This transcript is automatically generated.

Betsy Post 0:00
So welcome everyone to this evening’s DocTalk. I’m Betsy post here from COLONTOWN, and I’m here to host this amazing, incredible talk, the interview with an icon, Dr Nancy Kemeny on the hepatic pump for colorectal cancer, liver metastases. So it’s just such an honor to have Dr Kemeny with us this evening. She, of course, is the pioneer of the hepatic pump and has treated so many patients over her many years at Sloan Kettering, including many, of course, from COLONTOWN. Her name is, of course, talked about every single day, all day long in COLONTOWN, as is the pump and Dr Kemeny, we have an entire group called the HAI PUMP PEOPLE. This is the cover photo for that group. So we just are so excited to have you here this evening. We recognize your contributions, your work, your passion for patients, just everything that you’ve done throughout the years. It’s just such a humbling experience to have you with us to talk about the pump. We have so many patients whose lives have been changed by your work. These are just a few of them. I know that you know them all. You’ve done such amazing things for so many of us, like I said, and I’m just so excited to have you here to talk about the pump, also to record this so that those that can’t be with us this evening, and then, of course, as we onboard more and more patients and families every single day, they’ll be able to refer back to this. I can pin it right at the top of the group, and everyone can hear your genius, your expertise on the pump. So again, thank you for being here. I’m going to stop sharing my screen so that you can share yours, and I’m going to turn it over to you.

Dr. Nancy Kemeny 1:48
Well, thank you very much, Betsy, and also thank you for all the work you do. It’s a lot of work to help all these patients, and I really appreciate it. And I also want to tell you that many times I get patients and they tell me the way they got to me is through COLONTOWN. So it’s interesting how much you influence all these patients. So right now, the Entera is the only pump that’s available for implantable pump for hai for a little while we were using the Medtronic but it was really an inferior pump because we had to connect it to a catheter. That was the catheter coming from the Codman and Terra people. The pump is the lithium and its weight is five ounces, so it’s not that heavy, and it contains a drug reservoir that is attached to a long tube connected to the hepatic artery. The drug flows through the tube and is directly going into the hepatic artery, into the liver. Here’s a picture of the inside of that pump, and you can see that there’s two bolus needles. I mean one bolus needle, ONE needle that goes into the actual reservoir. So that if we’re doing a flow scan or some other injection directly into the catheter, we use the bolus needle. But if we’re refilling the pump directly, we use the regular need. The pump doesn’t run on a battery. It continues to power to be there, and I’ve had patients use the pump even 10 years out from when we started. So so why even think of regional therapy? Well, 15% of patients have liver metastatic diagnosis. Another 60 developed liver mets during their follow up. And as you can see, we have a number of colorectal patients a year in the United States now, this is what a liver met looks like. And you can see it’s taking its blood supply from the hepatic artery there. Here we sat, the hepatic artery giving the blood supply to this tumor. Now, what we did to make sure that it was coming from the hepatic artery is we injected a labeled FUDR, so it was labeled so we could see where it was going, either into the hepatic artery or the portal vein. And you can see much more got to the tumor through the hepatic artery. Well, if you look at the normal liver, the same amount got there from either the artery or the vein. So if you think that liver mets are perfused by the hepatic artery, if you think that some drugs are extracted by the liver, and then you have to think of the liver mets being the only site of metastatic disease. Which is possible because they’re coming up the portal vein into the liver. So if you could control the liver, you may be able to control the disease. So this is the picture showing you how the pump is placed under the abdominal wall. It’s connected to the gastric duodenal artery. And here’s the common hepatic, left and right hepatic. So you can see that we connect it up, and it should then perfuse the whole liver. Now we then have to do what’s called the macroaggregated albumin scan. And what we do, why we do that, is we want to make sure that we’re perfusing the liver and not outside the liver. So here’s a case outside the liver. This is the liver. This is the stomach. So if you were to start the treatment on this patient without correcting this problem, they would develop terrible ulcer disease. So we have interventional radiologists who can tie up the vessel going to the stomach if something like this happens, and we can still use the pump. Now, one of the things that we learned very early when we were working with this pump is that it may hurt the liver, not really so much the liver, as the bile ducts. And we thought, if the bile ducts are being inflamed, that possibly using Decadron would decrease that inflammation. So we did a randomized study. Yeah, we did a randomized study comparing FUDR plus Decadron, that’s a steroid to F UDR alone, we were blinded as the physician and nurses to who was getting the Decadron, only the pharmacist knew, but you can see here that the people who were getting the Decadron had less bilirubin elevation and actually had a higher response at a higher median survival. Now this was in 1992 when at that point, the response rate for colon cancer was about 15% so this was very high. So because of that, a national group, the clgb, took this idea and decided to do a randomized study of hepatic artery infusion versus systemic not allowing a crossover. At that time, the systemic chemo was founded here with the warrant. In this study, we did prove an increase in survival, an increase in response rate and an increase in hepatic disease free survival. So all these were highly significant. So we went on a memorial to test the idea of using the pump treatment that particular study I just showed you, this was with fudr alone. So these were the results with just fudr, no systemic chemotherapy. But we thought, since it was just using one drug, and as many of you know that if you use a combination of drugs, you get a higher response rate, so we thought, why not use the pump with systemic therapy. So the pump therapy, as you know, is given day one, emptied on day 15 of each month, and the systemic was going to go in every time you touch the pump. So this was our first study, small study, 49 patients. But if you look at the patient who had no prior therapy, all of them responded, 100% response rate. We had never seen that before treating metastatic colon, and we had a 50 month median survival and a number of them were able to get to resection. If you look at the previously treated patients, 85% had a response rate, meaning survival, 35 months. It’s very good for second line therapy, and this is what we call the waterfall curve. So each line here represents patient and and it represents the decrease in tumor that patient experience. So when I started out at Memorial, the responses I was seeing were up here, like just a few little responses in this area. This is more than a 75% reduction in the majority of patients. So to show you that, I’ll show you what that looks like. So here’s a patient with a lot of disease who was not resectable. There’s no way they could take the tumor out, because it was involving all the big vessels here, and this is her response. Now, it was still involving some of the vessels, but we argued, I argued with the surgeons to take her to resection. And we we did. There was no tumor, and she went on to live. She’s still alive. It started 2000-19-02, and she’s still alive.

