Alejandra Perez, MD, specialty in medical oncology, breast cancer prevention and treatment, Medical Director of the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center in Plantation, Florida, talks about the TAILORx study; a practice-changing study involving breast cancer patient treatment options.
Interview conducted by Ivanhoe Broadcast News in November 2018.
You have been seeing a lot of patients for a very long number of years. The TAILORx study; tell us what it is and why it is so exciting.
Dr. Perez: TAILORx study is one of the most important studies presented in the last number of years. It really changed the way we practice; it is what we call a practice changing study. TAILORx is a study that is looking at a very specific population of breast cancer patients. They have early stage breast cancer, hormone receptor positive, Her2 negative and they have no lymph node involvement. With those patients the question was always do they need chemotherapy or not. That is a question that we had for many years; many of those patients got chemo because we did not know if they really benefitted from chemotherapy and we had to do it just in case. It was a just in case approach. TAILORx study looked at this patient population and they did an Oncotype Dx on the tumor to look at twenty-one genes. Based on those twenty-one genes they tell you what your recurrence score is. Based on that recurrence score you are assigned to one of three categories; low risk, intermediate risk, or high risk. If your recurrence score was zero to ten that was a very low risk. Those patients were treated with hormonal therapy because we knew from prior studies that those patients did well with hormonal therapy alone. The patients that had a recurrence score of twenty-six or higher, were treated with chemotherapy because those patients were in the high-risk group and they benefited from chemotherapy. For the group in the middle, which was the majority of patients, we didn’t know if they needed chemotherapy so those patients with a recurrence score from eleven to twenty five, were randomized to two groups. One group was treated with hormonal therapy plus chemotherapy and the other group was treated with just hormonal therapy. The purpose of the study was to see if hormonal therapy was enough, if it was not inferior to hormonal therapy and chemotherapy. They enrolled about ten thousand women so it’s one of the largest studies ever conducted in breast cancer. In that intermediate group, we had more than six thousand women. The study was done all over the world, the US was the main country but there were other countries around the world. In the intermediate risk group, about six thousand women, we found out with that there was no difference. We looked at survival, we looked at how many patients had cancer, what we call invasive BC-free survival and it was identical for both groups. This study told us that this group of patients really did not benefit from chemotherapy, with very few exceptions. The exception to the rule is the premenopausal patients. They are very young patients, premenopausal, that have an intermediate risk score but on the high end, meaning sixteen or higher. For those patients we have a very individualized discussion with them to then decide if they need chemotherapy. For most patients in the intermediate risk category, recurrence score eleven to twenty-five, they did not need chemotherapy. That means that in seventy percent of women with breast cancer and these characteristics, we can avoid chemotherapy. That is a big number and has a very positive impact in so many ways including quality of life and cost to the healthcare system. In many ways, it is a very important study.
When you say seventy percent you mean seventy percent of women diagnosed with breast cancer around the world?
Dr. Perez: Yes, seventy percent of women with this type of tumor, estrogen positive, Her2 negative, early stage breast cancer so it is not every patient diagnosed with breast cancer. There are some breast cancers that because of the biology and the characteristics of the tumor, they need chemotherapy and we do not even do an Oncotype Dx. However, for this group of patients, seventy percent of women can avoid chemotherapy.
Which is a huge difference for many patients because chemotherapy, if you don’t mind go over some of the side effects of chemo and what a lot of patients do have to go through.
Dr. Perez: Chemotherapy is devastating to many women. We have made many improvements with administration of chemotherapy and I have to say that most of my patients go to work every day, they take care of their kids, and they go on. Women are tough so they do what we have to do but it is devastating. These are women that already went through surgery to remove part of their body, a breast, maybe both, it changes everything in you. Then with chemotherapy you lose your hair, you have dry skin, you have nausea, vomiting, you do not feel good; your immune system goes down. There are many things that interfere with your quality of life, with family, with jobs, with everything. Therefore, if you do not need chemotherapy, that is the best news we can give to a patient and we love giving that type of news. Because as oncologists we know that chemotherapy is not the best way of treating cancer, we are all actively looking at ways of eliminating chemotherapy for good. A lot of the research is really concentrating on targeted therapies and how can we just develop something better. However, chemotherapy still plays a very important role in cancer treatment and we use it every day, but hopefully one day we are going to be able to say chemo is something of the past.
And when you talk about hormonal therapy, these women that did not need the chemo are given hormonal therapy and what would that be in the form of infusion, would it be pills, how does that work?
Dr. Perez: Yes. Hormonal therapy may be a term that is a little bit misleading because it is not hormonal therapy, its anti-estrogen therapy, it is the opposite. Therefore, with hormonal therapy, yes, they do have side effects, but it does not compare to chemotherapy, it is more tolerable. It is a pill that you are going to take for five to ten years. We have studies looking at ten years of therapy. It is an easier treatment and yes there are side effects as well but nothing compares to the side effects of chemotherapy.
This is a ten-year study sponsored by the National Cancer Institute, there was no difference is what you are saying in the result of treatment for the women who have both chemo and hormonal therapy and then the women who just had hormonal therapy?
