Research Highlights From the San Antonio Breast Cancer Symposium, December 12, 2013
Listen to the December 12 updates from the 2013 San Antonio Breast Cancer Symposium on today's podcast! In this edition, we fill you in on the latest research about Arimidex (chemical name: anastrazole) for reducing the risk of a primary breast cancer, sticking to your aromatase inhibitor regimen, strength training and aerobics for the relief of aromatase inhibitor-induced joint pain relief, and survival improvements with bisphosphonates after early breast cancer. Dr. Brian Wojciechowski discusses the latest news.
Dr. Wojo is a medical oncologist outside of Philadelphia, PA, with Crozer Health. His research has been presented at the San Antonio Breast Cancer Symposium, and he is a speaker on medical ethics and the biology of cancer. Dr. Wojo sees cancer as a scientifically complex disease with psychological, social, and spiritual dimensions.
— Last updated on March 28, 2022, 5:49 PM
Jamie DePolo: Hello, everybody. This is Jamie DePolo, I’m the senior editor at Breastcancer.org. We’re down here in San Antonio at the San Antonio Breast Cancer Symposium. I’m with Dr. Brian Wojciechowski, who is Breastcancer.org’s medical expert and adviser. We have just seen many exciting presentations at the second day of the San Antonio Breast Cancer Symposium. Brian is going to break down what we heard and saw today. There were many, many studies on aromatase inhibitors today. Aromatase inhibitors are given to postmenopausal women who've been diagnosed with hormone-receptor-positive breast cancer, so that’s specifically the group of people a lot of this research is focused on. And just so everybody knows, the aromatase inhibitors are Arimidex, and the chemical name for Arimidex is anastrazole. There’s also Aromasin, which is exemestane, and there’s Femara, which is letrozole. And I'm giving you the medical names because all three of those medicines are now generic, so you’re likely to hear about them more by their chemical name than you are by their brand name, because they’re generics now.
So the first study we heard was very, very interesting. It was looking at using Arimidex, or anastrazole, as a preventive medication for high-risk postmenopausal women. In other words, women who have gone through menopause who are at very high risk of breast cancer, but haven’t been diagnosed. Brian, are we excited about this? This is pretty interesting research, wasn’t it?
Dr. Brian Wojciechowski: Yes, I think this was a very good, very interesting study that will give us another option for preventing breast cancer in these high-risk women. This is the IBIS II trial looking at anastrazole, which is also named Arimidex. To summarize what they found, the risk of breast cancer was decreased by about 50%, so it went from 6% to 3%, for a 50% reduction. I think it’s a great option for postmenopausal women for prevention of hormone-receptor-positive breast cancer. This did not help prevent hormone-receptor-negative breast cancer. Not surprisingly.
Jamie DePolo: If I’m remembering correctly, it did also reduce the risk of DCIS, ductal carcinoma in situ, correct?
Dr. Brian Wojciechowski: Yeah, and that was by about 70%, so it was even better than for invasive cancer.
Jamie DePolo: That’s pretty great. I know people are concerned about side effects with all the aromatase inhibitors. Did they talk about side effects in this study?
Dr. Brian Wojciechowski: They sure did, and this is really important. This is a major issue. Only about 70%, 7 out of 10 women, who get started on aromatase inhibitors actually finish. When you have 3 in 10 women going off the medication within the first year, that’s a big problem, because a lot of those women will have a recurrence that otherwise would not have recurred had they stayed on the medication. The first thing we learned from this study is that women really do have a lot of side effects from the medications. In my experience, they tend to downplay them because they want to stay on therapy or they don’t want to be perceived as complaining, but the rate of side effects, in terms of aches and pains in the joints and the muscles, was pretty high, over 50%. So, a majority of women were getting these side effects. So the first thing I would say is to doctors, that we need to pay more attention and really try to tease out what’s going on with our patients who are on these therapies.
The second thing we found out from this study, which was very interesting, is that not all of the musculoskeletal aches and pains were from the medication. You see, Jamie, this study had two arms. One arm was women taking the medicine, the other arm was women taking placebo, a sugar pill. They found out that even the women who were taking the placebo, which did not contain the medication, had a very high rate of aches and pains and joint pains and things like that.
Jamie DePolo: The "placebo effect."
