Vadim Gushchim, MD, FACS, Surgical Oncologist at Mercy Medical Center, Institute for Cancer Care, specializing in treatment of gastrointestinal tumors and Melanoma/Sarcomas talks about Isolated Limb Infusion.
Interview conducted by Ivanhoe Broadcast News in September 2017.
I want to talk to you about Sarcoma in particular, for our viewers can you give me a quick overview of what Sarcoma is?
Dr. Gushchim: Sarcoma is a malignant tumor of soft tissues; it’s a pretty rare malignant tumor compared to cancers or Carcinomas as you probably heard. It arises in muscles, necro tissue, bones, and fat. It could grow on extremities, or it can grow in the body wall or retroperitoneal areas. Today, we’ll be talking about a relatively common situation when a Carcinoma grows on an extremity.
What are the treatments when you have a Carcinoma on an arm, leg, or one of the limbs?
Dr. Gushchim: Historically, we’re talking about the 1970’s; the only treatment for those tumors was surgical amputation. In the past, we would amputate the leg. No leg means no problem, right? But in clinical trials, my surgical colleagues showed treating carcinomas with surgery and radiation in different sequences, radiation first, then surgery, or surgery first; then radiation achieves the same goal as far as the recurrence and survival of patients. Since probably mid-1980’s, surgeons stopped performing amputations in these quantities switching to organ-preserving or limb-preserving surgeries. We don’t amputate extremities for carcinoma but achieve the same results.
In advanced cases does it sometime become necessary to amputate the limb?
Dr. Gushchim: Unfortunately, you’re quite correct. I had several patients in whom amputation was the only choice. It’s a very painful conversation; it’s a life-changing event. Patients had to cope not only with the disease itself but with the loss of an extremity, which is quite difficult.
Tell me a little bit about ILI, what it stands for and what it means in terms of treatment.
Dr. Gushchim: Isolated limb infusion or ILI is a minimally invasive way to deliver chemotherapy to an extremity, to an isolated extremity. It’s a minimally-invasive cousin of isolated limb perfusion where you have to make an incision on the extremity, dig out the vessels with the cannulas connected; it’s a big production. Isolated limb infusion is achieved with small catheters, similar to cardiac catheterization. It’s usually done through a small needle stab in the groin to get into the vessel, and we thread the catheters through the aorta on the other side of different places and place them exactly where we need to deliver chemotherapy. Then we put a tourniquet just above the tips of the catheter. It isolates the extremity from the rest of the circulation, so very toxic drugs do not get into the system through the circulation. The concentration of drugs that we use is so high that it could eventually kill the patient. We can’t afford the risk of incidentally spreading the drugs to the rest of the body. The stakes are high for this procedure, but again, it’s minimally invasive, and it can get us out of pretty difficult clinical situations like with Melanomas or Sarcomas.
This treatment obviously would not be for every patient, for whom would you consider this treatment?
Dr. Gushchim: Well most commonly, this treatment is used to treat patients with melanoma. In the United States, that’s what it is approved for. In Europe, isolated perfusion techniques are more commonly used in Sarcomas. For different reasons, we don’t have the drug in the United States that they use in Europe. It’s less popular here for Sarcomas. Among the centers who do isolated limb infusion; there is some movement in trying to expand the same success as we have with Melanoma to patients with difficult cases of Sarcoma. For example, in recurrent Sarcoma, radiation is not possible anymore because you can’t repeat radiation with the same dose at the same place. I ended up doing this isolated limb infusions in difficult cases where radiation could not be done. It’s mostly recurrent Sarcomas of the extremity. Another important point, it needs to be on the extremities, to isolate this piece of the body from the rest of the body.
Because you’re applying a tourniquet to the limb, it can’t be for a very long period of time? Can you give me some specifics as to how many times you do the infusion and for how long you have the tourniquet applied?
Dr. Gushchin: You can’t keep the tourniquet longer than two hours. Otherwise, the muscle and other tissues will die off. We connect the catheters to the perfusion machine, so it continuously runs the drug through a warmer. The drug cannot get colder than our body temperature; otherwise, it loses its efficacy. We do the perfusion itself for thirty minutes. It’s a one time, thirty-minute continuous perfusion exposure of the drug.
So it cannot be repeated?
Dr. Gushchin: It can be repeated. For example, if a tumor grows back in like three, six, twelve, or whatever months, you can do it again. I have done it twice.
