Good evening, everybody, and welcome to tonight's webinar. My name is Bruce Stevenson and I have the honour and privilege of chairing this evening's webinar. Before I get started on the housekeeping, I just wanna say a huge, big thank you to our sponsors, Verback.
Without their generous sponsorship, we would not be able to listen to Gerard this evening. So, thank you, Verback for your generous sponsorship. Little bit of housekeeping for those of you that haven't been with us before.
If you have got any questions, please just move your mouse over the screen. You'll see a little control bar pops up. It's normally a black bar at the bottom, and there's a Q&A box there.
Just click on that and you can send through your questions there. And we will get to as many of those as we can at the end. We are not able to go back on slides during the presentation, so, there's no need to panic because we are recording the sessions and they will be up on the webinar vet's website.
In the next day or two, and then you can go back and you can rewind and you can slop, stop it and relook at doses or anything else that Gerard brings to our attention this evening, without panicking about it. So it is my great privilege tonight to welcome to the webinar vet, Doctor Gerard Johnson. He earned his Bachelor of Science in Biology from the University of Cumberland in 2007, followed by graduation from Auburn University College in Veterinary Medicine in 2011.
Doctor Johnson is a diplomat of the American Board of Veterinary practise and is a certified veterinary pain practitioner. He's also certified in Companion Animal Pain Management. An elite fear-free c certified professional, and an active consultant in rehab, sports medicine, and chronic pain for VIN.
As a frequent speaker at both regional and national veterinary conferences, Gerard embraces the opportunity to contribute to the veterinary community by discussing topics spanning the spectrum of pain management. Gerard, welcome to the webinar, vet, and it's over to you. Great, thanks for having me.
Good afternoon and good evening to some of you guys. Certainly appreciate you joining us today. Just to kind of set up a roadmap for what we're gonna try to achieve during the presentation is I'm gonna try my best not to speak too quickly because we've got a lot of slides to zip through, but we're gonna go through a couple of things when it comes to Steelfonte because I'm very passionate about.
About this product. I think it is, a great innovation that we can have in our toolbox for managing the most common form of cancer that we see in our patients, dogs and cats at least. So we're going to start out looking at some client and vet online presence because this, is one of those situations to where we're seeing a lot of positive, momentum.
With the product amongst a lot of social media platforms, then we're gonna go through some experience-based a survey that was performed just to kind of get a, a baseline for how, how things are going and the perceived experiences from some people. Then we're gonna go through some of the evidence, and then we're gonna go through some cases and some practical aspects for using it. It is one of these products to where we, have, have a lot of liberties in use in terms of, of cases and things like that, but there are some things that I find that we really, really need to pay our attention to.
So just really briefly before we get started, just to share just a very little bit about me and the practise, I am limited to surgery and pain management, that's all I do, which is a great, great thing for me because that's what I love to do. And I do have a special interest in orthopaedics and pain management. Man, of course, but oncology plays a big role into that.
Our practise has a lot of advanced imaging techniques. So, unfortunately, we do tend to find a lot of neoplasia in our patients. So, this was just kind of a natural progression for me to really jump on the Deelfonte bandwagon because it has been a great, attitude to our arsenal there.
But I would say above everything else, I'm very passionate about teaching. It is one of those things to where I feel like that is where I can serve the most, and I may not be the best at it, but I do try very, very hard. But regarding disclosures as it relates to tonight, as it was already mentioned, this is a Verback sponsored session.
So thanks again for that. And me personally, I am on Burback's advisory board, but also on advisory board for Zoeis and a speaker for them as well, and Deloco. Basically, when it comes to pain management and surgery, if somebody's got what I feel like to be a very ethical, appropriate product, I'm game to be part of that in any way that I can.
So as far as the practise goes, that little bitty red dot is where I'm sitting right now. And that's very important because I know we do have some international attendees, and I wanted to be very clear, some of the things that I may say, one is going to be in a really weird accent to some of you, but also because, some of the statements that I'm going to make are going to be FDA based information. So it may, I wouldn't say conflict, but it may be.
Little different than what, some of the statements from your regulatory body say. So just a full disclosure for that, this is kind of where things are going. I work in a very busy practise, as, as we all do, right?
And this one is one that I'm very proud to say we're very locally rooted and, and very community-based and very, compassionate care and advanced medicine-based. We try to Make sure we're on top of the most recent innovative things and, and bring just as much as we can to the public. And, and realistically, I think Steelfonte fit right into that picture.
And the great thing about this is it's not been that heavy of a lift, honestly. I mean, you can see from some of these, social media screen grabs that we have available to us, owners are pretty engaged in social media when it comes to Steelfonte and You know, nowadays to see anything positive on social media is an advantage. So that's a very good thing.
And, this is a, a Facebook group that, that is available for people to join that can share their experience and ask questions, and there are a lot of those other forms across different social media platforms that are available to us. This is another one. This goes through, basically a patient who had a mast cell tumour diagnosed and started asking questions to look for a vet that is local to them in Massachusetts to find someone that does Steelfonta injections.
Now, how, how, have they heard of that, whatever, but this person was concerned about having another anaesthetic event or another surgical event because of whatever reason. So these are some things that people recommended. And so the point being that, you know, people are engaged, they're asking questions, they're out there.
So I do think it begs the, The question, like, isn't this something worth paying attention to, you know, whether you're comfortable right now using that, that's OK. And my hopes is by the end of this, you'll see that it's really not that big of a lift. It's a fairly easy product to use and it's relatively predictable, and we're gonna go through some of those as we go through the cases this afternoon or evening or wherever you are.
So this is just another one. This is a little cocker spaniel, and, you know, a little mixed breed dog there that had, this is a scar that that occurred secondary to its Deelfonte. Injection.
This is another one. This is a story following a boxer named Dixie, and, you know, it's a boxer, so I'm sure Dixie has probably had more than one injection of Steelfonta by this point, but this is a good little story for us to follow on social media. And then Instagram, here's some pictures of some veterinarians injecting the product.
This is some pictures of, some hashtag #Steelfont injection. I don't admittedly know how Instagram works, but, it seems to be a good place for pictures for Steelfont patients. So, really awesome.
And here are some more social media posts, and this is a, a good example of the injection, injection technique, and then what happens during and after the recovery process. Here are some comments that owners have made, you know, talking about, this is something that I'm very happy that we did. This is the preference we had.