Dr. Brian Wojciechowski: Exactly. The placebo effect is very well known in medicine, and I think that when we go on a medication, when we start taking a medicine, we may get more aware of our body, and we may start to pick up on certain symptoms, aches and pains, and we may be more likely to attribute those to the medication more likely than if we were not on the medication. The other thing is, as we get older, aches and pains become more common. So, over time, women will naturally have more aches and pains. I think the take home message is that we’re not getting enough women through the hormone therapy, therefore we’re not saving as many lives as we should. Like I said before, doctors need to be more aware of the side effects that patients are experiencing, and we need to try to do everything we can to get our patients to stay on these therapies and get through it, because they really do save lives.
Jamie DePolo: Okay. And I remember, checking my notes here, the person who was presenting, the leader of the study, said he was surprised that they found that these women who were taking Arimidex, or anastrazole, there was a reduction in the diagnosis of other cancers. I believe it was colon cancer, or colorectal cancer, and skin cancer also were down in this group of women. So it’s kind of an added bonus, if you will, to take this preventive medication.
Dr. Brian Wojciechowski: Yeah. I was pretty excited about that result myself. That’s sort of an unplanned analysis, so it’s not the highest level of evidence. I don’t think we can 100% draw that conclusion yet, but I will say that that has been seen in other studies, and it’s definitely worth more investigation. And that’s something I’m going to be looking at in the future. That is certainly very exciting, and I’m not sure why they would help with those other cancers. Maybe those other cancers share some of the same characteristics as breast cancer. They may express hormone receptors as well, I’m not really sure, but that is very exciting. It’s something I’m going to be looking forward to, seeing final results in the future.
Jamie DePolo: Okay. So in your opinion, is this practice-changing? Do you think we’ll see a lot of doctors recommending high-risk postmenopausal women take anastrazole, or Arimidex, to reduce their risk?
Dr. Brian Wojciechowski: It’s another weapon in the arsenal. I think the biggest problem is not that we don’t have enough options, but that the women who should be on these are not. I’m not sure if the problem is that more doctors need to know about it, more patients, so that’s what we’re trying to do here is get the word out that yes, there are options for women who are at high risk for breast cancer, who have not yet been diagnosed, that they can do something to be proactive. To take these medications and decrease their risk, to cut that risk in half, which, that’s really significant. You get a lot of bang for your buck. And what this study means is that we have one more option.
Jamie DePolo: One more option. I guess I should mention that women can take Tamoxifen preventively and I believe also letrozole. Is that the other one? Femara? Or is there…
Dr. Brian Wojciechowski: The other one is exemestane, which is Aromasin. And then there's also Evista.
Jamie DePolo: Okay, Evista. So now there are four.
Dr. Brian Wojciechowski: Correct.
Jamie DePolo: And we know from other research that not as many women who would benefit from these are taking the medicines and, as you said, likely because of side effects. Which is a nice segue into our second study today, which…no this was not the HOPE study, I apologize. This study was looking at how the side effects of aromatase inhibitors were effecting how many women completed the whole 5 years of the protocol. It was, I thought, very interesting because bone and joint pain were not really the top side effects that people reported as why they stopped taking it. That’s usually what we hear about with aromatase inhibitors, bone and joint pain, but this study showed us something different.
Dr. Brian Wojciechowski: Yeah, and that surprised me, because I feel like when I meet a woman with breast cancer that I’m going to start on the AI therapy, I can almost predict who’s going to tolerate it and who’s not going to. I felt that women who've come in at baseline and have a lot of issues with arthritis or joint stiffness or musculoskeletal diseases like Parkinson’s disease, for example -- my perception is that it’s those women who are less likely to be able tolerate the drug. But what this study showed actually was that forgetfulness, trouble concentrating, poor sleep habits, and fatigue are what contributed to not being able to finish the therapy.
Jamie DePolo: Okay. The study also looked then to see how many of these women were having those issues even before they started on the aromatase inhibitor, correct?
Dr. Brian Wojciechowski: Yes.
Jamie DePolo: And that seemed to play a big role in whether the women were going to have those problems, excuse me, have those side effects after they started on the aromatase inhibitor.
Dr. Brian Wojciechowski: Yeah, those were the main factors. I think the lesson that at least I’m learning from this study is that you really have to address these things. Fatigue and poor sleep, in particular, probably plays a big impact in the sense that if you’re not sleeping well, then you’re probably not getting enough exercise, and you’re going to be more likely to experience joint and muscle pain. And that sort of ties in with the next study, as well.