Dr. Nancy Kemeny 10:12
And here’s another patient with massive disease. This patient, in the old days, would have been alive a few months there was such massive disease, and she went on to live five years after the scan. She never reoccurred in the liver, but she recurred in the lymph nodes. And here’s a patient. This is a PET scan. All these black spots represent tumors. And here’s the liver after the pump treatment, and you can see you don’t see any tumor here. Now, the pets aren’t perfect. You could still have tumor and not see it on the pet, but certainly you can see that it’s a great response. So this man developed this problem that we call bilirusclerosis. So you can see the the dilatation of his bile ducts. So we’re not really hurting the liver, but we’re hurting the bile ducts. And he developed an increase in his out plus. But when we stopped treatment, his out plus went down. Was 800 went down to 200 and since his bilirubin was never elevated, we never had to put a stent in him. And here he is, 15 years later. He never had a liver resection. He just had the pump treatment, and he had the problem I described to you. So even though he developed the biliary problem, he went on, as you see, went away, eventually he went on to live for 15 years now. What about second line treatment? We have all these new drugs that have been approved by the FDA, but they’ve done very little for the response rate or the survival. When we add panitumumab or Cetuximab with EGFR receptor drug, we do increase the response rate, but again, the survival is not that good second line. And here’s what happens, if we had the pump of second line. This is our work. Here these first two studies, and really doubling in the survival. And this is the European studies. They use oxaliplatin in the pump because they can’t use fudr, because it has freon. Who have a rule in Europe, they can’t use freon, they can’t use the freon pump, and they can’t and they don’t have fudr approved. However, the Netherlands has sort of who are now doing studies of the pump. Now, do have a pump they can use in Europe. And they did get approval for FUDR, so here’s a lady’s second line so that she progressed on CPT, or what’s called irinotecan, leucovoren, 5FUand this is the day we started the pump treatment. And here you can see this excellent response with the pump treatment. Now, here again, all these black things are tumor. This is how she looked after CPT 11, binary leucovoren (_?_) She failed the CPT five. She started the pump treatment. And here’s her scan, and she went on to a liver resection, but no tumor was found, and she went on to live 15 years after this scan, she died of a glioblastoma. So what about third line treatment? As you can see, that’s really bad. These drugs were approved. They’re very expensive drugs. They were approved because they gave about a six month increase. What she was, excuse me, was a one month. It was a one month, 1.4 and 1.9 month improvement in survival. That’s how they were approved by the FDA. Now here’s what happens with pump treatment, third line this is a response rate. This is the survival certainly better. And this is our curve from third line treatment. So these patients in this waterfall curve had all progressed on 5FU, oxali and irinotecan they’re still showing responses, or at least, stable disease. So what about patients who are unresectable? What can we do? So this is what we call a prospective study. We had all the patients who were deemed unresectable that our institution, and that means they really had their disease — and then we gave them pump therapy, systemic and Bevacizumab. This particular study was minute. We no longer use bevacizumab because we increased the billiary toxicity for this, so we no longer use it. But you can see that there was really no difference in the response rate. You could get people to a resection just with the pump and the systemic and this is what we call a landmark survival analysis, where we’re only putting in the patients who got resected after one year, and this is their survival curve. They we had one CR, we had five who never had a recurrence, three who had a recurrence, but we were able to salvage them. But still, this is a five year survival. So just to show you a patient that we were dealing with and what could happen. So here, clearly this patient, all these dark spots, are metastatic disease, and she was clearly unresectable. This is her PET scan, which, again, shows a very nice response, but you can’t rely just on pet because this is her cat scan. So you can see there’s still disease remaining, though much less than we started. So we did like a two stage resection. We took out disease on one side, we did a portal vein embolization on the other side so we could come back and take the other side. And here she is, 15 years later. Now, what’s interesting about this lady is she had more than 25 lesions. She had a known positive primary, which isn’t good. She had right sided disease, which is good. She had seven lesions that were ablated, not resected, and she she had KRAS mutation. All those things are bad, but she still was able to live 15 years, and so she still alive, cancer-free. So there are other institutions who have been publishing on this. Now this is from Pittsburgh group. What they did is they took 86 patients, and they matched up the patients who received modern chemotherapy and hai to modern chemotherapy alone. And this is the difference in their survival, 33 months versus 15 months. So it’s a doubling of survival with the pump therapy. So what about liver resection? We know that about 30% of patients are alive in five years after liver section, but 70% would reoccur either in the liver or extra hepatic. So we did a randomized study of liver resection and then randomized to pump and systemic versus systemic lung. And since it was a single institution study, we asked our statisticians, can we look at two years around