Tag Archive for: cancer research

When Should Clinical Trials Be Considered for Advanced Non-Melanoma Skin Cancer Treatment?

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When Should Clinical Trials Be Considered for Advanced Non-Melanoma Skin Cancer Treatment? from Patient Empowerment Network on Vimeo.

When should clinical trials be considered for advanced non-melanoma skin cancer treatment? Dr. Anna Pavlick explores the role of clinical trials, common patient concerns about participating in trials, and the phases of clinical trials in cancer research.

Dr. Anna Pavlick is a medical oncologist and the founding Director of the Cutaneous Oncology Program at Weill Cornell Medicine and NewYork-Presbyterian. Learn more about Dr. Pavlick.

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Transcript:

Katherine:

Where do clinical trials fit into a treatment plan for advanced non-melanoma skin cancer? 

Dr. Pavlick:

Again, my feeling is that clinical trials are opportunities for patients to be able to not only get the standard of care because many of our clinical trials offer patients the standard of care which is immunotherapy. 

But then we look to add something. And by adding something, can we make the responses faster, better, more durable? And that’s why asking your oncologist or your dermatologist about is there a clinical trial that I may be eligible for may make a huge impact on what happens.

We talked about immunotherapy. We talked about the targeted therapy. There are clinical trials that are now looking at injecting tumors with viral vectors. So, by injecting, we’re using the herpes virus which is the cold virus and injecting that directly into the lesion. Can that generate a better immune response to make things shrink up faster and provide more durable responses? 

And so, those are very exciting things. Most of these non-melanoma skin cancers have not metastasized. And even if they have, we’ve seen that if you inject the lesion that’s cutaneous, even if you have something that’s deeper, by really stimulating an immune response, you can not only contain the lesion that you’re injecting, but you will get a reciprocal response in the other lesions as well. So, it’s really a neat concept that’s really coming to fruition. 

Katherine:

What would you say to a patient who is hesitant in participating in a trial? 

Dr. Pavlick:

What do you got to lose? Patients are always very concerned that when they participate in a trial that they will get a placebo.  

Katherine:

Yeah. 

Dr. Pavlick:

And I think that’s the biggest hesitation and the biggest concern for many patients.  

And that has to be spelled out in the trial. The trial is going to say this is a trial where half of the patients are going to get a placebo or half of the patients are going to get X medicine. It is exceedingly rare in a treatment trial that there will be a placebo arm. Many times, if you’re talking about prevention, those are the studies that will want a control arm to get a placebo because the standard of care is you take this out, you do nothing and you watch.

Well, if you’re looking to see if doing something versus nothing is better, then they’re going to tell you. The standard is care is that we do nothing. However, in this trial, half the patients are going to get watched and get the standard of care. 

The other half of the patients are going to get either drug X or drug Y. And then at the end of the study, we’re going to see if those medicines actually benefited or didn’t benefit those patients compared to the patients who were just watched. Most patients who have active disease, whether it be locally advanced or metastatic are going to be offered trials that are either what we call a Phase I, a Phase II or a Phase III study.

So, a Phase I study is where we’re taking a brand new medicine that’s coming from the lab that looks to be very exciting. And we’re looking for what the side effects are and what is the right dose. So, it’s a very early trial where we’re not even sure what the toxicity is or what’s the right dose.  

Once we complete Phase I studies, we then get the information. So, we know the right dose. We know the side effects. We move onto a Phase II study. So, a Phase II study is where we’re going to look at a particular type of cancer and say everybody gets this drug at this dose and we know what the side effects are. We are looking to see if it truly is efficacious because from our very early research in the Phase I studies, we saw a group of patients with this particular type of cancer have a really nice response. And so, we’re looking for the efficacy of a drug in a Phase  II study. So, everybody gets treated. If we find something in the Phase II study that is a slam-dunk oh, my goodness, this looks terrific, we then go on to a Phase III study.

And so, a Phase III study is a randomized trial meaning half of the patients get one treatment. Half of the patients get the other treatment. Many times, I don’t get to pick what the patient gets. The patient doesn’t get to get what the patient picks. It’s randomized, but everybody gets a treatment. And Phase III studies take this new drug that we saw and got very excited about in the Phase II study, and we’ll compare it to the gold standard or the current standard of care for that particular disease. And then we compare the standard to the new treatment and see who wins. And that’s how we advance our learning. We advance what we do for people with this disease because if the new treatment does better than what we’re doing for everybody else, well now everybody else is going to get the new treatment.  

Advanced Non-Melanoma Skin Cancer Research Update

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Advanced Non-Melanoma Skin Cancer Research Update from Patient Empowerment Network on Vimeo.