Jamie DePolo: And you probably also have trouble concentrating or you forget things because you’re tired. To me anyway, it seems pretty logical that if you have been diagnosed with breast cancer, you’re probably under a lot of stress, which also contributes to all those side effects. I guess one thing I thought was interesting, and you just mentioned it too, that the presenter did, that she said, "Well maybe if we see women who are having these side effects before the aromatase inhibitor, maybe if we try and ease them even before the aromatase inhibitor is started, that may help women finish the whole 5 years of the medicine and get all the benefits from it." Which I thought was interesting because I have not heard anybody else talk about that.
Dr. Brian Wojciechowski: Yeah, and this is what’s going to change in my practice. When I meet a woman who I see is fatigued, not sleeping well, having trouble with forgetfulness and concentration, that’s going to be a red flag for me. I’m going to sit down with that woman and I’m going to say, "Look, how can we address this? This is really important that we get you back on track because if we don’t fix these things now, you’re not going to be able to finish the 5 years of treatment, and I’m going to have less of a chance to keep you cancer-free."
Jamie DePolo: Okay, and I guess what we might advise women to do, too, if you’re having those side effects after surgery and before you start any of these other aromatase inhibitors, talk to your doctor. There are things you can do to ease these, and it will help you in the long run. Don’t wait until it becomes a big problem after you start an aromatase inhibitor. Which, as you said, leads us into the next study, which is the HOPE study. These researchers were looking at exercise to reduce joint pain from aromatase inhibitors. I think this is really exciting because I’m very pro-exercise, and I love it when we can say that exercise helps relieve side effects. So, tell us what happened with this study.
Dr. Brian Wojciechowski: So, the most common reason for discontinuing aromatase inhibitor therapy is basically joint pains or stiffness. This study took two groups of women: one group was put on a program of strength training twice a week plus 2.5 hours of aerobic exercise per week, and that could be split up into a different number of sessions.
Jamie DePolo: And that was at moderate intensity, too, just so people don’t think that these women were out running marathons. It was moderate. So, you know, brisk walking.
Dr. Brian Wojciechowski: Yes. You don’t have to be an iron man here. So, the other group was simply put on the usual care. They could exercise, they could not increase their exercise, it was basically up to them. When you follow the women who exercised over time, and the investigators knew that they exercised because they measured their weight loss, they lost an average of 3% of their body weight and they also increased their exercise capacity, they found out that with exercise the women had decreased pain scores by about 30%.
Jamie DePolo: That’s pretty incredible.
Dr. Brian Wojciechowski: It’s a big difference. So, by going on a regular exercise program, a woman could decrease her chance of having joint pains by 30%, which is a huge difference.
Jamie DePolo: Oh yeah. That’s amazing. And the effect lasted, too, right? That’s another thing I thought was interesting. I believe when the research was presented it said that it lasted over a year even though the exercise program in the study didn’t last the year.
Dr. Brian Wojciechowski: Right.
Jamie DePolo: So that’s pretty cool.
Dr. Brian Wojciechowski: Yeah, it’s a durable effect.
Jamie DePolo: I’m excited about that.
Dr. Brian Wojciechowski: It’s really important. Like we said, I can’t say this enough, 30% of women stopping the aromatase inhibitor therapy is too high. We should not accept that as doctors and patients. We need to do whatever we can to be proactive, to look at a woman from a holistic perspective, encourage her to exercise, address those symptoms early on in the game before we start therapy, and then that way we’re going to save more lives.
Jamie DePolo: That’s great. And I’ll also point out, too, the researchers weren’t sure if it was a particular type of exercise. Somebody asked a question afterwards, you know, "Do you know if it was the strength training or was it the aerobic training that offered the benefits?" And they didn’t really separate it out. Somebody else who asked a question about, "Do you think yoga would help?" Yoga was not part of this program, but the researchers seemed to think that that would be helpful as well, just anything to get moving.
Dr. Brian Wojciechowski: I think so, and there was sort of a dose response effect. What I mean by that is that the more exercise you did, the better your pain tolerance seemed to become. So I feel like anything that you can do is better. Even older women with other medical problems that would prevent them from, say, getting on a treadmill can go to the gym and get into the pool if that’s available. I’ve even seen exercise machines at the gym where you put your hands on these grips and turn it like a little bike…a hand bike. So, these are the kinds of things that I’m suggesting to my patients.