just to look at five years survival? You really need a lot of patience. So they told us we could do 156 patients to give us that endpoint. And we did enter 156 patients, and 85% had the two year survival in the pump group, 69% in the systemic group. So if you look at that on a survival curve, this is what it looked like. This is the HAI group. Now if you look at the recurrence in the liver, the yellow is the pump group. You can see that there’s a much higher recurrence in the liver. If you don’t get the pump, this is very significant. So what it’s telling you is that the liver is being protected by the pumps treatment, so you’re having much less recurrence. Now if you look at the overall occurrence, it’s also better, but of course, not as great as it was in liver. Now this is a study done by my sister who compared surgery and chemo to surgery alone. She did this study with the Eco group. And here’s there hepatic, recurring (_?_) survival. It looks almost identical to our group, and we now have four randomized studies. This is the European study who didn’t use a pump they used a port and didn’t use FUDR. They did 5FU. So their study was negative, but all the other studies were positive, as far as hepatic disease free and disease free survival. So this is a curve from people at Memorial. So what we did is we looked at all the patients who had liver resection but were on protocol. They were on protocol, meaning they to enter the study. They shouldn’t have had disease outside the liver. And if we look at those who were resected after 2003 we can see here. Is the five year survival that 78% are alive five years. Now this isn’t actuarial survival. This is actual survival. So like 92 of the 118 are still alive at five years and a number of 10 years. So a study that came out, again from Memorial, sort of, I think, opened up the avenue for using pumps in many other centers. Because this study is a very large study, 2368 patients. And what they did is look at the patients who got Hai and the ones who did not and the ones who got hai were worse patients. They had no positive tumors. They had more tumors, no positive in the primary they had more tumors. They had clinical risk score and they had previous resection or RFA. So here’s the difference in survival in these two groups. It’s almost a two year increase in survival. Remember, I told you, the new drugs are approved with one month. There was one month increase in survival. This is two years. And you can see that even the patients with good characteristics like no nodes in the primary or solitary mets. Even the good patients did well, but all of them did significantly better. So a lot of people ask about Y-90 or spheres and liver transplants? I just want to give you a little information on that. We don’t have much information, but this is a study from the Pittsburgh group where they compared their patients with hai to the spheres of Y-90, and you can see the survival difference is almost doubled again with the pump. This is, this is our work at Memorial and third line. So this is our survival for third line, and this is the survival at Robert Wood Johnson with the spheres. So to compare again, what happens with spheres? All their patients were in third line, but they were previously treated, and ours are third line, with quite a difference in survival. Now this is a randomized study that came out about the spheres, where they compared systemic and Y-90 to systemic alone, and this is their progression free survival. This is their overall survival, which wasn’t different. And here’s the response rate, so slightly different if they got the spheres in systemic versus systemic alone. However, if you compare that to our group, so these are unresectable. So our group, this is an unresectable group of liver mets treated our institution, published by Angelica, the survival like 30 months versus their 14 the response was 72% versus their 34%. Now what about liver transplant? So the liver transplant, people say that what the results they’re getting are better than anything you could say with systemic chemotherapy, and that may be true, but they’re not comparing it to pump therapy, and I’m going to show you that in a minute. And also I want you to look at these studies. So the first study, first transplant study, they accrued 21 patients over five years, number one, and then this is their survival. So if you look at their five year survival, if you look at the 21 patients, only one patient is out there five years, and yet they’re reporting an excellent five year survival. So this is the actual five year survival. These are the curves around it. Now here’s the second SECA study. This one, they only had 15 patients, and again, look at who’s out at five years. There’s two patients out in five years, and again, they’re reporting this excellent survival, but they’re reporting this on very few patients, so I’m surprised they’re saying they get such great results. So now let me show you what we get in our pump patients. Remember, for these transplant studies, they’re looking at very good patients, patients with not a lot of tumor and all sorts of criteria to get into study. So let’s look at some of our patients. So these are our respectable patients. Now, if they don’t have a RAS mutation, they don’t have a smat or mutation, and this is their survival. This is five years. This is 32 that when we ran the study was 3200 932, they’re talking about one patient are alive here at like, 80% are alive at five years. Now, these are the unresectable patients. Now, you would think all of them would be dead, but actually, some of them do very well. If they don’t have a KRAS mutation, if they don’t have a T53 mutation, and they don’t have extra hepatic disease, here’s their survival. No resection. Just – here’s five years. So here we’re talking about 86 and we have 16 out that, some beyond. So I think that’s my list, yep. So now we have the questions.

