ADVERTISEMENT
Percutaneous Locoregional Therapies for the Treatment of Breast Cancer
This podcast episode is part of the SIO Corner, a collaboration between IO Learning and the Society of Interventional Oncology. Our guest host is Dr Elena Violari, Interventional Radiologist and member of the SIO’s Publications Committee. Dr Violari invited Dr Yolanda Bryce, an Interventional Radiologist and Director of the Interventional Radiology training program at Memorial Sloan Kettering Cancer Center to discuss percutaneous locoregional therapies for the treatment of breast cancer.
Transcript
Welcome to IOL Radio, the podcast for IO Learning, a digital publication that covers the latest advancements in interventional oncology. This podcast episode is part of the SIO Corner, a collaboration between IO Learning and the Society of Interventional Oncology. Our guest host is Dr Elena Violari, interventional radiologist and member of the SIO’s Publications Committee. Dr Violari invited Dr Yolanda Bryce, an Interventional Radiologist and Director of the Interventional Radiology training program at Memorial Sloan Kettering Cancer Center to discuss percutaneous locoregional therapies for the treatment of breast cancer.
Dr Elena Violari:
Hello everyone, and thank you for listening today. We're pleased to have Dr Yolanda Bryce as our guest. Dr Bryce is an interventional radiologist at Memorial Sloan Kettering Cancer Center in New York, where she also serves as the director of the Interventional Radiology Training Program. Yolanda, welcome and thank you for joining us today.
Dr Yolanda Bryce:
Thank you. I'm so happy to be here.
Dr Elena Violari:
Our main topic today will be to discuss percutaneous locoregional therapies for the treatment of breast cancer. My first question to you, Yolanda, is what initially drew you into interventional oncology? And then more specifically, what interested you in the treatment of breast cancer?
Dr Yolanda Bryce:
That's a very good question, and my journey here has been not direct. I went into radiology, specifically diagnostic radiology with the intention of doing interventional radiology. It's something that I had seen my last year of medical school, and it was the one thing I thought could engage me for the rest of my life. While I was in my radiology residency, I was involved in missionary work, especially in Jamaica, and the thought of not being able to practice medicine in a low income country was a little disturbing to me. And at the same time, I had an attending breast imager who was the most amazing doctor I had ever encountered. She was simply fabulous. And she was a breast imager, and honestly, I decided I wanted to be like her. So I decided to do a breast imaging fellowship, which I did at Memorial Sloan Kettering Cancer Center (MSKCC) where I am now.
And after I had gotten that position for fellowship for breast imaging, I said to myself "what am I doing? I want to be an interventional radiologist." So I decided to still pursue that, and I matched at the world-renowned Miami Cardiac and Vascular Institute (MCVI). So I did a breast imaging fellowship at MSK, and then I went on to do an interventional radiology residency or fellowship at that time. And when I finished, Elizabeth Morris who was chief of breast imaging at Sloan, and who was one of my mentors and one of the most fabulous people that you'll ever meet, super brilliant, super supportive, she wanted to bring me back to start the cryoablation program for breast cancer, which she had been trying to start, but she was getting a lot of pushback from different entities. And she thought because I was dual trained in both breast imaging and interventional radiology, I would be ideal.
So she made a great case, and honestly it wasn't very hard for me to make the decision because she was fabulous and she continues to be, but she's no longer my chief here. And so I joined Sloan to start the cryoablation program, and I was half-half breast imaging and interventional radiology. The division was a big strain on myself, so I now do interventional radiology, largely. I do breast imaging once a week because the people are great and I want to keep up my skills, and I like maintaining my breast imaging skills. I think it makes me a better interventional radiologist to treat breast cancer. Also, because I was doing cryoablation of the breast, I was put into the breast medicine disease management team (DMT). So my DMT was specifically breast cancer, and through that I not only treated primary breast cancer, but also metastatic breast cancer.
So I treat patients both on the primary side and also the area of metastatic breast cancer with oligo progression, oligometastasis, or when there is need for salvage when systemic therapies are exhausted or too toxic. So that has been my journey. I'm also a vascular specialist, so that is also part of my interest at this cancer center. So that is my experience of how I got into specifically breast cancer.
