Dy.

See More From INSIST! Lung Cancer

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 Why Do Lung Cancer Patients Need Molecular Testing Before Choosing Treatment?

Why Do Lung Cancer Patients Need Molecular Testing Before Choosing Treatment?

Transcript:

Katherine Banwell:

How does testing impact treatment and care? 

Dr. Grace Dy:

So, back in like maybe more than two decades ago, I was still in school. The treatment paradigm is sort of like a one size fits all. You come in with a lung cancer diagnosis. Everybody gets treated the same.  

But with advancements in technology and understanding of actually what we call lung cancer is really genetically very different from one patient to another. We are actually not even still able to tease out all the particular details, but there are some improvements that have been made along the way. And so, defining, for example, mutations in cancers, there are what we call driver mutations that have a matched targeted therapy.  

In certain patients, actually the target therapy works so much better than chemotherapy, for example. And that’s why we have it in guidelines based on the results of clinical trials showing that in the appropriate setting, if you have a mutation that we discovered through molecular testing, and then you use the matched target therapy, survival is so much better compared to, for example, chemotherapy.  

Same with immunotherapy. If we use a biomarker to test out which patients may actually respond well to immunotherapy alone – so, that’s a major treatment paradigm change within the less than 10 years wherein we define there’s a group of patients where that’s all they need. Non-chemo, just immunotherapy, and they will do well. 

Katherine Banwell:

What are some of the mutations that are being targeted? 

Dr. Grace Dy:

Right. So, it seems like every year, it’s growing. So, it started off with the poster child in lung cancer story of EGFR. So, we have EGFR mutations. Even EGFR mutations, they’re a subtype of mutations for – there are certain drugs that work better for certain mutations.  

So, we have the classical EGFR mutations, the atypical EGFR mutations. But EGFR mutations as a group are probably the most characterized given the longevity of the research that has been done. But there’s a lot more. 

So, for example, ALK, KRAS, BRAF, HER2, NTFK, NRG, RET, MET. Even those mutations, they’re all these new ones. It’s between the subtype of mutations. For example, we talked about EGFR. Same thing with MET. You have MET exon 14 skip mutations. But in the absence of MET skip mutations, there are also what we call MET gene amplification, MET protein over-expression that have matching therapies that may actually work better. 

But we’re still kind of scratching the surface. There’s a whole lot more being characterized and developed. Case in point, just a little over a year ago, there’s an LTK Fusion that was described. Very rare. But there’s a target therapy for it. So, unless you test it, you won’t find a matching targeted therapy. 

What Procedures Are in Place to Protect Lung Cancer Clinical Trial Participants?

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What Procedures Are in Place to Protect Lung Cancer Clinical Trial Participants? from Patient Empowerment Network on Vimeo.

What safety measures are in place to protect people in lung cancer clinical trials? Dr. Grace Dy reviews protocols to help maintain clinical trial safety.

Dr. Grace Dy is Chief of Thoracic Oncology and Professor of Oncology in the Department of Medicine at Roswell Park Comprehensive Cancer Center in Buffalo, New York. Learn more about Dr. Grace Dy.

See More From Lung Cancer Clinical Trials 201

Related Resources:

Lung Cancer Clinical Trials | Addressing Common Patient Concerns

 Questions to Ask Before Participating in a Lung Cancer Clinical Trial

 When to Consider a Clinical Trial for Lung Cancer Treatment?

Transcript:

Katherine Banwell:

What safety measures are in place to safeguard patients?  

Dr. Grace Dy:

So, there’s a lot of safety measures involved. Not just within the protocol but there are also governing committees. IRB, Scientific Review committees, that look over – and these committees typically also, actually, involve some patient advocates that will be reviewing the protocols to make sure it’s not just a scientific aspect that is looked into but also patient perspectives that are looked into when we review these protocols.  

So, from the medical perspective, protocols are generally written with guidelines to help treating doctors how to manage side effects. For example, because of the intense preparation – what we call pre-clinical, meaning the preparation done in animal models, in learning from other settings, for example; from other drugs, for example. If it’s not the first in class, you have a sense of what potential side-effects might be expected and so you prepare accordingly. 

Top Two Reasons Why CLL Patients Should Participate in a Clinical Trial

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Why exactly should a chronic lymphocytic leukemia (CLL) patient think about joining a clinical trial? In In the “Why Should CLL Patients Consider a Clinical Trial?” program, expert Dr. Adam Kittai from The Ohio State University Comprehensive Cancer Center – The James explains the motivation of clinical trials and the benefits CLL patients may receive from clinical trials. 

