What Questions Should You Ask About a Proposed Thyroid Cancer Treatment Plan?
What Questions Should You Ask About a Proposed Thyroid Cancer Treatment Plan? from Patient Empowerment Network on Vimeo.
What questions should you ask about a proposed thyroid cancer treatment plan? Dr. Wirth provides guidance on self-advocacy, seeking a second opinion, and discussing essential molecular testing for identifying targetable gene alterations.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
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Transcript:
Katherine:
What questions should patients ask about their proposed treatment plan?
Dr. Wirth:
So, Katherine your questions are so spot on, and these are the kinds of questions that we get asked in clinic all the time. And I could say one thing that I think, I don’t know if medical students still are in this, but I learned this in medical school. If a patient says to you, “What would you say to me if I were your mother?”
You’re not supposed to answer that question because of course you’re going to have your biases. But I realize people ask me that question all the time. And so, it’s a good question, so I should answer it because it’s a good question. But I think that I would simply encourage people to not be shy. Their doctors care deeply about them. Their doctors are pressed for time, but their doctors are always going to be happy to stop and answer every single question that the patient has. And the most basic questions are the best ones, but sometimes they’re also the hardest question to ask. But coming with a list of the important questions is very helpful. Bringing along a family member or friend and having them have their list of questions is also very helpful.
But writing down especially the hard questions can help you ask the question because it can be hard to say, “How long might this drug help me live?” Asking about how long I might live can be really hard to say, but if you’ve got it written down there, it’s a little bit easier to say. Or if it’s hard for you to get those words out, hand your doctor over your notebook, and your doctor can look at the questions and help answer the questions.
So, I just would encourage people to think in advance about what the questions are that they want to make sure that they cover and jot them down. And don’t be shy. Don’t be shy about saying, “Do you think it would be worthwhile for me to get a second opinion? And if so, who do you recommend?” And most doctors are perfectly content with somebody asking if they think a second opinion would be a good idea.
And I’ve always said if I were diagnosed with cancer, I would want to have a second opinion just to be sure that what my favorite doctor was saying to me really sounded right. So, don’t be shy about asking for second opinions. With thyroid cancer I also think now it’s so important that we’re doing the molecular diagnostics of the tumors for patients to identify those patients that have targetable gene alterations. And it is still a relatively new thing in oncology to do molecular diagnostics for thyroid cancer as well as other solid tumors. And so, it is something that is not always recommended or offered to patients. But that’s something that patients with thyroid cancer should absolutely ask their doctors about.
What Are the Benefits of Thyroid Cancer Clinical Trial Participation?
What Are the Benefits of Thyroid Cancer Clinical Trial Participation? from Patient Empowerment Network on Vimeo.
What are the benefits of thyroid cancer clinical trial participation? Dr. Lori Wirth discusses how clinical trials provide access to promising new treatments, offering patients additional options, and the potential for significant advancements in managing their disease.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
See More from Evolve Thyroid Cancer
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What Questions Should You Ask About a Proposed Thyroid Cancer Treatment Plan? |
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Transcript:
Katherine:
Dr. Wirth, what would you say to patients who are hesitant to participate in a clinical trial?
Dr. Wirth:
Oh, boy. So, that’s such an important question.
Katherine:
Yeah.
Dr. Wirth:
And I think that the natural reluctance to put oneself into an uncertain setting like a clinical trial is completely understandable.
But a couple of things that I would say is first of all there is a lot of really deep work that goes into identifying new agents that have promise in the preclinical setting from laboratories either within the pharmaceutical industry or within academics. The amount of smarts that goes into development new drugs as well as early testing to ensure safety and that there’s a real signal of activity, that amount of work that’s done before a clinical trial is launched is really quite significant. So, when we’re bringing a new drug into clinical trials, we already know that there’s a very good likelihood that that drug is going to have good activity.
Katherine:
Okay.
Dr. Wirth:
The other reason for patients to think about participating in clinical trials is when patients have metastatic disease in the solid tumor setting whether it’s colorectal cancer or breast cancer, unfortunately most of our treatments don’t work so well that there’s a chance of cure. However, if we can’t cure a cancer, the next best thing is to knock it back and hold it at bay for as long as possible so that people can feel well but also live as long as possible.
However, if we don’t have a drug that can work so well that can cure cancer completely many cancers ultimately are going to escape the control, and we’re going to need new therapies for those patients. When patients participate in a clinical trial that’s just giving them a whole other treatment option. And so, to have more options available gives more chances that there’s going to be a real homerun or a real success in terms of treatment.