Jamie DePolo: Just get out and move. Whatever you can do at whatever level is comfortable for you, because any amount is going to help.
Dr. Brian Wojciechowski: Exactly.
Jamie DePolo: Okay. Well, that’s awesome. And then our fourth study about aromatase inhibitors, as I said it was aromatase inhibitor day here in San Antonio, I thought this was also very interesting, as well. It goes into why don’t more women complete the whole 5 years of aromatase inhibitors. This study looked at, was there an effect of the aromatase inhibitors becoming generic, which, obviously, generic in everybody’s mind usually means lower cost. And they found out that there was a pretty big effect, right?
Dr. Brian Wojciechowski: Yeah, and in a sense it is a little bit of a common sense kind of thing. The medicine costs more money, you pay more out of pocket for it, you’re going to be less likely to take it. But it is nice to have this confirmed with a scientific study, because that gives us more ammunition to go after policymakers and providers, insurance companies, governments, and what-not in order to convince them that yes, we need to help women more, we need more assistance with co-pays, we need to lower out-of-pocket costs, because it really does affect ability to stay on these medications.
Jamie DePolo: It was a pretty striking difference. I don’t remember all the numbers, but I know, now that it’s a generic… I believe the co-pay for a generic AI is $9, and the co-pay for a brand name aromatase inhibitor is $33. So that’s a pretty big difference.
Dr. Brian Wojciechowski: Yes, and it can make a real difference for someone with fixed income.
Jamie DePolo: Yeah. Definitely. Okay. So, our last study, which was actually the last study we saw today, the last one we’re going to talk about today is about bisphosphonates. Bisphosphonates are medicines that are used to lower the risk of bone loss in people, right? Am I saying this right?
Dr. Brian Wojciechowski: Yeah. Classically, what we’ve used bisphosphonates for is to prevent fractures in people with osteoporosis. So, that’s very severe bone loss. And then eventually we learned that, in women with metastatic breast cancer who have disease that has spread to their bones, giving these medicines, these bisphosphonates, prevents what we call skeletal-related events. That’s a fracture, that’s a pathologic fracture, from cancer of the bone.
Jamie DePolo: Okay. So it’s basically breaking the bone due to have cancer in the bone.
Dr. Brian Wojciechowski: Exactly.
Jamie DePolo: And there have been a lot of studies on bisphosphonates because that was discovered, then people thought, well, can we use bisphosphonates to help treat? Because there seems to be this relationship between breast cancer spreading to the bone, and can we use bisphosphonates to maybe prevent that, or lower the risk of that? You can’t prevent anything 100%. And the results were mixed. So that’s why this study was so exciting, because this one study looked at all the other studies that have been done. And before I ask Brian to explain it, I just wanted to also tell everybody that when we talk about bisphosphonates, we’re talking about a brand name Boniva, which is ibandronate, and zoledronic acid, which is also known as Reclast or Zometa, and then clodronate, if I’m saying that right, which is Bonefos, right? Those are all the different types.
Dr. Brian Wojciechowski: Yeah. Those are the ones that were actually studied.
Jamie DePolo: And those are the ones, too, they’re injected. They’re not the ones that are taken daily or weekly as a pill.
Dr. Brian Wojciechowski: Correct. We have no data for the ones that are taken weekly as a pill.
Jamie DePolo: Okay. So why are we excited about this study?
Dr. Brian Wojciechowski: Well, this is a very long story, and the first studies go back to 1998. We’ve been waiting 15 years for an answer to this question. The patients in this study were patients who had non-metastatic disease. So it was cancer that was confined to the breast, or to the lymph nodes around the breast. Patients, basically, who we're treating for a cure. These patients would have had surgery and possibly hormone therapy and possibly radiation, and even chemotherapy, okay. So this was a very large study. The study was a type of study called a meta-analysis, which is the highest level of research. It combines a bunch of other studies into one large pool, and we can analyze the data. When we do this, when we combine all these studies together, that gives us the greatest level of assurance that what we’re finding is true. Okay. So this is the top of the pyramid in terms of study design. What the study showed was that women who received the bisphosphonate treatment along with the usual treatment for breast cancer had a lower risk of recurrence and a lower risk of dying from breast cancer. Not all the women, though.