This was not surgery. This did not require the level of recovery that some surgeries require. You know, this owner from a dog named Juice said that she was very concerned about the recovery time from surgery given the patient's age, and she couldn't believe how quickly he recovered from the Steelfonte treatment and that the dog was back to swimming and hiking just 6 weeks after treatment.
This one was very honest with Turnip. Turnip had a scary 24 to 48 hours because, you know, we had a little bit of swelling in the mouth. I'm not really sure where that was, but it looks like a brachycephalic dog if I had to guess that that was associated with that statement.
So, you could see where the facial swelling would be significantly concerning to the patient. But after all of that, everything was fine, and they would do it again without hesitation, which is great. And then this is, Dixie, you know, the husband did some research and learned about Steelfonta, and they had to look, but they found a veterinarian that was willing to give it, and, she went through the procedure beautifully.
So I think these are great testaments to how much like emphasis this has in the community and how aware clients are. And cancer, as, as you know, neoplasia is one of those things that is such a dramatic time and such a difficult time for owners, even if it is something that, that we would perceive relatively routine, even if we found, hey, it's a low-grade mast cell tumour, a client spends 30 nanoseconds on the internet, and they're going to instantaneously be petrified about what the complications and what things could happen. So, anything that we can provide to our clients to Gives some degree of comfort is helpful, I think.
Now, we talked about these owners seeking out information about veterinarians that are giving the injection. So, because Verback was receiving so many calls requesting, hey, can you tell me where a veterinarian near me is that will administer Steelfonta, they actually created this page on their website. And it is a, a vet finder.
This goes through basically any veterinarian that has purchased Stelfonta within a set time frame, goes up on this website, unless they opt out, which is a perfect option. They can, they can do that. But this is available to clients so that if they are going through, they're following this social media rabbit hole and they've found that, hey, I think Steelfonta may be a good option for my patient, they're able to track all the way to this public-facing website portion on Verback's website to find.
A vet Finder, and we, we have had patients come into the practise from this, you know, vet Finder. So it is, so it is an effective tool. And, you know, nowadays, people would much rather look on the internet to find the answer than call the company.
So, it's a great resource. For your clients. And if you are making the recommendations and you're not personally doing it in the practise, it's a good opportunity for you to potentially recommend to, clients where they could have this injection performed if you were not at the point to where you were comfortable to do this.
So, I mentioned earlier about a survey that was performed early on. And this is a, a survey that was performed looking at and asking really veterinarians and pet owners. You can see there was roughly 30 of each of those, and the patient cohorts ranged about 45, 44 patients anywhere from 1 to 15 years of age with a very wide range of tumour volume.
And it looks at basically what was your satisfaction level and how successful was the response to treatment. And after 28 days, 77% of those owners reported that the tumour had been removed after the treatment. And then 84% of those owners were satisfied with the healing process, which is great.
I mean, I think we have to understand and accept that. You know, even, even a surgery, we're probably. Gonna have 84% if we start actually looking back at, and not even suggesting complication rates, but this could very easily be a perceived problem from the client that, that you and I would really not associate with being a complication.
So this is a good number, I think, you know, 84% is, is really pleasing to me that clients did feel most of the time that this was a good option for them. And then further with this, this looked at the veterinarians, and then overall, about 86% were somewhere between very and somewhat satisfied. I don't know about you guys, but when I read a survey or study, I really struggle, like, what am I somewhat or am I very satisfied?
I don't know that I'm very satisfied about a lot of things. So, you know, you kind of take that information with a grain of salt. So overall, 86% of these veterinarians were happy with what they did and, and found overall that satisfaction.
So they, they were happy with everything and they did find overall that 93% of them said, hey, this was easy to do. You know, at the beginning, I can absolutely appreciate that this was a bit of a daunting task for people, you know, initially when I, I actually heard about some of the initial webinars, I believe originally out of Australia, if I'm not correct, a couple of years ago, I found out about them by accident. And jumped on them and I was so pumped about this product and it hadn't even been released in the US yet.
I was very, very excited. And, I can tell you single-handedly, this has been an amazing addition to our practise and it is so easy to do if you know the proper procedure and, and, and what things to follow. So, onto the science, which I only have a single slide of this because I don't want to put you guys to sleep this, this evening, but It's, it's a very exciting set of information, and I would encourage you guys to kind of deep dive into this because it's a really cool story.
And the company that identified and then ultimately created Steelfonte is, kind of a biosurveillance kind of ecological company that looks and just observes things in nature and see how things are. And what they saw in this certain situation. Is in this rainforest region of Australia, they found that there was this certain tree, which is the blushwood tree, the Fontania piro sperma is the, is the type of tree, that, all these marsupials that were scattered around were taking the fruit of this tree, but they were spitting out the seed, which they found to be very abnormal, right?
Because seeds are in general very highly nutritious, high fat content. And most animals would not spit it out unless they need to. So they started investigating that and realised that the outside of the seed, had some deterrent type molecules.
So basically, this diterpepe ester molecule, and, you know, not, not to nerd out too much, but, you know, esters and terpenes are really what are important for taste, astringency, odour, bitterness, things like that in the food that we eat. So if you have something that's a really acrid or acidic or, you know, astringent taste, they're gonna spit it out. It's kind of like chewing on a peach pit, wouldn't advise that, but very similar situation.
And they found when they isolated this molecule that it could actually be used as an intratumoral treatment, and, and they chose, you know, canine mast cells just because of the abundance of cases for that. And they realised that the way that this worked is that ester basically just became this like fruit grenade, essentially. So these, this molecule, when it's injected into that tumour tissue will activate the protein protein k C pathway, which is kind of that on and off railroad signal pathway that ultimately leads to cell death, and that's how the mechanism of this drug works, and we'll go through that a little bit more, but, You know, I could spend all night talking about this stuff.
It's really interesting and I would just encourage you to, to look at that because it's, it's, it's a pretty cool thing to, to understand really even just the origin and how cool of a job it would be to just be like, OK, well, that's abnormal. Let's figure out why that's abnormal. So that, that's just really cool.
But when we're talking about the product in general, right out of the gate, we need to talk about some of these black box warnings and This is important because this sets up some guardrails for us and how we are going to handle and administer this product. Now, the more glaringly obvious part of the black box warning is the human safety. So don't stick yourself or others in the practise.
That's just first step. Don't do that. But also, we will talk about this again, but the concomitant medications that we're going to go through, the corticosteroids, the H1 and H2 receptor blockers, those are absolutely key.