So, I would much rather have my patient have three options of treatment rather than two options of treatment. And we can always turn to the drugs that we have that are already FDA approved as long as somebody’s well enough to receive cancer treatment. If there’s a promising clinical trial of a new agent that’s only available in a clinical trial, and if we use that earlier in the course of the disease, that gives us more options for down the road.
Thyroid Cancer Research and Treatment Highlights
Thyroid Cancer Research and Treatment Highlights from Patient Empowerment Network on Vimeo.
What are the latest thyroid cancer research and treatment highlights? Dr. Lori Wirth discusses recent advancements, including successful clinical trials with newer therapies, and ongoing research into the latest targeted treatments for advanced thyroid cancer.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
See More from Evolve Thyroid Cancer
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What Questions Should You Ask About a Proposed Thyroid Cancer Treatment Plan? |
What Are the Benefits of Thyroid Cancer Clinical Trial Participation? |
Transcript:
Katherine:
Dr. Wirth, what are your research areas of focus?
Dr. Wirth:
Here at Mass General in Boston we focus on clinical trials looking at new therapies for patients with advanced thyroid cancer including iodine refractory thyroid cancer, anaplastic thyroid cancer, medullary thyroid cancer.
We also have a big program in studying in the laboratory what makes thyroid cancers tick in order to try to come up with new angles for new drug therapies based on preclinical work that’s being done.
Katherine:
Okay. In terms of thyroid cancer are there research developments that are showing a lot of promise that you’re excited about?
Dr. Wirth:
And so, Katherine, I’m so glad you’re asking that question because we’ve actually had some really big successes in clinical trials for patients with thyroid cancer recently. One of the big successes was a study called COSMIC-311 which looked at the drug cabozantinib (Cabometyx) in patients with iodine refractory thyroid cancer who had progressed on the first-line therapy.
Most commonly that’s lenvatinib (Lenvima), but you can have other first-line therapies as well. And that study was a randomized Phase III study that was done in an international setting and showed that cabozantinib had very good activity in the second line following progression on first-line therapy.
So, we now have treatments lined up for patients for the first line, but then also we have good treatment for patients who’ve progressed on the first-line therapy and need further treatment. So, that was one major success. Another major success recently was the LIBRETTO-531 trial. So, that was a randomized Phase III trial also done internationally in patients with progressive RET-mutated medullary thyroid cancer.
And that study randomized patients to receive either the RET specific therapy selpercatinib compared to a multikinase inhibitor either cabozantinib or vandetanib (Caprelsa). And the LIBRETTO-531 study showed that selpercatinib is much better than the older standard of care therapies in terms of response rates, durability of response. And we’re even seeing that it looks like there’s a signal where the overall survival is longer with serpercatinib compared to the older standard of care therapies.
So, whenever we have a strongly positive Phase II trial in oncology it’s a big win. And those are two examples of big wins recently. Another study that I would highlight has come out of Germany looking at the combination of pembrolizumab which is an immunotherapy drug in combination with lenvatinib the multikinase inhibitor in patients with anaplastic thyroid cancer.
And it was a relatively small study. It was a Phase II trial, but this Phase II trial in Germany showed very good activity with this combination of pembrolizumab (Keytruda) and lenvatinib in people with anaplastic thyroid cancer. So, that is very promising for the future for those patients as well.
Katherine:
Dr. Wirth, is there anything you’d like to add about the evolution of thyroid cancer care? Are you excited about anything that we haven’t already talked about?
Dr. Wirth:
I am so excited about our recent evolution in thyroid cancer care where we’ve gone from only having old fashioned IV chemotherapy which really doesn’t work very well in thyroid cancer to having really effective multikinase inhibitors for thyroid cancer patients. And now we even have gene specific targeted therapies that work even better in certain specific situations. And so, this evolution over the last 10 years has really changed the landscape of therapies available to our patients. And we now have drugs for almost all of our patients with thyroid cancer.
They have a good likelihood of working really well for a really long period of time. And that’s changed in my lifetime, taking care of people with thyroid cancer. And the progress that we’ve seen in the last 10 years is really only accelerating before our very eyes. One of the targets that we didn’t talk about earlier is the BRAF V600E mutation.
And I just want to talk about that very briefly because that’s actually the most common potentially targetable gene alteration in thyroid cancer. But thyroid cancer patients share that gene mutation with other cancers as well including melanoma, a subset of people with lung cancer, a subset of people with colorectal cancer as well. There are a lot of new drugs that are being studied in clinical trials targeting that BRAF V600E mutation and other cousins within that pathway of gene alterations that drive cancers.
And so there is a very active industry that is working on developing the next best therapy for all of these targets that we’ve talked about, NTRK, RET, BRAF mutations, immunotherapy approaches to people with all different types of solid tumors. And those kinds of clinical trials are being done now in advanced thyroid cancer.
