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Join Steven L. Chen, a breast surgeon, as we delve into the advancements in breast cancer treatments and the challenges of managing breast cancer-related lymphedema (BCRL). As survival rates improve, the focus is shifting to addressing the long-term side effects, particularly lymphedema, which significantly impacts patients’ quality of life. Steven will discuss the difficulties in early detection, innovative technologies like bioimpedance spectroscopy (BIS), the importance of patient education, and personalized exercise programs. We’ll explore the financial burden of BCRL, the effectiveness of compression garments, and advanced imaging techniques for early diagnosis.

Steven L. Chen is a breast surgeon.

He discussed the KevinMD article, “Navigating the challenges of breast cancer-related lymphedema.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast, and get CME for this episode by clicking on the CME link in the show notes. Today we welcome Steven L. Chen. He’s a surgical oncologist. Today’s KevinMD article is “Navigating the challenges of breast cancer-related lymphedema.” Steven, welcome to the show.

Steven L. Chen: Thanks, thanks for having me. I’m excited to be here with you.

Kevin Pho: So let’s start by briefly sharing your story and journey.

Steven L. Chen: So I’m the son of an immigrant surgeon, so I think perhaps surgery was in my blood. I went to the University of Michigan, Go Blue, for all my schooling and training for general surgery and critical care, and then went on to the John Wayne Cancer Institute in Santa Monica for my surgical oncology fellowship.

I started in academics and then went to private practice, and really have focused on finding ways to change medicine, and I guess really the world, for patients for the better. I started in health policy and then health services research, and now in product development.

Really been inspired over the years by role models that I’ve had, such as Dr. Bartlett at the University of Michigan, who invented both, at the high-tech side ECMO, but at the low-tech side incentive spirometry, both of which have literally saved thousands of lives if not tens of thousands. And then Dr. Don Morton and Armando Giuliano at the John Wayne, who invented the sentinel node procedure, which has prevented a huge number of people from getting lymphedema by reducing the number of lymph nodes routinely taken during cancer surgery.

Thus, I’ve always loved how research impacts people, and that’s how I jumped at the chance to develop products that I really thought would change people’s lives. I worked for a while on a product to help try to reduce the number of positive margins people had while they’re getting cancer surgery, and now working on this, which is the SOZO product, which helps to detect early lymphedema so that people can be treated early enough to prevent chronic lymphedema. All the while I still have my own private practice, still taking care of patients.

Kevin Pho: So talk about that blend. You are working with industry, you still see patients, you still have a private practice. So talk about those different hats that you wear as a physician.

Steven L. Chen: Yeah, so I think, and I actually said this, I was president of the American Society of Breast Surgeons some years ago, I said this as part of my presidential address. I think it’s really important for clinicians and doctors to be involved with people who develop products, whether they’re drugs or devices.

Because how many times have we sat there in the doctors’ lounge and complained, this thing doesn’t do what we want it to do, or, you know, if they had only asked me I would have told them that that side effect was a deal breaker, I’m never going to prescribe that. Well, they asked us, we just chose not to tell them.

When I was in academics people were like, ah, you know, I don’t know if you work with industry. And I said, I want the best products for my patients, and I want them to do the right things. So yeah, if someone asked me, I’m going to sit down and give them my advice. And as I gave them more advice, people said, hey, would you help us with developing it? And over the years developed some of those skills.

I did go back in residency for my health services research, and an MBA, and I think that helped people to see me as a credible source. And so now for the past ten years I balanced both, having my own practice, which I left academics to start, with developing these products that I think will change how we take care of patients.

Kevin Pho: Now for those physicians who are listening to you, who may be interested in that intersection between clinical medicine and industry and want to dip their toes into industry, what would you say is the single biggest piece of advice that you could share with doctors?

Steven L. Chen: I think the biggest thing is to be honest with them. I think a lot of people feel like, wow, if I don’t tell them what I think they want to hear, they’re not going to want to work with me. But if anything, companies, they want to make the best thing possible, because the best thing possible sells the best, right? And so if you tell them that you need to do this, they want to hear it.

I remember telling someone, you know, this surgical device doesn’t fit in my hand. And you saw their eyes just get huge, and said, is that a problem? I said, look, I can’t close the device. And they said, oh my God, well that’s a problem. And they called the engineer right from my OR, where they were showing me this prototype, to tell them, hey, I got a guy here who says he can’t fit it in his hand. Well, you meet with them, and I think we need to be honest with our feedback, and then they’ll be honest with us about what they’re working on.

Kevin Pho: All right, let’s talk about your KevinMD article, “Navigating the challenges of breast cancer-related lymphedema.” For those that didn’t get a chance to read your article, tell us what it’s about.

