Verzenio Side Effects: What Patients Are Reporting
Matthew Goetz, M.D.
December 4, 2018

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Matthew Goetz, M.D., professor of oncology at the Mayo Clinic where he is also co-leader of the Women's Cancer Program and chair of the Breast Cancer Disease-Oriented Group, discusses the research he presented at the 2018 San Antonio Breast Cancer Symposium on patient-reported outcomes from women being treated with Verzenio (chemical name: abemaciclib) plus an aromatase inhibitor as the first treatment for advanced-stage, hormone-receptor-positive, HER2-negative breast cancer.

Listen to the podcast to hear Dr. Goetz talk about:

  • what patient-reported outcomes are and why they're important for both doctors and patients
  • the Verzenio side effects reported in the study
  • how diarrhea caused by Verzenio can be proactively managed so a woman doesn't have to plan her life around a side effect

Running time: 9:31

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This podcast is made possible by the generous support of Lilly Oncology.

Jamie DePolo: Hello everyone, I’m Jamie DePolo, senior editor at Breastcancer.org. We’re podcasting all this week from the 2018 San Antonio Breast Cancer Symposium.

My guest for this podcast is Dr. Matthew Goetz, professor of oncology at the Mayo Clinic, where he is also co-leader of the women’s cancer program and chair of the breast cancer disease oriented group. His research looked at patient-reported outcomes on Verzenio plus an aromatase inhibitor as the first treatment for hormone-receptor-positive, HER2-negative, advanced-stage disease. Dr. Goetz, welcome to the podcast!

Matthew Goetz: Thank you.

Jamie DePolo: So first — just in case some of our listeners aren’t sure, when we talk about patient-reported outcomes — can you explain what they are and why they’re important for both researchers and patients?

Matthew Goetz: Patient-reported outcomes are something that has evolved over the last 10 or 15 years. Of course, when we study any drug, from a research standpoint, we are not only interested in how is that drug performing in terms of, for example, inducing response, improving survival, but also how does that drug impact side effects? In the past, the way that side effects have been reported and standardized, from a National Cancer Institute standpoint, is through something that is referred to as the common toxicity criteria or, if you will, a very granular grade 1, 2, 3, and 4. So, for example, if a patient had a low neutrophil count, we would be able to use a particular grade and say, "Well, that was a grade 3 or a grade 4," and a physician would know exactly what that meant. What we realized, however, is that when we started discussing patient symptoms, for example something like a hot flash, it was very difficult to classify a hot flash as a grade 1, 2, or 3, and we needed to actually develop tools that would better represent exactly the types and severity of the symptoms patients were having. Thus, over the course of the last 10 or 15 years, there's been these tools that have been developed that try to, with much more precision, allow us to be able to assess what these symptoms are, how patients are reporting them, and then to be able to assess, as we treat with drugs, do they get better or do they get worse?

Jamie DePolo: In your study, can you describe some of the side effects that the women reported?

Matthew Goetz: Sure. If we think about CDK4/6 inhibitors in general, one of the predominant side effects that has been seen of course is neutropenia, and neutropenia is just simply a low white blood cell count, or low neutrophil count. With the drug abemaciclib, also called Verzenio, one thing that we know is that the neutropenia rates are much lower, so we don’t see neutropenia as often, it tends not to be as severe. But a unique side effect that is seen with abemaciclib is diarrhea, and the diarrhea probably occurs in 70-80% of patients, so almost all patients have some diarrhea, and in a minority of patients, the diarrhea can be more problematic. So if we think about the CDK4/6 inhibitors, diarrhea is really, if you will, a unique side effect to abemaciclib.

Jamie DePolo: Are women on Verzenio, are they given a proactive antidiarrhea medicine, and in your study, did that seem to help?

Matthew Goetz: Yes, the experience with the drug has evolved. When the drug was first being studied, it was sort of a reactive. We’ll use something like an antidiarrheal or an Immodium only if you developed diarrhea, but as time has gone on we've realized that it’s probably best to actually proactively treat with the antidiarrheals or to actually be ready to use them at the first sign of diarrhea. What I often tell my patients is to use the antidiarrheals from the start, and if they’re not having any problems we can easily back off. It’s probably better to do it that way than, perhaps, to try to catch up and then to be dealing with the side effect of diarrhea.

Jamie DePolo: That makes great sense. To be, I guess, really realistic and get into all the details, we talk about Verzenio and it’s said that the diarrhea is predictable and manageable, which is great if you’re a doctor and you know what that means. But if I’m a person taking it, do I have to stay home for 2 hours? Can I go grocery shopping? Do I have to stay home for 2 days? Is it okay to go to work? What do you tell your patients when they ask about that?

Matthew Goetz: So that’s a really good question. As I think about my patients who have been treated with the drug, my experience is that in most patients, it is predictable and tolerable. What that means is that using antidiarrheals can essentially prevent the diarrhea completely. Every once in a while I'll run into a patient where the diarrhea is such that they require either a dose reduction of the drug, or, for example, we have to move from one antidiarrheal to another — in other words, try to use a different medication to control the diarrhea. So I think that with any drug, as you think about the gradation of side effects, we can say, in general, the diarrhea is predictable and is treatable. It’s a little bit like — I like to use the analogy with nausea with chemotherapy drugs — in most cases, it is predictable and it is preventable, but every once in a while we have patients who break through, and for those patients we try to have a strategy available by which we can escalate the antidiarrheals, so that patients are not faced with what you just talked about — "Gee, I have to stay at home because I am on the drug." I think the summary is that, in general, it’s well-tolerated and it’s preventable, but every once in a while we have patients where we have to escalate in terms of the antidiarrheals.

Jamie DePolo: So if I’m understanding you correctly, then, if a woman is taking Verzenio and she’s being treated with antidiarrheal medicines, then — in most cases, obviously, as you said there are some people that it's more severe — she doesn’t really have to worry. She doesn’t have to plan her day around managing diarrhea.

Matthew Goetz: Yeah, I think that would be the majority patients. And then I could think of, in my practice, I have — again probably the exception, less than 20% of patients — where, because of the diarrhea, we've had to reduce the dose. Often times reducing the dose is always of concern to physicians and patients because the thought is, "Well, if I reduce the dose, the efficacy is going to be altered or diminished." The good news is that the studies that have looked specifically at this, this question of reducing the dose, that that didn’t seem to alter efficacy. The outcomes of patients were not any worse if they required a dose reduction. So I think the message I would say to patients is that, if we do need to reduce the dose, we should do it and that can improve quality of life. Early data suggest it’s not impacting long-term outcomes at all for those patients.

Jamie DePolo: That’s very good to know. Were there any other quality-of-life issues that came out in your study? It seems like diarrhea was the number one, but were there others that were important?

Matthew Goetz: No, I think diarrhea is probably the predominant one. In general, I think when we think about these medications — I always like to tell my patients, if you start out and you have no symptoms from your cancer, it’s unlikely that I’m going to make your quality of life better by adding a drug. So these are patients where our goal is truly to preserve quality of life, and that’s where diarrhea can be an issue. So being very proactive and managing the diarrhea is ultimately our goal. There’s another group of patients, though, that perhaps are much more symptomatic because their cancer was causing symptoms — either bone pain or perhaps fatigue, because of the extent of the disease — and these are patients where we do believe that treatment in some way — if we're able to reduce the total amount of disease burden, the total amount of cancer -- that quality of life actually will be better.

Jamie DePolo: Thank you very much, Dr. Goetz. I appreciate your time.

Matthew Goetz: Yep, you're welcome.

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