To using this product. Now you could imagine what we are doing is destroying, we are creating an oncolytic effect within a tumour that has little bitty water balloons full of histamine and other really nasty chemical messengers, right? So we are having a controlled mass cell degranulation event.
So if we are not very judicious and very diligent about the way that we're managing these things, that controlled process could get really unregulated and uncontrolled, and you can have some very severe adverse events that could even be fatal, unfortunately, to the patients. So we have to be really aware of that. We'll talk about locations that this product is best used for, but it says very clearly here, don't inject them into places that we said not to.
So if you're talking about subcu mast cell tumours, now those are the ones to pay attention to. Subcutaneous mast cell tumours should not, could not, will not be injected. In locations above the elbow or the hack.
Now, we'll talk about that a little bit in a minute, but for obvious reasons, if you have a subcutaneous mast cell tumour in the flank, for example, and you start creating a situation where, like we said, a controlled degranulation event, a necrotic wound, you are going to create a significant pocket of inflammation that may or may not communicate with the outside. So if it's subcutaneous, it may not track to the outside, so you've got this accumulation, you are creating a very highly volatile abscess at that point, which can again lead to that degranulation event and unfortunately, death occasionally if we're not careful. And then the thing about the cellulitis and severe tissue sloughing, now we know to expect some of that, but we'll go through at least one case where that cellulitis and tissue sloughing got kind of off the chains, kind of in an area we were not expecting or they were not expecting, and that could lead to some prolonged recovery times.
So, just upfront, honest, this is the reality of what we're doing. A lot of this could be said for any oncological treatment that we're dealing with. So I wouldn't let this scare you.
I would just consider this like everything. This is going to be your black box. Now, this, I, I cannot say for sure, but I'm, this may be different in different countries.
So I would just say, you know, look at your box, look this stuff up so that you understand what are the guardrails that I have to work within, and then just be mindful there. OK. From a practical standpoint, so how do I use this in practise?
How do other veterinarians that are using this in practise, how do, how do we do that? What are the recommendations? How do we educate the clients on this?
You know, it, this used to be such a dramatic thing for me. I would go in this room with my nice little 3-ring binder, because I'm 100 years old, right? I This binder in there and I've got all these cool pictures and I'm like, yeah, this was my case, this was my neighbor's case, whatever.
Now, I literally hand them a QR code that has Verback's website and I'm like, look at this, call me back in 48 hours, you know, and it, it's amazing how things have changed and how easier it has gotten for us to use the product. So, I love to show this picture because it reminds me of a moon phase diagram, and I think whether that was intentional or not, I think it's genius because this product is very predictable. For most of the cases that you're gonna use this on, particularly cutaneous mast cell tumours, particularly for those, this is the kind of progression that you're gonna see when you first inject that mast cell tumour, you are going to get a direct oncolytic effect, meaning in your needle tract, your blebs of product, that is where you're going to get tumour cell immediately.
So that's gonna lead to your, you know, erythema, that's gonna lead to your edoema, that's gonna lead to your eventual bruising and things like that, because of that direct inflammatory and oncolytic effect. But that's over very quickly. I mean, that only lasts, you know, for a handful of hours, usually 48 to 96, you get that acute inflammatory response, but the drug, and, and I may be speaking out inappropriately here, but I'm pretty sure the drug itself leaves the body within a handful of hours.
So what we're left with is the protein kinase pathway disruption or that on and off train signal that we look at that leads to ultimate cell death through a lot of different mechanisms, which, you know, you can look that up, we don't have time for that tonight necessarily, that's a different show, but ultimately you end with this permeability, this tumour vasculature then allows the inflammatory cells to the body. So, Absolutely not, like a vaccine, but kind of think about that. This opens up the floodgates and allows the body to do what the body's supposed to do.
Your body has exquisite mechanisms for for dealing with damaged DNA, for dealing with abnormal cells, but it's not until the tumours can trick your immune system into saying, you know what, hey, I'm fine. I'm supposed to be here. Well, this is kind of what we're doing.
We're taking away that lock and key mechanism so that the body can get in there and do the work that it's supposed to do. So it shuts off the vasculature to that tumour, so there's no river feeding the land, and then it basically dries out. So that wound will go through that necrotic phase.
It will form a dry eschar and it's going to fall off. Now, whether that falls into the client's floor or gets slurped up by the dog, who knows? I don't wanna know, but it just goes away, right?
It falls off. And then you deal with this very predictable, progressive wound healing. And depending on where it is in the body, I think, and the size of the tumour, that's gonna depend on how quickly it's gonna fully heal.
I've had patients that have complete healing within like 2 weeks, and I've had patients that take 4 months to heal. It just depends on the situation. The size, the dog, just like any wound would, you know, you're gonna say, OK, well, a neonatal wound is probably going to heal a lot faster than geriatric wound.
Think about it the same way. Now, indications, right? Where are we going to use this?
Cutaneous, fair game, rock on anywhere. Now, I would say the caveat to that is, start thinking about your anatomy, right? We have a dog.
In the practise, I think this week, actually, that one of my associates, we were kind of consulting about whether this dog was a Steelfonta candidate. Now, from a size standpoint, which we'll talk about in a minute, the dog absolutely was a candidate for that. This was a cutaneous mast cell tumour, but it was right beside the prepu.
Now, I said, rock on. You can inject this mass, but you need to educate the client. That this could cause some changes to the direction of the pre-pu as that scar contracts, meaning it could change, you know, the dog may be urinating at a 45 degree angle at the time, by the time this is done.
I, I've, you know, it, it's happened. However, one could argue without some pretty skilled tissue reconstructive techniques, that may happen with surgery as well. So we've had this conversation with a client and they're kind of mulling it over, but I, I would not in that situation consider this a, kind of a contraindication about location.
Now, if it's near the eye, things like that, you need to have a conversation with that, and I'll, I'll leave that decision-making to you, but I would always just keep in mind is like, when this scar heals, what am I going to be left with? Where are we going to be, right? And, and sometimes that is, this is still a surgical wound.
Regardless, there's still a surgical situation, so just be mindful of that. Now, this is where we have a little bit of limitation when it comes to the subcu mast cell tumours for, for reasons that we already discussed, but ultimately, if it is below the elbow or below the hock, the amount of subcutaneous space could lead to an excessive accumulation of inflammatory debris, histamine containing like just rockets. I mean, it's a big deal, so don't do that, right?