Steven L. Chen: Yeah, so basically what it is, is trying to really talk about, now as we’ve gotten better at treating patients for medical cures, we have to talk about survivorship. And I tell people, once I know you’re going to survive, the last thing that we need to figure out is how you’re going to thrive after your cancer is no longer your first problem that you wake up to every morning. And one of those things in cancer surgery is lymphedema.

And so I think one of the things that people don’t really think about is most doctors are pretty fatalistic. They think lymphedema happens to people, and if anything maybe it’s my fault because I took out too many lymph nodes or whatnot, but at the end of the day they think that it can’t be changed.

And what I learned from the ImpediMed folks who developed this SOZO device is, if you detect lymphedema early and you get them to treatment early, they don’t progress to chronic lymphedema, or they progress less. Not never, but they progress less.

And in what other disease have we thought to ourselves, oh, we need to prove to ourselves that early detection is important? Early detection is important everywhere, and early treatment is better every time, right? We haven’t come across a disease yet that we said, wow, yeah, treating that early, you know, who cares, right? This is another example of this.

So having a device that says I can find lymphedema early enough that if I put you into compression early you won’t get chronic lymphedema of the type that you learned about in medical school, where people have weeping wounds and things like that. I think that was the genesis of writing this article, was taking people along the same journey I had when I was thinking about lymphedema, where I went from having my surgical mentors tell me if I do these surgeries in a different way I can give you less lymphedema, to the next step of saying, even those people are still at risk, how can I give them even less lymphedema?

Kevin Pho: Now to get everyone on the same page, give us a 30-second primer of what lymphedema is, how it affects patients, and especially as it relates to breast cancer surgery.

Steven L. Chen: Yeah, so lymphedema is basically the pooling of lymphatic fluid, and the backup of lymph fluid into typically here a limb, although in theory you could get lymphedema anywhere, head and neck, chest wall, whatnot. But probably the biggest area that we talk about lymphedema is after lymph node surgery or radiation to a lymph node bed, and breast cancer being one of the top cancers in the world and in this country.

Historically we used to take out all the lymph nodes, axillary lymph node dissection. Now we do a sentinel node, but a lot of people still get lymphedema. And so by detecting that early, we hope to be able to get people into compression, which helps them to actually resolve their lymphedema and keep it away.

The biggest problems that people have, they range from very subtle things like just heaviness, their rings don’t fit, all the way to, I can’t button buttons, my wounds weep, I can’t heal little cuts. And then even at the most extreme areas you can actually develop cancer and things like that in lymphatic channels.

Kevin Pho: All right, so tell us about some of the challenges when it comes to early detection of breast cancer-related lymphedema.

Steven L. Chen: So I think the biggest challenge is a lot of people don’t want to talk about it. They almost feel like, if I talk about it patients will complain about it. Well, they might not complain to you, but they complain to their friends about it, about how their arm feels heavy.

And also detecting it presymptomatically. But the problem is, detecting it presymptomatically involves, right, if you don’t have a SOZO device, involves things like taking a tape measure and measuring it accurately each time, or getting a dunk tank and dunking their arm in it to measure changes in volume. Those are both pretty time consuming, inconvenient, and with the tape measure it’s somewhat difficult to replicate. If you do it three times in a row you’re not going to get the same number.

Whereas a SOZO device is a bioimpedance device that passes an electrical current through you, and it measures different types of fluid, like extracellular and intracellular fluid, and muscle mass and fat mass. And so it can tell you if one arm is bigger than the other, or one leg is bigger than the other. And by doing that you can say, aha, the arm that I’m concerned about is getting bigger over time and it’s bigger than the unaffected arm, this is probably early stage lymphedema, let’s get them into treatment.

And having that reproducible number really helps both the compliance for the patients, but also it helps clinicians, because it’s a quick, easy, reproducible way to measure people over time.

Kevin Pho: Now the device itself, how non-invasive is it?

Steven L. Chen: It’s completely non-invasive. You basically take off your socks and shoes, you stand on a set of electrodes, then you put your hands on the other set of electrodes, and it passes the current through you. No needles, no injections. The most invasive thing is you’ve got to take off your shoes in public, which you know is a barrier for some people obviously, but pretty minor barrier I’d say.

Kevin Pho: And then once you detect early lymphedema, what options do we have with treating that? Is it purely compression?

Steven L. Chen: So the first step is obviously compression, wearing a sleeve, wearing a glove for four weeks, and that’s all that we did in the clinical trial. Beyond that you have things like decongestive therapy, where people do massage or they have machines that give you decongestive therapy. And also never underestimate the value of exercise, physical therapy, and occupational therapy. It’d be completely remiss to not talk about those things are helpful. So many patients who are at risk of lymphedema are worried that exercise is going to make it worse. If anything, exercise probably makes it better.

Kevin Pho: So tell us a success story where a patient underwent breast cancer surgery, used this device that you’re talking about, early detection of lymphedema, and had a positive outcome that moved the needle because of it.