Whereas 15 years ago it was really difficult to get a trial up and running for people with thyroid cancer because it was seen as such a rare cancer, kind of a niche cancer where there’s not a lot of money to be made in developing drugs compared to the numbers of women with breast cancer or numbers of people with lung cancer.
It’s a different story now. There’s a lot of active drug development specifically for people with thyroid cancer.
Understanding Targeted Thyroid Cancer Treatment Approaches
Understanding Targeted Thyroid Cancer Treatment Approaches from Patient Empowerment Network on Vimeo.
What are targeted thyroid cancer treatment approaches? Dr. Wirth explains standard options like multikinase inhibitors, newer gene-specific treatments, patient suitability for targeted therapies, and common side effects.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
See More from Evolve Thyroid Cancer
Related Resources:
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What Are the Benefits of Thyroid Cancer Clinical Trial Participation? |
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Transcript:
Katherine:
Thank you. Dr. Wirth, what are the targeted treatment approaches for treating thyroid cancer?
Dr. Wirth:
Yes, so we do have new options for treating iodine-refractory thyroid cancer, also anaplastic thyroid cancer, and then the medullary thyroid cancer.
So, the first group of drugs that were studied starting a decade ago and have become standard of care options for these patients are the multikinase inhibitors, which are targeted therapies. But the drugs target multiple kinases not just one kinase, so we call them multikinase inhibitors. Lenvatinib (Lenvima) is the multikinase inhibitor that’s used most often in iodine refractory thyroid cancer.
But we have other multikinase inhibitors as well. Cabozantinib (Cabometyx) is a drug that’s available now for second-line therapy in iodine refractory thyroid cancer. That’s a multikinase inhibitor. And then for medullary thyroid cancer multikinase inhibitors were studied about 10 years ago as well.
And cabozantinib (Cabometyx) and vandetanib (Caprelsa) are both multikinase inhibitors that have good activity and were FDA-approved for the treatments of medullary thyroid cancer. But one of the things that’s been so exciting in the last five to eight years is that we now know that a large portion of all of these various thyroid cancers are driven by specific gene mutations.
And many of those gene mutations lead to expression of abnormal proteins that make the cancer a cancer cell. And in many circumstances, those abnormal proteins driving the cancer cell growth are now targetable with gene-specific therapies. So, there’s been a lot of progress made recently in that area of the work that we do, which has really led to some great successes.
So, the first example of a really great success was in targeting the TRK protein, TRK. And that is aberrantly expressed in a subset of the iodine refractory differentiated thyroid cancers by virtue of a gene alteration called a fusion. So, you can see NTRK1 or NTRK 3 fusions driving a subset of iodine refractory differentiated thyroid cancer.
And there are now a couple of drugs that target TRK very potently and specifically including larotrectinib (Vitrakvi) that was studied in multiple different types of tumors all driven by NTRK fusions, including a fairly large cohort of patients with iodine refractory differentiated thyroid cancer. And in the thyroid cancer patients, we saw really high responses with larotrectinib, which is an oral drug taken by mouth at home every day.
And not only did we see very high response rates, but we also are seeing very durable responses where patients can remain on larotrectinib month after month after month or even for years with a significant regression of their thyroid cancer. Sometimes people even will have a complete response on larotrectinib. And they can tolerate larotrectinib well for the most part for a very long period of time. So, that’s a targeted therapy success story for patients with NTRK fusion-positive thyroid cancer. Another example is targeting RET fusions and RET mutations. So, we see RET fusions in iodine refractory differentiated thyroid cancer in a portion of them.
We also occasionally see RET fusions driving anaplastic thyroid cancer. And then more than half of patients with medullary thyroid cancers will have RET mutations. And so, the gene mutation is slightly different than a gene fusion, but the end result is very similar so that RET is overactive in these cancers and now is druggable with RET-specific inhibitors. The one that’s been studied the most in thyroid cancer is selpercatinib (Retevmo). And similar to larotrectinib and NTRK driven thyroid cancers serlpercatinib and RET-driven thyroid cancers has great activity, very high response rates, very durable responses. And again, it’s taken at home every day by mouth, and it’s really very well-tolerated overall.
Katherine:
Well which patients are a good fit for a targeted treatment approach?
Dr. Wirth:
So, the patients that are a good fit are patients first of all who need a systemic therapy.
So, for example, if a patient has had a thyroid nodule that’s not all that big, a biopsy shows it’s thyroid cancer, and the patient has a complete resection of that disease and may or may not have gotten treated with radioactive iodine.
