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State of the Union: The Changing Decisions in Breast Care

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Roshni Rao, MD, Chief of the Division of Breast Surgery at Columbia, discusses advances in breast cancer surgery, individualized screening, emerging therapies, and the decisions shaping breast care today.

Surgical Advances and Shifting Standards

Looking back over the past year, what feels like the most significant change in breast cancer care?

One of the biggest changes is that we're now applying the findings from the SOUND and INSEMA trials in clinical practice.

Those trials looked at patients who have tumors that are less than two centimeters, that are estrogen and progesterone receptor-positive and HER2-negative, and whose lymph nodes look clear on an axillary ultrasound. For those select patients, we're just not doing a sentinel node biopsy at all. We're not doing any surgical axillary staging.

That's exciting because traditionally we've always thought, oh, we have to remove at least one or two lymph nodes to sort out whether they have cancer or not. But we're using other ways to determine whether patients with these small tumors need chemotherapy. And we've realized that, for this select patient population, removing lymph nodes just isn't necessary.

We had talked about those studies before, but now they've gotten into clinical practice. We've actually applied the findings in our own setting at Columbia.

Who qualifies for this approach, and how did you determine which patients could safely avoid lymph node removal?

The patients definitely have to have tumors that are less than two centimeters, so they can't be big tumors. They have to be postmenopausal. The studies didn't include premenopausal patients in the populations we're applying these findings to, so we really can't extend those recommendations to them. And you have to do an axillary ultrasound.

This is where the whole concept of providing multidisciplinary care is important, because not everyone routinely does axillary ultrasound. That's been a change in our protocol.

When these studies came out, that's one of the nice things at Columbia. We got together with our medical oncology colleagues, our radiation oncology colleagues, and radiology, and sorted out, okay, how do we do this properly? What's everyone comfortable with? And we made our own tweaks to it.

Can you give some examples of those tweaks?

Yes, for example, in one of the studies, the minimum age for inclusion was 50. But if you look at the patients who were actually studied, the median age was 63. So the overall feeling was, okay, it's great that the eligibility criteria started at 50, but we don't feel this is appropriate for patients who are that young.

Our medical oncology colleagues, including Dr. Dawn Hershman, didn't feel comfortable applying the results to those younger patients because that wasn't really the age of the patients studied. 

So we carefully looked at the data as a group and decided where we felt it was appropriate to omit the sentinel node biopsy and where we didn't. And now we're applying that approach to patients being treated at our center. There are pending studies that could potentially shift that age. That's the next thing to figure out. But right now, we didn't think it was appropriate.

Does avoiding lymph node removal change other aspects of treatment?

Yes, and that's the important thing. There are different ways we give radiation. We can give whole-breast radiation, or we can give more focused, partial-breast radiation. If you don't do a sentinel node biopsy, then you can't necessarily offer that focused radiation.

The overall thinking from the study was that if the lymph nodes were negative on ultrasound, and we knew those patients were going to get whole-breast radiation, the radiation might take care of a few cancer cells that were in the lymph nodes.

But if you're considering partial-breast radiation, then you have to have a conversation. Are you better off doing a sentinel node biopsy, proving that it's negative, and then allowing the patient to have partial-breast radiation? Or should you omit the sentinel node biopsy, knowing that the patient may then have more limited radiation options?

It's becoming much more nuanced and complicated. Not removing the lymph node affects the choices and treatments further down the line. 

Shared decision-making is critical because you don't want to skip the sentinel node biopsy and then have the patient visit with a radiation oncologist and find out that, because of that decision, they're limited to a different radiation schedule. They should have that conversation with the radiation team beforehand, or with their surgeon, to sort out which approach they want.

Determining Who Needs Less Treatment

Are there other areas where you're working to reduce treatment without compromising outcomes?

There's an interesting study we're involved in now called DCISionRT. It's something we're doing in conjunction with our radiation oncology team, specifically for patients with stage 0 breast cancer, or ductal carcinoma in situ.