Steven L. Chen: We have so many of them, including people who have seen their lymphedema get reversed even when they had early stage lymphedema. But so many people who they talk about things like improved peace of mind, of knowing that they aren’t developing lymphedema. So that’s the early wins, right.

The next ones are women who have their lymphedema picked up early and get into compression, and their numbers actually come back down, and we see that a lot.

And then finally the people who they stop their chronic lymphedema in its tracks. In our clinical trial we saw a roughly two-thirds reduction between the group that was using a tape measure for detecting lymphedema versus the people who use the bioimpedance device to detect lymphedema. And when you compare those groups you had a two-thirds reduction roughly of progression of chronic lymphedema. And so we know that this can happen.

And you know, it’s hard to beat a randomized study. Obviously stories are amazing, but for clinicians data is everything, and I tell people, how often do you get a randomized study on something like this? So I always refer to those. And also not to mention the cost of treating lymphedema. A lot of lymphedema therapy hasn’t been well covered by insurance, and so people are paying out of pocket, and the cost even for insurers is maybe $15,000 to $20,000 over two years to treat someone who has lymphedema. So it’s worth it for everyone, both patients, doctors, and insurers.

Kevin Pho: And once someone is diagnosed with cancer-related lymphedema, is it something that’s lifelong? Do they just have to manage it with long-term compression, or is it something that could really be stopped in its tracks?

Steven L. Chen: Yeah, so in our clinical trial we actually just recommended that they do four weeks of compression, just four weeks, and if their numbers improved or stabilized they didn’t have to do any more compression.

Once you have chronic lymphedema though, you’re looking at lifelong compression. You’re going to wear that sleeve as much as you can tolerate for as long as you can tolerate. And things like this, where we’re currently in a massive heat wave, wearing a sleeve is incredibly uncomfortable and my patients just don’t want to do it, right? And it’s understandable.

But if you show them, hey, there’s this number that shows that you have lymphedema, they will do it, because they know it’s worthwhile. It’s like knowing your cholesterol versus having an actual heart attack, right? And someone says you had a heart attack, you say, wow, I’m going to change my diet. Yeah, you should have improved your diet just because, and you haven’t even checked your cholesterol. Let’s be real, most people don’t change their diet. We’d like to think they will, but I think all of us know that they don’t.

Kevin Pho: So tell us what the current standard of care is. What’s the penetrance of this device, and what do breast cancer surgeons normally do? Do they normally screen for early lymphedema?

Steven L. Chen: So ideally the answer to that would be yes, they would normally screen. But I would say that the most common thing that people do is probably don’t ask about it, or they wait for a patient to complain about it, or maybe they ask how’s your arm doing, and if the patient says oh it seems fine, they don’t get beyond that.

And while every breast surgeon knows that lymphedema can happen, I don’t think it’s been integrated well into our workflow of saying this is something that we should do all the time. And I think part of that is because of how difficult it is. And having a device like this makes it just more straightforward, because your medical assistant can do this, as opposed to you sitting there with tape measures yourself.

Kevin Pho: And is something like this covered by Medicare and private insurers?

Steven L. Chen: So Medicare covers it, and a number of private insurers do, but not all private insurers do yet. And this has actually been somewhat of a struggle. This has actually been included in the NCCN guidelines, that you should screen for lymphedema, and that if you have a bioimpedance device available you should use the bioimpedance device to screen for lymphedema and follow for lymphedema.

And yet despite that, some insurance companies are still of the opinion, well, we don’t need to cover it, either because not enough people are asking for it, or they say, well, it’s still experimental. And I tell them, well, we have a randomized trial. And they said yes, but you know. And I said, it’s in the NCCN guidelines. They said yes.

And so we’ve been working with each insurer one by one, and over the last year we’ve gained a lot of coverage for a lot of patients. We have I think something like 11 or 12 states that 80 percent of patients are covered, and a number of states that is more than half. But all Medicare covers already.

Kevin Pho: We’re talking to Steven L. Chen. He’s a surgical oncologist. Today’s KevinMD article is “Navigating the challenges of breast cancer-related lymphedema.” Steven, we’ll end with some of your take-home messages that you want to leave with the KevinMD audience.

Steven L. Chen: Yeah, I think the biggest thing I would say to take home is that we need to keep listening to our patients. And as it pertains to lymphedema, now that we know a couple of things, one that there is a way to detect things early, and two that early detection changes whether they’re going to get chronic lymphedema or not, we need to all reorient ourselves, whether we’re the surgeons, the medical oncologists, the radiation oncologists, or the primary care doc who’s following them, to say, hey, what is going on with your arm, should I get you to someone who can test you, and should we get you into treatment?

I think now that we know these things, we have to stop burying our heads in the sand about lymphedema and say, lymphedema happens, it’s not anyone’s fault, but we can treat it, and by treating it we can make you better.

Kevin Pho: Steven, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Steven L. Chen: Thank you.