Dr Elena Violari:
That's a wonderful and very inspiring story. You obviously have a very unique skillset and very unique training, and through your story we understand one more time, how important mentorship is throughout medical school and training. Tell use more about the current state of your practice at MSK.
Dr Yolanda Bryce:
Right. At Sloan, we're very specific in what we do. People don't treat hepatocellular carcinoma (HCC) and colon and neuroendocrine. Everybody's very much siloed, that way we can be very deep within that specific area with regards to speaking, teaching and research and so forth in clinical practice. So at MSKCC, I only do breast cancer from the cancer standpoint. I mean there's things that everybody has to do, the bread and butter stuff, biopsies, gastrostomies, biliary drainages. There's some things that every IR does on whichever patient, but when you're talking about the disease management specific to your practice, I just do breast cancer and vascular care. But with regards to breast cancer, that's all I treat. So whether it's local treatment of a primary breast cancer or metastatic breast cancer in the liver, in the lung, wherever it may be, that's my practice. As I said before, I still do breast imaging once a week, which I do believe helps me with my overall care of the breast cancer patient. So in my practice, a lot of clinical breast. I do also research in this space, and then I speak as well.
Dr Elena Violari:
Wonderful. Diving into our topic now, which is to discuss percutaneous locoregional therapies for the treatment of breast cancer, in an era where surgery is also very minimally invasive, for example, surgeons went from performing radical mastectomies to all the way down to doing a lumpectomy, when is breast cryoablation indicated for malignant breast tumors? When do we consider the patient an ideal candidate for cryoablation instead of surgery?
Dr Yolanda Bryce:
So that is a very good question, and the evolution of surgery is a reflection that smaller cancers are being discovered because of the practice of population-based screening. It used to be that cancers were so large that they'd even have to resect, as you said, the pectoralis muscle. Now the cancers are typically caught while screening. So mainly they're usually 2 centimeters or less, and therefore, yes, that is reflected in a smaller surgery. However, there are some patients that even though those surgeries are now much smaller than it was before, they're still not eligible for surgery for a myriad of reasons.
First of all, I should state that a patient's eligibility for surgery is determined by the breast surgeon. We would like to determine that eligibility, but honestly, the breast surgeon is who says if a patient is eligible or not. And once that decision is made, it could be made for many reasons. Frailty, the patient age, comorbidities, usually it's some kind of cardiopulmonary disease, the patient is on anticoagulation and that cannot be stopped, the patient has some kind of concomitant cancer and they're receiving systemic treatment for that and stopping that treatment is not optimal in order for wound healing to occur after breast surgery. I've had patients referred to me that they had severe chronic liver disease that was a contraindication for surgery. So honestly, my practice is treating patients that are not surgical candidates and also some patients that after speaking to the breast surgeon, refuse surgery and it is well documented that they refuse surgery. And so to answer your question, the eligibility is determined by the breast surgeon and if they're not eligible for one of the reasons I said, and I'm sure there are many auditors, they're the ones that determine the eligibility and refer or don’t refer to me. And then the patients that feel they're not eligible after consulting with a breast surgeon, I have it documented that they have refused surgery, and if feasible, and if it's indicated, I do the procedure.
I should say that I treat patients differently. Let's say a patient is not a surgical candidate, so therefore I am kind of their one hope. For instance, I have a patient that I saw today in clinic. She has a very large cancer, it's 5.4 cm and she has been seen by a breast surgeon. She is not a candidate because of frailty for breast surgery. She's not a candidate for chemotherapy again because they think that she will not be able to tolerate it. She is HER2 positive, so they're thinking maybe they'll use some immunotherapy, but she doesn't have many options, and so they have referred her to me to see if I could do the surgery.