What we used to do was that whenever we performed a lumpectomy for these patients, we would follow it with radiation. But there have been studies showing that, for select populations who are treated with a lumpectomy and have good margins, they may not need radiation at all.

The problem was that we had no way of figuring out who did and didn't need it. So we were essentially radiating everyone. What we're looking at now is the genomic analysis of the DCIS to help sort out whether those patients really need radiation.

We can send patients to radiation oncology, where they run this analysis. It helps determine whether you're at high risk of having a recurrence if you don't receive radiation, or whether your risk is low enough that radiation may not be necessary.

We're doing that with Dr. Eileen Connolly, our radiation oncologist. It's another study we've been participating in, and we're applying the approach to some extent for patients who are particularly interested in omitting radiation.

Earlier Detection and Individualized Screening

We're also seeing advances in breast cancer detection, including contrast-enhanced mammography. How are these tools changing the way you think about screening?

Being able to bring contrast-enhanced mammography to Columbia has been very exciting because it gives us something that seems to be better than just doing regular mammograms for certain patients.

Mammograms are the best screening tests we have, but there's always been this overall sense that there should be something better, right? We've been looking for that over the years.

We've tried MRI, but it's very sensitive, and we end up getting a lot of false positives. We find a lot of things that end up being nothing. And ultrasound is very labor-intensive and hasn't been a particularly good additional screening test. So we've been trying to sort out what's the best way to do this.

Who is a good candidate for contrast-enhanced mammography?

Contrast-enhanced mammography is helpful particularly for patients who have dense breast tissue. It allows us to sort out what's going on in areas where the breast tissue overlaps and makes things harder to see.

Let's say your lifetime risk of breast cancer is 17%. You're above average risk, but you're not necessarily high risk enough to qualify for MRI, and you have dense breast tissue. What do we do with you now? That's where contrast-enhanced mammography may be helpful.

Before, we were mostly adding ultrasound for patients who needed something beyond a regular mammogram. But we didn't have great options. Now we have another option for what I would call the "tweeners," right? Patients who are between average and high risk, or patients who can't get an MRI because they're too claustrophobic or whatever it is.

It allows us to do what we call enhanced surveillance. More screening than just a regular mammogram, but not an MRI.


The Benefits of Contrast-Enhanced Mammography


Do you think screening will become increasingly personalized to a woman's individual risk?

I think that's where we're going to go, because risk assessment and screening are becoming so complicated. It's not just one-size-fits-all anymore. It's not just come in and get your mammogram once a year. We really have to have a conversation, and there are probably going to be more options going forward.

There are some interesting studies looking at CT scans specifically for breast cancer. They're not there yet, but there's also the WISDOM trial, which has published some preliminary results. That trial is trying to sort out an individual patient's risk and then really personalize their screening.

Because does every woman over the age of 50 have to have a mammogram every single year? Probably not, but we just don't know who does and doesn't.

Understanding High Breast Cancer Risk

Columbia has a high-risk breast cancer program. What does it mean to be considered high risk, and how do you make that determination?

There are several things we use to sort out whether someone's high risk. We have different calculators that allow us to calculate someone's risk, and a lifetime risk of 20% or higher is generally considered high risk.

The other thing is family history. If your mother and sister had breast cancer, for example, you're at high risk. If you have one of the genetic mutations associated with breast cancer, you're at high risk.

There are other circumstances, too. If you had radiation to the chest wall when you were a child, you could potentially be at high risk. But the three most common reasons are high risk by calculation, a strong family history, or a genetic mutation.

For someone identified as high risk, what happens next? How do you decide what kind of screening or preventive care they need?

If you're high risk, you qualify for enhanced surveillance. And that's true even if you don't have a family history. If we calculate that you're at high risk, then that's what we would offer.

There are also medications such as tamoxifen that we can potentially use for risk reduction. But it's a complicated discussion, right? It's not something you can just sort out quickly.