Betsy Post 25:57
Yes. So now we have some questions. We’re going to do a little bit of Q and A, and so I’m going to ask some questions here that were presubmitted and things that folks were thinking about. And so hopefully everyone will get a lot out of this portion as well. So Dr Kemeny, the first question is, in what clinical situations do you offer the pump?

Dr. Nancy Kemeny 26:24
Well, there’s three situations. One, where you are able to perform a liver resection, and then we want to use the pump afterwards to prevent recurrences in the liver. Two, you have metastatic disease. It’s definitely not resectable, and you use the pump to try to shrink the disease. Now, in some patients, you don’t shrink it enough to get to resection, but you do still increase their survival just by using the pump. But in some you’re able to shrink it enough so you can get to resection.

Betsy Post 27:04
So a little bit of a follow up to that, if you don’t mind, if you could talk a little bit about the decision to get a pump at the time of a liver resection, versus perhaps waiting to see what happens and then having a recurrence. Is it still possible to get the pump in that scenario? Or would you recommend, you know, a patient really pursuing the pump at the time of resection and not waiting for recurrence?

Dr. Nancy Kemeny 27:34
Yeah, I would definitely recommend doing at the same time, because once you close the patient, you try to re operate. It’s one harder to get to pump in, and two, you’re doing it then to prevent the recurrence. So if you’re waiting for recurrence, I mean, yes, you can do it then, but it’s much better to do it and try to prevent recurrence. Yes, because some of these patients you know, have their liver section. They have less liver. Remember, they’ve taken out part of the liver. So sometimes ablation and other things that you can do to liver are sometimes harmful to the liver.

Betsy Post 28:16
So one of the questions was, Do you offer the pump with the idea of curative intent?

Dr. Nancy Kemeny 28:21
Yes, my hope is that, one, we never get a recurrence in the liver, and they do well. Two, if they’re unresectable, I get them to resection. So I always think I can cure them. Sometimes it doesn’t happen.

Betsy Post 28:39
And the next question is, what criteria make a patient a candidate to get the pump? And kind of as a follow up to that, there was a specific question, if a patient has small, stable lung meds, is it still a potential option? So what makes it a good candidate for the pump? And then what if a person has stable lung mets? Is that still an option?

Dr. Nancy Kemeny 29:04
Yeah, well, obviously the best candidate is a person with just liver disease. That’s the best. But of the disease outside the liver, like lymph nodes or the lung, is is better than most of the other mets, because one you can treat many of the lung mets with just ablation, especially if they’ve just one or two, and you could still go ahead and treat the liver. And a lot of people don’t die from one met. They live much longer than from liver mets. So if you have one or two lung mets that you have a lot of liver mets, it’s still worth doing the pump, but trying to take care of the one that’s, in other words, trying to inflate them to something.

Betsy Post 29:46
Okay, so in your opinion, why has Sloan Kettering been so successful with the pump, and why has it taken so long for other hospitals to implement a pump program? Program.

Dr. Nancy Kemeny 30:01
It’s not easy to implement a pump program. You have to have the surgeon. You have to have a medical oncologist willing to do it. You have to have an interventional radiologist. So there’s a whole team of people. So this can’t just be done in any little hospital. Usually, that needs to be done in, you know, larger cancer hospitals, where they have all these facilities. Now, the the people who are driving this pump, you know, as they went out to the community where the surgeons, the surgeons that trained at Memorial, saw the results they were getting. So they wanted to give that to their community people. And so they went out and tried to do it. Now they have to persuade the medical oncologists. Now there is a financial part of this. You know, the pump is, is not that expensive, FUDR, is not that expensive. Filling the pump doesn’t give you a large income. So a lot of medical oncologists who, you know, are having problems living as they are with the economy the way it is, weren’t keen on on taking this on. So I think those were two problems. The other problem was that I would get up at medical meetings, you know, when I presented that first randomized study, the caogp study, I presented my results, and then the discussion at that meeting said, “Oh, well, only Nancy can do this”, you know, which is totally inappropriate at that meeting. But there were things like that. It was like this kind of thing that only we could do this, when now we know that other people can do and there’s a lot of centers that have opened up, a lot of centers that have come for training, both the medical and the surgical. People have come for training, and they’re doing very well. Because I hear from them, they’re doing very well.