Now the tumor is 5.4 centimeters within a very small breast. So with her, I'm treating her with a palliative intent. It will be my goal to treat the entire tumor, but it's going to be difficult. I will do my best to treat all of it, but because of the size and because of the small breast, I may not be able to treat all of it. I treat the case in a patient who is not a surgical candidate different from a patient who is a surgical candidate and is refusing surgery. In a patient who is a surgical candidate, I would never do a cryoablation if her tumor was 5.4 centimeters or multicentric and so forth. In those patients, I have a very candid conversation with them and describe to them the very bad idea that it would be to do a cryoablation on something that has a very high risk of recurrence because of the size and so forth. So I treat different populations depending on their eligibility for surgery and their willingness for surgery.
Dr Elena Violari:
That's a great answer because you gave us an idea of the size criteria and patient eligibility for surgery. So you mentioned that the size of the mass, the location, and the stage affect your decision in offering this treatment, correct?
Dr Yolanda Bryce:
Yes, that's correct. So for patients that are not surgical candidates, I just take it on a case by case basis and as long as I believe I can create an ice ball big enough to at least debulk most of it (~95% of the tumor) without injuring the skin too much, I will take that on. In a patient who is a surgical candidate, I try to stick with the published data. If we look at the ACOSOG Z1072 trial data and the interim results from IceCure and the different results that are around, we know that when tumors are 50 mm or less, there's not a lot of DCIS, they're HER2 positive, the patient is above 50, we can more confidently treat those patients with curative intent.
Dr Elena Violari:
You briefly touched on it, but in addition to HER2, how does the hormone status of breast cancer affect the decision making for offering cryoablation? You mentioned we have data correlating these factors with outcomes for onco-cryoablation.
Dr Yolanda Bryce:
Yes. To me, the most important criteria for whether I accept or not is size and location. Again, if I'm treating for curative intent, which honestly I try to do, but I know if a patient is, again, a surgical candidate, my curative intent is focused on a very narrow population, and that is driven to me by size. If a tumor is about 2 cm or less, that is usually my cutoff point to treat somebody who is a surgical candidate. At 2 cm, I know that in my practice I can get great results with that size. I don't care as much about whether it's hormonally positive or HER2/neu or so forth, with the exception that I then want the medical oncologist to be involved in order to provide systemic therapy, whether it's hormonal therapy, HER2/neu blockade, and so forth.
So that is how I think about it. I know that trials are focused on hormonally positive disease, but in my practice that has not been an issue. I have treated triple negative breast cancer in patients after consultation—and I like to emphasize this—after they have consulted with a breast surgeon, if they are still refusing surgery and it's documented by the breast surgeon. I have treated triple negative breast cancer up to 2 cm, thankfully with good outcomes and I find size to be the biggest component that I've seen regarding outcome.
Dr Elena Violari:
What about histopathology? Does that affect the decision making for cryoablation? For example, invasive ductal carcinoma vs ductal carcinoma in situ vs lobular carcinoma, does that affect your decision?
Dr Yolanda Bryce:
Yes, so ductal carcinoma in situ, over and over the publications have shown that when a lot of DCIS is involved, the results are poorer. There is one trial that is being conducted now where they're trying to test cryoablation in DCIS, and it's a very focal DCIS that they're conducting the trial in. I do not routinely treat DCIS. I do do it again, and if a patient is not a surgical candidate and they understand the limitations, because DCIS is tricky. You can't see it all with imaging, you can only see what you see, which is it calcifications on a mammogram or non-mass enhancement on MRI, then you may be able to see those areas, but there's also areas that skip and so I don't routinely treat DCIS for those reasons. In fact, I had another consultation for clinic today with a lady with multicentric DCIS, a surgical candidate, and I told her that there is nothing published that supports doing cryoablation in that population and so I will not be doing her procedure.
Dr Elena Violari:
What are some of the absolute contraindications for breast cryoablation? You just mentioned multicentric DCIS. When do we say that a patient is not a candidate for this procedure, besides multicentric DCIS?