Jamie DePolo: It was just a particular group.
Dr. Brian Wojciechowski: That’s right. The effect was only seen in the women who were postmenopausal, either by age or by virtue of being rendered postmenopausal by a suppression of the ovaries by medication. The common thread there is that these women had very low levels of estrogen.
Jamie DePolo: That seems to be what it takes to get this to be beneficial.
Dr. Brian Wojciechowski: That’s what you need to see the benefit, a low-estrogen state. Okay. And the difference was pretty profound. Like you said, some of the studies in the past had shown a difference. Some showed no difference. But the benefit in terms of recurrence was about 3%. So, if you had 100 women and you treated all of them with bisphosphonates, you’re basically saving three of them out of 100 from recurrence.
Jamie DePolo: That’s pretty good.
Dr. Brian Wojciechowski: It’s pretty good, actually. You’re basically treating 33 women to save one from recurrence. And that’s about the same size as the benefit from, say, chemotherapy. If you like chemo, you like bisphosphonates.
Jamie DePolo: It is the same benefits.
Dr. Brian Wojciechowski: Yes.
Jamie DePolo: That’s great. And again, we want to emphasize this was for postmenopausal women. They were the ones that saw the benefit.
Dr. Brian Wojciechowski: Exactly. A low-estrogen environment. I would not use it in a woman who was premenopausal, okay, who did not have her ovaries suppressed.
Jamie DePolo: Okay. We were talking a little bit about this while this study was being presented. There was a question, if a woman were diagnosed when she was premenopausal, became postmenopausal during treatment, if she was on some sort of hormonal therapy, then would you start her on the bisphosphonate? The study really didn’t look at that group of women so we can’t really be sure about that.
Dr. Brian Wojciechowski: That’s correct. We really don’t have the data for that. And bisphosphonates are not without side effects. So I wouldn’t want to necessarily subject a woman to that treatment if I wasn’t 100% sure that she would benefit. I think it would be up for discussion, I could talk to my patients about it and say, "Here is the risk and benefit, here’s the level of certainty," and we would make a decision together.
Jamie DePolo: Okay, and what are some of the side effects of bisphosphonates?
Dr. Brian Wojciechowski: One of the main side effects that does get a lot of attention is called osteonecrosis of the jaw. It’s a big word, yeah. It’s basically death of the bone around a decaying tooth. It’s really not an issue if you have good teeth. It’s not an issue if you have no teeth. But it’s really people with poor dentition, we say, a lot of disease in their teeth, then it becomes a problem.
Jamie DePolo: A lot of gum disease, a lot of cavities.
Dr. Brian Wojciechowski: Yeah. So whenever I put a woman on this treatment, I always make sure she’s seeing a dentist first.
Jamie DePolo: Okay, that makes sense. Are there other side effects, or is that really the big one?
Dr. Brian Wojciechowski: That’s really the big one that we worry about. The other side effect is sometimes it can cause kidney damage. So, very, very rarely someone will need kidney dialysis, maybe even permanently, but that’s very, very rare in breast cancer patients. So, for the most part, it’s safe, but the side effects, when you see them, can be quite profound.
Jamie DePolo: Now for this study, too, do you think this is going to be practice-changing?
Dr. Brian Wojciechowski: I think it will be. Bearing in mind that this is a study presented at a conference and it still has to go through the peer-reviewing publication process. But my prediction is that it will be the new standard of care within about a year.
Jamie DePolo: Okay. So if we see postmenopausal women diagnosed with hormone-receptor-positive cancer, it’s likely that they’re going to be taking some form of hormonal therapy plus a bisphosphonate. Is that right?
Dr. Brian Wojciechowski: That’s correct.
Jamie DePolo: Okay. That sounds very good, because as you said, it’s a pretty significant decrease in the risk of recurrence, as well as the risk of dying from breast cancer. Those are two good things, we want to reduce both of those risks. Okay. I think those were the big studies today, we thank everybody for listening, and we will be back again tomorrow with more from the San Antonio Breast Cancer Symposium. Again, I’m Jamie DePolo, I’m the senior editor at Breastcancer.org, and explaining this research to us has been Dr. Brian Wojciechowski, Breastcancer.org’s medical advisor. And, again, thanks everybody for listening.