But if they’re disease free they don’t need any further therapy. And a lot of patients are in that category which is the best-case scenario. But when patients have persistent disease that eventually is going to grow over time, then we do genotyping of the tumor or molecular diagnostics. It’s the same thing, different phrases. But then we’ll extract the DNA from the cancer cells to see what types of targetable gene alterations might be present driving that thyroid cancer. In patients who are found to have an NTRK fusion, a drug like larotrectinib is an option.
If we see a RET fusion, then a RET specific therapy might be an option. So, you need to have some disease that needs a systemic therapy, and then the target needs to be present as well.
Katherine:
What are the common side effects for a targeted approach?
Dr. Wirth:
So, the side effects are a little bit different flavor for the different drugs. So, larotrectinib, for example, is a potent and specific TRK inhibitor. And TRK is expressed in the development of the nervous system as well as the maintenance in full grown people of the nervous system. So, you can have on target TRK related side effects involving the nervous system from when patients are on larotrectinib.
So, we can, for example, see a little bit of dizziness or gait unsteadiness which is a direct result of inhibiting TRK. Or sometimes patients will develop kind of an unusual pain syndrome where when they’re getting close to the time that they’re supposed to take their next does of Larotrectinib when the amount of drug in the body is beginning to wane, then some patients will develop pain like joint pain for example, pain from arthritis but it seems to be exacerbated.
And then when they take their next dose of larotrectinib the pain goes away as well. So, there’s some impact on pain control that we can see as a side effect of larotrectinib. Fatigue I think is the other probably most common side effect which probably also is an on-target side effect from larotrectinib.
Katherine:
Yeah.
Dr. Wirth:
There can be some inflammation in the liver which we can see in blood tests, so we have to monitor blood tests for that kind of inflammation, which is uncommon but can be seen and sometimes will require some dose reductions in order to not have to worry about liver injury in a particular patient.
What Are Initial Thyroid Cancer Treatment Approaches?
What Are Initial Thyroid Cancer Treatment Approaches? from Patient Empowerment Network on Vimeo.
What are initial thyroid cancer treatment approaches? Dr. Lori Wirth explains why surgery is the primary treatment, when radioactive iodine is appropriate, and the need for lifelong thyroid hormone replacement after thyroidectomy.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
See More from Evolve Thyroid Cancer
Related Resources:
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What Are the Benefits of Thyroid Cancer Clinical Trial Participation? |
What Questions Should You Ask About a Proposed Thyroid Cancer Treatment Plan? |
Transcript:
Katherine:
So, what are the main treatment classes for each type?
Dr. Wirth:
So, surgery is always considered a mainstay for any type of thyroid cancer whenever possible. Often patients will present with a lump in their neck that is noticed either by themselves or on physical examination and is noticeable before the cancer has spread to other parts of the body. And that’s definitely the best-case scenario. If those cancers can be completely resected by surgery with either a hemithyroidectomy or a total thyroidectomy, then there’s a reasonably good chance of cure in many cases.
So, surgery is first and foremost the treatment that we think about. Then for the subtypes of thyroid cancer that arise from the regular thyroid cells namely papillary thyroid cancer, follicular thyroid cancer, oncocytic, and high grade.
Those patients will often also be treated after surgery with radioactive iodine.
The normal thyroid tissue takes up iodine from the blood in order to make thyroid hormone. And we can make iodine radioactive, give that to a patient, and it can sometimes be taken up by the thyroid cancer cells just like normal thyroid cells would take up normal iodine from the blood. And if those cells take up radioactive iodine, then they’re killed off by the radioactive iodine. We know, however, that anaplastic thyroid cancers don’t take up radioactive iodine.
So, we don’t use radioactive iodine ever in anaplastic thyroid cancers. And then also in medullary thyroid cancers, because they’re really a completely different cell altogether, those cancers are not treated with radioactive iodine as well.
Katherine:
Okay.
Dr. Wirth:
So, most patients will need to have surgery. Many patients will also be treated with radioactive iodine. And for many, many patients with thyroid cancer, that’s all the treatment that they need, and they’re done.
There are, however, patients who will have more aggressive thyroid cancer or thyroid cancer that’s already metastasized to other parts of the body. And if those cancers don’t respond to radioactive iodine, then we consider them radioactive iodine resistant or refractory. And then we have other treatments in the arsenal for those cases.
Katherine:
This may seem like a very simple question to you. But once the thyroid has been removed, doesn’t the patient then have to take some sort of supplement for the rest of their lives?
Dr. Wirth:
Yes, exactly. So, the job of the thyroid gland mostly is to make thyroid hormone. And thyroid hormone is one of the things that governs the body’s metabolism. So, if you take away the thyroid gland, then without the thyroid hormone replacement patients will become hypothyroid. And eventually it can be so severe that people can be quite, quite, quite ill. So, anyone who’s had a complete thyroidectomy will need treatment with thyroid hormone replacement for the rest of their lives.
