Highlights from the 2020 San Antonio Breast Cancer Symposium

Some women with cancer in up to three lymph nodes can use the Oncotype DX test to help decide treatment, a new chemotherapy pill, and new findings on CDK 4/6 inhibitors for early-stage breast cancer were some of the notable headlines from this year’s San Antonio Breast Cancer Symposium. The annual conference, like many events this year, was held on an all-virtual platform. While we missed the opportunity to join in-person with researchers and advocates from around the world in Texas, the virtual science program delivered important and exciting news in breast cancer research. Catch up with the rest of our coverage.

Living Beyond Breast Cancer CEO Jean A. Sachs, MSS, MLSP, spoke with Virginia Kaklamani, MD, DSc, professor of medicine at the University of Texas Health Sciences Center, about the major findings presented at SABCS and what they mean for you. Topics discussed include

• the RxPONDER trial in early-stage, hormone-receptor positive breast cancer
• the CONTESSA trial of tesetaxel in metastatic breast cancer
• new data on sacituzumab govitecan (Trodelvy) for metastatic, triple-negative breast cancer
• discussion of two trials looking at CDK 4/6 inhibitors for early-stage, hormone receptor-positive breast cancer.

Virginia Kaklamani, MD, DSc
Virginia Kaklamani, MD, DSc, is professor of medicine in the division of hematology/oncology at the University of Texas Health Sciences Center in San Antonio and is the leader of the breast cancer program at the Mays Cancer Center. Read more.

 

Jean A. Sachs, MSS, MLSP

Chief Executive Officer, Living Beyond Breast Cancer

Jean began her work with LBBC in 1996 when she became the organization’s first executive director; she was named CEO in 2008. Jean brings a lifetime of women’s advocacy experience to her role as CEO. She lives LBBC’s mission everyday by speaking with newly diagnosed women about their needs and gaps in support. Read more.

Jean Sachs:

Hi, everybody. It's Jean Sachs. I'm the CEO of Living Beyond Breast Cancer. Today we will be talking about the 2020 San Antonio Breast Cancer Symposium. This is really the big meeting for anybody and everyone who is interested in scientific advancements in breast cancer. And of course this year it was done virtually, and it’s really important that it still happened, but sad for all the advocates that weren't able to be together and connect.

I’m really hoping next year, things will be different. But today, we're very fortunate to have with us, Dr. Virginia Kaklamani. She is one of the co-directors of the Symposium and a professor of medicine in the division of hematology/oncology at the University of Texas Health Science Center. She is the leader of the breast cancer program at the Cancer Therapy and Research Center. Welcome, and thank you so much for joining us.

Virginia Kaklamani:

Thank you for having me, Jean.

Jean Sachs:

We really appreciate it. I know you had a long week. From what I know, you're probably still reading through lots of studies, so we won't take too much of your time. If we could jump right in and get your take: What was the big news coming out of this meeting? What were the important studies that our community needs to know about?

Virginia Kaklamani:

I think one of the most important studies that were presented was the RxPONDER trial. This is a trial looking at women with early-stage, estrogen receptor-positive breast cancer who had one to three positive lymph nodes. That trial tried to see whether there's a subset of these women that we can safely avoid chemotherapy with. The answer is, "Yes, we can." They ran the test called Oncotype DX, which is a genomic test. They found that women who are postmenopausal, whose Oncotype DX score is anywhere between 0 and 25, do not get a benefit from the addition of chemotherapy.

Interestingly, in our premenopausal women, there actually was a benefit to chemotherapy. That's very important, because that was probably surprising to most of us. The goal of the study was to show that chemotherapy doesn't benefit either the premenopausal or the postmenopausal women. I think one of the thoughts is that chemotherapy in this younger patient population puts them into menopause. And putting them into menopause decreases the amount of estrogen that they have. This by itself decreases the risk of recurrence. So, whether it's a chemotherapy effect, whether it's a menopause effect, nobody knows. We can't tell from this study. The end results for somebody going to clinic on Monday morning is that these women that are premenopausal will benefit from chemotherapy, but the postmenopausal women will not.

