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Podcast: Do Women With Early Stage Breast Cancer Need Chemotherapy?

By on 06/14/2018
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Research suggests that many of them might not. Einstein Perspectives recently spoke with Dr. John Leighton, Division Chair of Hematology and Medical Oncology at Einstein Healthcare Network, for his interpretation.

Bill Fantini:  Women with early-stage breast cancer might not need chemotherapy, according to a new study published in the New England Journal of Medicine.

Bill Fantini: I’m Bill Fantini with Einstein Perspectives. For more on this study, we hear from Dr. John Leighton, Division Chair of Hematology and Medical Oncology at Einstein Healthcare Network. Dr. Leighton, you were at the presentation of findings from this new study about chemotherapy. What did you learn?

John Leighton, MD

John Leighton, MD

Dr. Leighton: What I learned is we have tools available to us to help women whose breast cancer that is confined to the breast and not involving their lymph nodes that if we test their tumors, we can decide which patients can have a benefit from giving chemotherapy and those who do not need chemotherapy and therefore wouldn’t be subjected to the side effects of chemotherapy.

Dr. Leighton: This test, however, called the 21-Gene Breast Cancer Assay or Oncotype DX Assay, only is used in women whose breast cancers have estrogen or progesterone receptors and don’t express a protein called HER2. Assay is a test that’s performed from the patient’s tumor where they look, in this case, they study it for 21 different genes, and these genes are felt to be predictive for a breast cancer that may or may not be more likely to return. By doing this type of testing in a lab, we receive a score that allows us to determine how aggressive the patient’s tumor is and help us guide our treatment choices. All patients who undergo this test would be recommended some form of oral hormonal therapy for at least five years as a preventative treatment.

Bill Fantini: What I was reading about, the study indicated that it’s women with early-stage breast cancer. What exactly do we mean by that?

Dr. Leighton: Early-stage breast cancer means that the tumor is confined to the breast. It has not spread to any of the lymph nodes or anywhere else in the body. In this particular situation, it meant that the tumor had to be five centimeters or smaller.

Bill Fantini: Does the age of the patient make any difference?

Dr. Leighton: The age of the patient typically does not make any difference in terms of the results of this assay, but there was one subgroup where women under the age of 50, it was suggested that there may still be a role for chemotherapy; however, one method to help protect women under the age of 50 from having their breast cancer come back is to give what’s called ovarian suppression therapy, which often is hormonal shots to stop their cycles and to put them into menopause more quickly. They did not have that data available at the presentation.

Bill Fantini: Why has chemotherapy been administered to women with early-stage breast cancer to date, and what are the drawbacks of that?

Dr. Leighton: Well, chemotherapy, for many, many years, had been shown to decrease the chance of recurrence of early-stage breast cancer, particularly in other parts of the body, and it also improves survival. It helped women live longer. The challenge that existed for years is that we had to treat many women who might not necessarily need the chemotherapy to make sure that we were treating the ones who absolutely needed it. We didn’t have any type of marker or validated test that could tell us who must get treatment.

Dr. Leighton: The 21-Gene Assay came out in the late 1990s, and it has been refined since that time as a tool to help us predict which of the women with early-stage breast cancer benefit the most from chemotherapy in terms of preventing their cancer from returning. It also prevents us from giving unnecessary chemotherapy, which can lead to side effects such as abnormal blood counts; hair loss; fatigue; rarely, heart damage; or extremely rarely, acute leukemia. Many women will have other side effects from chemotherapy, such as going into premature menopause or also experiencing some changes in how they think or how they feel their mental abilities are. These are all potential side effects. There is clear benefits to chemotherapy in the right people, but we want to avoid over-treating those who don’t need it.

Bill Fantini: It sounds like this is something of a game-changer.

Dr. Leighton: I think it is quite significant. The main thrust of this study is that this test predicts three groups. There’s a very low risk group who has a very good prognosis who does not need chemotherapy at all and would be treated with the oral hormone therapy. There’s a group that is considered at higher risk of recurrence for which there is a clear benefit to chemotherapy in helping to prevent the cancer from coming back and helping women live longer, but 70 percent of the women in the study were in what’s called the intermediate risk group. This is the largest group and also the group for which we really didn’t know what the best treatment was. This study suggests that for these women who have what’s called endocrine receptor-positive breast cancer, clean lymph nodes, and a tumor under five centimeters for the intermediate risk group just like the low risk group, giving oral hormone therapy after surgery, and if they have radiation, is as effective as adding chemotherapy to that hormone therapy.

Bill Fantini: Is this research continuing?

Dr. Leighton: There are trials like this that have been performed in the lymph node positive group, meaning that the tumor spread to the lymph nodes underneath the arm. That study has completed accrual, but we don’t have any data yet. I think that’s the next set of data that we’re looking forward to, to see if the benefits from personalized treatment that we see with women who have normal lymph nodes can extend to those whose lymph nodes are impacted by the cancer.

Bill Fantini: What part did Einstein play in this study?

Dr. Leighton: Einstein, as we have in the past, participated in this nationwide clinical trial, and we enrolled patients on this trial that was ultimately one that will change the standard of care for our patients. This was actually an international trial as countries such as Ireland and Peru as well as Canada also enrolled patients.

Bill Fantini: As a doctor who treats women with breast cancer, what does this study mean to you personally?

Dr. Leighton: It means several things. It means that we have tools that allow us to confidently predict which women need to receive chemotherapy and those who can be treated with hormone therapy alone. It means that we can offer our patients personalized treatments appropriate to their disease and their tumor type. It tells us that we can avoid the side effects of chemotherapy for many women. I think this is quite important because although we as oncologists are used to dealing with these side effects and know how to manage them, they can still be difficult on patients either in the short term or in the long term.

Bill Fantini: I’m guessing that the possibility of treating without chemotherapy makes your conversation a little easier with those particular patients.

Dr. Leighton: I would tend to agree. I think many patents that we’ve seen, and we’ve had this discussion within our group, when they’ve had these intermediate scores, their preference oftentimes is not to receive chemotherapy when there’s a choice. The challenge, before this study, is that we really didn’t know what the right approach was, and we and the patients would reach an educated mutual decision as the best course.

Dr. Leighton: Now, we have confidence in our decisions that if a woman has an intermediate score based on this gene assay of their tumor and we recommend hormone therapy alone that we’re clearly offering them the best and least toxic approach to treating their cancer.

Dr. Leighton: I think these are exciting times in the care of cancer patients. We get excited when we hear of new drugs to treat our patients. We get excited when we hear of new drugs with different ways of working, non-chemotherapeutic drugs, drugs that impact the immune system, oral drugs that target specific proteins, but it’s also exciting to find that certain patients don’t need the most aggressive treatment and that we can offer them the best treatment and avoid the side effects of chemotherapy.

Bill Fantini: That’s John Leighton, MD, Division Chair of Hematology and Medical Oncology at Einstein Healthcare Network. For Einstein Perspectives, I’m Bill Fantini. Thanks for listening.

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