Dr. Anna Pavlick highlights ongoing research into preoperative immunotherapy in non-melanoma skin cancer. Dr. Pavlick emphasizes the importance of clinical trials and provides guidance on how to inquire about participating in these studies.

Dr. Anna Pavlick is a medical oncologist and the founding Director of the Cutaneous Oncology Program at Weill Cornell Medicine and NewYork-Presbyterian. Learn more about Dr. Pavlick.

See More from Evolve Non-Melanoma Skin Cancer

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Transcript:

 Katherine:

What research is showing promise? What are you excited about? 

Dr. Pavlick:

Oh, my goodness. Skin cancer research is really skyrocketing. 

We have been able to use immunotherapy. Again, we developed this in metastatic melanoma but have really looked at the large-tumor mutational burden that squamous cell and basal cell cancers have as well as Merkel cell and have been able to take immunotherapy from one setting and apply it to the next setting.

And we’ve seen some really spectacular results. Many times, we were just using immunotherapy to treat these malignancies, but the thought process has been well, what happens if we move it sooner and we give it to patients before we take them to the operating room?  

So, I think the thing that’s really been exciting has been looking at giving immunotherapy prior to surgery rather than giving it as prevention after surgery. 

And the reason we found that very meaningful is that we did a clinical trial giving patients somewhere between two and four cycles of preoperative treatment. And then we took them to the operating room which gave us the opportunity to look at that tumor and see what the immunotherapy did to the cancer. And a very high percentage, more than 50 percent of those patients were found to have no cancer whatsoever left in the specimen that was removed from their body.

And so, now we’ve got studies going on saying since patients have the potential to do so well with immunotherapy before surgery, A, do we even need to do surgery? B, if we do take them to the operating room, do we need to give them more preventive immunotherapy or can we just say you had such a great response, you’re done with treatment? 

 

And so, there is lots of exciting things that we’ll be identifying within the next few years that really, I think, is going to make a huge impact on patient’s lives. If we find out that immunotherapy can eradicate cancers, we may prevent people from having to go to the OR for resection. So, stay tuned for that, very exciting.   

Katherine:

How can patients learn more about research? What sorts of questions should they be asking their healthcare team?  

Dr. Pavlick:

I think research to me is always an opportunity because this is how we move science forward. 

So, I think whenever a patient is given a diagnosis of a cancer, whether it be an early-stage cancer or a later stage cancer, I think their physicians are obligated to really talk to them about clinical trial options for them.  

And sometimes, in early-stage cancers, there aren’t any. But sometimes there are prevention studies that may be taking place that once they get the diagnosis, they get treated for their cancer. They may be eligible to participate in prevention studies. So, I think that should always be a question that patients ask is, “Okay, other than the standard of care, are there any research studies that I may want to consider or need to know about?”  

What Are Potential Impacts of Artificial Intelligence on AML Patient Care?

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What Are Potential Impacts of Artificial Intelligence on AML Patient Care? from Patient Empowerment Network on Vimeo.

How might acute myeloid leukemia (AML) patient care be impacted by artificial intelligence? Expert Dr. Andrew Hantel from Dana-Farber Cancer Institute and Harvard Medical School shares his perspective on potential risks and benefits of the impact of AI on AML patient care.

Download Resource Guide | Descargar guía de recursos

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Transcript: 

Lisa Hatfield:

Dr. Hantel, can you elaborate on the significance of oncologists believing that AI-based clinical decision models need to be explainable? And how might this impact AML patient care and decision-making processes?

Dr. Andrew Hantel:

Sure. So I think just taking a step back and saying you know what is AI, and what does explainability of AI even mean? So AI or artificial intelligence is essentially computer algorithms that learn to some extent like us, but in other ways differently, kind of how to process information and make decisions based on that information or make recommendations, at least.

And to some extent, like you or I, we can’t really explain “Why did I decide to have Cheerios this morning versus having like whole wheat toast or something?” It’s kind of difficult for me to say, “Oh, I just felt like I wanted to do that instead of that.” To some extent, AI also does that. It can kind of arrive at a decision after digesting a lot of different data over its lifetime to say that it prefers Cheerios versus whole wheat toast.

But it can’t necessarily tell you why it wanted one versus the other. And in medical decisions, to some extent, the same things can happen. It can’t really adequately explain to some extent why it might recommend one treatment versus another. And we like to think that in medicine, we’re making evidence-based recommendations that we choose treatment one or treatment two over treatment three, because the evidence for one and two is better for the person in front of us.