1. Improve Future CLL Treatments

Clinical trials examine the benefits of a specific treatment for a specific cancer and cancer stage. If you or your loved one participates in a clinical trial, there can be a double benefit to participation. The data gathered from clinical trials assists researchers in improving future CLL treatments for the patient who participates in addition to other CLL patients. Clinical trials can often have underrepresentation by BlPOC patient groups, and it is important for these groups to be represented in trials in order to develop the most refined treatments for all patient races, ethnicities, and genders.

2. Gain Access to Unavailable Therapies

In addition to improved treatments, clinical trial participation has other patient benefits as well. If you or a loved one participates in a clinical trial, the patient gains access to treatments or therapies that may not be accessible in another way. Clinical trials sometimes use different combinations of treatments that haven’t been used previously for a specific stage or type of cancer. Or clinical trials may offer access to a cutting-edge therapy that may ultimately be both more effective while also causing fewer side effects, which could result in a major win-win for patients.

By participating in CLL clinical trials, patients can help improve future CLL treatments for themselves as well as for others. If you have additional questions about clinical trials, ask your doctor or other healthcare provider. If they don’t have information about trials for your specific cancer and stage, they can check with specialists who would more familiarity. You can also find a database of clinical trials at clinicaltrials.gov.

What Do MPN Patients Need to Know About Clinical Trials?

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What Do MPN Patients Need to Know About Clinical Trials? from Patient Empowerment Network on Vimeo.

What is a clinical trial and how does patient participation work? This animated video provides an overview of clinical trials, the process, and details key steps for engaging in your care.

See More From MPN Clinical Trials 201

Related Programs:

Understanding Common MPN Clinical Trial Terms

Understanding Common MPN Clinical Trial Terms

 Understanding Clinical Trial Phases

Understanding Clinical Trial Phases

 MPN Clinical Trials: Updates on MPN Treatment and Research

Clinical Trials As an MPN Treatment Option: What You Should Know

Transcript:

Brian: 

Hi, I’m Brian and this is my doctor, Dr. Liu. 

I have myelofibrosis, which is a type of myeloproliferative neoplasm, or MPN as it’s commonly referred to. 

And when discussing therapy with my doctor. She suggested a clinical trial might be my best treatment option. Dr. Liu, can you please explain what a clinical trial is? 

Dr. Liu: 

Absolutely. In basic terms, a clinical trial is a research study that involves human volunteers. The goal of cancer clinical trials is to discover new and improved approaches to prevent or treat the disease.  

There are typically four phases of a trial. Each phase gathers valuable information about the treatment and helps measure its effectiveness1.  

But, Brian you had some hesitations at first, right? 

Brian:  

That’s right.  Although I trusted your advice, I definitely had questions about the process.  

One thing I worried about was safety. I asked Dr. Liu how I would be kept safe if I participated in a clinical trial. 

Dr. Liu: 

I hear this concern a lot from patients. But every trial has a strict safety protocol, with set guidelines in place to protect patients.  

Additionally, researchers must follow patient safety rules, which are regulated by the U.S Food & Drug Administration (the FDA). And an institutional review board (or IRB) regularly reviews a study at each study location. Plus, many trials are overseen by a group called a data and safety monitoring committee2. 

Finally, there is also a clinical trial team that can include healthcare team members like cancer researchers and oncology nurses. This team regularly observes the health of each participant, through each stage of the process. Because of this, trials often involve more testing and visits, which can be a bigger commitment for a patient. 

Brian: 

When Dr. Liu explained the safety measures, it helped me feel more confident in the process and comfortable about participating. So, then I asked which trial she would recommend for my individual disease.  

Dr. Liu: 

It’s important to note that every trial has “eligibility requirements” that include things like a patient’s age, health, and prior treatments they have received. These requirements determine whether a patient qualifies for a trial. 

We talked about which trials may be a good fit for Brian and discussed the pros and cons of each one. We also reviewed the logistical and financial impact the trials could have on his life.

Brian: 

That’s right. Dr. Liu also pointed out that patients can leave a trial at any time–for any reason– once they have enrolled.

Dr. Liu: 

That’s right—participation is completely voluntary. 

Brian: 

One of the main reasons that I joined a trial was because I wanted to find out if a treatment in development would be more effective in treating my cancer. AND I wanted to help advance research forward, so I could help the MPN community.  

Dr. Liu: 

Right, Brian. Patients may have different reasons for participating, but trials are the only way to develop and study new and improved treatments for MPNs. 

Now that you understand more about trials, how can you find out more? 

  • Start by asking your doctor if there are any trials that you are eligible for.  
  • If there is a trial that your team recommends, ask to discuss: 
  • The treatment approach used in the study and the purpose of the trial. 
  • The risks and benefits of participation. 
  • The financial costs, if any, and if there are assistance programs to help if you need it. 
  • The location of the trial and whether it can be coordinated with your local institution if it isn’t conveniently located—or if transportation is available. 
  • And, how often you will need to visit the trial site and how long the trial will last. 
  • Finally, continue to educate yourself, using resources like clinicaltrials.gov. 

