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HR+, HER2- Early Breast Cancer

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High-Risk Features

High-Risk Patient ID

Clinical Trials

Adherence and Support

Medication Adherence and Patient Support

Standard of care: oral endocrine therapy

For patients with hormone receptor–positive (HR+) early breast cancer (EBC), oral endocrine therapies (ET) such as tamoxifen and aromatase inhibitors (AIs) are effective treatment options and the current standards of care for adjuvant therapy.1-4 Despite the clinical benefits of adjuvant therapy, only around half of patients with EBC are fully adherent to their oral adjuvant treatment within 5 years.5,6

The rate of filled tamoxifen prescriptions declined over time
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Medication adherence and persistence

Supporting patient adherence and persistence to their adjuvant therapy is important for the management of these patients.7,8 For patients with EBC, increases in adherence and persistence to adjuvant therapy were associated with a decrease in all-cause mortality.9


Medication adherence is “the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen”


Start medication or observation

Adherence: Percentage of doses taken as prescribed

Stop medication or end observation

Medication persistence is “the duration of time from initiation to discontinuation of therapy”


Start medication or observation

Persistence: Days taking medication (without exceeding permissible gap)

Stop medication or end observation

Factors that influence medication adherence are multidimensional7,10
Understanding these factors can help facilitate the development of effective adherence interventions with the goal of improving patient outcomes.7
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Social and economic factors
  • Age
  • Financial status
  • Personal or clinical support
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Condition-related factors
  • Comorbidity burden
  • Disease stage
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Therapy-related factors
  • Tamoxifen use
  • Experience with adverse events and/or chemotherapy
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Healthcare team and system-related factors
  • Out-of-pocket costs
  • Hospitalizations
  • Personalized care plan
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Patient-related factors
  • Pre-existing depression
  • Belief in drug efficacy
  • Value in doctor’s opinion

Strategies to promote therapy adherence in patients with HR+ EBC

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As healthcare providers (HCPs), it is important to work with patients to promote treatment adherence. Strategies implemented in the clinic to ensure patients are taking their medication as scheduled are centered around open and honest communication between the healthcare team and patient.11-13 Methods used in the clinic to help increase medication adherence include shared decision-making, the SIMPLE strategy, motivational interviewing, and adopting evidence-based interventions to manage side effects.11-14

SIMPLE strategy

The SIMPLE strategy is a summary of methodologically proven, adherence-enhancing strategies that can be applied to patient care. Below are some examples of adherence-enhancing strategies12:


The SIMPLE strategy to improve adherence
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The first treatment cycle

The first treatment cycle is a vital stage of the treatment journey, during which HCPs establish patient-provider trust and effective communication.
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  • During the first treatment cycle, it is essential to see your patients frequently and help manage adverse events and dose adjustments as needed.
  • The initial treatment cycle helps establish trust for the subsequent cycles and for the rest of their treatment journey.15
Doctor discussing risk of recurrence with a patient

As HCPs, it is important to ensure adjuvant therapy adherence by building a trusting relationship and promoting a consistent dialogue between the healthcare team and patient. Allowing the patient to understand they are part of the journey and ensuring open lines of communication during the initial treatment cycle will also build trust so that the rest of the patient journey can be as smooth as possible.15

Related Resources

Downloadable PDFs

Download PDF Medical Answer PDF Document Created with Sketch. INFOGRAPHIC: Survivorship Care for Patients with High-Risk EBC
Download PDF Medical Answer PDF Document Created with Sketch. INFOGRAPHIC: High-Risk, HR+/HER2- EBC: Treatment Adherence
Download PDF Medical Answer PDF Document Created with Sketch. INFOGRAPHIC: High-Risk EBC: Supporting Patients Throughout Their Treatment Journey
Download PDF Medical Answer PDF Document Created with Sketch. INFOGRAPHIC: Practical Management of Patients with High-Risk HR+,HER2- EBC


The Challenge of Adherence
Over the years, one of the things that I've learned is that your patient is not always going to adhere to what you're telling them to do, whether it is for radiation, whether it is for surgery, whether it is for the oral medications that you give them. And I think we need to, as physicians, understand why that this particular problem arises in the clinic. And the challenge is to be able to not only identify the reasons for it, but to also be able to overcome those barriers. I think the first and foremost challenge that we have and that we need to be able to understand is, communication between the physician or the healthcare provider and the patient. And if that is poor, everything disintegrates from there on. It's important that the physician communicates adequately to the patient, the basis of their disease, and also makes sure that the patient's actually understanding what that disease is that they have.
01:13
They need to be able to understand the benefits of therapy, and of course the benefits of using their medications appropriately and properly. And communication is key. Building that relationship between the healthcare physician as well as the patient is vital, and it's the most important barrier that you need to overcome. So the whole concept of adherence and persistence in my mind can be summarized by the fact that you need to have all three components, that's the patient, the provider, and the healthcare system communicating with each other to overcome this very, very important problem. Because, if you want drugs to work, you have to actually take them. Drugs will simply not work if you're not taking them. So communication and connection between these three components are vital.