So we want to make sure. That we are fair game. With any mast cell tumour that's cutaneous, we need to be careful in terms of location when it comes to subcutaneous.
It doesn't mean you can't do it. That just means you need to be careful about location. Now, the question that I always pose, or, or at least originally is like, well, like, not to sound silly, but how do you know?
Because I was always educated that. This is a histological diagnosis, not a gross diagnosis. Now, when we say in this context, cutaneous versus subcutaneous, kind of the way that I think about that when we talk about gross anatomy.
If I can move the skin and the tumour doesn't, I'm gonna consider that a subcu. Just err on the side of caution because chances are very good that this is gonna be subcutaneous, and I, you know, shall not inject that in an abnormal location. But if it is moving with the skin, and it seems to be adhered to the skin, obviously I'm gonna assume that's a cutaneous mast cell tumour, and we're gonna go, you know, depending.
Now, there are some important steps for success when we go through this. Number 1, I would say 1, #1, #1 is going to be your concomitant medications. Once you get past level 2, this is a crock pot situation or a bean pot situation, depending on where you live.
So what I mean by that is you put the work in at the front and then you just let it do. You let it do its thing, you let it go, you let the body handle everything. So once stage one and two is done, all you're doing at this point is treating the client.
You're not so worried about what's going on with the dog in terms of if everything goes as we expect it to go, your input should be fairly minimal at this point. But the thing about it is, is this concomitant medication situation is very important. Now, this is a little convoluted, if you look at it kind of from a macroscopic view.
But if you kind of hone into it, it makes sense, and I would say these are not hard and fast rules in terms of timing. What this means is, is you need to make sure at the time of injection, your dog has pain relief, your dog has a corticosteroid. And your dog has an H1 and an H2 blocking agent, period.
So you could imagine if we're dosing prednisolone at 0.5 mg per kg twice a day, that's 1 mg per kg per day, right? That could start to get beyond some anti-inflammatory dosing in some patients, meaning, which is always the case I run into, right?
If this dog has an endocrinopathy, what if this dog is diabetic? Do you treat this dog with the steroid and potentially throw them out of regulation? To do Steelfonto or do we not?
So that's the conversation that you have with the clients because this is non-negotiable. Any endocrinopathy, any other health issue is not gonna supersede the need for steroids in these cases. Now when we look at the type.
Of receptor blockers, your your histamine blockers. Now, the one that we use the most because of where we are in this country, famotidine and diphenhydramine. So Benadryl and Pepcid are generally going to be the ones that we reach to the most, but that is not set in stone.
These basically just need to make sure that we're dealing with the product that is going to help block those histamine receptors, both the top 1 and type 2. So they're gonna go in and they're gonna have an effect on both the mast cell and the surrounding area so that we can reduce that histamine binding to the vessels, etc. Now, the question also is is brought up, well, what about omeprazole?
And I, and I don't know the answer to that, to be honest with you, but I would say this does not meet the criteria that we're looking for, for our histamine receptor, because that is not how your omeprazole and things like that work. These PP receptors do not do what histamine receptors do. Now that could be great for other things and probably isn't a big deal to use it.
However, that is not going to fulfil your recommendation or fulfil your requirements here. So if you look at the timing here, this is where it gets a little convoluted. We'll talk a little bit more about pain relief because I'm 100% adamant about that.
It is a must. It must be done. I would say.
10 days is probably gonna be your minimum, 7 to 10 days, depending on the size and location of the tumour. I do find that distal limb masses or injections in the distal limb tend to be a little bit more uncomfortable than those that may be in the flank, but that's not a hard and fast rule. So I would say there's really no situation where we would not do some type of pain relief, and we'll talk about that in a little bit more about what we can and can't use.
Obviously, we're not gonna use, an NSAID alongside these steroids, so that does limit us a little bit in regards to our high-impact therapy. So we'll talk about that in a minute. But if you look at your timing just really quickly, day 0, which is gonna be the day that you give the injection, these patients need to have been.
On a corticosteroid for 2 days minimum, 48 hours minimum. That is going to give the medication time to change that cellular transcription, do all that stuff that it's supposed to be doing, so that the, the, the animal is as stable from a membrane standpoint, if you will, then we can get it. And then the histamine blockers, those are really only important once we start popping those histamine balloons in the mast cells, generally.
However, this can be a little tricky for the clients to remember. So for me, I start the pain medication, I start the corticosteroids, I start. Histamine blockers at the same time.
So I start them all 48 hours prior to the injection. Now, that's up to you. That is not following the schedule, but it is kind of over exceeding the schedule.
So I, I'm not worried about that too much, but that is totally up to you, however you want to practise with that. Now, We as veterinarians tend to be a little soft. I'm getting kind of old and grumpy, so I do not bother to send these patients home at all.
It does not bother me, and I will tell clients, if we have not given this medication in 48 hours prior to you coming in and the morning of, they will have to go home. Because I'm not even comfortable trusting that me giving these injections in practise is going to be effective enough. Now, it probably will, but it's still just a scenario to where I'm very, very, very specific about that, and I will be like, look, I love you.
I don't mean to be mean to you, but we cannot do this today. For your patient's safety. Now, that happens more times than I can shake a stick at because clients forget it's hard.
I get it, I understand, but they have to give it 48 hours as directed, and they have to give it the day of. If you are doing your histamine receptor blockers the day of treatment, that's OK. Have them do it in the morning, but you really don't need to be the one giving it unless you are comfortable without a shadow of a doubt that you have waited the length of time that's necessary for that drug to be peak plasma level.
And, and that's, that's up to you, but I personally, that's not a monkey I'm willing to shake, so I'll let the clients handle all of that, and we're gonna go home. They're gonna go home if they haven't done what they need to do. So, this needs to be clear.
We need to understand this. This is on the website, so this exact picture is on the website for you to reference as needed. And there's also other literature out there that you can get to show this as well.
Now, tumour volume, we mentioned on that survey originally that patients range from a 0.1 to a 10 cubic centimetre tumour. Now this is a situation to where we may actually be measuring these a little bit differently than we are accustomed to, because when we measure a tumour, we are often measuring length and the width of the tumour.
So we're forgetting the 3rd dimension in a lot of those, so the Z axis we tend to forget. So, when we do that, we have to calculate the length, we have to calculate the width and the height of the tumour. Now, because these are never perfect spheres, our calculation needs to have that little fudge factor in there.