Betsy Post 32:03
So we know that a lot of that work with the pump was done at Sloan Kettering by you. How can all patients receive that level of care that Sloan Kettering has provided with the pump, no matter where they’re treated, at one of these newer centers, for example, that are offering the pump. How do we know that they can receive that type of care?

Dr. Nancy Kemeny 32:25
Well, again, if a person, they have just opened up and you’re going to be the first pump patient, I don’t know you know, but there are a lot of centers now that have got quite a few pumps, and I hear from them, they’re doing quite well, you know, and they, I just went to a conference in Kentucky where they were showing some cases from colon and colangeal where they were getting great results. And they were also, what’s interesting at Kentucky, what they were doing is they have a program to integrate all the other medical oncologists in Kentucky, you know? So not just the people I train, they’re doing outreach programs to train the other sectors so that people in the sticks of Kentucky can get this kind of treatment. So hopefully that’s going to happen in other centers as well.

Betsy Post 33:21
It’s amazing. That’s an amazing… So once a patient decides to get the pump, what needs to be taken care of before the surgery, in order to make sure the pump can be implanted?

Dr. Nancy Kemeny 33:40
Not much. If they can undergo an operation for a colon resection, you do need to have your colon resected. Doesn’t have to be resected before the pump goes in, but it has to be resected when the pump goes in. The reason we like to resect the the primary disease is the systemic chemotherapy you’re using as a lower dose, because of high doses of systemic with the pump may get too much toxicity, because FUDR is like 5FU. So if you’re giving FUDR into the liver, and then you’re giving your normal 5FU systemic, you may be too much. So you have to lower your doses. So you have to take out the primary, as I said, either before or at the time of the pump placement. And you can take it out at the same time as the pump placement. That’s not a problem. So you have to have that. You have to, you know, be worked up. I mean, you can’t be morbidly sick, you know, with heart disease and everything else. You have to be able to undergo an operation, but you know that’s that’s about it, and you have to make sure you don’t have massive disease outside of them. So obviously you need a CAT scan. You don’t have to have a PET scan. We don’t always do PET scans. I’ll tell you why. PET scans sometimes light up things that are not that, and then you get confused. So if we have a good cat scan and doesn’t show disease outside the liver, you’re a cat

Betsy Post 35:09
That’s good, good to understand the difference. So if a patient goes through with the pump, they get the procedure, what can they expect from an average type of recovery, and then also what daily life activities may need to be modified after getting a pump?

Dr. Nancy Kemeny 35:29
Alright, so the first thing is, I’ll answer the second question first. So when you have a pump in then remember that catheter goes up and is tied into the hepatic artery you know, the (_?_) to do venal artery is tied in. So I am not in love with jogging, you know, on a hard surface, because I actually saw one young woman where the catheter came out.

Dr. Nancy Kemeny 35:54
Okay, so they can jog on a treadmill if they want, they can bike if they want. They can swim if they want. Swimming doesn’t affect it. They cannot go scuba diving, because this is a pump that works by pressure. So the main thing is that they can’t do significant jogging and scuba diving. Otherwise, they can do their exercises. They can bike and do that kind of thing. So that’s how it affects it. You know, I didn’t show the slides on the clgp study. They looked at quality of life and the people who got the pump and didn’t get the pump, and the quality of life was better in the pump issues, because they were feeling better even though they had an operation. Systemic group did not have an operation, even though there was operation in the pump group, they were feeling better and their quality of life is better, so I don’t think it affects living quality of life, except for those two things I told you. And what was the first part of that question?

Betsy Post 37:11
It was, what can, what can patients expect during the procedure, and the the average recovery?

Dr. Nancy Kemeny 37:18
Okay, so again, it depends on how much surgery you’re doing. If you’re just putting a pump in, it’s very quick because, as a matter of fact, it’s laparoscopic pumps that they’re putting in. The person’s out of the hospital in three days. If they are getting a liver resection, depends how much of a liver resection they’re getting, that will limit how long you’re in the hospital and how you’ll feel afterwards. It’s not really the pump procedure that’s changing, you know, your time in the hospital. It’s the what they’re doing to you. You know you’re doing the colon resection, the liver section, that kind of thing. Does that answer that?

Betsy Post 37:59
It does, do patients still get systemic chemo at the same time as —

Dr. Nancy Kemeny 38:06
That’s the board’s question, people say, my patients say, Oh, well, you know, I progressed on systemic. I don’t need systemic Well, if you do FUDR alone, you’re getting one drug, one drug. If you do FUDR with systemic you’re getting more drugs. Okay, and we’ve shown in all the systemic literature that you do better when you have a combination of drugs. So I don’t like giving FUDR alone. I don’t think you get the same results. Number one. Number two, if you do, if you do alone, you’re not treating the rest of the body, so you have more chance of getting lung mets and the other mets that come up. So you need the systemic for that. So the first studies that were done with the pump, and they used just pump alone, showed the this recurrence, the extrahepatic recurrence, which, by the way, occurs in transplant too. They don’t tell you that they get the same kind of recurrence that we get with the pump, with lung being the most the most usual place for recurrence.