Personalized Treatment Approaches in Advanced Thyroid Cancer Management
Personalized Treatment Approaches in Advanced Thyroid Cancer Management from Patient Empowerment Network on Vimeo.
How can advanced thyroid cancer be managed in a personalized way? Expert Dr. Megan Haymart from the University of Michigan discusses personalized treatment approaches and patient advice for optimal care, shared decision-making, and support programs.
[ACT]IVATION TIP
“…if your disease has progressed and you’ve seen an endocrinologist and maybe they don’t routinely give these targeted treatments, make sure you’re referred to an appropriate person who does. Two, I would encourage individuals to make sure that they had tumor sequencing, which means they can look at the tumor and see what is the mutation.”
See More from [ACT]IVATED Thyroid Cancer
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Advancing Thyroid Cancer Care: Tailored Treatment and Patient Involvement |
Transcript:
Lisa Hatfield:
Dr. Haymart, can you discuss the role of personalized medicine in managing advanced thyroid cancer, particularly tailoring treatments based on individual patient characteristics?
Dr. Megan Haymart:
So advanced thyroid cancer, when I think of those words I’m specifically talking about patients who have distant metastasis that is progressing. So it’s not just that they have a small site of sort of cancer recurrence that’s sort of stable. This is disease that’s progressing. And the things that have really changed in the past five to 10 years is we have more targeted treatments for these individuals.
There have been more clinical trials that have been completed, and these trials have shown which patients might be appropriate candidates for these treatments. And so my activation tip for this question is if you have advanced thyroid cancer, if you have disease that’s progressing, it’s not treated with standard therapy.
One, make sure you see physicians who are capable of treating this disease. So even though I see 95 percent of all thyroid cancer patients, I’m an endocrinologist and I actually, I’m not the one who gives these targeted treatments to the 5 percent or less who have advanced disease, I would refer them to my medical oncology colleague. And so, if your disease has progressed and you’ve seen an endocrinologist and maybe they don’t routinely give these targeted treatments, make sure you’re referred to an appropriate person who does.
Two, I would encourage individuals to make sure that they had tumor sequencing, which means they can look at the tumor and see what is the mutation. And it’s possible that there’s either an already available drug or a clinical trial that’s targeted towards their specific tumor mutation.
Lisa Hatfield:
Dr. Haymart, how can patients engage in shared decision-making with their healthcare providers to determine the most appropriate treatment approach for their thyroid cancer? And what role do patient navigators or support programs play in improving outcomes for disadvantaged patients navigating the complexities of thyroid cancer treatments?
Dr. Megan Haymart:
So a key thing here for thyroid cancer for 95 percent of patients is you have time on your side. So patients shouldn’t feel rushed to make a decision. So you have your clinic visit, you don’t need to make a decision on your treatment by the end of the visit. You can gather more information, so you can read more using reliable resources that your physician recommends. You can talk to your friends and family members. You can tell your healthcare provider, “You know, I appreciate the information that you gave me. I need more time to process this. I’ll be in touch with you.”
So patients don’t need to feel rushed during that decision-making process. It’s important that they know that for most of the time, for thyroid cancer, it’s preference sensitive decisions, meaning shared decision-making is totally appropriate. There’s no right or wrong answer in many of these scenarios.
And so the patients can really tailor it to them and what their priorities are. There’s been less data on patient navigators in the realm of thyroid cancer, but for other cancers, it’s been shown to be very useful and helpful, and patients have had positive responses to working with patient navigators. But if they aren’t available at your institution, don’t feel bad about bringing in a family member or a friend as an extra set of ears, and as someone that you can talk things over with later.
Advancing Thyroid Cancer Care: Tailored Treatment and Patient Involvement
Advancing Thyroid Cancer Care: Tailored Treatment and Patient Involvement from Patient Empowerment Network on Vimeo.
What are some ways that thyroid cancer care is being advanced? Expert Dr. Megan Haymart from the University of Michigan discusses updates in thyroid cancer guidelines, shared decision-making, and actionable patient advice for personalized treatment.
[ACT]IVATION TIP
“…patients should carefully ask the risks and benefits of each of the treatment options, so they can make a pro/con list for themself and really tailor it to what’s a priority to them.”
See More from [ACT]IVATED Thyroid Cancer
Related Resources:
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Personalized Treatment Approaches in Advanced Thyroid Cancer Management |
Transcript:
Lisa Hatfield:
Dr. Haymart, with your involvement in creating thyroid carcinoma guidelines and your research on optimizing cancer care delivery, what recent advancements or changes in thyroid cancer management do you find most promising for improving patient outcomes?