Jean Sachs:

That is so interesting, the way you just explained that. I was going to ask you specifically about the premenopausal women, who, of course, will have to continue having chemotherapy. So, you think part of it might be just the impact of the chemotherapy in shutting down their ovaries?

Virginia Kaklamani:

Europeans have been thinking that for a very long time. We've tried to do studies. We actually did some studies in the late '90s in the United States and the studies, the way they were designed, did not have the perfect arms. The goal of any study is to try to recruit patients. You have to have the physicians comfortable with the study. You have to have the patients comfortable with the study. It was very hard to randomize women to chemotherapy versus no chemotherapy at that time. So the perfect study was never done. I don't even know if it's going to be done. But the end result is that some of us feel that it's a chemotherapy effect. Some of us feel that it's a menopause effect. Until we know for sure, I think most of us will be compelled to give women chemotherapy. But I bet you it's us shutting down the ovaries with the chemotherapy that's really doing it.

Jean Sachs:

That's very interesting and we'll keep following that. What about the CDK4/6 inhibitors? I know there were two different studies on that new drug.

Virginia Kaklamani:

The CDK4/6 inhibitors, as you know, have revolutionized our treatment in metastatic, estrogen receptor-positive breast cancer. They've improved survival by quite a bit. They're drugs that we now use as standard of care.

These are the first studies that have looked at early-stage breast cancer to try to avoid metastatic disease altogether. One of the studies, called the monarchE trial, was positive, showed that abemaciclib, which is one of the CDK4/6 inhibitors, improved outcomes. Another study, which was the PENELOPE-B study, and which was a much smaller trial, did not show a benefit.

These drugs seem to be beneficial for very high-risk women. I don't want people coming out and saying, "Oh my God, I have a one-centimeter tumor, negative lymph nodes. I should be on a CDK4/6 inhibitor." Because the answer is, "No." But for women who have multiple positive lymph nodes, larger tumors, these drugs may be effective.

It's still a little early to tell. If you look at the lengths that these studies went on for, that we have results for so far, we're talking about a couple of years. As you know, ER-positive disease can recur 5, 10, 15 years later. Having data for a couple of years is probably not enough, but it definitely is an early sign. We'll see what the FDA thinks of the data when they look at it to see whether these drugs will be approved in the early-stage setting. But definitely something that I think has a role in treatment of ER-positive, early-stage breast cancer.

Jean Sachs:

Well, it's exciting to see this new type of treatment moving into the early-stage setting. We know it's been in the metastatic setting for a while. I know there was some new information about pregnancy after breast cancer. You want to share a little bit about that?

Virginia Kaklamani:

That was a meta-analysis. We've had now a lot of studies. Obviously it's very hard to do the perfect study – take half of the women and tell them to get pregnant, and the other half and tell them not to get pregnant.

All the data that we have is from analyses on women who have had breast cancer and have tried to get pregnant. Some of them have, and some of them have not. There's a lot of biases going in. The bottom line is, it seems to be safe for women to get pregnant after breast cancer. But it's definitely not easy.

The drugs that we use, as far as chemotherapies, can damage the ovaries and cause a lot of fertility issues, which is why it's so important for women to try to have some sort of fertility consultation before they start chemotherapy. The notion of, "Oh my God, am I going to delay my treatment?" That's OK. The treatments will be delayed by maybe a couple of weeks. The whole point of trying to have some fertility preservation is extremely important for those patients.

Jean Sachs:

So here we go again, it's good to have chemotherapy, because it damages your ovaries, but then it makes it harder for you to get pregnant. So important to have that consult with a good reproductive endocrinologist. Living Beyond Breast Cancer has a lot of resources on that. For anyone who needs it, please come to our website, lbbc.org.