And AI can also kind of explain things some ways to that extent, but in other ways it might not know all of the other characteristics of the person that aren’t in that computer that make us think treatment one or two is better than three. And so our ability to actuallyd say, “Is the AI making this decision appropriately and able to explain why it came to decision one and two?”

If it can’t do that, we can’t actually understand whether or not it’s gone wrong and whether or not we should trust what it’s recommending. And so for that, we kind of have to create artificial intelligence models that are explainable by saying, “I’m telling you, you should choose this option versus that option because of reasons A, B, and C as they apply to this patient who is being taken care of.” And the hope is that there are ways computer scientists are using to try and get AI towards that.

But we really need to make sure that we create an AI that’s trustworthy in order for us to make you know AML patient care decisions that do better for our patients, because we know that AI is powerful, and it can bring in a lot of different data sources that are difficult for any human to make in any kind of scenario. But to be able to do that in a way that doesn’t put patients at risk and that really improves their care and improves our ability to maintain and optimize people’s health is essential. And so while AI is not kind of right now being used to make decisions in AML patient care, it’s going to be tested probably in the near future to help out with that in clinical trials and controlled settings.

And so you as a patient or somebody who is very interested in the power of AI, I would say once we start to hear about those things, it might be something that you’re interested in participating in a trial, or you’re interested in kind of learning more about that. We could come back and talk about that more. For the moment though, I think it’s just more of a risk that we’re trying to avoid of making AI that’s not explainable and potentially harms patients rather than helps them.

Lisa Hatfield:

Okay, thank you. One of the things I know in some cancer research is they are using artificial intelligence and machine learning models to help predict outcomes based on certain therapies. And I wonder if you have any comments on, because the data used is historical and real time coming in all the time, but we know there are inherent biases based on disparities in healthcare anyway from underrepresented communities. Do you think that those biases can be overcome in future models that are used to predict outcomes to treatment for different types of cancers?

Dr. Andrew Hantel:

Yes. So I think there’s a number of different biases that can come into artificial intelligence models. And it’s the same, a lot of the same biases that we have in our current clinical trials, and that historically marginalized groups have not been well-represented, either in participating in trials or in their data that’s input into these AI models. And for kind of the same reason, we don’t really know how generalizable the data that we have from the trials or from the AI really apply to those populations.

We assume because they have a lot of the other same characteristics as the people who are in the trials or kind of in these models that we can apply those data to them. But I think the push is to use both data sets and to encourage participation in trials for those communities, such that we know that these drugs and that AI are safe and effective for them.

And so there are both efforts to do that in leukemia and cancer broadly, and across healthcare even more broadly. And that can be either by working together with kind of multinational consortia of physicians and researchers to kind of pool data that includes patient populations from around the world. And the same thing is being done for trials as well as to kind of help make sure that the people who are underserved also kind of within our own communities are included in both of these processes.

Lisa Hatfield:

If a patient were to come on to you and said, “Dr. Hantel, I looked up on ChatGPT, what is the best treatment for me given these mutations or this characteristic of my disease?” What might you say to them? Would you involve that in your decision-making? Would you discuss that with them a little bit more? How would you handle that?

Dr. Andrew Hantel:

I think I would just generally be curious about you know what the actual transcript of the conversation was like. I think right now one of the major concerns for a lot of AI is that it can hallucinate things. And so there are some famous examples of lawyers putting in you know kind of briefs that they wanted to file and the AI coming up with like court cases that never existed to justify things. And so the last thing that we want is in medical decisions for people to rely on kind of made-up facts to make treatment choices.

And so, I’d be interested in kind of its medical decision-making process and kind of the data that it was able to rely on to make the decision. More from the standpoint of curiosity and education for myself to understand how patients are interacting with these things, as well as to make sure that the patient was also understanding kind of the information that was being put out and wasn’t having any misconceptions.

I think that the potential for these AI to help patients is vast in terms of their ability to understand a lot of the medical jargon and a lot of the information that’s coming at patients through portals and everything else, that could be very scary. But I also want to make sure that we’re not kind of overloading patients with what we think is an answer, but actually can come with a lot of falsehoods and harm.

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What’s REALLY the News You Can Use?

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“New study shows baby otters prevent diseases!” “Chocolate promotes weight loss!” Don’t we wish headlines like that were true?  Unfortunately, some of the things we read about possible new cancer treatments are just about as likely.   

Because we seek hope from these good reports, it can be easy to misinterpret what we hear about studies and results. How do you know when reading about a study’s findings whether it’s a real breakthrough or just a sensational story? 

First, let’s go over the basics of research.  