Dr Yolanda Bryce:
Okay. So again, let's be clear about the population we're talking about. In a patient who is a surgical candidate, what should drive you to not do the procedure is if you do not believe that you will be able to treat the person with curative intent. Everybody does things a little differently. I know I have done pretty sizable tumors and gotten a great result. Not everybody is that good at doing it or has that much experience in doing the procedure. I use multiple probes to do the procedure. Not everybody's comfortable with using multiple probes. I use my thought, and what I use and what I teach when I speak on this topic is that every centimeter of tumor deserves a probe or repositioning of the probe.
I know confidently, very confidently in my practice, I can do two centimeters of tumor very effectively. And so I have to just be very honest with myself and know what I'm going to be able to offer this patient who is a surgical candidate, who I want to treat with curative intent. In another patient who is not a surgical candidate, I push the limits on those patients. So the tumor might be very close to the skin. Even then, as long as the tumor's not attached to the skin, I'm able to create a margin. But you have to look at everything as a case by case basis. Am I able to generate an ice ball large enough to engulf the tumor without destroying the patient's skin?
So you have to assess on a case by case basis if something is good. So some patients, especially the patients that will not be going to surgery and you're kind of like their last hope, there are situations where I know the tumor is involving the skin, but I think I can treat at least most of the tumor and then send the patient to radiation to try to clean up the rest. So the determination if somebody's eligible for your procedure is really case by case. And I know that that is not a very great-
Dr Elena Violari:
No, we're moving more towards personalized medicine, so what you're describing is perfectly what should be done. Every case is different. And as you've mentioned, every operator's comfort level is different as well. Before you do the procedure, what workup do you do imaging wise, lab wise, prior to the intervention?
Dr Yolanda Bryce:
Okay, so with imaging, I want to make sure that I'm seeing the extent of the tumor. So I look at what is available to me, which is usually a mammogram and ultrasound, and that's typically enough. Sometimes, let's say the mammogram gives me a centimeter of four because I can see the dense cancer in a fatty breast and I know the tumor measures four, and an ultrasound, it's only half of that size. Then I go with the modality that is showing me the largest size of the tumor. And if there's a discrepancy, let's say on mammogram I'm seeing a certain size like the example I'm giving, versus ultrasound, then I try to put markers that can be seen under ultrasound at the extent of the tumors. And I do that under mammogram. I ask one of my colleagues in breast imaging to do it for me usually.
They work so well with me, and I really appreciate them so much. But they will help me in that they put markers at the extent of the tumor so that I can see it, because I typically do the procedure under ultrasound guidance. And if there's any question, like the breasts are very dense, I like to have additional imaging such as an MRI or contrast enhanced mammogram. So at the very least, mammogram and ultrasound to make the determination. And then in some specific cases such as very dense beasts or the lesion is vague and I'm just not sure, I may add MRI or contrast enhanced mammogram.
So, in IR, everybody routinely gets labs. I don't think they're necessary because it's a procedure that is very low risk. But they do routinely draw labs and they'll check for their usual, the BMP, CBC, and INR. And I don't do much with those because for me, I don't stop anticoagulation, I don't stop antiplatelets. For the safety of the patient, if the INR is crazy high, they need to address that. But I treat them in their therapeutic range, which is usually 2.5 to 3.5. I treat them, I do cryoablation in that range. I think for the IR service at my institution, they want platelets at least 20,000 for any low-risk procedure, so we all adhere to that. So if labs are drawn and labs are available, those are the guidelines I use.
Dr Elena Violari:
Do you perform ablation under ultrasound guidance? I've seen some papers out there also mentioning MRI guidance.
Dr Yolanda Bryce:
Yes. So I do it routinely under ultrasound. There have been some occasions that I have done it under MRI. Also I think they changed the device for MRI ablations, so I no longer do it at all. But I have done it. It's a little cumbersome. I can tell you that a way to do it that keeps the probe in place, just a little trick for those who want to do it under MRI, is to start the ablation, and that sticks the probe in its spot before you release the compression on the breast. Just a little tip that works well. But I do it mostly under ultrasound.
Dr Elena Violari:
Do you utilize any skin protecting methods? You mentioned earlier having a patient with a large 5-cm tumor. In those patients, do you use hydrodissection to prevent cutaneous burns or any muscle protective techniques?