Moving to a different area, there was a study that found symptoms were under-recognized during radiation treatment, and that doctors were reporting conflicting accounts about people making their appointments, especially with younger people and people of color. If you could share what that was about.

Virginia Kaklamani:

That was worrisome. In up to 30 percent of cases, there was a difference between what the patients reported as symptoms and what the physicians reported as symptoms. It seems like we're not paying as much attention to our patients as we should. Radiation causes side effects. If we're not recognizing those side effects, that's a major issue.

It's also important to counsel our patients ahead of time as to what to expect. So that women go into it, knowing that, yes, they will have some pain. Yes, they will have some discoloration on their skin and some burning and some swelling. This is just part of the radiation course. Once the expectations are understood, it's easier for them to go through the treatment. It's easier for them to understand what their side effects are, understand this is not foreign. They're not the only ones experiencing these side effects. Again, the communication between the physician and the patient needs to be better.

Jean Sachs:

We certainly hear from a lot of women how fatiguing radiation can be, having to go 5 days a week, usually following chemotherapy or surgery. I think they're sort of told just push through it. I thought this was really interesting. We need to make sure patients really share what they're experiencing with doctors.

Can we move into the metastatic setting? What were your big takeaways for the metastatic community?

Virginia Kaklamani:

A couple of very new exciting drugs would be my takeaways. One is an oral taxane called tesetaxel. That was from a clinical trial called the CONTESSA trial. As you can see in oncology, we're moving more and more toward oral medications. This has some good things and some bad things to it. The tesetaxel seemed to improve outcomes when you combine it with capecitabine, which is another oral drug that we have.

This is the first study. This is a registrational trial. The FDA will look at the data. I think it's very likely that they will approve the medication, but this is just the first step to using tesetaxel in a metastatic setting, and then in the early-stage setting as well. Fewer toxicities, less neuropathy, very little alopecia, which is extremely important. Women won't lose their hair. Actually, a small number of women lost their hair. Again, very promising for metastatic. This was ER-positive, but there's trials ongoing for ER-negative breast cancers as well. I'm sure HER2-positive will be coming soon as well.

Jean Sachs:

Great. Anything for triple-negative?

Virginia Kaklamani:

For the triple-negatives, the ASCENT trial looked at an antibody-drug conjugate called sacituzumab govitecan.  It's also called Trodelvy. It showed a doubling of overall survival. These triple-negative breast cancer patients, who had already been in at least two other treatments for metastatic disease, when they were on Trodelvy they lived for 12 months versus  months if they received our standard of care chemotherapy, which was actually a very good chemotherapy.

This drug is already approved, but it was conditionally approved based on the results of this trial. The FDA will look at this data, as well. I'm sure they will continue the approval of the drug. And, because it's an antibody-drug conjugate, it's a little more targeted. Not as many side effects, which again is so important for our patients.

Jean Sachs:

I think this move to more of the oral chemotherapy, particularly while we're dealing with COVID, I think has been a good thing as long as there's compliance. Fewer trips to the hospital.

Virginia Kaklamani:

You pointed out one of the issues with oral chemotherapy: compliance. When you get IV drugs, the patient and the physicians know that they get it because they come to clinic, they get the infusion, and then they go home. With the oral medications, are they getting it correctly? Are they're taking it with, or without, food? Are they throwing it up because it causes nausea? Did they even pick it up? Did the specialty pharmacy send it to them? When did they start taking it? How much is the copay?

All of these things are extremely important with the oral medications that don't really exist as much with the IV medications. Our patients need to be very aware of that need to go on the company websites and get the patient assistance information. All of these companies have really good patient assistance information that the patients need to go and check out.

Jean Sachs:

I agree. It's complicated. But definitely a direction that is hopeful to be moving in. I want to end asking you about immunotherapy. I know the breast cancer community has been waiting to see if immunotherapy is going to be effective. What did we learn?