Basics of Research

  • Scientific method is how scientists figure out if some treatment makes a difference by conducting an experiment.  
  • In cancer research, the experimental process of understanding if a particular treatment is effective and safe is called a clinical trial.  
  • One study can seem to prove almost anything; it’s only through repeated, tightly monitored and designed clinical research that we can know that a treatment actually works.  An example: I ate chocolate AND I lost weight; that doesn’t mean the chocolate CAUSED the weight loss. 

Cancer Research Facts

  • There are strict regulations for designing and conducting trials and reporting results, monitored by the Food and Drug Administration (FDA). 
  • The journey from an idea to an approved treatment can take many, many years, thousands of scientists, hundreds of thousands of patients, and millions of dollars. Only a fraction of clinical trials result in an approved treatment that is available to the public.  
  • Cancer researchers start with experiments in the laboratory, often done on cells, tissues, or animals whose cells work like human cells. If the results are promising, the researcher (also known as a Principal Investigator or PI) will apply to the FDA to begin a clinical trial, sharing data and a detailed design for testing the treatment on humans.  
  • Once the application is approved, the trial begins and goes through a series of phases that are closely monitored not only by the FDA, but by the internal review board (IRB) of the institution where the trial is taking place. These phases determine if the treatment works, if it’s safe, and ultimately if it works better than what has been regarded as the “standard of care” for a specific cancer type. 
  • If the clinical trial meets the criteria stated in the initial design, it is presented to the FDA for approval. There is even more rigorous review of the research design and results, including peer review by other researchers, before the treatment is approved. 
  • Once approved for public use, the treatment is continuously scrutinized for long-term side effects and other adverse events that may indicate serious problems. Sometimes, a treatment approved for one cancer type seems promising for others, and it will go through another clinical trial. 

Here are some factors that add credibility to articles and news stories that report findings:  

  • It’s reported by a neutral (non-political or entertainment) source. Examples include the Associate Press, Nature magazine, and medical publications such as the New England Journal of Medicine of the Journal of the American Society of Clinical Oncology (ASCO). 
  • The phrase “versus standard of care” lets us know there was an experimental group that did receive the test drug and a control group that did not. 
  • Funding sources, when identified, are the National Institutes of Health, academic medical centers or research universities.  
  • The sample size is very important: the larger the study, the more significant the results and the farther along in the clinical research process it has proven valid. 
  • The entity making the report isn’t trying to see you something. 

The good news? There are AMAZING treatments currently in clinical trials that once would have seemed like science fiction. This June, our team will report “breaking news” about new cancer treatments from the ASCO annual meeting in Chicago. We are thrilled to share with you that one of OUR programs, Empowering Providers to Empower Patients (EPEP), is being published among ASCO’s online abstracts.  

Have a question about something you see online? Reach out to us at tracy@powerfulpatients.org and we will help you interpret how the information might apply to you. 

Should Prostate Cancer Patients Consider a Treatment in Clinical Trials?

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Should Prostate Cancer Patients Consider a Treatment in Clinical Trials? from Patient Empowerment Network on Vimeo.

Prostate cancer expert Dr. Andrew Armstrong explains how prostate cancer clinical trials work and discusses why patients should feel confident exploring this option at any stage of their cancer journey.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine Banwell:

At what point should a prostate cancer patient consider participating in a clinical trial? 

Dr. Armstrong:

Sure. If you look at the National Comprehensive Cancer Network, NCCN guidelines, you’ll see that clinical trials should be discussed along all parts of the journey. 

And that’s because clinical trials often can change how we think about cancer, how we treat cancer, can improve cure rates, can improve survival. Most of our drugs and treatments that have been successful in all cancer have been the result of clinical trials. 

And it’s not always appropriate, though. We have very many treatments that can cure patients, and we don’t want to interfere with that, but sometimes a clinical trial can layer on top of that cure rate. 

But many patients, their cancer becomes resistant to proven therapies. That’s certainly an area where clinical trials can make a big difference, either to put off chemotherapy or more toxic therapies, or in patients who have exhausted proven therapies. That’s certainly appropriate. 

But sometimes clinical trials do not involve placebos. They involve combination therapies, they involve layering on top several approaches to try to improve the survival on top of standard of care.  

And so as a director of a research program, we have all sorts of trials. They come in Phase I, Phase II, Phase III. Really only the Phase IIIs involve placebo controlled or controlled trials. Phase II tend to be early studies, where everybody gets a therapy and it’s preliminary to determine efficacy. Phase I is really trying to determine the safety and dosing of an experimental drug. But patients can benefit across the spectrum. 

So, it’s important, particularly if you have advanced disease, to go to a site, like a comprehensive cancer center, for a second opinion to see if there is alternatives to what you might get in the community.  