Our appointments, especially for new patients, tend to be longer because we really do sit down and discuss all of this with them. One of the nice things is that we now have a nurse practitioner at each of our sites: Herbert Irving Pavillion, The One, Hudson Valley, and NYP Westchester.

They're breast specialists embedded in our department. They're not surgeons, but if patients have a question about what their actual risk is or what they need to do to figure that out, they can make an appointment with them.

We use different risk models depending on the patient's particular factors, and then we can really drill down into what their risks are. And then we can sort out with them what their goals are for screening, right? Some patients come in and say, "I'm a bit of a minimalist. I want to do only what's absolutely necessary."

And some patients, for whatever personal reason, have a lot of concerns and anxiety about breast cancer. They find it more comforting to come in every six months for some sort of screening or assessment, or even just an exam.

So our nurse practitioners can sit down with patients and discuss not only what they're eligible for, whether that's mammography, ultrasound, contrast-enhanced mammography, or MRI, but also what their goals are for screening.

That sounds like a tremendous amount of information for patients to navigate, particularly if they're learning about their risk for the first time.

It can be overwhelming. Sometimes I have patients who come in because they had a cyst identified on their mammogram or ultrasound. The cyst is totally fine, but we're asking questions and finding things that suggest the patient may be at higher risk.

Their OB-GYN or primary care doctor may have referred them to us to ascertain their risk. We do that assessment and find out they're high risk, and that may never have crossed their mind.

For those patients, the amount of information can be overwhelming. You almost have to have them come back once they've had a chance to digest it so you can talk again. 

I always tell someone when we're discussing their high risk for the first time, "You don't have to make any decisions today. This is just our first chance to talk about this." Then we'll have them come back and talk about what makes the most sense for them.

I also encourage patients coming in for a new patient appointment to bring someone else with them, whether that's a friend, a significant other, or whoever it is. It's always helpful to have another set of eyes and ears to hear what's being said or take notes for you.

Breast Cancer in Younger Women

We're seeing more breast cancer in younger women. Has that been reflected in your patient population, and what does it mean for treatment decisions?

Yes, that is definitely occurring. My colleagues Dr. Reyes and Dr. Wiechmann and I looked at our own population of younger patients to sort out what surgeries they were having and whether more surgery was beneficial.

And we found that wasn't necessarily the case. As long as they don't have a genetic mutation that changes that recommendation, they can still undergo breast conservation. We're definitely seeing younger women. There has been a rise in the incidence of breast cancer in younger women, and by younger, we mean under the age of 40.

How does treating someone at that age change the conversation, especially around fertility preservation and long-term quality of life?

Certainly, you want to make sure they don't have a genetic mutation, because if they do, then we usually recommend more aggressive surgeries to reduce their future risk. But if they don't have a genetic mutation, then a lot of the treatment is similar. It depends on the receptors, the aggressiveness of the cancer, the lymph nodes, and those types of things.

There is an additional layer of discussion involving fertility preservation. A lot of the chemotherapeutics and medications we use put women into menopause. And we know that can be problematic at a very young age. It can be problematic for bone health, and cardiac issues later in life are impacted when we put women into menopause.

So there are other conversations we have to have to sort out not only what we're going to do for the breast cancer today, but what we're going to do to make sure you're still active and able at the age of 80, right?

Lymphedema, Recovery, and Long-Term Care

We've talked about minimizing lymph node removal and reducing the risk of lymphedema. For patients who do develop lymphedema, what does good care look like today?

The good news is that the best way to avoid lymphedema is by not doing axillary surgery. So we're doing more and more of that. We're doing a lot fewer complete axillary lymph node dissections than we ever have before. 

I used to do axillary dissections almost every other week, and now I can go months without doing one. And that's not just me. It's an international trend. We've really gotten away from doing these procedures as frequently, which is great for patients. But there is a subset of patients for whom we absolutely still have to do them.