Dr Yolanda Bryce:
I do hydrodissection on probably all my patients. I don't know if there's been a single case where I have not used hydrodissection and it is very simple. You just use a very small gauge needle, like a 21- or 22-gauge needle, attached to a tubing, and I just inject normal saline the entire procedure. It is not warm, normal saline, just room temperature, regular normal saline. I don't want to affect the ice ball. And I do that throughout the procedure. I think the literature a lot of the time says that they should be 5 mm from the skin. That has not been my experience. If the tumor is not attached to the skin, you can typically get a good margin with a lot of hydrodissection.
If you use a lot of hydrodissection, especially if the tumor is very large, that is going to result in a very large breast and it is very uncomfortable, so you have to warn the patient about that, but it is possible. I also use a heat pack in a sterile sleeve as an added protection, but honestly, I do believe that if that ice ball touches the skin, I don't think the heat pack is going to do much so that hydrodissection is key. I don't worry about the pectoralis muscle at all.
Dr Elena Violari:
Can you briefly describe your technique in needle placement? When do you use more than one probe? You already mentioned that every 1 centimeter of tumor deserves a probe—can you elaborate a little bit on that?
Dr Yolanda Bryce:
Yeah, so I just dissect the tumor. I repeat the ultrasound before I do the ablation, so I don't rely on outside imaging. I look at it myself, I plan while I'm there, right before the procedure. I measure it and I decide where I need to spread out my probes. And yes, the rule of thumb to me is every 1 cm of tumor, I try to put a probe, and so I line up the probes to segment the lesion.
Dr Elena Violari:
Does your treatment cycle of cryoablation depend on the size of the lesion or the location?
Dr Yolanda Bryce:
I try to aim for 10 minutes, freeze, 8 minutes passive thaw, another 10 minute freeze, and then active thaw to just remove the cryoablation probes. I don't always get there. If the tumor is very close to the skin and I'm having a lot of trouble maintaining that separation of the ice ball from the skin, I'm not able necessarily to make that full time. Sometimes the trick is to drop the intensity of it. I start out at 100, but if I'm having a lot of trouble, then I lower it to an 85% intensity. I don't know if intensity is the correct word, but the maximum energy, I use 85, and that's supposed to maintain the size of the ice ball without making it any larger is what I've been told. And so I may try that. So I try to reach 10 minutes, I should say, and 8 minutes thaw, and 10 minutes repeat, freeze. But sometimes I do not get there because of the proximity of the ice ball to the skin.
Dr Elena Violari:
That leads me to the next question. What makes a case technically challenging?
Dr Yolanda Bryce:
Large tumors close to the skin.
Dr Elena Violari:
And what's the best predictor of technical success?
Dr Yolanda Bryce:
Size of the tumor.
Dr Elena Violari:
Imaging wise, my experience is mainly with cryoablation for renal tumors where you can see the ice ball very well under CT guidance. Imaging wise, with ultrasound guidance, are you able to have a predictor of technical success?
Dr. Yolanda Bryce:
So the best predictor under ultrasound is again, when you're doing the procedure, anyone who has done it under ultrasound knows that you are only seeing the artifact of the ice ball. So I wish somebody would come up with some kind of great AI ultrasound configuration to help better predict. I rely on knowing that I put the probe in the right place, I know where I put the probe, I measure the ice ball that's farmed. Again, I'm measuring just the artifact. And that it is at least one centimeter larger on each size than the tumor. So if the tumor, let's say is two centimeters, I know I need a four centimeter ice ball or so forth. So I think that has been my best judgment of how this turns out. You never know for sure until you get that follow-up imaging.
For my follow-up imaging, my technique is I do three months after the procedure because I think the inflammation has died down enough by then. I do the imaging. I like to do some kind of contrast study. I tend to use contrast enhanced mammography at my institution just because it's better tolerated by some of these patients that are older, and also a lot of them have pacemakers. So I tend to use contrast enhanced mammogram with ultrasound at the three month mark. If somebody has no contraindications, then I do use mammogram, ultrasound, and contrast enhanced MRI to follow them up.