Katherine Banwell:

Yes. What would you say to someone who might be hesitant to participate in a trial? 

Dr. Armstrong:

Participation in a trial involves shared decision-making, just like being diagnosed, embarking on initial treatment, even embarking on standard of care treatment. Everything is shared decision-making in terms of risks and benefits.  

Sometimes a trial is not in a patient’s best interest, and it’s important for a physician to be upright about that and up front about the risks of a trial. 

I think when patients have exhausted proven therapies, it’s quite appropriate to talk about therapies that might be in the research pipeline that are showing some promise, that have demonstrated at least success in the laboratory or in small numbers of patients coming before.  

For example, in 2022, a brand-new drug just got approved called Pluvicto, or PSMA lutetium. This is a new smart bomb for prostate cancer. Just last year it was a research drug, but this year it’s successful and being used in the clinic. All those hormone drugs I mentioned earlier, those were research drugs five years ago. So, we don’t make advanced, we don’t extend lives without participating in research. We’re not happy with the way things are, we want them to be better. 

And the only way to make them better is by studying them. And not all of these trials are successful, unfortunately, but many are, and that’s why we are seeing men live longer and have better survivorship nowadays. 

How Has Cancer Research Evolved in Light of the COVID-19 Pandemic?

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How Has Cancer Research Evolved in Light of the COVID-19 Pandemic? from Patient Empowerment Network on Vimeo. 

What have been some benefits for cancer research during the COVID-19 pandemic? Expert. Dr. Shaji Kumar describes some of the clinical trial changes that have been born from the pandemic to improve access to care and to decrease the risk of infection for cancer patients.

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Transcript:

Mary Leer:

Are there any noticeable trends born out of the pandemic that will be or could be a benefit to the future of cancer care or research?

Dr. Shaji Kumar:

That’s a very important question, and I think we always learn from adversity, and I think this is going to be no different. I think, especially when the pandemic hit back in the spring of last year, we all had to think fast on our feet to figure out how best to continue to tell about the best care for the cancer patients without compromising the care in any way. And we knew that bringing the patients back into the clinic at the same rate we did before the pandemic would expose them to significant risk for infection, so how do we continue with treatment? There have been very different things people have tried…one of them is to try and get the medications to patients at home. If they are on IV medications, they can be changed to something that’s comparable that can be given by mouth. We already did that for some patients. For some patients who used to come to the clinic very often, so we figure out is there a way for them to get some of those testing done in a clinic much closer to home, so they can avoid the travel, they can avoid being in a bigger city, they can avoid being in a bigger institution, again, reducing the risk of exposure, and then you look at those numbers and then decide on the next course of treatment. We converted many of the clinic visits to video visits. Nothing is as good as having the patient right in front of you, but this is the best we could do under the circumstances.

And I think that helped. So I think the clinical trials was a big problem because in many of those trials were done in a very rigid fashion with very little variability allowed within the protocols. And everybody loosened from the clinical trial sponsors, the pharmaceutical companies, the institutional review board, the investigators to try and build flexibility into those clinical trial structures to allow patients to continue to be on those trials, So what does that mean for the future? I think the video visits are here to stay, I think we will continue to utilize that and bring patients back to the clinic only when it’s absolutely needed. I think the clinical trials will have in-built flexibility so that patients can enroll on clinical trials remotely, they can potentially be given some of those medications at home, maybe it would be something where we would check into the patients on a regular basis to make sure things are proceeding in the right way. I think there are increasingly technologies that will allow the patients to communicate in real time with the care team and also provide many of the data that we need through iPads or iPhones, Apple watches, whatever we end up using.

So that is that I think that technology will rapidly take off in the next few years. So I think a lot of the care of the patients with cancer in general, and particularly cancer patients, is going to look very different five years from now, because of all these things that we have always thought of and we thought, “Yeah it will take time to implement, it’s difficult.” Now we figure it out in a year. We can do a lot of those things.

Jeff Bushnell:

What’s the final takeaway for the average cancer patient and caregiver, how to get through this? What’s your bottom line for us all?

Dr. Shaji Kumar:

Your cancer treatment comes first, let’s not compromise on it, let us do it as safe as we can by observing all the instructions in terms of social distancing, masking, avoiding gatherings, getting vaccinated, and make sure you keep connected with your care team. You don’t have to be in the clinic to do that. There’s a variety of different tools, I think every hospital has options to either through their medical records to message their care team, or set up video visits and so forth.

So we want to be in a state where it was before the pandemic in terms of your communications, but use the technology, so we can decrease the risk of exposure without compromising the quality of care.