Dr. Megan Haymart:
So I think there are a lot of exciting changes that are coming. But the one that I’m the most excited about with the guidelines is the guidelines are going to emphasize tailored care more and shared decision-making more. And so I think these are key. And so for a lot of thyroid cancer management, there is not one right or wrong treatment option. It depends a little bit on the patient and what their preferences are.
And so for preference sensitive decision-making, there’s going to be a lot more emphasis on including the patient in that decision-making. There’s no right or wrong choice. The patient can think about what concerns them the most and then prioritize things based on that.
So, for example, total thyroidectomy, which means removing all of the thyroid versus lobectomy, which removes half the thyroid. For some patients with low-risk disease, either option is okay. The benefit of doing a lobectomy is there’s less surgical risk, so less risk of voice problems, less risk of low calcium. The disadvantage is that sometimes there’s more follow-up needed, maybe more ultrasounds needed. You don’t know by blood work necessarily that all the cancer’s gone. So you get more information by doing the total thyroidectomy but the total thyroidectomy has more surgical risk.
So, for example, if someone is a singer and they really don’t want their voice to be damaged and they’re not that worried about cancer coming back, lobectomy might be the choice for them. If someone has a lot of anxiety about wanting to know that absolutely everything is gone and the idea that they might need more ultrasounds makes them anxious, maybe total thyroidectomy would be a better option for them.
And so moving forward, I think there’s going to be this emphasis on personalized care, shared decision making and sort of tailoring the care to the patient. And so my activation tip for this question is that patients should carefully ask the risks and benefits of each of the treatment options, so they can make a pro/con list for themself and really tailor it to what’s a priority to them.
Lisa Hatfield:
Okay. Thank you. And one follow-up question I have to that as a cancer patient myself is, whether a patient and their doctor chooses a more or less aggressive treatment with their thyroid cancer, what does the follow-up look like? Are labs and imaging done forever for that patient to make sure there’s not a recurrence or is it just for a certain period of time?
Dr. Megan Haymart:
So this is a great question. About, I don’t know, 10 years ago everybody was getting almost the same treatment, right? So we’ve started to tailor it more and there’s far more people getting lobectomy now than they were 10, 20 years ago. Which is great. The disadvantages, we don’t have as much long-term data on these individuals.
And so it’s a little hard to be conclusive about when is the right time to stop follow-up. The longer we get out, the more data we’ll have on how long we need to follow these patients who had lobectomy, but I think that’s an excellent question. It’s just the fact that there’s been a shift in management and we haven’t had time to catch up to like, how should surveillance or long-term survivorship care change.
Emerging Advancements in Thyroid Cancer Treatment
Emerging Advancements in Thyroid Cancer Treatment from Patient Empowerment Network on Vimeo.
What are the latest thyroid cancer treatment advancements? Expert Dr. Megan Haymart from the University of Michigan shares an overview of treatment updates along with proactive advice about actionable mutations for personalized thyroid cancer treatment.
[ACT]IVATION TIP
“…if you have high-risk advanced disease that’s progressing, I think it’s very important to ask your physician if they’ve done tumor sequencing to see if there’s any actionable mutations, because then you could have more targeted treatment.”
See More from [ACT]IVATED Thyroid Cancer
Related Resources:
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Advancing Thyroid Cancer Care: Tailored Treatment and Patient Involvement |
Personalized Treatment Approaches in Advanced Thyroid Cancer Management |
Transcript:
Lisa Hatfield:
Dr. Haymart, new advancements in thyroid cancer treatment are emerging. What are some promising therapies on the horizon, and how might they benefit patients?
Dr. Megan Haymart:
So there’s a couple of exciting new treatment options that are available. So one is for high-risk patients who have advanced disease. So this will be a minority of all the patients I see. So it’s probably five to 10 percent that have high-risk advanced disease that’s progressing at most, probably closer to 5 percent. For these individuals, we now have targeted treatments where we can do molecular testing of the tumor, and try to identify the mutations and then give treatments that are targeted towards those mutations.
Not everybody needs this. So many of my patients do great with sort of the standard therapy of surgery, maybe surgery and radioactive iodine if they have papillary or follicular thyroid cancer, they had some lymph nodes involved, but there are some where they have distant metastasis, it’s aggressive, it appears to be growing. And so we do have new treatment options and there’s more and more trials and treatment options becoming available every day.
The other exciting thing that’s available now is there’s new treatment options for lymph node metastasis. So most of the time for lymph node metastasis, you’re going to have another surgery. You always want to see the surgeon first, but sometimes there’s patients who’ve had multiple neck surgeries. The surgeon can’t go back in, or it feels like it’s too high risk to go back in.