And then I look at those imagings at 3 months and I decide how else to follow the patient. Let's say the tumor was 1 cm and the ablation zone around the tumor is very good. It's very good. It's surrounding the tumor, it's big. I'm very confident that this patient will do fine and that I got the tumor. Then I'll see her at 1 year follow up. If I'm not sure, then I do it in 6 months. And ideally, if I'm using a follow-up technique in a patient that is a surgical candidate, I like to do mammogram and ultrasound yearly, and an MRI yearly, but they offset each other by 6 months so that every 6 months they are getting some kind of imaging of the breast.
Dr Elena Violari:
What are some potential procedural risks or complications you discuss with patients before cryoablation?
Dr Yolanda Bryce:
The biggest thing is skin injury, and it's not something that I shy away from. I think I've been doing this long enough, and unfortunately because of the kind of patients I treat, I have injured a lot of skin. So I actually put it into the description of the procedure and I tell the patient, "if the skin is burnt during the procedure, I will send you home with Silvadene cream and some pain medication." And in my back pocket, I know that if it is a very major burn, which hasn't happened to me yet, I will consult plastic surgery. So the biggest complication is skin injury. Other things that I've noticed is, especially if the ice ball is close to the nipple, and I should say I try never to direct my probe toward the nipple, but if the ice ball has been close to the nipple, sometimes the patient complains of a shooting pain or sensitivity of the nipple after the procedure. So depending on the location of the tumor, you might want to warn them.
The one thing that really you should emphasize with the patient in my experience... And just the other day I gave a talk and somebody asked me "how do I deal with the mental agony that they're able to palpate something after?" And the answer is that you have to prepare them beforehand. So the area of treatment, especially if you have to generate a big ice ball, it's going to be palpable to the patient for a very, very long time. Even up to a year, patients say that in the area of treatment, they're able to feel the treatment there. And I try to tell them beforehand, before the procedure as part of just the initial consultation, and honestly I repeat it the day of the procedure because I want it fresh in everybody's mind, the patient and the family.
I tell them that "after the procedure, it could last up to a year more. You're going to feel something in the breast, in the area that was treated. It is not the tumor, it's not the tumor growing. It is the ball of inflammation that is surrounding the dead tissue that is eating up the dead tissue and replacing it with normal tissue. But it will take a long time to go away." And it's one thing that I do stress because I guess it can cause quite a bit of mental anguish if you don't prepare the patient beforehand.
Dr Elena Violari:
That's a great way to approach that, by preparing them. Can you update us on the current evidence for cryoablation for breast cancer? Briefly, which studies are you quoting when you're offering this procedure or when you discuss this with the referring doctors?
Dr Yolanda Bryce:
Well, there's been one very significant landmark trial and that was the ACOSOG Z1032 trial. Rache Simmons was the first author of that paper and principal investigator, she's at Cornell. And so that paper showed that tumors 1 cm or less, when treated you had a 100% success rate, and that's because they used only 1 probe. There was other studies, namely one by Peter Litrov in 2009 that showed that larger tumors up to 5.8 cm can be treated successfully with multiple probes. Those are older studies. There are registries. Significantly, though, there are 2 new studies that are currently underway. One is called FROST and one is called IceCure-3. IceCure-3 just recently published their interim results that they showed in patients. And their population again emphasized they're surgical patients, or surgically eligible patients I should say. They're with tumors that are hormonally positive, 50 mm or less, HER2 negative, and the patients are 50 years or older, I believe.
So it's a very specific population. And all of these patients will be going on to adjuvant radiation and hormonal therapy. And so the interim results for the IceCure3 trial have shown that there is a 2% recurrence rate, which is very acceptable and not bad compared to surgical recurrence rates, which is in that range. So those are promising. We'll have to wait for the full results to mature. And so those are the 2 trials that will be important in our time.
Dr Elena Violari:
What are your thoughts on combining breast cryoablation and immune checkpoint inhibitor immunotherapy for treatment of advanced breast cancer?