How frequently do you do this procedure, is this limited to the surgeons who really have the expertise? At just a few centers across the county?
Dr. Gushchin: Correct. It’s not a very common procedure, not because it’s super complicated, but because there are very few surgeons that are trained this way. Also, Melanoma or Sarcomas are rare tumors to begin with, and we’re sub-selecting patients. It’s seldom to find a patient who needs this procedure. Also, not many oncologists think about this procedure. For example, my colleagues who are aware of this option, they frequently send the patient to me. Therefore, we do two to six procedures a year [here at Mercy Hospital].
What are the risks of doing this procedure?
Dr. Gushchin: The main risk is losing muscle of the extremity. The chemotherapy and interrupted blood flow are both risk factors for muscle dying off. That’s the main risk. The muscle may react with pretty intense inflammation about two to three days after the procedure. Patients feel great the first day, they walk, they have no problem then the extremity swells up, and that’s when they’re hospitalized for five to six “boring days.” During those days, we monitor their chemical levels, CPK an enzyme that muscles produce, that shows the muscle damage. So that’s the main risk. Sometimes, the inflammation is too severe, and the swelling of the muscle is so pronounced we need to do an additional procedure called fasciotomy to relieve the pressure. It’s not a pleasant occurrence, but that’s what we’re looking for. Furthermore, the loss of muscles can causes walking difficulties or difficulty in using the arms, if we’re talking about the arm.
Can you talk to me about Krissy, about her situation?
Dr. Gushchin: She is quite special because I never performed this procedure on a pregnant patient. The reason radiation was not possible in her case was that the patient refused radiation. It was, some would say, an irrational fear but if the patient refuses, you can’t do too much. I certainly understand her position, too. My colleague reached out to me, asking if I would consider this procedure in a pregnant patient and I didn’t know how to answer. I had never done it before and never thought about doing it. I decided to reach out to the inventor of the method John Thompson, from Sydney, Australia and he provided me with some calculations about the blood level expected from the drug and the isolated limb infusion. It was very encouraging, and I presented this case to the patient’s obstetrician and the patient, and we reached the consensus that it’s a reasonable risk to take. We did the procedure to shrink the tumor. It shrunk enough to be excised completely without negative margins. The purpose of the procedure was to allow margin-free resection of the sarcoma. I believe that amputation was avoided.
Had she decided to wait until after the pregnancy was completed would she have been risking her life in not getting treated?
Dr. Gushchin: It’s a difficult question to answer. I was led to believe that the tumor, the Sarcoma, started growing very fast with the pregnancy. Antidotal, it happened, and I thought that if we delayed a little bit more, I’m not sure about her life, but we definitely wouldn’t have saved the extremity for sure. Maybe I would have saved the life too, but I’m kind of cautious on this.
But definitely the limb?
Dr. Gushchin: Definitely.
How long have you been doing the ILI here?
Dr. Gushchin: Since I started, eleven years ago.
Two to six patients, is obviously not very frequently. Are you doing a little bit more, are you seeing more?
Dr. Gushchin: The most common indication is Melanoma. Five years ago, a bunch of new drugs were approved for advanced Melanoma, and as a result, I saw a slowdown in referrals. It’s not a rational decision that doctors are making regarding not referring patients for isolated limb infusion. I as well as my other colleagues at the conferences, still think that there’s a place for isolated limb infusion in modern time, even when other drugs are available. There is still a benefit to it. However, most doctors either don’t think about it at all, or it’s not the first thing that pops in their head. When somebody thinks about how to treat patients with advanced Melanoma, they think about immunotherapy.
Is there anything I didn’t ask you that you would want people to know about this?
Dr. Gushchin: I would say that as far as surgery is concerned, it’s a very boring procedure. I usually say that the reason surgeons are doing this is that everybody is afraid of the level of perfectionism required for this type of procedure. The catheters need to be positioned perfectly, the drug should be perfectly heated, and the tourniquet should be perfectly placed. If something goes wrong, there is a very high price to pay. We can’t undo something. As a surgeon, it’s very disappointing that the surgery does not require you to do anything. We are just orchestrating the events. But it is very important to take charge in this situation because so many things can go wrong and we need to anticipate every event. On the one hand, I’m a little bit disappointed that we’re doing less of them; but on the other hand, it’s an emotionally challenging procedure. But we don’t have to do anything with our hands, so maybe it’s not that bad.
END OF INTERVIEW
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