Women with Early Breast Cancer May Not Benefit from Chemotherapy

New findings from a groundbreaking Trial Assigning Individualized Options for Treatment (Rx), or TAILORx trial, show no benefit from chemotherapy for 70 percent of women with the most common type of breast cancer.

Dean Tsarwhas, MD, Medical Director, North Region, Cancer Services, Northwestern Memorial Healthcare, joins the podcast to explain these findings and to let women know that this could help identify women with a low risk of recurrence who could be spared chemotherapy.
Women with Early Breast Cancer May Not Benefit from Chemotherapy
Dean Tsarwhas, MD
Dean Tsarwhas, MD is the Medical Director, North Region, Cancer Services, Northwestern Memorial Healthcare.

Learn more about Dean Tsarwhas, MD

Melanie Cole (Host): Many women with early stage breast cancer who would receive chemotherapy under current standards may not actually need it according to a major international study that's expected to quickly change medical treatment. My guest is Dr. Dean Tsarwhas. He's the Medical Director in the north region of cancer services at Northwestern Memorial Healthcare. Welcome to the show, Dr. Tsarwhas. What has been the standard of care for early stage breast cancer?

Dr. Dean Tsarwhas, MD (Guest): Thank you, pleasure to talk to you today. You know, breast cancer is I would say a multi-disciplinary disease where patients undergo surgery, sometimes chemotherapy, radiation, hormone therapy, and sometimes targeted therapy. But in terms of patients we're talking about today with this study, we're discussing patients with estrogen receptor positive, lymph node negative, and HER2 negative breast cancer. And for those patients, the standard was hormone therapy, which means blocking estrogen, or chemotherapy. And this study we're discussing helps to determine what the optimal treatment is for patients.

Melanie: The findings of this study are being hailed as great news for breast cancer patients, Doctor. So tell us what's significant about the findings, and what's different now. Tell us a little bit about this clinical trial.

Dr. Tsarwhas: So this clinical trial looked at over 10,000 patients with breast cancer, and they followed these patients over nine years, and looked at patients that had estrogen receptor positive breast cancer, negative axillary nodes, and they had a what's called HER2 negative breast cancer. In these patients, we as oncologists didn't know which was the optimal treatment. Should these patients after surgery receive hormone blocking therapy? Should they receive chemotherapy or a combination? And oftentimes back in the early days we would err on the side of giving chemotherapy. This study helped us determine what the best treatment was and then to administer chemotherapy to those patients who need it and to avoid chemotherapy for those who don't need it.

Melanie: Doctor, as women are told when they get that horrible diagnosis of breast cancer, they're told to make sure that they find out what type of breast cancer that they have and to be informed. Would you reiterate for us please what kinds of breast cancer that we're talking about?

Dr. Tsarwhas: So again, in this study, it looked at patients that had estrogen receptor positive breast cancer - that's an important fact to know - that had where the cancer had not spread to the lymph nodes, and had a marker called HER2/neu, and they were negative for this marker. This is the study population that was looked at, and in these patients who overall have a good prognosis, there still is a risk of recurrence. The study looked at also using a test called an Oncotype DX Recurrence Score that is a genetic test looking at- that helps us determine prognosis of these patients. By using this test we're able to better tailor our treatment, whether it's to administer chemotherapy, or hormone therapy, or a combination.

Melanie: Is the Oncotype Breast Recurrence Score tested- is that routine to be administered to all breast cancer patients?

Dr. Tsarwhas: Well this test is looked at in patients that have estrogen receptor positive breast cancer and who are patients that do not have axillary lymph node involvement, although there are studies looking at this test for patients that do have axillary lymph node involvement. But it's an important test that we as oncologists use in helping making the determination for what the best treatment is after surgery.

Melanie: Doctor, how many women might be affected? Is this a very common type of breast cancer?

Dr. Tsarwhas: So first of all, breast cancer is the most common cancer in women in the US and worldwide, and this has implications for tens or hundreds of thousands of patients over the years in terms of how we treat breast cancer.

Melanie: Wow, I mean it really is an incredible study. Tell us a little bit- I mean the study is amazing for women to think about, but what are some of the side effects of chemotherapy that thousands of women may now be spared of thanks to this research?