Betsy Post 39:15
Does getting the hepatic pump therapy reduce the amount of systemic chemo that needs to be used?

Dr. Nancy Kemeny 39:21
Yes, yes, get a reduction so the toxicity should be less. Sometimes, because you’re getting both treatments, some people experience so you know you have the toxicity you get. If you’re receiving systemic with the pump, like you should be, you will still get some systemic toxicity depending on the patients, some people don’t get it all, but some people do get diarrhea, blood, catdepression, and remember, as far as the pump is concerned, the major toxicities that we could hurt the liver, the bile ducts so we’re checking very carefully the liver function test every two weeks. And if you are going somewhere that’s not Memorial, and you’re doing a program with them, you can ask them, you know, what are my liver function tests? You know? And what’s happening? I have patients ask me, even though I’m supposedly an expert, they’ll ask.They’ll look at their bloods and say, Well, what about this outboss, what about this bili, you know, they’ll ask, which is fine.

Betsy Post 40:39
Okay. Someone asked if the dosage on the systemic would be decreased immediately as soon as the therapy started.

Dr. Nancy Kemeny 40:48
Yes.

Betsy Post 40:49
And this was a good question, actually, that I don’t see, but I think it’s important, and it kind of belongs here. And that’s, are there side effects with the hepatic pump therapy, like there are with the systemic

Dr. Nancy Kemeny 41:03
The side effects, the systemic side effects you’re getting are from the systemic drug. The liver side effects you’re getting are from the pump, you know, the elevation in bilirubin or liver function tests. So that’s from the pump, though you can get elevation liver function tests like from oxali and irinotecan so those systemic drugs can also do this, but it’s more common to have it after a pump treatment that looks systemic.

Betsy Post 41:34
What will the overall side effects or toxicity of the treatment?

Dr. Nancy Kemeny 41:39
Well, the overall we just discussed it. The overall would be that the bad toxicity would be that you elevate what’s called a bilirubin, and then we stop the pump treatment. We put Decadron in the pump. We actually hold a systemic right then too. And hopefully the bilirubin comes down. In the cases where it doesn’t come down, they would require a stent. So that’s the toxicity. I don’t want – it should be a rare toxicity.

Betsy Post 42:11
How often will a patient need to return to the doctor’s office and what is the pump refilled with each time during active treatment?

Dr. Nancy Kemeny 42:21
During active treatment, one so the way we handle our patients, so to make maybe explain, this is, the pump drug goes in once a month, FUDR, two weeks later you get saline. So with many of my patients, they got the saline where they lived, you know, by their local doctor, and got the systemic there and then returned to me once a month for the pump treatment. Now, like in Kentucky, what they’re trying to do is teach the local doctors, you know what to do and how to give the drugs so that they don’t have to return once a month, they’re trying that, you know, they’re trying the protocol to try, but, but you have to some doctor definitely has to see you once a month to look at all the liver function tests and decide what dose of FUDR is going in. The systemic dose is easier for a lot of doctors, because they know that if you’re getting a lot of diarrhea, you lower the dose, or if you’re getting a lot of blood count depression, you lower the dose. But the pump therapy is sort of special. You really have to carefully look at the liver function test.

Betsy Post 43:39
How long does active treatment, with the pump therapy tend to last? And are there a maximum number of treatments?

Dr. Nancy Kemeny 43:47
There aren’t a maximum number of treatments. It depends on your liver function test. So if they’re, if they’re getting a high dose, usually you don’t get a high dose in for, you know, many cycles. But for instance, the cholangeal patients, who we sometimes don’t get to a section, so they’re continuing on their treatment. They can sometimes get these low doses for years, so there’s no maximum treatment. It’s your liver function that tells you that. And then you said, How long was active treatment? Well, the treatment you’re doing you you’re if you don’t have resectable disease, they should be looking at your scan every two months to see if you become resectable. And if you have resectable disease, you’re getting six months of treatment afterwards, is what we call adjunct, six months. So there’s an ending to the adjuvant for the metastatic, which means it’s not resectable. You you put in, you know, you keep going with your treatment until you get to a section.

Betsy Post 44:52
So the next question is, for some of the folks with the longer term, so, you know, we’ve talked, you talked about those longer term patients. So if a patient gets a recurrent in the liver after being finished with active treatment, or might have deposits or artifacts in the abdomen, would the pump still be able to be used if the pump had already been placed?

Dr. Nancy Kemeny 45:17
Yeah, that’s a good question. So if, well, two things can happen. Let’s say you’re an adjuvant patient, and you finished your adjuvant treatment, and six months later, you have a recurrence. So it depends where you have the recurrence. If you have recurrence in the liver, you would you can use the pump again, if the liver functions are okay. If you have a recurrence in the lung, you can use systemic and you don’t have to go back to your pump treatment because your liver is okay. But if, if you have recurrence in lung and liver, you can do both.