So we need to have something, some little coefficient or some little factor in there to take away some of the error in the calculation, and we'll, we'll kind of look at that a little bit in a second, but, if you see kind of down there in the bottom, you see it's the length times the width times the height times 0.5. Now that ultimately is going to give you a measurement of volume in cubic centimetres, and then you can use that calculation.
To then figure out how much of the injectate you need to be pulling up. Conveniently, that dose is equal to the tumour volume times a half, so times 0.5, right?
So we're taking half of the tumour volume in general. Now, that is important because this is going to dictate whether this client or, or excuse me, whether this patient is a candidate for this injection. Because what you do not, what you cannot do is inject these patients that have a tumour volume that exceeds 10 cubic centimetres.
It is just not worth the risk to the patient to do so. Now, when we look at volume, sometimes these are teeny, teeny little tumours. You should always feel comfortable to put at least 0.1 of a cc in there.
So 0.1 mills is going to go in about everything, minimum. Now, your maximum has to be calculated, and I will tell you why.
So when we look at these, you need to make sure that your maximum tumour volume. Does not exceed 0.25 mils per kilo of body weight or more than 5 mils regardless, right?
And I'll tell you, this dosage calculator calculator will set you free in those situations because there was one day that I'm like sitting here doing the math cause I don't need no calculator, right? So I'm figuring all this stuff out and I'm like, why is this not coming out correctly? So I checked it against this calculator and I'm still getting the same thing.
It's not matching what I calculated because I didn't take into account the maximum injectable volume. This was a relatively large tumour on the proximal tarsus, I believe, of this small Pomeranian. So we're immediately out of possibilities because this was beyond the injection volume.
So be mindful of that. Now this is on the website as well, and I would encourage you. We're all good at math.
That's why we're here we're doing what we're doing, right? So make sure that you're use, I, I would recommend, right? Like, take a picture of this, use the QR code, whatever that looks like, and use this calculator for each one because there's always gonna be one of those cases to where you forget, OK, well, I'm actually gonna exceed the tumour, the volume of injection because this tumour is on a tiny dog and it's relatively large.
So that, that's a big, big, big suggestion point. And then remember, it goes through how do you do this. So you accurately measure, you enter them in there, you get the correct dose, you draw it up and you inject it.
Now, when we go through the injection, it is very important to think about the precautions here. Now, we want to just use standard PPE. I wear glasses.
I'm OK with that. If you don't, maybe put on a pair of goggles, maybe put on a face shield, wear a lab coat, wear something disposable games. Now, remember, this is not chemotherapy.
So you don't necessarily have to have all of those. It certainly wouldn't hurt, but you don't necessarily have to have all of those, depending on your, your local regulating body, that may be different. But for us, it's, you know, we do not have to treat it as, as chemo per se.
So a lab coat, standard PPE is more than adequate with these, wearing gloves because you wouldn't want necessarily to get this prolonged contact with your hands. Now when you inject this, it, it's important to keep in mind that you wanna make sure you have a lure lock syringe, which is not always easy, try to find with these like TB or 1 mil syringes. So make sure you've located those, you have those set aside.
When you're injecting, think about what you would do for a local block, like a local anaesthetic field block. So you go through, you're at a single point of injection, and you are fanning. All throughout the tumour.
So, you know, you're just kind of injecting here, here, here, here, just like you would to block it with lidocaine, bupivacaine, linocaine, whatever you call it, where you are, . The important part here is absolutely do your best to go through one hole, because if you pin cushion this tumour, you're just going to lose product. It's not going to necessarily say you're going to lose enough that it will not work, of course not, but you could theoretically, if you go through enough holes and it drains out like a sieve, reduce efficacy of the drug.
And the other thing that I have found is some of these tumours are going to receive significant volume. So after you're done, I always have a little gauze in my hand, in my non-dominant hand. So after I've done my fan, I've done my injection, I will remove the needle and then put gauze on there just for 30, 45 seconds, just in case that not, not really pressure, just enough at the injection site that we're not going to have enough of that leak out onto the dog or onto the table, and then they shake and get it into the assistant's hand or the eyes, whatever.
The other thing is don't poke yourself. Most ERs in human side are probably not going to be as familiar with this drug as, as we might be. So as standard protocol, if you inject yourself and you take your product insert and you go to the ER, they're going to debride your thumb or your finger or whatever.
And if you look at this picture at the bottom here, that's actually what happened. So this is not caused by the wound caused by the drug. This was actually a debridement done by the ER physician.
Now, that doesn't matter. I mean, you could still theoretically have a wound. It may just Be a big red bump, who knows, but we don't want to find out.
So, so don't be that guy, don't be that person, just don't inject yourself as best you can. And if you do, tell your ER physician like, hey, this is what I've used. Here's the, here's the thing.
Let's read this before we get the scalpel out, OK? Just so you know. Now, what evidence do we have?
And we'll go through this really quickly just for the sake of time, but this has been going around for a while. So this is something that, you know, we, they started doing exploratory cases in 2009, . I was not even a vet in 2009, so that's pretty cool to think.
And then you can look at this timeline, and it's been going on, we have learned more, it seems like every month there's more and more things and hopefully more and more indications coming in the future. This study was released back in 2019, that was a randomised clinical trial study, clinical study, excuse me, that looked at the efficacy and the safety of this intra-tumoral treatment. It didn't even have a name at the time.
But the molecular name Tiglanoltiglate is there. So this is a study that you can pull up and take a look at. Just to summarise that really, really quickly, after 1 to 2 treatments, 7, well, one treatment, 75% of dogs went into complete remission for that.
After 2 treatments, it went up to 87%. So that also means that some of these dogs did not respond fully or had progressive disease. Now, there's a lot of reasons that that can happen.
You know, we take off mast cell tumours all the time that, that metastasize before we even look at it. So, this is just kind of part of it. So we would never expect 100% here.
So 75 and 87% is pretty good. I think I have had one, maybe two dogs that have required two injections ever, but I always set that expectation with the clients that to get a full response or a complete response, we might need to do two injections, but it is not a super common thing to happen. So these dogs were disease-free at 12 months, which is fantastic.
Of those 80-something dogs, 64 of them were available for follow-up. And, you know, at 12 months, you can kind of see that, you know, 89% still had complete remission. And then, you know, 57 of those dogs had no evidence of local recurrence there.