The Challenge of Adherence & Persistence

Dr. Dawood highlights the challenges of patient adherence and provides insights on how she works with patients to identify and overcome any barriers.


Individualizing Therapy: Setting the Patient Up for Success
So when I'm sitting in the clinic and I see a patient for the first time, I know I'm going to be taking a long journey with that patient. And so we need to first realize that as physicians, that right from the very beginning, you have to individualize therapy plan. And I think the first and foremost question that we as physicians ask ourselves is how do we identify a patient who is at higher risk for that particular tumor, or in this case breast cancer? And what is their risk of perhaps poor adhesion and persistence? And I've talked about barriers before, but I think you need to actually think about these various components when you are actually taking your patient through that journey. Medication-specific factors, illness-specific factors, patient-specific factors. And I think patient-specific factors is something we should not forget as physicians, where is your patient coming from? Ethnicity makes an issue. Cultural barriers are an issue as well, and you need to be able to address that right from the very beginning.
01:26
How do I manage this in my clinic? Again, establishing a relationship with your patient. Positive beliefs and views on medications are also so important. I have a patient currently in my clinic that will not take any oral medication no matter what you do. And you have to be able to circumvent that and actually talk to your patient as to why do they have these beliefs? Is there a way that we could potentially overcome that barrier? So understanding those key beliefs of your patient is also very, very important. So how do I motivate my patient? Like I said, it's not only motivating your patients, sometimes it's motivating the family members that are with your patient, because they can help in that decision making process. They can help your patient sometimes who doesn't believe what you are saying, but the family members are believing what you're saying.
02:20
To take them through that journey and say, "Trust your physician, take the medication, work together so that we can make a therapy plan that's best for you." Identifying risks are also I think something that we can't negate. Risk in terms of what is going to benefit patients, what is not going to benefit your patient. So when I'm in my clinic, and I have my patient for the first time, I think the three points that I would take away from this conversation is, you need to be able to individualize plan of care for your patient. It's not just a one stop shop thing, it's a journey that you take your patients through. And remember, it's a shared decision making process, not only with your patient, but the members of the family of the patient. And developing that relationship with your patient is key, and you're not going to be able to develop it on one sitting. It's that journey that you take your patient through that's going to develop your relationship.

Individualizing Therapy: Setting the Patient Up For Success

Dr. Dawood shares how she identifies, manages, and motivates patients who are at higher risk of poor adherence and persistence.


The Importance of Getting the First Cycle Right
As a physician I've learned that that first treatment is probably the most important treatment that you're going to give your patient, because if you can get it right, your patient's going to trust you enough to take them through that journey. Now if you're going to get it right, it's important to get the dose right, and if you're going to get the dose right, it's important that you see your patients more frequently. And what I've learned is in that first cycle of therapy, be it oral medications for chemotherapy, or IV medications for chemotherapy, see your patients frequently during that period of the first cycle. And if you have to stop treatment during that first cycle, it's fine because you haven't gotten it right yet. You're still individualizing therapeutic plan for your particular patient. So if you need to stop, you need to take a step back, allow the patient to recover, allow them to understand that it's okay to take a little bit of a break and then get back into it, that's fine as well. So each patient has that journey that you need to take with them.
01:13
But this is a short-term journey. The first cycle. I think that first cycle allows you to be able to establish your relationship for the subsequent cycles. But patients may also have questions about the fact that if they didn't have side effects or adverse events during that first cycle, could it potentially happen in subsequent cycles? And you need to have that conversation that it may potentially happen, but at the same time we're there for them, we can help them through that journey. And if there's a lot of communication back and forth that will help them in terms of being able to handle those side effects. The shared decision making process is vital. Allowing your patient to understand that they are part of the journey with you, and making sure that they have open lines of communication during that first cycle so that they can bring about effectively communicating with you the side effects, the potential fears that they have during that first cycle so you can help them through that cycle appropriately so that the rest of the journey is as smooth as possible.

The Importance of Getting the First Cycle Right

Dr. Dawood discusses how getting the first treatment cycle right establishes trust with the patient through the rest of their treatment journey.