Betsy Post 45:54
Great. And when active treatment with the pump therapy is finished, does the pump stay in?

Dr. Nancy Kemeny 46:03
Well, most of my patients want the pump to stay because once you remove a pump, it does not go back in. It cannot go back in, you lose that artery clutch. So most recurrences come within two years. So I definitely would not remove a pump before two years. But since some occur a little bit later, it’s not a bad idea keeping, you know, the adjuvant pumps in, you know, till maybe four years to make sure there’s no recurrence before you take it out.

Betsy Post 46:35
Okay, so what is the pump refilled with when active treatment is finished?

Dr. Nancy Kemeny 46:42
It can be refilled with a compound called glycerol, which lasts for eight weeks. So you don’t have to come every two weeks to the doctor’s office, because if you’re filling it with saline and Heparin, it has to be filled every two weeks.

Betsy Post 47:02
Okay, so if we have patients, kind of this goes to removal, but she says she is a pump patient, and approaching three years of surveillance only, the last pump treatment was in January of 21 and drives, you know, an hour every eight weeks to get the pump serviced. How does, how do the medical teams make the decision on timing and removal of the pump when no events of disease?

Dr. Nancy Kemeny 47:32
They don’t make that decision. I mean, it’s sort of them, and the patient, if the patient says, Look, I don’t want to do this drive. It’s three years, I don’t have a recurrence, you could remove it. You made it to three years, which is very good. And you may never see your recurrence, but you’re taking a small chance that if there is a recurrence, you can’t use the pump again. So you have to decide, as a patient, whether you want to do that, and how much of you know problem it is for you to make that drive.

Betsy Post 48:03
Are there other considerations or other situations for having the pump removed, such as complications?

Dr. Nancy Kemeny 48:12
Well, if you get what’s called a pump infection, unfortunately, they’re extremely rare. But if you have an infection, if it if it occurs right at the time of surgery, there’s two things that can happen. One, they just remove it and move the whole area to a higher spot and put in a new pump. Or they clean out the areas best they can give you antibiotics. So the things you have to do with an infection now it’s again, it’s very rare to have infection, because when these pumps are filled by, you know, very specialized nurses who know what they’re doing, the area is, you know, cleaned off and kept very sterile, and therefore you shouldn’t have a pump infection. But sometimes you have a pump infection from the surgery. You know, somehow the whole area got contaminated because you had a bowel surgery, somehow it got contaminated, then you have to deal with it right away.

Betsy Post 49:09
So that’s my list of questions, and I know we’re not taking live questions. There are a couple here that I think you’d be okay to answer. One of them is, are there any contraindications for the pump if a patient doesn’t have disease outside the liver, which, I think, you know, is a good question?

Dr. Nancy Kemeny 49:31
I don’t think there’s a contraindication, if you’re talking about, for instance, if somebody who has hepatitis, you know it’s not a contraindication. You many they have made treatments for hepatitis, and if they stay on their hepatitis treatment, you can get a pump. You cannot get off your hepatitis treatment because you can have problems. We have one case like that with a severe problem. So you stay on your hepatitis medicine, you still can get a pump.

Betsy Post 50:00
And if you’re not comfortable answering this one, I’m okay with that. But someone asked, you know, for those cancer centers that are out there, such as MD Anderson, that still don’t offer the pump, do you have thoughts on that?

Dr. Nancy Kemeny 50:14
Well, recently, people from MD Anderson told me that they were going to do a pump trial. They have been very rigid about starting a pump trial for some reason, you know, a matter of fact, I get patients of them just incredible, because the patients that they want to pump and they say, we’ll go to New York, you know? So they they actually say that, but now they’ll be able to say they can go to other centers that are closer to them, okay?

Betsy Post 50:45
And then again, if you’re not comfortable answering, that’s okay, because I know we weren’t taking any really live questions, but I’m trying to just ask a little bit. Is there any documentation or evidence that you know, there could be other regimens used with the pump, other than fudr?

Dr. Nancy Kemeny 51:04
Well, in Europe, as I said, they don’t have a pump, but they have a catheter going to the liver, and they use oxaliplatin. They get some extraction. If you don’t get extraction of the drug, there’s not an advantage to using so for instance, with irinotecan another one of our good oncology drugs, there is no advantage, so it’s no point doing but oxaliplatin, there’s a slight extraction. So there there’s a little advantage. So in Europe, they’re showing advantage of doing inter hepatic, you know, like we do with the pump, but they do with the catheter into the liver. So there is, and we have done some studies on minimizing which also has some extraction in the liver. Now we haven’t tested, you know, new drugs like the EGFR receptors and those kind of things, because we needed a number of centers doing this, so we may be able to test new drugs and see what happens.