We now sometimes use percutaneous ethanol ablation. We’re starting to use radio frequency ablation to treat these isolated lymph node mets when surgery is no longer an option. And so I think that it’s exciting because we have opportunities for patients that we didn’t have in the past. And I think it’s just going to continue to improve in regards to use of these new therapies.
Lisa Hatfield:
Okay, thank you. And do you have any activation tips for that question?
Dr. Megan Haymart:
My activation tip for this question is specific to individuals with high-risk advanced disease that’s progressing, And so if you have high-risk advanced disease that’s progressing, I think it’s very important to ask your physician if they’ve done tumor sequencing to see if there’s any actionable mutations, because then you could have more targeted treatment. Some of these targeted treatments work better, some of them have lower side effects, and so it’s really an era of more tailored care, and this is an important question to ask.
Lisa Hatfield:
Dr. Haymart, how do genetic mutations and molecular markers influence treatment decisions in thyroid cancer and what personalized medicine approaches are being developed?
Dr. Megan Haymart:
So for patients with advanced disease, and it’s progressing, so they have distant metastasis, it’s growing. We can now test for mutations in the tumor to see if there’s any actionable mutations that patients can get targeted treatment. And so that wasn’t available in the past and it is now. And I think it’s really changed the way we take care of our advanced thyroid cancer patients. And my activation tip for this question is, if you have advanced progressing thyroid cancer, ask your doctor if your tumor has had sequencing to see if there’s an actionable mutation because there may be a targeted treatment that you’re a candidate for.
Understanding Thyroid Cancer Treatment Options and Follow-Up Care
Understanding Thyroid Cancer Treatment Options and Follow-Up Care from Patient Empowerment Network on Vimeo.
What’s key for thyroid cancer patients to know about treatment options and follow-up care? Expert Dr. Megan Haymart from the University of Michigan shares her expert knowledge about various treatment paths and proactive patient advice to ensure optimal care.
[ACT]IVATION TIP
“…it would be important to ask how many surgeries have you done in the past year? Typically high volume is considered more than 25, very high volume, some of the physicians, some of the surgeons will do 100 a year. So that’s very important to ask this and ask them what is their complication rate? What are the complications that we might see?”
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Transcript:
Lisa Hatfield:
Dr. Haymart, can you explain the typical treatment journey for someone newly diagnosed with thyroid cancer and what can patients expect in terms of surgery, radioactive iodine therapy, and follow-up care?
Dr. Megan Haymart:
So patients typically have a biopsy and that’s how they find out they have thyroid cancer. Afterwards, they’re most often referred to surgery and so when they meet with the surgeon, the surgeon might talk about one, not doing the surgery, so just following it. But we don’t do that as often, but sometimes with small cancers and depending on what else is going on in a patient’s life at the time. Two, they might offer lobectomy. So the thyroid is a butterfly-shaped gland in the neck. So they might talk about taking out half the thyroid, not the whole thyroid. Or they’ll talk about a total thyroidectomy, taking out the whole thyroid. They should talk about the risk and benefits of both of those.
After the surgical pathology is back if someone had a total thyroidectomy for papillary or follicular thyroid cancer, radioactive iodine is a treatment option. And again, it’s not recommended for everybody, but for some patients, the things within the pathology look higher risk. There might be lymph nodes involved or signs of invasion. Radioactive iodine is a treatment option.
And then long-term, most patients are followed with neck ultrasounds, with laboratory work. Sometimes if there’s more suspicion, they may have additional, a suspicion of recurrence, they may have additional imaging, but for the most part, it requires lab work and periodic neck ultrasound during follow-up.
And so when patients are sort of along this pathway, I think a couple of things are important to know. One, sometimes it doesn’t move super fast. So it’s pretty typical, like between diagnosis and meeting with the surgeon, it might be a month, and then surgery might be a month or so after that. Radioactive iodine might be a couple months after that. And so that first six months to a year can be very stressful for a patient. So I think that’s important to know.
And then two, I think it’s important to make sure that when you go along this process, you have physicians that you trust and that you can rely upon. So you can still talk with your PCP who you know quite well. You may now have an endocrinologist that you see, and this might be new for you. You may have a surgeon that you see, and this might be new for you. And so you want to ask them the questions that you have.
And my activation tip would be that you want to make sure that you have high volume and experienced specialists. So, for example for surgery, it would be important to ask how many surgeries have you done in the past year? Typically high volume is considered more than 25, very high volume, some of the physicians, some of the surgeons will do 100 a year. So that’s very important to ask this and ask them what is their complication rate? What are the complications that we might see?