One of the things our plastic surgeons offer is lymphaticovenular anastomosis. They take the lymphatics that drain the arm and connect them to little blood vessels. And they can do that at the same time we're performing the axillary lymph node dissection.

The results are mixed. There are some studies showing that it's effective and others suggesting it may not be effective in the long term. The durability isn't entirely clear. So once patients develop lymphedema, a lot of the treatment is still focused on managing symptoms.

We use lymphedema sleeves. We use pneumatic devices that patients can wear at home, including at night, to help move that fluid out. We offer surgical approaches, but if those aren't successful, treatment is generally focused on symptom management.

Breast cancer often involves years of follow-up. How does Columbia support patients over the long term?

For the surgical team, we generally follow patients for up to five years. We don't necessarily follow them beyond that because many times their medical oncologist or radiation oncologist is still following them. And they can always come back to us if they have an issue.

I think the exciting thing is that you can go to any breast cancer walk or race, and there are so many breast cancer survivors. People are doing fine. They're getting to a point where they're getting beyond it and moving on with their lives.

And that's excellent for younger patients, obviously, as well. They get to a point where this is no longer front and center in their lives.

For patients who are high risk, we generally try to have them followed in our high-risk clinics, which are run through our nurse practitioners. They've termed what they do the Breast Health Network because they're not just looking at surgery. They're looking at breast health overall.

They can follow patients at any of our different sites, and our medical oncology team also has a high-risk program. So we're trying to get those patients into the high-risk programs, which is where they belong. They don't have to see a surgeon, which is a good thing.

New Surgical Techniques and Emerging Therapies

Columbia recently began offering robotic nipple-sparing mastectomy. What excites you about this approach, and where do you see its potential?

I'm really excited about it. Dr. Wiechmann has led that initiative, and she and Dr. Johnson are going to be leading the charge. Then they'll get the rest of us trained. I've been wanting to use that robot for years.

There do seem to be benefits. We're able to hide the incision in a place that we often can't if we're doing the procedure open. And there are several studies suggesting that sensation is better preserved for patients. The visualization is so much better, too. To do a proper mastectomy, you have to get all the way up to the clavicle. Trying to remove all that breast tissue through small incisions is tougher.

And we think part of why sensation may be better preserved is that, when we're trying to reach those areas during an open procedure, we're having to put a lot of tension and torque on the skin flaps. With the robot, you don't have to do that as much because you're not trying to get your whole hand in there. You're using these little instruments.

Not everyone is a candidate for it, but I think it's a huge advance. Right now, robotic surgery is a little slower. There's more involved in getting the robot set up and docked. But the robots are only going to get better, right? They're going to get smarter.

I think there's also a misperception among the public that the robot is doing the whole operation. We're still guiding it. It's still our hands guiding those instruments and the cautery. It's not like we sit back and let the robot do its thing.

It's almost like we should call it augmented surgeon surgery rather than robotic surgery, because it's augmenting what I can do.


Five Questions About Robotic Nipple-Sparing Mastectomy


What new research is particularly exciting to you right now?

One thing is the I-SPY trial. We've been participating in I-SPY for years, and there have been a lot of exciting things that have come out of it. One that's starting to come along now for larger tumors is intratumoral injection. It's using the whole concept of immunotherapy and trying to get your body to fight the tumor cells. There's an arm of I-SPY that should be opening soon, looking at these injections.

The idea of being able to inject directly into the tumor is fascinating to me. It's almost like a vaccine, if you will, trying to get the body to recognize and attack the cancer. Years ago, before I was even in practice, there was this thought of whether you could inject chemotherapy directly into a tumor. But they found that it didn't work.

Now they're taking a different approach to how they're creating these medications. They're much more complicated. They're specially formulated to get into the cancer cells and essentially force those cells to break apart. Then the immune system picks up on those dying cells and says, okay, we need to start attacking that.

So what we're injecting isn't just chemotherapy. These are very complicated antibody-based molecules that have been developed for intratumoral injection. It's a research study, but I think it'll be very interesting when that study opens.