Betsy Post 52:12
Thank you so much for that. Someone’s asking, you know, with your retiring and you know, are there other, you know, oncologists at Sloan Kettering that are comfortable with the pump?

Dr. Nancy Kemeny 52:26
All the oncologists, all of them, have been trained, many of them by me, and they’re very comfortable with the pump. So there’s no problem coming to Memorial. And of course, we still have great surgeons. So those are two things going on,

Betsy Post 52:41
I think there’s only a couple more. Someone asked about using the EGFR but I think you said, of course, that you can use that with the pump.

Dr. Nancy Kemeny 52:51
You can, we have a study on that you cannot use Bevacizumab, right? So no use EGFR drugs.

Betsy Post 52:59
Yes. And one patient did say that, does a TP53 mutation make the pump, you know, and something that could not be,

Dr. Nancy Kemeny 53:10
No, it doesn’t make it. It just that, like KRAS mutation and other mutations, some patients do worse with if you have mutations. But that doesn’t mean you can’t do it. It just means that they may not do as well as a person who doesn’t have those mutations. Okay?

Betsy Post 53:31
I think this is mostly everything, except there someone was asking about a catheter related infection risk. Is that something that’s a major risk?

Dr. Nancy Kemeny 53:40
The way a catheter can get infected is if you have, like a urinary tract infection, and it’s not treated, and somehow you infect the whole body, you can infect the catheter. So when you’re on a pump, you shouldn’t get infections that are not treated, they should be treated. Now, I just want to say that there are a lot of centers out there, so you should, you know, try to find the center that’s closest to you and and go to them and talk to them about what they’re doing and what’s going on, so you don’t have to come just to Memorial.

Betsy Post 54:31
That’s an important message. So thank you for that. You know, I think, yeah, with all centers opening up, it does make it a lot more accessible. And I think, of course, as part of your legacy and a part of your work, because you trained, I think you trained all of them. So there was a comment about, do you become ineligible for clinical trials or other studies if you’ve had the pump?

Dr. Nancy Kemeny 54:56
You shouldn’t. I mean, it depends on the study. I do want to say something about spheres. You know the microspheres. I really think that the patients that are thinking about that should do the pump first. Because I really think once you’ve done the microspheres, I don’t think the pump results are as good. So you can always do the microspheres after the pump. There’s no problem. We’ve done that a lot in our institution. So and we do, what we do is we use like localized microspheres, which are much give you a much higher response and treating the whole liver. So let’s say we did the pump that we’re doing very well, but one area is growing. You could do a localized sphere there, but I would suggest not doing the spheres before the pump.

Betsy Post 55:48
Thank you for that. I guess just a question that that I have, are there any words of wisdom that you’d like to share with this, this kind of subset of patients, these liver mets patients upon your retirement, any food for thought or lessons learned about living well, or anything you’d like to share.

Dr. Nancy Kemeny 56:13
I think that the other thing you have to do as a patient is that, let’s say you doing very well from the liver and suddenly develop a lung met consider treating everything aggressively. So the lung mets can be ablated. Things can be removed, you know, just don’t continue with just chemotherapy and chemotherapy, things can be removed and ablated and dealt with to make your life longer and more comfortable.

Betsy Post 56:44
Great. And is that a conversation you feel like the patient should have with their oncologist, and bring it up if the oncologist is not okay?

Dr. Nancy Kemeny 56:53
Yes. So I have a patient in the south, you know, started the pump treatment there, and they’re doing very well. Lived, sorry. Then she developed lug mets, and so then the surgeon there had to send her to me, because the people down there weren’t really going to treat the lug mets aggressively, you know.

Betsy Post 57:17
Think that’s such an important message. It’s definitely something we try in COLONTOWN, you know, get the second opinion, the third opinion, and, you know, advocate for yourself and ask the questions. And, you know, don’t be afraid. So it’s great to hear that from you that the patients are not being seen as, you know, problematic if they’re trying to advocate for themselves. Yeah, and we did have a comment just to say, thank you so much for persisting in the face of bias from your own colleagues and paving this path that patients truly appreciate. So there’s so much appreciation and admiration and respect for you and our community. I know that I speak for all of us when I say that, so we are just so thankful for this talk. I know that many people will watch the recording, you know, in the future, so you’re going to help a lot of patients, just from just from this. So I hope I didn’t miss anything. But the comments are coming in just saying how grateful we are for her, what a rock star you are all of those things, and I know that that’s all true, so I hope I didn’t miss anything that was too I tried to ask everything that we had, you know, done in advance, so hopefully I did get to all of that.

Dr. Nancy Kemeny 58:35
Well. Thank thank you again for doing all the work you’ve done. Thank you to all my patients.

Betsy Post 58:42
I know you’ve got quite a few of them in here tonight that are here to support you, so there’s no doubt about that. Thank you so much. We really appreciate you once again, and we’ll be in touch. Thanks for everyone attending. Also. We appreciate all of you for being here for Dr Kemeny and and to to hear all about the pump.