Dr. Perez: So the groups were identical, the women treated with hormonal therapy and the women treated with both chemotherapy and hormonal therapy had the same outcomes. We looked at survival; overall survival was ninety eight percent for both groups. One was ninety-eight percent the other one was ninety eight point one percent so no difference. When you look at their endpoint, which was invasive disease survival, it was also very similar. They looked at five years initially and now we have data with up to nine years and we see identical numbers, there was no difference. It is now very easy for us to sit down with a patient, we have this discussion one on one and say okay, these are your numbers and this is what TAILORx study shows, patients that are in this category that have these numbers that you have they do not benefit from chemotherapy. A low risk of recurrence, it does not mean no recurrence, there is always a risk of having a recurrence, but it is very low for those women. It is very low, look at the survival rate it is ninety-eight percent so we are talking two percent risk of recurrence.
Again, this is not for all women diagnosed with breast cancer this is for, go over the criteria one more time and then there are many cases in advanced stages that chemo is very important.
Dr. Perez: Right. In America, we diagnose two hundred and fifty thousand women with breast cancer every year. There are very different types of cancer so this study only applies for the patients that have early stage breast cancer, meaning that the cancer did not spread to the lymph nodes, early breast cancer, hormonal receptor positive and Her2 negative. Those are the main criteria, so these really apply to you. We have other studies that are looking at other types of women, women with positive lymph nodes but this particular study TAILORX just looked at that specific population.
So the study is complete, the results of the study we now know and this is what doctors and clinicians are implementing?
Dr. Perez: Yes, it is practice changing. Of course, we are going to be following those patients forever, we are going to have long-term data, but the study is completed and this is something that we use now in clinic every day and our patients are benefitting from it enormously.
How do your patients respond to the news?
Dr. Perez: They are thrilled, the other day I saw a young woman that came and they were having bets, the whole family, and everybody had a number in mind and who is going to win the bet. You know everybody’s strength, coping in different ways and when you say here are your numbers, you do not need chemo, that is all they need to hear.
And moms with work and kids not to have to go that stress with chemo it is such a huge difference. What do you want to say women in general about getting checked, getting screened, how important it is if you get breast cancer to catch it early. And should we still be doing our self-exams in your experience and what do you want to say to the women out there?
Dr. Perez: Women we need to take control of our health. If we do not do it, nobody else is going to do it. The key to a cure is early detection; there is no question there. That mammogram once a year is extremely important. Seeing your doctor, having a breast exam, paying attention to any symptom, any finding, anything that you think is abnormal just bring it to the attention of your physician, because if we find it early we can cure it. When we find it very late, those women can live for many years because of the advancements that we have had in breast cancer but it is not the same. If we want to cure, it we need to find it early and the gold standard continues to be a mammogram, so that is the best thing you can do.
Anything else you would like to add? Do you have a website?
Dr. Perez: Yes, the one thing we did not talk about, there is a subset of women in this study that are very young, the premenopausal women. Those women we have to really look at differently because some of them could benefit from chemotherapy. It is usually the patients that fall in that category, the intermediate risk with recurrence score of sixteen or higher. If you are premenopausal, it is very important that you discuss it with your doctor because some women can benefit from chemotherapy.
If you are premenopausal, your tumor can be more aggressive right?
Dr. Perez: Young women always have more aggressive tumors. So if you’re premenopausal and you recurrence score is more than twenty-five you’re going to get chemotherapy but if it is sixteen to twenty-five, some patients in that group can benefit from chemotherapy. That is the group of patients that we have to look at it in a different way and really sit down with them and just do a case-by-case approach.
The test that you mentioned, Oncotype Dx, are doctors doing this with tumors, is that automatic or do you have to ask for it?
Dr. Perez: It is not automatic you have to ask for it. It is very important that doctors know this information. I hope they do already because this information was presented at the recent American Society of Clinical Oncology meeting, which is the most important meeting in the world for oncologists. It was presented there so I hope that everybody has access to this information and they are using it every day. This is a game changer.
It is really taking a biopsy of the tumor and having this test done to see what the genetic makeup is?
Dr. Perez: These women went through surgery already so we have their tumors. They had a lumpectomy or mastectomy and we already have their tissue. We keep those tumors for years so yes we send that tumor, the patient does not have to do anything. They do the Oncotype Dx and they give us back the results.
So ask for it if your doctor didn’t say anything about it you have to mention it. You think most doctors are going to know?
Dr. Perez: I hope so.
It’s going out nationally?
Dr. Perez: Women are in control and women know before they come to you, they have been on the internet for a long time and they come with questions. I’m seeing a new patient next week, and I already got a message from her, please ask the doctor is she is going to order an Oncotype Dx for me, I don’t even know what the case is and she wants to know. Therefore, that shows you that if the doctor does not know about it the patient most likely is going to tell them, please order an Oncotype for me.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Diana Gonzalez, PR Sylvester Comprehensive Cancer Ctr
305-243-8219
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