Could that eventually lead to treatments developed for an individual patient's tumor?

Yes, exactly. I think not only for the tumor type, but at some point for the individual.

You could potentially take a little piece of the tumor and say, okay, this is how we're going to train your body to attack this particular tumor. We've created this molecule specifically for you, and that's what we're going to inject. That's where I think things could eventually go.


Advancing Breast Cancer Treatment: Dr. Roshni Rao on the Latest Breakthroughs from the I-SPY Trial


How might increasingly personalized treatments change the timing of surgery?

It's going to make operating room scheduling much more complicated!

Even with I-SPY, they're doing these adaptive trials where they give systemic therapy, chemotherapy or an antibody they think should work, and then they look at the MRI response. If the MRI shows that the tumor has completely responded, then you take the patient to surgery. If the MRI shows it hasn't responded, then you go to the next chemotherapy agent or the next more aggressive treatment.

It's this idea of giving just what you need to make the tumor go away and then surgically removing at least part of it. I think that's where we're going for tumors that need systemic therapy.

For smaller tumors and early-stage cancers, I think we're still going to be doing surgery first. I don't think every patient is going to receive systemic treatment before surgery. But for a lot of patients, I think that's going to be the approach: treat to response and then do the surgery.

Could this approach also apply to patients whose cancer has returned?

Recurrence is a little different, right? Because to some extent, the tumor is already telling you, "I didn't respond. I came back."

You presumably gave it what you thought were the best treatments, and the cancer came back anyway. So recurrent cancers are generally going to be treated with more aggressive therapies.

The Future of Breast Care

Looking ahead, what do you think is one of the biggest unanswered questions in breast cancer care?

I think one of the things we still need to sort out is whether every patient who has a lumpectomy for invasive cancer needs radiation. Because I think there's a large proportion of patients who don't need radiation, but we just haven't been able to figure out who those patients are.

If we look at the NSABP B-06 trial, which was done back in the 1980s, patients underwent lumpectomy by itself, lumpectomy with radiation, or total mastectomy.

The patients who had lumpectomy without radiation had about a 40% risk of local recurrence. But this was an old trial. It was before a lot of our advanced treatments, including some of the systemic therapies we use today.

So 40% had a local recurrence, but that means 60% didn't, even in that old trial, right? We looked at the 40% recurrence rate and said, okay, that's unacceptable. Everyone needs radiation. And that was the right approach.

But the trial also tells you that there were patients who didn't have a recurrence even without radiation. How do we figure out who those patients are? 

I think it's going to have to involve genomic analysis. It's going to have to be developed in a very systematic way, just like the Oncotype score was developed to help guide chemotherapy decisions. I think we need something similar for radiation.

But that's harder because you'd have to find a trial where patients routinely didn't receive radiation, or try to develop a randomized trial. And that's very difficult today because recurrence rates are so low. So that's one of the big questions we're still trying to answer.

If there's one thing you wish more women understood about breast cancer risk and screening, what would it be?

I can't tell you how often I still see patients who are convinced that if they just wait until they feel something, it's okay. There are still a lot of misconceptions about mammography and whether it really helps.

And I think there's no doubt that mammography saves lives. There have been clearly demonstrated survival benefits to routine screening mammography. Sometimes, in all these advanced discussions, we lose that.

We're still recommending that women start mammograms at age 40 and get them every year. In my mind, that's kind of a minimum. If you want to do something different, come and visit with our Breast Health Network and sort out which route is right for you.

The other thing is family history. We had a breast cancer awareness event at Hudson Valley recently, and one of the patients there was surprised to learn that about 75% of patients diagnosed with breast cancer don't have a family history.

She was someone who had breast cancer herself, had gone through treatment, and was doing fine. But she said nobody had ever told her that. And we've known that for years.

So I think that's something women really need to understand. You don't have to have a family history to get breast cancer.

 

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