All right, there we go. We already said that. And then healing times, this is important and pretty remarkable if you ask me.
Most of these dogs, 96% of those sites had healed by 84 days. Antibiotics are a big question. In the original part, original studies of this, only 12% of those had antibiotics, but I will say that I can't say that all of those had evidence to need antibiotics.
It may have just been done, out of an abundance of caution, and that's OK. There's no reason that you can't do antibiotics if you feel like you need to. Bandaging, one of those cases was bandaged, and then one of them was treated with saline or flushed with saline to kind of control some odour.
And of those cases, an e-collar, was put on two of those cases that were treated. Now, that doesn't mean you shouldn't use an e-collar, that doesn't mean that you should let these patients just lick with reckless abandon, you know, so just. Use the standard wound therapy protocols that you would use in your practise.
Pain management in that original study, they said 63% of those received, analgesics in that pivotal trial. I would say that's not no bueno. 100% need analgesics, whether they pretend or act like they do or not.
I would say follow the Wasava guidelines as far as pain management goes. We are a little, you know, restricted because of the steroid as previously mentioned. So that leaves things like acetaminophen, that leaves things like gabapentin, plus or minus maybe tramadol if you believe in it, you know, however that goes with you, you know, use what you're comfortable using, but use something.
Something needs to be done to make sure these patients are comfortable. Adverse reactions, number one, of course, is going to be wound formation at the treatment site. That is our goal.
We want that to happen. But then you start going down the list, tumour injection site pain, yep, I would say anticipate that, you need to be preemptive with this. Lameness, treated limb, I've seen that a handful of times, not significantly.
Vomiting, diarrhoea, I've seen that a few times, and whether that, now that's the other thing too, right? Like, is this a histamine response or is this just a pain response, is this whatever? So we need to be aware of those kind of things.
And then it just goes down the list and you can kind of take a look at that. When we talk to how do we educate the, the, the pet owners, you want to make sure that we are monitoring, and the most important thing, I believe, is monitoring and encouraging. So monitor these patients early, monitor them for a while to make sure that there's no evidence of mast cell degranulation and potential anaphylactic or anaphylactoid type responses.
It's very important. And that's generally the first week, the 1st 7 days, you want to make sure there's no signs of mast cell degranulation. Absolutely make sure the clients are given the con meds that they're supposed to be and make sure that you're gonna know what to expect.
Make sure that the analgesia is appropriately, make sure they know that there's gonna be bruising, there's gonna be heat, there's gonna be swelling, and that does not necessarily mean that there's an infection. Make sure to remind them, this is what's going to happen. I have seen a few dogs that you give the injection and the skin remains intact.
I do not anticipate that each time. I do not expect that each time. So I tell clients we need to expect that we are going to get an area of necrosis.
We are going to get a crater, we're going to have some eggGate. We're going to have an eschar, and it's going to turn into an ulceration. Now, eventually, you know, that will become your healing point, but I always talk to them about if you've ever gone to the dermatologist and you've ever had cryotherapy.
After the first couple of days, the process is actually pretty similar, you know, it's just a deeper, more effective, more predictable wound, but you're going to have that ugly wound or ugly, you know, dry, blackish skin that's going to fall off. And, and the better we manage that, and the better that we anticipate that problem, the better off we're going to be. And then from the week, you know, 1st week to the 3rd week, we want to make sure that we're encouraging those pet owners to say, hey, you know, this is the situation, this is what we can expect.
If there's, you know, some pitting edoema, things like that, we need to know, let us know, but this may not be an actionable item. So these are things that we just need to know. You need to call me, you need to email me, whatever that process looks like to you, make sure that we are keeping them on the right path.
OK, before we move on to some cases really quickly, just, you know, remember, like I've said, this is a very innovative product and it's an effective product in the majority of cases that you're going to treat. The indication, the label indication is for non-metastatic mast cell tumours. So keep that in mind, the label indication.
The FDA has stated that, you know, this is not a drug that you cannot use off-label. But you need to use with extreme caution. This is just not worth it, I would say in most situations.
Those cutaneous mast cell tumours can be rare, anywhere. Subcutaneous ones have to be below the elbow, below the hawk. One treatment, two treatments, you're gonna get about 87% of these dogs.
After one, it's almost 70%, so it's pretty good, pretty effective. It's gonna start working within hours of injection. You're gonna start to see bruising, you're gonna start seeing swelling, you're gonna watch it unfold before your eyes.
Most of these wounds, well, yeah, I would say most of these, that's a fair statement, are going to be healed within the first month. Some of them. Are going to be a lot more extensive, and I'm gonna show you a few cases, one of them being mine, that required a lot, you know, a lot more time to heal, but still went and was great.
OK, so this is your textbook case. This is what you want to happen. So this is a cutaneous mast cell tumour on a geriatric breed, mixed breed dog, and this was injected and you can see at 8 hours, you've got that mild inflammation.
They have shaved the hair around the, the tumour. This is not something you have to do, but I would encourage you for cleanliness, do that, because once they start producing that exudate, it's gonna be much easier to clean. So by day 4, you've got that little raisin there that's just about to fall out.
By day 7, I would expect at day 5, that thing had fallen off, but the next picture, next assessment was at day 7, you can see our crater, and then by day 28, that has completely healed, and day 42, there is zero evidence that that tumour was there other than that little pink scar. Now, they are not all that great, you know, sometimes we have wound extension for one reason or the other. I'm not sure there is a definitive answer as to why this patient responded the way that it did, but you can see that even at day 0, we had a, you know, pretty gnarly little swelling.
Day 1, you're starting to get bruising, you know, it's starting to progress, and by day 7, there was a significant wound that has developed. Now, knock on wood, I have not seen quite an extensive wound formation, but, It can happen and in rare cases, it does, and we need to be prepared for that. So you can see the progression regardless of all of this.
The dog went on to heal. By day 84, you can still see that there's a very healthy granulation bed, but it's still not 100%. Healed at 84 days.
Now, the thing that's important to remember here is even though this was difficult, the client, or the, the veterinarian, excuse me, was still glad they did that. The client was glad that they did that. This was an older dog.
The owner was probably not going to put him through surgery. So, you know, what would the outcome have been? So sometimes the option is not to do nothing.
So, so here is a good example of, we had a little bit of a hiccup, but overall, it was a very favourable outcome. OK, so from some personal cases of mine, this one's Dale. She was my absolute favourite.