Managing Adherence and Persistence in the Clinic
The way I look at persistence and adherence to medications, I think I would look at it in two aspects. You have persistent adherence to medication early on, and you have persistent adherence to medications that you're giving your patient long-term, where some patients actually can fall off the bandwagon in terms of taking their treatment long-term. So you need to be able to have established an appropriate relationship with your patient, and your patient will then tell you why is it that they're not adhering or persisting with their medications.
00:47
I have a patient that I've been giving some oral medications for the past couple of years, and she was really, really good at taking that medication over the first couple of years. But by the time it was the third year, I noticed because my pharmacist called me up and said that this patient hasn't been picking up her medication. So I called her in, I had the discussion, and I asked her, "Why is it, after all these years, you're not taking the medication?" And one of the key elements here was I think she forgot the importance of taking that medication, that it was reducing the risk of her disease coming back. And this patient had early-stage disease.
01:25
So it's sometimes very easy for patients to become complacent, they think they're doing well, which they are doing well because they're taking that medication, and it's sometimes important to reiterate. It may not be the only reason why they're not taking the medication, but I personally believe that the reasons why they don't take their medication early on versus later is something that you need to be able to define appropriately because I think that they're very different.
01:50
I also think that it's important that you incorporate various healthcare professionals in your team to be able to follow up with your patient. Nurses, nurse practitioners, sometimes the hospitalists, even the fellows that are in training with you, they can call up patients, they can talk to patients. Sometimes a patient may not feel that they can come and tell you that they're not taking the medication because they've been with you throughout the entire journey, and they don't want to make you feel that they've let you down in any way, shape, or form. So sometimes having just someone different ask them that question can give you the information that you're looking for.
02:25
So a simple strategy, always simplify the regimen characteristics to your patient. Let them know that it's easy to take the medication. It's not as difficult as it may seem. Make sure that you are imparting the correct knowledge to your patient at different time points. Understand your patient's beliefs. See if you can modify it to allow them to be able to take the medications appropriately. Make sure that you're having appropriate communication, not only with a patient but also their family members. Because like I said before, culture does make a difference. And there are some cultures where family members probably have a more important role to play in patient adherence and persistence more than what the physician will have in that role.

Managing Adherence & Persistence in Clinic

Dr. Dawood summarizes her top advice for managing adherence and persistence throughout the treatment cycle with patients in the clinic, including reiterating the benefits of treatment and coordination with the multidisciplinary care team.


Managing Fatigue to Maintain Quality of Life
As a medical oncologist, one of the most important lessons that I've learned over the years, is that fatigue is a very important component of therapy in patients with any type of cancer. Now we have a lot of scientific evidence that tells us how to negate or how to improve fatigue in our patients. But the first thing that I do when I'm taking my patient through that journey and that first cycle of therapy, I will tell them that it is vital that they incorporate exercise within their normal daily activity, because that's what's going to prevent or reduce fatigue from happening. We need to be able to assess for fatigue regularly. And every time a patient comes to my clinic, I will ask them, are you getting tired? How are you doing your normal daily activities? Are you going to work regularly? Have you reduced the number of hours that you're working?
01:10
Are you doing more home-based working? And if needed, if my patient is still getting fatigued, despite the exercise regimen that I will put them on, do I need to modify medication dosing or the way I'm actually giving it to try and reduce the fatigue, because at the end of the day, you don't want to negatively impact the quality of life, and fatigue is something that will negatively impact the quality of life. I actually tell my patients, please do at least 30 minutes of exercise every day. It could be walking, it could be running. I've given tips such as using little weights around their wrists or around their ankles as a little bit that they can do every day in their normal daily activities, which improves fatigue. Yoga is good for something that I actually encourage my patients to do. 15 minutes of yoga every day is something that we regularly recommend for our patients.
02:04
And if you need to taper up that exercise routine, we tell our patients five to 10 minutes of exercise every day, and increasing it by gradual increments of one minute every day, is something that they could potentially do easily at home. And again, I get my physiotherapist, I get my nursing staff to actually call up my patients to actually find out if they're exercising every day or not. So we're monitoring them in the clinic, we're monitoring them at home, so they know that they need to exercise daily. So I think fatigue is a very, very important component that you should not forget to assess in the clinic. It's a vital component where you tell your patients to exercise, because if they're not fatigued, their impact on their quality of life is not as bad in terms of medications. And of course, if you're not fatigued, you're more likely to take your medications to begin with.

Managing Fatigue to Maintain Quality of Life

Fatigue is a very important side effect of cancer therapy. Dr. Dawood shares how she counsels patients to manage fatigue, how to assess fatigue and modify treatment as needed.

References

  1. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet. 2005;365(9472):1687-1717.
  2. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet. 2015;386(10001):1341-1352.
  3. Burstein HJ, et al. J Clin Oncol. 2019;37(5):423-438.
  4. Burstein HJ, et al. Ann Oncol. 2021;32(10):1216-1235.
  5. Partridge AH, et al. J Clin Oncol. 2003;21(4):602-606.
  6. Hershman DL, et al. J Clin Oncol. 2010;28(27):4120-4128.
  7. Paranjpe R, et al. Breast Cancer Res Treat. 2019;174(2):297-305.
  8. Cramer JA, et al. Value Health. 2008;11(1):44-47.
  9. Hershman DL, et al. Breast Cancer Res Treat. 2011;126(2):529-537.
  10. Yussof I, et al. Breast. 2022;62:22-35.
  11. Elwyn G, et al. J Gen Intern Med. 2012;27(10):1361-1367.
  12. Atreja A, et al. MedGenMed. 2005;7(1):4.
  13. Salvo MC and Cannon-Breland ML. J Am Pharm Assoc (2003). 2015;55(4):e354-e363.
  14. Franzoi MA, et al. Lancet Oncol. 2021;22(7):e303-e313.
  15. Dawood S. The importance of getting the first cycle right. Lilly Medical Education website. Published February 14, 2023. Accessed May 25, 2023. medical.lilly.com/us/diseases/ebc-patient-support

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