Virginia Kaklamani:

Immunotherapy is effective, but it's effective in a certain kind of breast cancer patient. In the metastatic setting, we have now three different large clinical trials in triple-negative breast cancer. It seems that a subset of triple-negative breast cancer that has what we call immunogenic tumors, so tumors that immunotherapy can target, those tumors get a benefit from immunotherapy in combination with chemotherapy.

But it also seems that immunotherapy is beneficial in the early-stage setting. In patients with, again, triple-negative breast cancers that have pretty large tumors, where you give it in combination with chemotherapy, especially prior to surgery, they can improve our outcomes. I think it’s very important for our patients to know that these studies have already finished. We have two drugs approved in breast cancer now. The second one approved about 2 or 3 weeks ago, and there's a lot more to come.

Jean Sachs:

That is exciting. All of these studies, if you go on to lbbc.org, you can read a little bit more about them. Is there anything I missed, anything else you want to add?

Virginia Kaklamani:

I think the one thing that we have not discussed and which is so important for our patients, is the use of opioids. There was a study looking at women having mastectomies and potentially reconstruction, and how many of these women were converted into chronic opioid users because of these surgeries. It showed that 13 percent of these women were becoming new chronic opioid users. This is very important. This is a failure of our system in many ways.

These women are having surgery. Some of those surgeries are not completely medically necessary. Maybe they're not being told ahead of time what the risks are. Maybe they have some preconceived idea that this is exactly what they need to do, and they go and have these surgeries done. Then, the other failure of our system is, we're not able to help these women get over the symptoms by offering them non-pharmacologic treatment.

The easy thing is, "Oh, here's a prescription for Norco. Here's a prescription for morphine." Then when the woman comes back and says, "I'm still having pain." "Well, here's your refill. Here's another refill." Next thing you know, the woman's addicted. Most of the women that this happened to were younger women. Women that have Medicaid. Women that were also getting chemotherapy. Women that had breast cancer, because that study included women that were having these procedures for a variety of reasons, not just breast cancer.

Our patients are high risk for becoming addicts, and we are the ones responsible for that. Our system really needs to be geared toward this and make sure that we counsel our patients and we also offer them other strategies to help with their pain.

Jean Sachs:

I did hear some conversation about that and it was really shocking. As an advocacy group we will think about what we can do. We really do try to help women make the best informed decision and sometimes more isn't better. But, I think it is often hard for people to understand, "Wouldn't I want to do the most to prevent?" That surgery is a big deal. It's not a little thing.

Virginia Kaklamani:

Those surgeries are big surgeries. Reconstruction could be a 5- or 6-hour operation.

Jean Sachs:

We will certainly do what we can, and if you have any ideas to share, but that's just so distressing, because we already know the opioid problem in this country alone is completely out of control.

Virginia Kaklamani:

It is.

Jean A. Sachs, MSS, MSLP:

Thank you for bringing that to our attention. I want to thank you so much, Dr. Kaklamani, for your time and for all you do all year long for the breast cancer community and for the Symposium, which, for all the advocates, is really such an amazing opportunity. I've been going to those meetings for so many years. I remember when they were very small and now you go and there's just so many advocates that are integrated in, along with the international scientific community. Do you think we'll be able to be together next year? Can I ask?

Virginia Kaklamani:

I think so. We're starting our vaccination this week. I just had to sign up for it, which is exciting.

I think it'll be a combination honestly, of a live and a virtual meeting, because some people may not be able to come. It's, as you mentioned, so important for this data to be shared all over the world.

Jean Sachs:

You and all of your colleagues are so generous with their time and sharing their information with the advocate community. We really can't thank you enough.

Virginia Kaklamani:

Thank you.

Jean Sachs:

Thank you for spending time with us. Remember, everybody go to lbbc.org. We have more information on all these studies and we will be continuing to follow the trials and provide regular updates. If you're in need of support, remember we have a Helpline, as well as closed Facebook communities. All you have to do is log on, send an email, and we will join you to those communities so you can connect directly with other women who are in a similar situation. Take care, be well, and stay safe.