This, her name was actually Dale too because Dale 1 had passed away years ago. And, so she was a, you know, a senior to geriatric basset hound at the time and it's important to remember. That she has had a history of chronic pancreatitis, whatever that really means to anyone.
And I only say that because she did have a little bit of an adverse event, but I couldn't say 100% that was still fonta-related. We assumed it was, but, you know, I think there is a little bit that we need to, keep in mind with that. Her mast cell tumour was near her right stifle.
It was cytologically graded as low grade. Now, when I graduated vet school, that was not something that anyone agreed on doing. That was like something that you just didn't do, right?
You have to do grading based off of the tumour, but I would encourage you to look around because there is, several Several papers now that look at the correlation between cytologic and histopathologic grading, and there is some good correlation there. So people always ask, well, what do I get a tumour grade? Do I need to do that?
Do I, you can. You can do it off of cytology. You can request it if that's something that you want, there are options if you were going to do that.
Now, what's interesting about Dale is, is the wound or the, the tumour itself was well out of the range of injection, right? You see there, when we calculate that tumour volume. It was 20.5 cubic centimetres.
That's double. So that was a big no. And this was sent to me by a local veterinarian that we have a really good relationship.
She's a very, very nice lady, but she kind of set me up for failure here, right, because she, you know, looked at this gigantic tumour and then I walk into a room and then I look at the tumour and the tumour looks at me and I'm kind of like, ma'am, we are, you know, you go through your big spiel to be very diplomatic about it, but I'm like, there is just not really a good way that we can safely treat this. She was like, we are absolutely going to treat this, you just need to figure out how we're going to treat that, and I said, yes, ma'am. So what we ended up doing is trying some techniques that I had historically done for, surgical mast cell tumours.
Now, I would not say this is going to happen every time, and I would not encourage you to do this, but there are options in certain cases. So you can see that we went ahead and started all of her concomitant medications at that point, and, At the time, I had injected it with some triamcinolone, just because we were pulling the stops. We needed something to try because she was not taking this dog to surgery.
This was, we had to interact or we had to act here, and we needed to be successful. So we were successful, big surprise. So after about three weeks-ish, we got the tumour volume down to 9.4 cubic centimetres just with those.
And I would also say an important practical tip here is you need to measure at the time of diagnosis. And you need to plan for your injection there, one, to make sure you've got enough drug in the hospital, but you need to make sure that, you know, it's well within ranges, and then as you start the concomitant medications, the peripheral effects of that tumour should dissipate. So you may have a tumour that's 5 cubic centimetres on the day of whatever diagnosis it is, then you come in for treatment and this thing has gone all the way down to 3 or 2, or in several situations, you've got a small mast cell tumour that you don't know where it went.
So that is something you need to be acutely aware of and talk to the clients about. Now, it's not gone away, it's just significantly harder to find. OK, so really quickly, day one, this is what it looked like, real ugly.
Now keep in mind this is photo perspective, right? This is not giant, it's just a short little basset hound leg with a stream close up that the owner sent to me, so don't panic. This is not like the size of a watermelon.
So you can see at day zero, you have a lot of swelling, a lot of edoema. At day 3. Now, what you can't see is the caudal aspect of that wound has started to divide from healthy tissue.
So that is the point to where most of these dogs start to become relatively comfortable. So you could see at day 4, we've still got some tissue edoema around, but by the time that that eschar pulls away at day 5, this dog is relatively normal. The edoema has improved, not gone away 100%, but relatively improved, and she's comfortable, she's eating, she's drinking, she's running around, she's doing what she needed to do.
And these are ugly. I will, you know, fair warning, they are not this extreme, and, you know, I would say I have not had a dog react like this, and I'm glad she was my first one because it set the stage, and now I am pleasantly surprised every time I get a dog that we treat. So day 7, you can see and probably smell through the camera screen what this looks like.
Day 9, it's all disappeared. The owner never found it, so you can draw your own conclusions about what happened to it. This dog did not have any collar on at that time.
Day 11, you can start to see, frankly, that's a very unhealthy granulation bed, but by day 15, we're getting there. It's a little dry, it's not something that I would be terribly comfortable with if I were managing this in a standard fashion for wounds, you know, with all of your lotions and potions and all of that stuff. But it's kind of doing its thing.
So, do we intervene? Do we leave well enough alone? That's your clinical judgement.
In this case, we left well, well enough alone. By day 26, it started to match some of the cases we showed earlier. So it's a nice, very flat, somewhat dry granulation bed, but it's there.
Day 28 really contracted down, which is weird. We don't think it always happens in the distal limb, but it did in this case. By day 31, that's a scab, you know, day 37, you could flick this thing off with your pinky if you wanted to.
And then, you know, like I said, this dog was doing phenomenal after about day 5. And then 6 months later, here's what you were left with. You had the scar, and I will say happily enough, and for whatever reason, I don't have photos of this, but we managed this dog for several years after the Stellefonta, and we ended up unfortunately having to euthanize her for uncontrollable osteoarthritis.
But, you, without knowing, without reading the record, you would have no idea which limb was injected. So it healed up that well, and the hair covered the scar impeccably well. So some associated clinical signs that we need to be aware of.
Like I said, she had some lameness, the swelling, obviously, she was uncomfortable. My pain management was not on point for this case, and I've learned my lesson since then. She was lethargic.
And this all started within that 1st 24 hours and really only lasted for that 1st 3 to 4 days. Vomiting and diarrhoea did happen, so that, that's what I mentioned, like, was this related, was it not? It was around day 6, which conveniently was around the time that ER disappeared, kind of lets you draw your own conclusions on what happened there.
But because this was a new drug, new to me, I contacted Verbex, technical support people just to let them know kind of what happened. The client was absolutely ecstatic that this was a non-surgical, non-anesthesia model. Now I'm not saying you can't do sedation anaesthesia.
I do a lot of these under sedation, just for safety and patient comfort, but you don't necessarily have to. It was a very predictable outcome. She just loved how quickly it healed.
In her case, she used an e collar for maybe a day, but ultimately there was no, e-collar, used, and the dog did not bother it excessively, which you want to avoid. You want to create that situation to where the wound should heal the way it should heal, and you. Don't want to disrupt that as much as you could.