Dr Yolanda Bryce:
So it's a very interesting topic and I was involved with a pilot study that we had at my institution regarding perioperative breast cancer, combining it with immune. Specifically it was a double immunotherapy intervention. It's a very interesting concept. The thing with breast cancer, and this is different from other cancers, is that breast cancer tends to be silent compared to other cancers, meaning that the body doesn't pick up that there's cancer in the body when breast cancer is present. So the utility of cryoablation is that it provides proteins that are not denatured, and that's different than if you're doing thermal ablation using heat rather than cold. So it creates proteins to be released that can serve as antigens because they're not denatured and they can serve as information to the immune system.
And so when that happens, if you combine that with an immune inhibitor... Because again, not because there's a lot of antigens suddenly in the body is there going to be an immune response. So there are checks and balances within the immune system, and so PDL1, PD-1 is one interaction that causes there to be kind of like, breaks on the immune system. So once there's antigens in the system to set the stage for immune response and you combine that with an inhibitor of some kind of pathway to break up the interaction that is inhibiting the immune response. When that is combined, there's a promise that there could be an immune response. So in our pilot study where we treated patients with cryoablation and nivolumab and ipilimumab, we saw that there are certain suppressor cells, they're called PDL1, high T-cells. There were suppressor cells. When we combined the therapy, those cells were much lower in the system and that resulted in a bigger ratio of effector T-cells to regulatory T-cells. So that prompts the immune system hopefully towards a response.
And this is kind of just a pilot study, so there hasn't been any long-term study. I'm hoping to study the same thing in metastatic triple negative breast cancer, the same idea, using a PDL1 inhibitor with cryoablation. So that seems very promising.
Dr Elena Violari:
Wonderful, so are you currently involved in any research trials?
Dr Yolanda Bryce:
No. That pilot study is done and is being published. The next step is for this other project that I mentioned with metastatic breast cancer. That has just started the institutional review board process, so it is currently not active and we will see where it goes.
Dr Elena Violari:
Any final thoughts about the future of treating breast cancer with locoregional therapies with or without combination with immunotherapy?
Dr Yolanda Bryce:
I think it will be very interesting to see the FROST and IceCure-3 data. I think there will be a lot of registries. There is an industry that has been trying to do a randomized control study. That'll be very difficult. But I think at least there are going to be some industry based registries, and hopefully that will generate enough data to define the population that this procedure is useful in, as well as giving us enough data to be included in the NCCN guidelines. That is going to be very difficult because breast surgery has so much data, and for so long. They have so many patients. It'll be hard. But hopefully with enough registries and the results of some of these newer trials, we will get closer. And if we're not in the NCCN guidelines, at least it will be enough information for a scientific basis to perform the procedure more confidently.
And it's important because patients are hearing about the procedure and are asking for it themselves, so it's no longer something that is just being offered to them. Sometimes they're actively pursuing trying to find someone who is able to do this for them. And hopefully with enough data, with enough trials... I need to publish my data, it will be retrospective... But hopefully with enough registries and everybody providing the procedure with good technique... And I do emphasize that, and it pains me because a lot of the trials have been done with poor technique and that's why the results have not been so promising. The same ACOSOG Z1072 trial had such poor technique, and so hopefully the more people that get involved have good technique, are able to contribute to good registries, we'll have enough data to scientifically push the procedure forward.
Elena Violari:
I agree with you, and I'm looking forward to seeing those studies and the results and the data, and I agree with you that technique is probably the most important in getting those good results. So it's been a pleasure speaking with you today, and thank you so much for spending your time with us and for sharing your knowledge and expertise in this topic. This was very informative. I've learned a ton, and I'm so thankful for you accepting our invitation to come and speak with us.
Dr Yolanda Bryce:
Well, this was wonderful and I appreciate the opportunity, and I'm excited that people are finding this subject of interest. And it's only a good thing. It's only a good thing, and the more radiologists that are involved, it's a very, very good thing. So thank you so much for having me.