Dr. Tsarwhas: Right. So chemotherapy is chemical therapy given by the vein or by mouth, and oftentimes these drugs have side effects on other parts of the body. For example, there can be hair loss, nausea or vomiting, risk of infection, sometimes there can be neuropathy or numbness that can be long-lasting. Also there can be early menopause that can result from chemotherapy.

So of course we want to use chemotherapy for those who will benefit, but we want to spare chemotherapy for those who we know that it won't help, and that's what this study helped to determine.

Melanie: So tell us about what this means for women after surgery. Is radiation still part of the standard course?

Dr. Tsarwhas: So this study did not involve radiation. Radiation is standard for patients who undergo a lumpectomy or some patients who undergo a mastectomy. This study looked more at the role of hormone therapy or endocrine therapy as well as chemotherapy, but it did not involve radiation therapy.

Melanie: So now come to the emotional and mental part of this for women. Breast cancer is such an emotional type of cancer. Without chemo, which seems to be something that a lot of women, Doctor, think, "Okay this is going to really help get rid of it." As much as they're scared of chemo, do you feel or do you find that women will worry now about recurrence if they don't get chemo? Are they going to sit there and wonder all the time?

Dr. Tsarwhas: That's a great question. There's no question that patients want to do what's best for them to live as long as possible, to prevent cancer from coming back, and many people think that means that they must receive chemotherapy. This study can reassure patients that when tens of thousands of patients were looked at and followed, they found that by giving chemotherapy versus giving hormone therapy, there wasn't an advantage of giving chemotherapy in those patients. So they can be reassured that not undergoing chemotherapy, to get a standard hormone blocking therapy, they can do just as well without the side effects of chemotherapy, and that is huge for the patient's emotional well-being.

Melanie: Certainly it is, and thank you so much for clearing that up for us. So help us better understand the significance of the study results, Doctor, as you wrap this up. How much does this change things for physicians, for you, and for their patients? Do you think it's going to change the standard of care now?

Dr. Tsarwhas: Well I think it's definitely changed the standard of care in that I would say that this study was practiced changing. We never knew what to do with patients who had what's called an intermediate score on the Oncotype test. Those patients who had a score between eleven and twenty-five. Those with a score under eleven we knew that they did very well and didn't need chemotherapy, and those patients did well with just hormone blocking therapy. Those who had a score of twenty-six and above, we knew there was a chemotherapy benefit. What oncologists didn't know was that in that mid-range score between eleven and twenty-five, whether to give chemotherapy and hormone therapy or hormone therapy alone. And this study can reassure us in those patients that there was no advantage of having chemotherapy, but of hormone therapy.

The only sub-group there was a difference however in women who were under the age of fifty, there was some small benefit of chemotherapy for scores between sixteen and twenty-five. And the younger population there was a benefit of adding chemotherapy in that mid-range score. But for most patients with the mid-range score, they can do well without the use of chemotherapy.

Melanie: Are there any questions, Doctor, to end this really fascinating segment that you would like patients to ask you? If they come to you and they've got these types, these parameters, this type of breast cancer, what questions would you like them to ask you? Or what information would you like them to have?

Dr. Tsarwhas: Well first of all, they should ask, "Is my cancer appropriate to have the Oncotype DX test performed?" And they should have that done if they're under the age of seventy-five, if they have a lymph node negative breast cancer, and if they're at risk of recurrence. So number one, should they have the test done? Number two, once that test is done to go over the results with their doctor, and discuss the implications. Because this is one of the first times where genomic or genetic testing on tumor has made a big difference in the outcome in how we treat breast cancer.

Melanie: Thank you so much for being with us today, for sharing your expertise, and for explaining so well this- what could be a complicated study, but you've made it so easy to understand, and so important for women and their loved ones to understand and those questions to ask their physician. Thank you so much again for joining us. You're listening to Northwestern Medicine PodTalk. For more information on the latest advances in medicine, please visit www.NM.org/podcasts. That's www.NM.org/podcasts. I'm Melanie Cole, thanks so much for listening.