She did not like how it smelled or how, as she would say, juicy it was, which I realise is a very gross word, and I apologise, but she said, it didn't bother me as much, but just always tell people to have extra towels and sheets around because it's going to need to be changed pretty frequently. This next 17 year old American bulldog mix, teeny, teeny, teeny tiny little mast cell tumour, and I have it circled because it went away, basically, from a visual standpoint, cytologically, you could find it if you stuck it again, but, but visually it was not something we could see. Look at the progression there by day 9 and then day 90, completely gone.
It was like a little pink button. Here's an example of some of your atypical ones. This was on the muzzle, absolutely resectable, but it would require reconstruction to get appropriate margins.
This one did not create a significant wound at all. Now, for whatever reason, I don't know, could be the vasculature of the face, whatever, speculation, but by 3 weeks, there was no detectable, raised tumour. It was just a small scar, and then by 30 days, the hair was growing back, the redness had gone away, so it, it was in much better shape.
OK, so for the sake of time, I'm gonna end with this slide, and I would just remind you that we need to make sure as we go through this, you need to make sure to monitor for those potential catastrophic incidences and make sure that we are prepared for any type of mast cell degranulation episode. knock on wood, have never seen it happen in an uncontrolled way, and the dogs generally do very well, but we are prepared for it. Explain to the owners what to see, remind them what they're gonna see, and just encourage them through that.
And, and having that open communication, making sure you're forward booking, making sure you're paying attention to these things, the client is gonna be, much more satisfied with the process. OK, with that, I will take some of your questions. Hopefully, we have time for that.
Gerard, thank you so much. I really appreciate your time and your insight, and a huge big thank you to our sponsors, Verback, for, allowing us to listen to your insights. It, it has been fascinating.
Thank you for that. My pleasure. Folks, just a reminder that we are recording this webinar.
It will be up on the webinar vet's, website in the next day or two. A lot of the questions that have come through, Gerard answered. Some of them was great.
The question came through and he answered it as if he had read it. So well done on that one, Gerard. The one question which, being an experienced speaker like yourself, I'm sure you're anticipating, what about cats?
What about cats? So, the response that I have gotten from the oncologist is that mast cell tumours respond so or are, excuse me, not respond. Mast cell tumours are behaviour.
Very different in cats. In certain locations, they're less, aggressive. Some locations, maybe they're not.
But no, this is not a product you're going to use on a cat for a lot of reasons. Most of those being the unpredictability of how this is going to respond to a cat. So, unfortunately, right now, we don't have that option for cats.
But somebody's playing with a pip somewhere and may come up with it. Yeah, I'm sure they are. The other question, that has popped through a couple of times is, what about other tumours?
Yeah. So, one thing that you can see an indication on, if you guys are, those of you that know what plums are or used to plums in the formulary, they actually have an indication in the formulary, for equine sarcoids. If you look at some of the studies, and I'll encourage you to do that, there are studies on soft tissue sarcomas.
Now, these are not labelled at this point. I would not say do those, but one stands to reason. I'm sure mast cell tumours were not just coincidentally.
The one that they chose, but they are the most prevalent ones. So it's going to be significantly easier for us to study that when it is something that you see all the time, right? So I would say that is the reason that we chose, they chose mast cell tumours.
Now, I can't speak for them, but if you do look, there are papers in myri models that look at other types of tumours. There are, absolutely labelled indications in, in certain formularies for equine sarcoid. So, we are not there yet.
Don't start poking other tumours with it, but I'm hopeful that in time, especially, your soft tissue sarcoma families, because to me, I would rather have it for those than mast cell tumours, and that's just me coming from a surgical standpoint. I would much rather take a mast cell tumour than a soft tissue sarcoma off, but that's just me. Last question because we are running out of time.
What happens when you're injecting and you're fanning out if some of the product goes IV? Yeah, so, that's something I would definitely call in, but my, what I have heard the response to that, thankfully I don't have firsthand experience of that, undoubtedly that is taken up very quickly into the venous system, lymphatics in the venous, and the way that the drug works, it is so diluted by the time it gets to that point, giving it in that manner, should not. Result in any significant observable effect.
However, don't quote me on that. Make sure to call Vervac when that happens, but the responses that I have heard from oncologists and other, you know, researchers that are using that is the drug is in and out so quickly, and it is knowingly taken up by the vasculature short of a direct IV, like larger vein IV injection. I would not anticipate serious reactions or serious responses, but again, don't quote me on that.
Call it into Verback and get an idea, but, I have injected plenty of them near the cephalic vein in particular, and the saphenous vein actually, . I do everything I can to make sure and in those locations, it would be good practise to go in one location, aspirate, go in one location, aspirate, just to confirm that you're not gonna be in that location, just cause, you know, it's not a, not a thing we want to find out what would happen if we don't have to. Absolutely, but you have said a number of times through your presentation, have all your emergency crash cart kind of stuff handy, just in case.
One last question, cause I think it's a real good one. In those bad cases like you got with that whole leg sloughing and that, would you consider something like wet to dry bandaging or would you? Yeah, anything that you are gonna do to manage a wound of any kind is fair game.
I will say the beauty of this product in my hands is I have not found that to be necessary in a lot of cases. However, if, Dale's wound had been in a location that a bandage would have been reasonable, I would have loved to put a product on there that would have donated some moisture, not necessarily a wet to dry, but maybe like an alginate or a, hydrogel, some type of product that's gonna say, hey, take this moisture because you dry. But absolutely, if you wanted to do a wet to dry, you can certainly do that.
There's no reason for you not to do that. I would typically suggest let's wait until the tumour falls and goes away because we don't want to interfere with the natural, you know, kind of process. So if you constrict the wound, the bandage gets tight, the owner puts it on too tight, there could be some problems with that potentially.
So I would wait when the, when the. Tumour bed exhibits and shows its head, that's when you can start your bandage care, if you needed or wanted to do that. Yeah, yeah, I think we all underestimate just how fantastic granulation tissue is.
Yeah, yeah, I agree. Fantastic. Gerard, once again, thank you so much for your time and your insight.
It has been an absolute pleasure listening to you and gaining your insight into what is obviously a fantastic product. In your hands and hopefully in all the hands of the people that have attended this webinar. A big thank you as well to Verback for sponsoring it and for allowing you to chat to us.
So thank you to you both. Yes, thanks again. To all of you that have attended tonight, thank you very much for your time.
I hope you found that this was as worthwhile a webinar as I did. And as always, last but not least, Dawn, my controller in the background, thank you so much for making everything run smoothly. From myself, Bruce Stevenson, it's good night.