Brian: 

We hope you found this information useful! Visit powerfulpatients.org/MPN to learn more about clinical trials and MPN research. 

Dr. Liu: 

Thanks for joining us! 

Three Ways Patients Can Access Clinical Trials

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What are some ways that cancer patients can access clinical trials? In the “How Can Clinical Trials Be Accessed?” program, expert Dr. Seth Pollack from Robert H. Lurie Comprehensive Cancer Center and cancer survivor and patient advocate Sujata Dutta share three ways cancer patients can access clinical trials and advice to patients about clinical trials.

1.Talk to Your Doctor or Healthcare Provider

If you or your loved one would like to learn about available clinical trials, ask your doctor or other healthcare provider. They can find clinical trial information for you, or they can check with a specialist who might have clinical trial information readily available about your specific type of cancer.

2. Get a Second Opinion

If you or your loved one’s doctor does not find any clinical trials or if you want to find some additional options, getting a second opinion could help with locating clinical trial options. If you can schedule a second opinion consult at an academic medical center, you are more likely to find some clinical trial options. Academic medical centers are often connected to research universities that carry out clinical trials and research studies.

 3. Check Reliable Patient Advocacy Websites

Cancer patients and their loved ones can also reliable patient advocacy sites for information about clinical trials. In addition to the Patient Empowerment Network (PEN) website, try resources like the American Cancer Society and The Leukemia & Lymphoma Society (LLS) websites. The National Institutes of Health also maintains a large database of clinical trial options on the ClinicalTrials.gov website.

By taking advantage of clinical trial opportunities, cancer patients can access tomorrow’s medicine today, receive closer monitoring of their cancer, and help improve and refine treatments for future treatments. If you’d like to learn more about clinical trials, check out our Are Clinical Trials Safe? program.

Why Should DLBCL Patients Engage in Their Care?

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Why Should DLBCL Patients Engage in Their Care? from Patient Empowerment Network on Vimeo.

DLBCL expert Dr. Jane Winter explains the benefits of being an engaged and empowered patient and shares key questions for patients to ask their doctors.

Dr. Jane Winter is a hematologist and medical oncologist at Robert H. Lurie Comprehensive Cancer Center at Northwestern University. More information on Dr. Winter here.

See More From The Pro-Active DLBCL Patient Toolkit

Related Programs:

The Benefits of Having a Role in Your DLBCL Treatment Decisions

 
 What Is the Patient’s Role in Their DLBCL Care

 Should DLBCL Patients Consider a Second Opinion

Should DLBCL Patients Consider a Second Opinion?

Transcript:

Laura Beth:

Dr. Winter, why do you think it’s important for patients to be empowered in their DLBCL care?  

Dr. Winter:

You know, a patient who is, I like the word “engaged” as well as “empowered.” I think it’s important for patients to be empowered or engaged because medicine is very complicated and very fragmented these days.  

Now, it’s so difficult to be a patient and to be sick and not be able to really take control. So, patients need to be empowered and they need partners, advocates. It’s a very sad comment on our healthcare system, but to be sure that things don’t slip through the cracks, we, the providers, the hematologist, our job is tough, but we need a patient to partner with us.  

So, for example, if you’re a patient with diffuse large B-cell lymphoma as your diagnosis, make sure to ask, “Was there a result for the FISH?” You need to make sure that doesn’t slip through the cracks. Or, if you are going for a second opinion or going to another medical center, make sure you have your records. I really wish that every patient who had a scan of one kind or another as they walked out the door got a copy of that scan, a disc. Now, that would make life so much simpler. But, make sure that you keep your own records. It’s hard and hopefully, every sick individual has a family member or a friend, someone who’s going to help them with this because this is very tough.  

But, ask questions. “Are there clinical trials I might be eligible for? Are there alternatives to the therapy you’re recommending?” These are all important questions to ask. Don’t be afraid to say, “With this treatment, what is the likelihood that my disease is going to come under control and be cured?” I think you need to know that. And, “Is there a difference between this treatment and that treatment?” Do we know? Oftentimes, we don’t have the answer for the newer treatments, but we’re hopeful.  

I just want to underscore the existence of a growing number of clinical trials that patients need to consider and think about. It’s hard at the time of the new diagnosis to be struck with not only the emotional impact of a new diagnosis and so on and not feel well and so on, but just ask the question. “Are there clinical trials I might consider?” So, that’s important, and also have optimism because the vast majority of patients, we do amazing, amazing things, and that’s why it’s so much fun to be a hematologist right now is that we have so many new and exciting treatments. And what’s more exciting than to make someone healthy again?  

So, these are exciting times.