And then similarly for the endocrinologist, you want to ask what proportion of your patient population are thyroid cancer patients? How comfortable are you following thyroid cancer patients long-term? And you may get varying answers. And so I think it’s important just to ask these questions so that you feel comfortable that you have experienced providers taking care of you.
A Patient’s Perspective | Participating in a Clinical Trial
A Patient’s Perspective | Participating in a Clinical Trial from Patient Empowerment Network on Vimeo.
Colorectal cancer survivor Cindi Terwoord recounts her clinical trial experience and explains why she believes patients should consider trial participation.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.
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Transcript:
Katherine Banwell:
Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?
Cindi Terwoord:
Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”
And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.
Katherine Banwell:
Mm-hmm. Had you had a colonoscopy before, or was that your first one?
Cindi Terwoord:
No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.
Katherine Banwell:
Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?
Cindi Terwoord:
Well, I have a friend – it was very interesting.
He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.
And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.
And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”
Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”
Katherine Banwell:
Mm-hmm. Did you have any hesitations?
Cindi Terwoord:
Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.
Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.
I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.
Katherine Banwell:
Oh, good for you.
Cindi Terwoord:
I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.
Katherine Banwell:
That’s a great idea.
Cindi Terwoord:
Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.
Katherine Banwell:
In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?
Cindi Terwoord:
Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.
I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”
I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.
Katherine Banwell:
Mm-hmm. So, how are you doing now, Cindi? How are you feeling?
Cindi Terwoord:
Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –
Katherine Banwell:
Cindi, what advice do you have for patients who may be considering participating in a trial?
Cindi Terwoord:
Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered.
And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.
And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.”
But that was all very helpful, and I did get free parking for a few weeks. I mean, sometimes I’d have to remind them. I’d say, “It’s costing me more to park than to get treated.” But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it.
Katherine Banwell:
Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with?
Dr. Pauline Funchain:
First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.
It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?
So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results.
And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible.
What Are the Risks and Benefits of Joining a Clinical Trial?
What Are the Risks and Benefits of Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.
Why should a cancer patient consider a clinical trial? Dr. Pauline Funchain of the Cleveland Clinic explains the advantages of clinical trial participation.
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
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Transcript:
Katherine Banwell:
Why would a cancer patient consider participating in a clinical trial? What are the benefits?
Dr. Pauline Funchain:
So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.
We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.
I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.
And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.
Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial.
Katherine Banwell:
Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them?
Dr. Pauline Funchain:
Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.
So, sort of getting all the subtleties of what those risks and benefits are, I think, are really important.
Katherine Banwell:
Mm-hmm. What are some key questions that patients should ask?
Dr. Pauline Funchain:
Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C.
How Can Clinical Trials Be Accessed?
How Can Clinical Trials Be Accessed? from Patient Empowerment Network on Vimeo.
Clinical researcher Dr. Seth Pollack and patient advocate Sujata Dutta explain the benefits of participating in a clinical trial. They review important questions to ask your doctor and share advice for finding a trial.
Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.
Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.
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Transcript:
Katherine Banwell:
Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?
Sujata Dutta:
I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.
And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.
Katherine Banwell:
Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?
Dr. Seth Pollack:
Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.
And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.
Katherine Banwell:
Would specialists have more information about clinical trials than say a general practitioner?
Dr. Seth Pollack:
So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.
So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.
Sujata Dutta:
There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.
Katherine Banwell:
That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?
Dr. Seth Pollack:
Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.
And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.
Katherine Banwell:
Yeah. Sujata, what would you like to add?
Sujata Dutta:
Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.
So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.
Are Clinical Trials Safe?
Are Clinical Trials Safe? from Patient Empowerment Network on Vimeo.
Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.
Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.
Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.
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Transcript:
Katherine Banwell:
Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?
Dr. Seth Pollack:
No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out.
Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.”
Katherine Banwell:
So, you need to weigh the pros and cons of the trial.
Dr. Seth Pollack:
You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about.
Katherine Banwell:
Yeah, yeah.
Sujata Dutta:
Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason.
If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.
Katherine Banwell:
Good.
Can data from trials even be trusted? Dr. Pollack, is that the case?
Dr. Seth Pollack:
Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately.
So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm.
Sujata Dutta:
I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too.
Katherine Banwell:
Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all?
Sujata Dutta:
No. Not at all.
I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem.
Katherine Banwell:
Beyond these misconceptions is there anything else you hear? Dr. Pollack?
Dr. Seth Pollack:
No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.
And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.
Katherine Banwell:
That’s great to know.
Are Clinical Trials a Logistical Nightmare?
Are Clinical Trials a Logistical Nightmare? from Patient Empowerment Network on Vimeo.
PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.
Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.
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Transcript:
Katherine Banwell:
The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?
Sujata Dutta:
Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.
So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.
You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.
